Should i take plan b with food: Emergency Contraception – “Morning After Pill”
Emergency Contraception – “Morning After Pill”
Emergency contraception provides an important safety net when you have sexual intercourse and no contraception is used or the contraception used is compromised (missed birth control pills, missed Depo injection, condom slips/breaks, etc.).
Emergency contraception pills are hormone-containing pills taken to give you a burst of hormonal contraception, which will likely prevent ovulation, fertilization, and/or implantation. Emergency contraception will not harm an already existing pregnancy.
You should take the emergency contraception pill as soon as possible; up to 120 hours (5 days) after unprotected sex.
Emergency contraception pills are free to all Yale students and Yale Health members when acquired at the Yale Health Center.
Emergency Contraception Pills
- My Way (Plan B – levonorgestrel) is available over-the-counter, without a prescription.
- Ella (ulipristal) is available by prescription from a provider in Student Health, OB/GYN or Acute Care.
(See Emergency Contraception Comparison Chart and/or contact the Yale Health Ob/Gyn Department if you’re not sure which option is best for you.)
Where to Get Emergency Contraception at the Yale Health Center
(free for all Yale students, and all Yale Health members)
- Yale Health Pharmacy (either going to the Pharmacy directly, or after consulting with a provider in one of our clinical departments)
- Acute Care
Other Locations (purchase price varies)
- Commercial pharmacies, like CVS, Walgreens, etc.
Emergency contraception pills reduce the risk of pregnancy by approximately 75%. In other words, out of 100 women who have unprotected intercourse mid-cycle, approximately 8 would become pregnant. With use of emergency contraception pills, only 2 of the 100 would become pregnant.
- My Way becomes less effective if used 3-5 days after unprotected sex, while Ella’s effectiveness stays the same for the full 5 days.
- Both medications are less effective for obese women. My Way retains its effectiveness up to a BMI of 30. Ella is effective up to a BMI of 35.
- My Way is less effective when unprotected sex occurs closer to the time of ovulation. Ella is more effective than My Way closer to ovulation.
Side Effects of Emergency Contraception Pills
The most common side effect is nausea, with or without vomiting. There are ways to decrease this if you become nauseous easily. Take the pill with food. You may elect to take prescription or over-the-counter anti-nausea medications about 30 minutes prior to the first dose of an emergency contraception pill.
In 1997, the Food and Drug Administration reviewed the evidence and concluded that emergency contraception pills are safe and effective. In 2006, the FDA approved the sale of Plan B/My Way over the counter (OTC).
If you happen to already be pregnant and take emergency contraception, the hormones in emergency contraception pills have been shown not to affect the baby.
Important Note: Emergency contraception should not be used as your primary method of birth control. It is much less effective than methods designed for continuous protection from pregnancy. If you pick up 4 or more emergency contraception pill doses in a year, the Yale Health Pharmacy will notify the Ob/Gyn Department, so they can reach out to discuss better options for preventing pregnancy.
Taking the Medication
A Yale Health nurse or pharmacist will give you a dose of My Way, or you may have a provider prescribe Ella for you.
The treatment consists of one pill. If your provider recommends an antinausea medication, take it first. Wait 30 minutes to one hour and then take the emergency contraception pill. It is helpful to take the pill with food, and not on an empty stomach.
Your period may start a few days earlier or a few days later than expected. If it does not start within a week of when expected, you should come in for a pregnancy test and/or evaluation.
If you have not started your period within 3 weeks from the date of using emergency contraception, you should come in for a pregnancy test and/or evaluation. If you feel pregnant sooner, you should do a pregnancy test at that time.
Reasons Not to Take Emergency Contraception
Emergency contraception pills might not be a good option for you if you have a history of allergy to the medication, if you are significantly overweight, or if the unprotected sex occurred more than 120 hours earlier. There are no known medical conditions for which emergency contraception is unsafe.
Remember, even if it’s been more than 120 hours, and the episode occurred at mid-cycle, the chances of becoming pregnant are still low (less than 10%).
The Paragard copper-containing IUD, if inserted within 5 days (120 hours), provides over 99% effective emergency contraception, plus ongoing effective contraception for up to 10-12 years. It is inserted with a minor office procedure in the Ob/Gyn Department. You can make an appointment via MyChart or by calling 203-432-0222.
If barrier contraception (condom) wasn’t used, or if it failed, you should consider the chance that you’ve been exposed to a sexually-transmitted infection (STI). You should discuss this further with a nurse or provider.
If the sex was unprotected because it was nonconsensual (for example, sexual assault or date rape), please talk to one of our caregivers to learn about the resources available to you at Yale, including The Share Center.
Plan B FAQs | Plan B One-Step®
Plan B FAQs | Plan B One-Step®
- What is Plan B?
Plan B One‑Step is progestin‑only emergency contraception that helps prevent pregnancy before it starts when taken within 72 hours after unprotected sex.
Plan B is a backup method of preventing pregnancy and should not be used as regular birth control. Use as directed.
- How effective is Plan B?
Plan B can significantly decrease the chance that you get pregnant. When used as directed, about 7 out of every 8 women who could have gotten pregnant did not become pregnant after taking Plan B.
- Does Plan B work for women with a BMI over 25?
We hold the same belief as the FDA, which states that there are no safety concerns that preclude the use of levonorgestrel emergency contraceptives in women generally, and continue to believe that all women, regardless of how much they weigh, can use these products to prevent unintended pregnancy following unprotected sex or contraceptive failure. The most important factor affecting how well emergency contraception works is how quickly it is taken. When emergency contraception is taken as directed within 72 hours after unprotected sex or birth control failure, it can significantly decrease the chance that a woman will get pregnant. In fact, the earlier the product is taken after unprotected intercourse, the better it works. Emergency contraception is not 100% effective, which is why it is critical that women have a “Plan A” (regular) birth control method or start one if they don’t have one. If you have any further questions, we encourage you to talk to your healthcare provider.
- How does Plan B work?
Plan B helps prevent pregnancy by temporarily delaying ovulation. That is, it works by stopping the release of an egg from the ovary, so there’s no egg to meet the sperm. No egg, no fertilization, no pregnancy.
- Will Plan B affect my fertility or ability to get pregnant in the future?
Plan B will not impact your ability to get pregnant in the future.
- What happens if I’m already pregnant and I take Plan B?
- Can I continue to take my regular birth control after taking Plan B?
Yes! Plan B does not impact the effectiveness of any regular birth control methods, so you can continue your regular birth control right away—or start one, if you don’t have a regular method.
- When should I use Plan B?
Plan B is emergency contraception you can take after:
- You didn’t use any form of birth control or had unprotected sex
- There was an issue with your regular birth control method (eg, the condom broke or slipped)
- You missed a dose (or more) of your regular birth control pill
Use the countdown calculator
- How soon after unprotected sex should I take Plan B?
- How do I take the Plan B pill / Can I take Plan B with food and/or water?
Plan B One‑Step is one pill that you place in your mouth and swallow, preferably with water. You can take Plan B with or without food. The most important thing to know about taking Plan B is that it must be taken within 72 hours (3 days) after unprotected sex to help prevent pregnancy before it starts. The sooner you take it, the better it works.
- Can I take Plan B if I’m breastfeeding?
Yes, you can use Plan B when you are breastfeeding. In general, no harmful effects of progestin‑only pills, like Plan B, have been found on breastfeeding performance or on the health, growth, or development of the infant. However, random cases of decreased (less) milk production in mothers have been reported.
- How often can I take Plan B? Is there a limit to how many times you can take Plan B in a year/lifetime?
Plan B emergency contraception should not be used as a regular method of birth control. However, if you have already used Plan B, it can be safely used again after another instance of unprotected sex or birth control failure. It will not affect a woman’s future fertility.
Plan B doesn’t provide long-term protection against future pregnancy—it works to help prevent pregnancy after only one act of unprotected sex or birth control failure.
- I had another incident of unprotected sex the day after taking Plan B. Am I still covered?
Plan B only stays in your body for a short amount of time. It doesn’t provide long‑term protection against future pregnancy; when taken as directed it works to help prevent pregnancy after only one incident of unprotected sex. If you are sexually active, even occasionally, see your healthcare professional or visit a family planning center/clinic to find a regular method of birth control that suits you.
Find a Family Planning Clinic
- When is it not appropriate to use Plan B?
Do not take Plan B:
- If you’re already pregnant, because it won’t work
- If you’re allergic to levonorgestrel or any of the ingredients in Plan B
- In place of regular birth control
- If you’re male
This product is not intended for use in postmenopausal women.
Use before the first menstrual period is not appropriate.
- What are the possible side effects of Plan B?
- Do certain medications affect how well Plan B works?
Examples of drugs or herbal products that could decrease the effectiveness of Plan B include barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate, and certain HIV/AIDS medications.
Contact your healthcare professional before taking Plan B if you have any concerns or are taking any of these medications.
- Do I need a prescription to get Plan B?
No. You can find Plan B yourself in the family planning aisle—no prescription or ID needed. There’s also no age requirement—anyone can buy it.
- Do any states have restrictions on buying Plan B?
No. Plan B is available for purchase in every state—no prescription or ID needed. There’s also no age requirement. Anyone can buy it.
- Where can I buy Plan B?
You can find Plan B yourself in the family planning aisle of all major retailers, including CVS, Walgreens, Rite Aid, Target, and Walmart. It’s also available at smaller pharmacies and some food stores around the country. Click here to find a store near you.
Prefer to order Plan B online? You can buy it directly from our site.
Remember, Plan B must be taken within 72 hours (3 days) after unprotected sex. If you need it right away, you can get it right off the shelf at the stores above.
- Can I buy Plan B online?
Yes. Plan B is available online here.
Remember, Plan B must be taken within 72 hours (3 days) after unprotected sex. If you need it right away, you can get it right off the shelf at local retailers. Wondering where Plan B is stocked in your area? Find a store near you.
- Is there any way to save on Plan B?
- How do I talk to my friend, family member, or partner about taking Plan B?
- What other resources can I turn to for information about Plan B and emergency contraception?
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Emergency Contraception Basics | Everyday Health
If you’ve recently had unprotected sex and know you do not want (or are not prepared) to have a baby, you need emergency contraception — quickly.
What Is Emergency Contraception?
If taken as soon as possible after unprotected sex, emergency contraception (EC) can be very effective in the case of a birth control fail, sexual assault or rape, or any other situation where you think you might be pregnant and don’t want to be.
Emergency contraception can help you prevent pregnancy. It comes in several forms:
- A progestin (levonorgestrel) pill, also known by the leading brand name Plan B One-Step
- A pill that contains ulipristal acetate, also known by the brand name ella.
- Higher than usual doses of combination oral contraceptive pills that have both estrogen and progestin
- The copper IUD, which once inserted into the uterus makes it hard for sperm to fertilize an egg
Which Emergency Contraception Method Is Right for You?
Different methods are more effective depending on a few variables, such as how long it has been since you had unprotected sex and your weight. To help figure out which form of emergency contraception is recommended for you, take this quiz from Planned Parenthood.
EC Is Backup, Not Primary, Birth Control
Remember, it’s crucial to find a reliable and consistent form of birth control to minimize the potential of an unplanned pregnancy. “You should not rely on EC pills as a long-term birth control method,” says Pari Ghodsi, MD, an obstetrician-gynecologist in Los Angeles and spokesperson for the nonprofit group Power to Decide, a campaign to prevent unplanned pregnancy. “They are a backup method, not a first-line birth control method.”
The 4 Different Types of Emergency Contraception
1. The Progestin Pill for Emergency Contraception
Also known as the “morning-after pill,” the progestin or levonorgestrel pill is often associated with its leading brand, Plan B One-Step. Generic brands include Take Action, My Way, Option 2, My Choice, AfterPill, and Next Choice One Dose, according to Planned Parenthood.
The progestin pill is a single pill that should be taken as soon as possible — within 72 hours of unprotected sex — and the sooner you take it, the better it works, according to the Plan B One-Step website.
The pill contains the hormone levonorgestrel, which is a progestin found in birth control pills and other forms of hormonal contraception that stops or delays ovulation to prevent pregnancy, says Dr. Ghodsi. Progestin is a synthetic version of progesterone, a natural hormone produced by a woman’s ovaries that plays a key role in pregnancy.
According to Planned Parenthood, levonorgestrel morning-after pills can lower your chance of getting pregnant by 75 to 89 percent if you take them within three days after unprotected sex.
Plan B side effects aren’t very common, but your next period may come earlier or later than expected, and be heavier, lighter, or more spotty, notes Planned Parenthood. You may get an upset stomach, feel lightheaded or dizzy, or have tender breasts for a short period of time. If you vomit within two hours of taking the pill, it will not be effective and you’ll need to take it again.
How to Get the Progestin Pill: No Prescription Needed
Plan B and similar pills are all available over the counter. “One of the challenges is that people are unaware that you do not need a prescription to obtain emergency contraception,” says Keosha T. Bond, EdD, an adjunct assistant professor of health behavior and community health at New York Medical College in Valhalla. “An individual may be discouraged from requesting emergency contraception because they think you have to be female and show ID. The truth is that you don’t have to be a woman or to have identification.”
The Progestin Pill: What Does It Cost?
Plan B usually costs about $40 to $50 nationwide, according to Planned Parenthood.
On the Plan B website, it costs $49.99 plus tax. Generic versions usually cost about $11 to $45.
If you have health insurance or Medicaid, it’s likely that you can get the progestin pill for free — but you’ll need to get a prescription from your doctor or healthcare provider so your health insurance will cover it (even though you don’t need a prescription to buy these types of pills over the counter).
You may also be able to get the morning-after pill for free or low cost from a Planned Parenthood health center, your local health department, or another family planning clinic.
The Progestin Pill: Where Can You Find It?
Plan B and other similar pills are available in the family planning aisle of many major pharmacy chains. In cases where it’s kept locked up or behind the counter, a pharmacist “should be able to provide it for you, but you may come across some pharmacists who may try to prevent you from getting it, because a lot of people are very judgmental,” says Dr. Bond. “They see it as an abortion pill, but it’s not. It prevents ovulation.”
Keep pushing for what you need, or ask to work with a different pharmacist in the store if you come across this kind of behavior. Or look on Bedsider’s Emergency Contraception Locator tool to find local clinics or physicians that can help you obtain emergency contraception in your area.
2. Ulipristal (ella) for Emergency Contraception
Ella is the brand name of a pill that contains ulipristal acetate, which delays or possibly prevents ovulation, according to Planned Parenthood.
Like with Plan B, you just take one pill. “When taken as directed, ulipristal is more effective in preventing pregnancy than progestin-only or combined emergency contraception pills,” Ghodsi says.
According to Planned Parenthood, ella reduces your chances of getting pregnant by 85 percent if you take it within five days of unprotected sex.
Ella works better than other EC pills for people who weigh 155 pounds or more. But if you weigh 195 pounds or more, ella may not be as effective.
Like with Plan B and similar pills, after you take ella, your next period may come earlier or later than expected, and be heavier, lighter, or more spotty, notes Planned Parenthood. It’s not common, but you may get an upset stomach. If you vomit within two hours of taking ella, it won’t be effective and you’ll need to take it again.
Where to Find It: Ella Requires a Prescription
According to Planned Parenthood, you need a prescription to get ella. Speak to a healthcare professional immediately if you want to use this option — they may be able to send a prescription right to your local pharmacy.
You can also get a prescription for ella online ($105) and have it shipped to you with next-day delivery. Or visit your local Planned Parenthood or another family planning or health clinic.
Depending on which state you live in, you may be able to get a prescription for ella directly from your pharmacist.
Ella usually costs about $50 at a pharmacy or drugstore, according to Planned Parenthood, but it might be free if you have health insurance or Medicaid.
You may also be able to get ella for free or low cost from a Planned Parenthood health center, your local health department, or another family planning clinic.
3. Combined Birth Control Pills for Emergency Contraception
Known as the Yuzpe method, it’s not the preferred method of EC, because it causes more side effects and is less effective than other methods. It also must be done under the supervision of a physician. (The number of pills you would take depends on the brand of birth control that you have.)
The Yuzpe method is thought to be about 75 percent effective at preventing pregnancy, and it’s best used within three days of having unprotected sex.
Nausea and vomiting are common with high doses of birth control pills, notes the Cleveland Clinic.
Combined Birth Control Pills: Where Can You Find Them?
This may be a good option if you have a prescription already and easy access to a supply. But “do not try to do this on your own,” says Ghodsi. “You need to know the specific amount to take.” Talk to a reproductive healthcare provider or a pharmacist about how many pills to take if you are already on this kind of birth control method and you have it on hand, because “the number of pills needed to use as emergency contraception differs for each brand of pill,” she says.
4. Copper IUD (Paragard) for Emergency Contraception
The Paragard nonhormonal IUD (also called the copper IUD) is a small piece of flexible plastic shaped like a T that has copper wrapped around it.
The device, which makes sperm less likely to fertilize an egg, can be used as a regular form of birth control or as a form of emergency contraception. According to Planned Parenthood, if you have one inserted within five days of having unprotected sex, it’s more than 99.9 percent effective against pregnancy and then provides very reliable contraception for up to 10 years.
“The IUD is the most effective EC method in preventing pregnancy,” says Ghodsi. It can then be left in and used for long-term birth control, or removed at any time if you want to try to get pregnant.
Copper IUDs can make your periods heavier and cause cramping, especially in the first three to six months, adds Planned Parenthood. You may also have some cramps when you first get your IUD, but these side effects often improve over time.
Copper IUD (Paragard): Where to Find It
To use the copper IUD as EC, you will need a healthcare provider to insert the device into your uterus.
To get an appointment, call your doctor or health clinic as soon as possible.
If you weigh 155 pounds or more, the copper IUD or ella is a better emergency contraception option for you than other forms, notes Planned Parenthood.
Emergency Contraception Recommendations to Consider
If you are overweight or obese, emergency contraceptive pills may be less effective, although they may still work and they’re not harmful. You may want to speak with a physician about whether you should choose a copper IUD instead, because “copper IUDs are effective in women of any weight,” Ghodsi says.
Also, if you choose to use pills for EC, it’s essential to use reliable contraception for the remainder of your cycle, because in many cases, ovulation is simply delayed, not prevented altogether. Therefore, pregnancy could still occur in that cycle if you have unprotected sex after using EC pills.
Embrace the Power of Emergency Contraception
Some people think there’s a stigma associated with using Plan B or another form of emergency contraception, as if using it means you’re not being responsible, says Bond. “That’s not the case at all. I don’t think having access to Plan B increases a person’s nonuse of other methods. Condoms break, and Plan B may be your best bet for preventing pregnancy.”
Also, if you’re using a form of EC, “you are being responsible by taking the next step to prevent pregnancy,” adds Bond. “If you are not ready to have a baby, I think it’s a very responsible decision to use emergency contraception.”
Emergency Contraceptive Pill (Plan B)
What is it?
The emergency contraceptive pill, or “morning after pill”, is used to prevent or reduce the chance of an unplanned pregnancy after unprotected sex. There are different brands of this pill but the brand offered at the health unit is Plan B. Plan B contains a high dose of the hormone progestin (Levonorgestrel).
Examples of unprotected sex:
- No birth control used (hormonal method or condom)
- Birth control failure such as missed pills, patch fell off, forgot to replace Nuvaring, late for Depo injection, etc.
- Condom broke, leaked, slipped off, or not used at all
- IUD/IUS came out
How to take this medication:
Plan B is a pill that can be taken with water. This medication is most effective if used within 24 hours after unprotected sex, but can be used within 5 days after unprotected sex. Effectiveness of Plan B decreases the longer you wait to take it.
A nurse will take your blood pressure before giving you the medication.
Tell your health care provider if you vomit within 2 hours of taking Plan B. Another dose may be needed.
Do NOT take this medication if you:
Are allergic to Levonorgestrel or had an allergic reaction to Plan B in the past.
Are pregnant or suspect you are pregnant.
Have abnormal bleeding from your vagina.
Have active liver disease.
Have or suspect you have breast cancer.
Tell your health care provider if you:
Have high blood pressure.
Experience headaches or migraines.
Are taking any medications (see “Drug Interactions” section below).
Plan B may be less effective in people with a body mass index (BMI) of 25–29 and not likely effective if BMI is 30 or higher. A nurse can help you figure out your BMI.
Contact your health care provider right away if you experience any of the below symptoms:
- Itching and rash
- Cramping or severe pain in your stomach or belly before you get your next period (warning sign of ectopic pregnancy)
- Heavy bleeding from your vagina that isn’t your period
Plan B may cause some side effects. These usually pass within 24 hours of taking Plan B. Common side effects are listed below. If any of the below symptoms last longer than 48 hours or are severe, contact your health care provider.
- Abdominal pain
- Breast tenderness
- Migraine or severe headache
- Lower belly pain
- Painful menstruation
- Discharge from vagina
The following medications can make Plan B less effective:
- Anti-HIV drugs
- St. John’s wort
- Ulipristal acetate
This medication should be kept at room temperature and in dry conditions. Do not allow medication to freeze. Keep out of reach and sight of children.
Points to remember:
You may experience spotting a few days after taking Plan B. Your next period should come on time but may be a few days early or late. If your period is over 1 week late, talk to your health care provider about a pregnancy test and to discuss your options.
You should use a different form of birth control or not have sex until your period returns. Unprotected sex that happens after taking Plan B can still result in a pregnancy.
Plan B should not be used on a regular basis as a form of birth control.
Taking Plan B within 3 days of having a Pap test may affect your results.
Plan B does not provide protection from sexually transmitted infections.
FDA’s Decision Regarding Plan B: Questions and Answers
Please see Questions and Answers, August 24, 2006
1. What is emergency contraception?
Emergency contraception is a method of preventing pregnancy to be used after a contraceptive fails or after unprotected sex. It is not for routine use. Drugs used for this purpose are called emergency contraceptive pills, post-coital pills, or morning after pills. Emergency contraceptives contain the hormones estrogen and progestin (levonorgestrel), either separately or in combination. FDA has approved two products for prescription use for emergency contraception – Preven (approved in 1998) and Plan B (approved in 1999).
2. What is Plan B?
Plan B is emergency contraception, a backup method to birth control. It is in the form of two levonorgestrel pills (0.75 mg in each pill) that are taken by mouth after unprotected sex. Levonorgestrel is a synthetic hormone used in birth control pills for over 35 years. Plan B can reduce a woman’s risk of pregnancy when taken as directed if she has had unprotected sex. Plan B contains only progestin, levonorgestrel, a synthetic hormone used in birth control pills for over 35 years. It is currently available only by prescription
3. How does Plan B work?
Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.
4. What steps did FDA take in considering switching Plan B from prescription to nonprescription (over-the-counter (OTC)) status?
FDA received an application to switch Plan B from prescription to nonprescription status. FDA staff reviewed the scientific data contained in the application which included among other data, an actual use study and a label comprehension study.
On December 16, 2003, we held a public advisory committee meeting with a panel of medical and scientific experts from outside the federal government. The members of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health, met jointly to consider the safety and effectiveness data of nonprescription use of Plan B. Although the joint committee recommended to FDA that this product be sold without a prescription, some members of the committee, including the Chair, raised questions concerning whether the actual use data were generalizable to the overall population of nonprescription users, chiefly because of inadequate sampling of younger age groups.
Following the advisory committee meeting, FDA requested additional information from the sponsor pertaining to adolescent use. The sponsor submitted this additional information to FDA in support of their pending application to change Plan B from a prescription to an over-the-counter product. This additional information was extensive enough to qualify as a major amendment to the NDA. Under the terms of the Prescription Drug User Fee Act (PDUFA) performance goals, major amendments such as this may trigger a 90-day extension of the original PDUFA deadline.
Now FDA has completed its review of the supplemental application and concluded that the application could not be approved at this time because 1) adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and 2) a proposal from the sponsor to change the requested indication to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for a full review. Therefore, FDA concluded that the application was not approvable.
5. Why didn’t FDA follow the recommendation of the Advisory Committees?
The recommendations of FDA advisory committees are advisory in nature and the Agency is not bound to follow their recommendations. FDA makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.
6. Why did FDA issue a Not Approvable letter?
The agency issued a Not Approvable letter because the supplemental application did not meet the criteria for approval in that it did not demonstrate that Plan B could be used safely by young adolescent women for emergency contraception without the professional supervision of a licensed practitioner. The issuance of a Not Approvable letter does not mean that a supplemental application cannot be approved. The Not Approvable letter describes what the applicant would need to do to obtain approval for the supplemental application. In this case, the applicant would have to either provide additional data demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug or provide additional support for the revised indication to allow for marketing Plan B as prescription-only for women under the age of 16 and as nonprescription for women 16 years of age and older. Not Approvable Letter.
7. Was there a difference of opinion within the Center for Drug Evaluation (CDER) and Research regarding the final decision?
Yes, there was a difference of opinion within CDER. The scientific interchange of ideas is widely encouraged during the review process to ensure a thorough vetting of the issues. However, ultimately, a final decision must be made based on the evaluation of the data, taking into account all of the views expressed.
8. Is this FDA’s final decision regarding the availability of Plan B for OTC use?
No. The Not Approvable letter to the sponsor outlines what the sponsor must do to obtain approval of the supplemental application.
Wide availability of safe and effective contraceptives is important to public health. We look forward to working with the sponsor if they decide to pursue making this product available without a prescription.
9. Oral contraceptives have been used for four decades, and this product has been approved and used safely since 1999. How could FDA turn it down?
Oral contraceptives as a class of drugs are only available by prescription. This product has been used safely by prescription only and for the reasons already stated, it is not being made available for OTC use at this time.
10. The sponsor has talked about making the product over-the-counter for young women over a certain age and behind-the-counter for younger girls. Is there evidence to support such a scheme? Does FDA have the authority to carry it out?
The sponsor has submitted a plan and the FDA is examining its regulatory authority to approve a product marketed in this manner.
11. Did the FDA bow to political pressure in making this decision?
No. This decision was made within the Center for Drug Evaluation and Research.
12. Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?
No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director.
What You Should Know About the Morning-After Pill – Cleveland Clinic
You probably think of emergency contraception as the “morning-after pill,” but that’s actually a bit of a misnomer. There are different kinds of emergency contraception that a woman can use as many as five days after unprotected sex, and some of them aren’t actually pills.
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Ob/Gyns don’t recommend using emergency contraception as a
primary form of birth control, but in an unexpected or emergency situation,
there are options.
Ob/Gyn Diedre McIntosh, MD, addresses some common and important questions.
Q: What are options for emergency contraception?
A: There are currently four available methods:
- Levonorgestrel (Plan B One-Step ® and generics). These pills contain a synthetic hormone called progestin and are available over-the-counter. They prevent pregnancy by delaying the release of the egg from the ovary to prevent fertilization. They will not work if you are already pregnant.
- Ulipristal acetate (ella®). This medication also suppresses or delays ovulation but is only available by prescription. It will not work if you are already pregnant.
- Copper-releasing IUD. Once it’s placed in the uterus by a healthcare professional, it offers additional pregnancy protection for as long as you keep it in, up to 10 years.
- Yuzpe regimen. This method calls for a woman to take multiple birth control pills that total 100 mcg of estrogen and 1 mg of progesterone twice in a 12-hour period. It is the least effective method of emergency contraceptive, and will not work if you are already pregnant.
Q: How long can you wait to take the morning-after pill?
A: It’s ideal to take Plan B One-Step® within 72 hours (that’s three days) of having unprotected sex. You can take it up to five days after, but there’s a higher failure rate the longer you wait. Ella® can be taken up to five days later without a drop-off in effectiveness.
The copper IUD can also be placed up to seven days later. The Yuzpe method is best used within three days of unprotected sex.
Q: How does the copper IUD work as an emergency contraceptive?
A: It’s the most effective form of emergency contraceptive. It causes an inflammatory reaction in the uterus, so it creates an unfavorable environment for sperm and for implantation to occur.
The one big difference
with the IUD is that it could disrupt a good pregnancy. If a woman is considering
a copper IUD and has had abnormal periods, she should make sure to do a
pregnancy test first.
Q: Can the morning-after pill make you spot?
A: Yes. Emergency contraceptive pills tends to delay ovulation, so you might have a delay in your regular menstrual cycle and have irregular bleeding for that first month afterward.
Q: Can the morning-after pill make your period late?
A: Yes, you might find that your period is pushed back one or two days.
Q: Does the morning-after pill make you sick?
A: It can make people nauseous, but most people tolerate it pretty well. If you vomit within an hour of taking it, contact a healthcare professional.
Q: Can you take the morning-after pill twice in one month?
A: You can take it more than once a month, but we do not recommend using it as a main form of birth control – not only because of the cost but because you will have irregular cycles.
Additionally, with the pills there’s a higher failure rate the greater your BMI. So for women with a BMI over 30, those medications will be less likely to be effective.
Your Ob/Gyn can help you find the most appropriate
contraceptive option for you.
Does Plan B Always Work? Morning-After Pill Q&A with Experts
Anna Targonskaya, MD — Obstetrician-Gynecologist, Medical Advisor
Emergency contraception can stop you from getting pregnant if you’ve had unprotected sex or your birth control method didn’t work. But you may wonder, how effective is Plan B, really? Does it always work? For this Flo article, we asked experts all about the morning-after pill and whether you can still get pregnant after taking Plan B. Let’s dive in!
90,000 What if your parents climb into life and decide everything for you?
Parental control, inability to make decisions, low self-esteem, need for approval. Sound familiar? If so, chances are good that you are dependent on your parents. Together with the psychologist Elena Novoselova, we figured out what separation is, how to set boundaries with your parents and how to understand that they are manipulating you.
Psychologist, member of the Russian Psychotherapeutic League, presenter on the Silver Rain channel, author of books
What is separation and where does dependence on parents come from?
Separation is the separation of oneself from one’s parents and the willingness to take responsibility for one’s life.A grown-up child needs to fill his bumps, do what he wants, and not what his parents want. Economic, psychological, physical separation usually occurs in a complex. If a person has not materially separated from the parental home, then there will be no separation at the psychological level either.
Such a departure from the family is not about scandals and a break in relations. This happens in a balanced way, with a good warm conversation about how you grew up and want to go into your life, while still loving your parents. But if a person leaves, but the umbilical cord is not cut and mom calls 25 times a day, demands a report, a key to the apartment and can call in without warning, then this is already a conflict situation . And it arose not at the moment of separation, but much earlier.
It all depends on the position of the mother. If she appoints the child as the main person in her life, its meaning, then a dependent relationship, a maternal complex, arises. The little man is appointed responsible for mom’s mood, happiness, for her living every day.And he has to overcome this complex.
The problem with maternal power in Russia is very serious, our mother is sacred, because we are in the field of Christian culture, where everything comes from the holiness of the mother [and parents in general]. We grow up with the feeling that mom needs to be loved, whatever it is, mom needs to obey.
At what age does separation from parents occur?
Getting out of adolescence is the best time to break up. For some it happens earlier, for some later.It is now generally accepted that girls at 24 years old, boys at 25 years old ends adolescence, but this is at the level of physiology. A person can mature for an independent life at both 18 and 20, it all depends on the life story.
What happens if you do not separate in time?
Then the person begins to live according to the standards of the previous generation. This will inevitably cause a huge number of problems. There will be unpleasant situations associated with the fact that the mother’s baby is always with her, and he / she is already 40 years old.In this case, you will hardly be able to create your own life.
Take, for example, a man, he is 30, he has a girlfriend. While their relationship is at the stage of the candy-bouquet period, mom is happy, they go to visit her, she meets them with pies. Exactly until the moment when he is going to marry, then this girl becomes the most unpleasant in the world, because she claims to be a precious son.
If a person is separated from his parents, then the relationship with them becomes a hundred times better.Then true love begins without fear and duty. And if the separation did not take place, this is an eternal teenage rebellion.
How to build personal boundaries with parents?
The first thing to do is think about who you are and what you want. And then calmly sit down and talk with your parents. Explain that you are an independent, adult person and understand their anxiety, but if they continue to patronize you, you will not be happier about it. And offer a plan for their further participation in your life.
How not to quarrel with your parents?
There is no need to be afraid of quarrels. There are two types of conflict: hidden and open. In situations where the other side, for their own reasons, does not want to understand that the child already has a life of his own, and still sees the baby in an adult, one must go into conflict, otherwise there is no way.
In general, the concern about separation is not childish, it is just the children who have to solve it. You will feel guilty because the feeling of guilt and the feeling that you should be a good child is instilled from childhood.
But respecting and loving parents does not mean obeying and living by their rules.
It is important to understand clearly that you cannot be responsible for the emotional part of your parents’ life. Mom is an adult, and the task of managing your emotions and bad mood is hers, not yours.
Sometimes one mother’s call is enough to ruin the day, and she may not say anything, just by intonation – these are the same manipulations as not calling, turning away, breaking some established rules.Let’s say you agreed to call me every evening, because you are worried about your mother’s health, and she does not answer the phone. You can’t find a place for yourself all evening or you go to her – there is no time for your life here. If all this is unpleasant for you, if it ruins your life, it is important to act and not be afraid of a quarrel.
“Do as your mother said”: who are the manipulators and can they be resisted
“Do as mom said”: who are the manipulators and can they be resisted
What to do if parents are constantly worried, call and forbid?
Prohibiting an adult is already impossible.Parents can express their negative emotions. They are always worried, from the moment the child is born, until the end of days. The task of parents to cope with this anxiety. But the easiest way to deal with it is to control the child, and not soothe anxiety in yourself.
It is important to acknowledge that parental anxiety is normal, but it is theirs, not yours. Tell them something from time to time, maybe as little as possible so that they don’t worry. It is not necessary to lay out all the subtleties of your life, excessive frankness is not needed .
If they call too often and try to control, I must say that it is unpleasant for you. Explain that if you do not pick up the phone, then you are busy and will call back when you are free, maybe the next day. It is important to break this chain of control. Talk about it and say: “I’m sorry, I love you very much, but this causes a lot of trouble.” At first, everything is at the level of negotiations.
What if your parents do not accept your partner?
If you believe that this person is valuable in your life, then your parents cannot influence your choice.If they press, scandal, say bad things, then you should stop communicating on this topic. These are personal boundaries.
It is important to remember that parents are not part of your new family and you have two ways: to separate so that they are happy, or to minimize their meeting with a partner, explaining that since they cannot create calm relationships in the family and cope with their emotions, then you will see each other on big holidays.
What if parents interfere with raising children?
Very often grandmothers consider grandchildren as their children.It is important to determine who the mother is here and who is responsible for these children. For how the grandmother will affect the child in childhood, the mother will have to answer in adulthood. It is necessary to negotiate and determine: I am your child, and these are already my children, then there will be demand not from you, but from me.
What if your parents decide who you are, where to study and what profession to choose?
When we talk about separation, we mean already adults, independent people. At the age of 16, this is still a child, and only a very talented person at that age knows who he wants to be, but there are few of them.And when a teenager says that he is dropping out of school to become the world champion in skateboard, and at the same time all his activities are limited to skating in the yard, then, of course, some kind of parental policy is needed here, because the person is clearly confused.
On the one hand, if no arguments helped, let him get confused, let him go to his skateboard. By the age of 25, he will regain consciousness and go to the institute he wants to go to. There is nothing wrong with allowing a person at the age of 16-17 to taste life and color.
On the other hand, when something is forbidden to him, it is also not so scary. He will unlearn, put his diploma on the table and go to make music. It doesn’t break anyone as much as it seems. But parents also need to remember that the child will not always be able to graduate from the university that they have chosen for him. You can lead a horse to a watering place, but you cannot force it to drink.
How do you know if your parent is manipulating you?
The first is a projection of a role on you. You didn’t talk to me like that, you didn’t call me, so I felt bad.The second is the demand for duty and such phrases as “you are ungrateful, I have devoted my whole life to you.” Although no one asked. And in general where the word “should” appears, there is no love, there is debt .
If you think deeply, who decides whether there will be a child or not? Parents. And it turns out from sexual pleasure: a man and a woman decided that they want to have sex and they will have a child. And then he becomes responsible for everything that happens to his parents.
The child did not ask to give him life and devote himself to him [so he does not owe anything].
How not to feel guilty?
Speech in such a situation is about emotional dependence, which was hung on a person. This dependency is formed by the parent. For example, young children are usually self-centered, they believe that everything depends on them. Therefore, if the mother is in a bad mood, the child will think that he is to blame. And what is to blame? How is it to blame? Why is it to blame? It is impossible to understand this at 5–8 years of age. It’s just a sense of guilt.From here, this very mother complex is laid. You are only to blame because mom wants to.
I have to sit down and figure it out: why do I feel guilty? It is better to write down the points of what you may be to blame. It turns out that nothing. If you do this kind of work, these feelings will pass. And if you are really to blame for something, call and apologize.
And one more time. Seven Top Tips for Successfully Separating from Parents
Separation goes well only when a person no longer depends financially on his parents and is able to support himself.Living on the money of mom and dad, it is impossible to separate from them.
Get a home
The same goes for housing. As soon as you have your own living space, for which you will pay on your own and where you will be a full-fledged owner, relations with your parents will begin to build in a different way.
Talk to your parents
It all starts with a dialogue.Explain to your parents that you are already an adult, independent person, that you want to live on your own and be responsible for yourself, tell about your future plans and how you are going to provide for yourself and how you see your relationship with your family in the future. In an ideal world, this should be enough for your parents to understand you.
Don’t tell your parents everything about yourself.
Parents are worried, this is normal.To make them less anxious, share some moments of your life with them, but do not go into details and leave something that may upset, scare, or anger them outside the parentheses. Excessive frankness can only harm.
Build personal boundaries
This is a subtle art that will have to be learned. You can’t push your parents away when they bother you, but immediately run to them as soon as you need help or money.Indicate that this is your life, do not pick up the phone if it is uncomfortable for you to speak, do not run to obey parental orders at the first command, warn them that if your choice in personal or professional life does not suit them, you will no longer discuss it with them.
Do not be afraid of conflicts
Many continue to obey their parents simply for fear of conflict. But there is no need to be afraid of them.Parents often manipulate the child, your task is to resist these manipulations and make it clear for yourself that you are a separate adult person who has the right to your life and your choice. And if mom and dad do not want to accept this, the conflict cannot be avoided.
Understand who you are and what you want
An adult must do this work on himself in order to become an independent, independent unit.Only by understanding who you are, what you want in life, and not your parents, what you love and what you don’t, will you be able to stand firmly on your feet and separate yourself from your family.
“She pulled her hair and screamed obscenities”: a monologue of a girl who survived domestic violence from her mother
“Pulling by the hair and screaming obscenities”: a monologue of a girl who survived domestic violence from her mother
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90,000 Russians can extend the New Year holidays due to omicron-strain
This will depend on whether the strain is causing severe disease.
An expert virologist allowed the extension of non-working days in January if the omicron causes a severe course of the coronavirus and medicine is overloaded.
URA.Ru was informed about this by a virologist, corresponding member of the Russian Academy of Sciences, head of the cell proliferation laboratory at the V.A. Engelhardt Pyotr Chumakov.
“Little is clear about the omicron strain. If it turns out that he still causes a severe form of the disease, then, I think, this ( extension of non-working days in January – approx.ed. ) is quite possible. There is no such thing yet. This will depend on the specific epidemiological situation. And then the authorities will make decisions based on the availability of free beds. The main factor is how well medicine copes with such an influx of patients. If there are problems with this, they will probably introduce them, ”said Pyotr Chumakov.
Immunologist-allergologist, doctor of the highest category, candidate of medical sciences Nadezhda Loginina stressed that the decision to introduce additional non-working days is primarily for the state.
“It’s not for me to decide, but there is a point in extending the vacation only when people observe the regime of self-isolation. If they do not comply with it, then it is better to give people the opportunity to work, ”the doctor said.
As reported, Vladimir Putin instructed regional authorities to approve local action plans to prevent the spread of the omicron strain of coronavirus infection by December 15. The due date is specified until December 15th. Responsible persons, in addition to the governors, were appointed the head of the Ministry of Health of Russia Mikhail Murashko and the head of Rospotrebnadzor Anna Popova.
In addition, Putin ordered the government to pay attention to the timely treatment of patients and the isolation of those in contact with them. The Cabinet of Ministers was also instructed to monitor the situation in potential foci of coronavirus infection.
The government was also instructed to form a stock of medical supplies, medicines, oxygen, personal protective equipment, the possibility of deploying additional beds, attracting ambulance vehicles and personnel.