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Deflazacort uses. Deflazacort: Uses, Dosage, and Side Effects of This Corticosteroid Medication

What is Deflazacort used for. How does Deflazacort work. What are the potential side effects of Deflazacort. How should Deflazacort be taken. What precautions should be considered when using Deflazacort. Why is a Steroid Treatment Card important for Deflazacort users. How does Deflazacort interact with other medications.

Содержание

Understanding Deflazacort: A Comprehensive Overview

Deflazacort is a powerful corticosteroid medication used to treat a wide range of inflammatory and autoimmune conditions. As a member of the corticosteroid family, it plays a crucial role in managing various diseases by suppressing the body’s immune response and reducing inflammation. But what exactly is Deflazacort, and how does it work in the body?

Deflazacort works by interfering with the release of certain chemicals in the body that cause inflammation. This mechanism of action makes it an effective treatment for numerous conditions, including autoimmune diseases, joint and muscle disorders, allergies, and even some types of cancer. Its versatility in addressing various health issues has made it a valuable tool in modern medicine.

Key Features of Deflazacort

  • Belongs to the corticosteroid class of medications
  • Available in tablet form
  • Used for both adults and children
  • Also known by the brand name Calcort®
  • Requires a prescription for use

Medical Conditions Treated with Deflazacort

Deflazacort’s anti-inflammatory and immunosuppressive properties make it suitable for treating a diverse array of medical conditions. Which specific ailments can benefit from Deflazacort treatment?

Autoimmune Diseases

Deflazacort is often prescribed for autoimmune conditions where the body’s immune system mistakenly attacks its own tissues. Some of these conditions include:

  • Systemic Lupus Erythematosus (SLE)
  • Autoimmune Hepatitis
  • Sarcoidosis

Joint and Muscle Disorders

Inflammatory conditions affecting joints and muscles can be effectively managed with Deflazacort. One of the most common applications in this category is:

  • Rheumatoid Arthritis

Respiratory Conditions

Deflazacort can help alleviate symptoms of certain respiratory conditions, such as:

  • Allergies
  • Asthma

Oncology

In some cases, Deflazacort is used as part of cancer treatment protocols. While not a primary cancer treatment, it can help manage certain symptoms or side effects associated with cancer therapies.

Proper Administration of Deflazacort

To ensure the effectiveness of Deflazacort and minimize potential side effects, it’s crucial to adhere to the prescribed dosage and administration guidelines. How should patients take Deflazacort for optimal results?

Dosage Guidelines

The appropriate dosage of Deflazacort varies depending on the condition being treated, the patient’s age, and other individual factors. For adults, the typical dose range is usually between ½ to 3 tablets daily, although higher doses may be prescribed in acute cases. Children may be given a different dosing schedule, sometimes on alternate days.

Administration Instructions

  1. Take Deflazacort in the morning with breakfast
  2. Swallow the tablet whole with a glass of water
  3. Follow your doctor’s instructions regarding the duration of treatment
  4. Do not stop taking Deflazacort suddenly without consulting your healthcare provider

Is it safe to miss a dose of Deflazacort? If you forget to take a dose at the usual time, take it as soon as you remember, along with some food. However, if it’s almost time for your next dose, skip the missed one and continue with your regular schedule. Never take a double dose to make up for a missed one.

Precautions and Considerations Before Taking Deflazacort

Before starting Deflazacort treatment, it’s essential to inform your healthcare provider about your medical history and any current conditions. What specific factors should be considered before initiating Deflazacort therapy?

Medical Conditions to Disclose

  • High blood pressure
  • Heart problems, including previous heart attacks
  • Liver or kidney issues
  • Diabetes or glaucoma (personal or family history)
  • Thyroid disorders
  • Osteoporosis
  • Epilepsy
  • Myasthenia gravis
  • Stomach ulcers or bowel disorders
  • Mental health conditions
  • Current or past infections, especially tuberculosis (TB)
  • History of blood clots

Special Populations

Certain groups require extra caution when using Deflazacort:

  • Pregnant or breastfeeding women
  • Individuals planning to receive vaccinations
  • Those with a history of allergic reactions to medications
  • Patients who have experienced muscle pain after taking steroid medications

The Importance of the Steroid Treatment Card

Patients prescribed Deflazacort for more than three weeks will receive a ‘Steroid Treatment Card’. Why is this card crucial, and what information does it contain?

The Steroid Treatment Card serves as an important medical identification tool. It informs healthcare providers about your steroid treatment, which can be critical in emergency situations or when undergoing other medical procedures. The card typically includes:

  • The fact that you are on steroid treatment
  • The specific steroid medication (Deflazacort)
  • Your current dosage
  • The duration of your treatment
  • The name of the prescribing physician

Always carry this card with you and ensure the information is kept up to date. Present it to healthcare providers, especially before undergoing any medical procedures, surgeries, or dental treatments.

Potential Side Effects and Complications of Deflazacort

While Deflazacort is an effective medication for many conditions, it can cause side effects, especially with long-term use or high doses. What are the potential adverse effects of Deflazacort, and how can they be managed?

Common Side Effects

  • Increased appetite and weight gain
  • Mood changes, including irritability or euphoria
  • Difficulty sleeping
  • Acne or skin changes
  • Increased susceptibility to infections
  • Muscle weakness
  • Increased blood pressure

Serious Side Effects

While less common, some serious side effects may occur and require immediate medical attention:

  • Signs of allergic reaction (rash, itching, swelling)
  • Severe mood or behavior changes
  • Vision problems
  • Unusual bruising or bleeding
  • Symptoms of stomach ulcers
  • Signs of infection (fever, persistent sore throat)

How can patients minimize the risk of side effects? Follow your doctor’s instructions carefully, attend regular check-ups, and report any unusual symptoms promptly. Long-term use of Deflazacort may require additional monitoring and potential adjustments to your treatment plan.

Drug Interactions and Deflazacort

Deflazacort can interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. What types of drug interactions should patients and healthcare providers be aware of?

Medications That May Interact with Deflazacort

  • Anticoagulants (blood thinners)
  • Diabetes medications
  • Certain antibiotics
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Antifungal medications
  • Some antiepileptic drugs
  • Medications that affect the immune system

To avoid potential complications, always inform your healthcare provider about all medications you’re taking, including over-the-counter drugs, herbal supplements, and vitamins. Your doctor may need to adjust dosages or monitor you more closely when combining Deflazacort with certain medications.

Long-Term Use and Discontinuation of Deflazacort

For many conditions, Deflazacort may be prescribed for extended periods. What considerations should be kept in mind for long-term use, and how should the medication be discontinued?

Long-Term Use Considerations

  • Regular monitoring of bone density
  • Potential need for calcium and vitamin D supplements
  • Periodic eye exams to check for glaucoma or cataracts
  • Monitoring of blood sugar levels, especially in diabetic patients
  • Vigilance for signs of adrenal suppression

Discontinuation Protocol

Abruptly stopping Deflazacort can lead to serious health issues. How should the medication be discontinued safely? Your healthcare provider will typically create a tapering schedule to gradually reduce your dose over time. This allows your body to adjust and resume normal hormone production. Never stop taking Deflazacort suddenly without medical supervision.

During the tapering process, you may experience some withdrawal symptoms, such as fatigue, body aches, or mood changes. These are usually temporary and should resolve as your body adjusts. Report any severe or persistent symptoms to your healthcare provider.

Special Considerations for Deflazacort Use in Children

Deflazacort is sometimes prescribed for children with certain medical conditions. What unique factors should be considered when using this medication in pediatric patients?

Growth and Development

Long-term use of corticosteroids like Deflazacort can potentially affect a child’s growth. How is this risk managed? Healthcare providers typically use the lowest effective dose for the shortest duration possible. Regular monitoring of the child’s growth and development is essential during treatment.

Dosing in Children

Pediatric dosing of Deflazacort may differ from adult dosing. Children are often prescribed doses on alternate days to minimize potential side effects while maintaining therapeutic benefits. The exact dosage will depend on the child’s age, weight, and the condition being treated.

Immunizations

Corticosteroids can affect the immune system’s response to vaccines. What precautions should be taken regarding immunizations in children on Deflazacort? Live vaccines should generally be avoided during treatment. Consult with your child’s healthcare provider about the appropriate timing of vaccinations in relation to Deflazacort therapy.

Deflazacort in Pregnancy and Breastfeeding

The use of Deflazacort during pregnancy and breastfeeding requires careful consideration. What should expectant or nursing mothers know about using this medication?

Pregnancy

While Deflazacort can be used during pregnancy if the benefits outweigh the risks, it’s crucial to discuss the potential impacts with your healthcare provider. Some considerations include:

  • Possible increased risk of cleft palate in the first trimester
  • Potential for low birth weight
  • Risk of adrenal suppression in the newborn

Breastfeeding

Deflazacort can pass into breast milk. Is it safe to breastfeed while taking this medication? While small amounts in breast milk are generally not harmful, discuss the risks and benefits with your healthcare provider. They may recommend monitoring the infant for any signs of adrenal suppression or other effects.

Managing Deflazacort Treatment During Illness or Surgery

Patients on long-term Deflazacort therapy may require special management during periods of illness or when undergoing surgery. What precautions should be taken in these situations?

Illness and Stress

During periods of illness or significant stress, the body’s demand for corticosteroids may increase. How should Deflazacort dosage be adjusted? Your healthcare provider may recommend temporarily increasing your dose to meet this increased demand. Never adjust your dose without medical guidance.

Surgery

If you’re scheduled for surgery, it’s crucial to inform your surgical team about your Deflazacort use. Why is this important? You may need a temporary increase in your steroid dose before and after surgery to prevent complications related to adrenal insufficiency. Always show your Steroid Treatment Card to healthcare providers in these situations.

Emergency Situations

In case of severe illness or injury, patients on long-term Deflazacort may require emergency corticosteroid treatment. Carrying your Steroid Treatment Card and wearing a medical alert bracelet can ensure proper management in unexpected situations.

Deflazacort is a potent medication that offers significant benefits for many patients with inflammatory and autoimmune conditions. However, its use requires careful management and regular monitoring to maximize benefits and minimize potential risks. Always follow your healthcare provider’s instructions closely and communicate any concerns or unusual symptoms promptly. With proper use and vigilance, Deflazacort can be an effective tool in managing a wide range of medical conditions, improving quality of life for many patients.

Deflazacort tablets. Deflazacort medicine at Patient

Deflazacort belongs to a class of medicines known as corticosteroids (more commonly called steroids).

Your pharmacist will give you a blue ‘Steroid Treatment Card’. Carry this with you at all times.

Take deflazacort with a drink of water at breakfast.

If you need any medical treatment, make sure the person treating you knows you are taking deflazacort. This is because your dose may need to be increased for a short while.

Deflazacort tablets
Calcort
In this article
  • About deflazacort
  • Before taking deflazacort
  • How to take deflazacort
  • Getting the most from your treatment
  • Can deflazacort cause problems?
  • How to store deflazacort
  • Important information about all medicines

About deflazacort

Type of medicineA corticosteroid medicine
Used forAllergic and inflammatory conditions in adults or children
Also calledCalcort®
Available asTablets

Deflazacort belongs to a group of medicines called corticosteroids. It is sometimes referred to simply as an oral steroid.

Corticosteroids like deflazacort are used to treat a wide variety of conditions. Some examples include autoimmune diseases (for example, systemic lupus erythematosus (SLE), autoimmune hepatitis, sarcoidosis), joint and muscle diseases (for example, rheumatoid arthritis), and allergies and asthma. They are also used in the treatment of some cancers.

Deflazacort works by interfering with the release of certain chemicals in your body which cause inflammation.

Before taking deflazacort

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking deflazacort it is important that your doctor knows:

  • If you have high blood pressure.
  • If you have had a heart attack, or if you have any other heart problems.
  • If you have any problems with the way your liver works, or if you have any problems with the way your kidneys work.
  • If you (or a close family member) have either diabetes or an eye condition called glaucoma.
  • If you have any of the following conditions: an underactive thyroid gland, ‘thinning’ of the bones (osteoporosis), epilepsy, a condition causing muscle weakness (called myasthenia gravis), a stomach ulcer, or a bowel disorder.
  • If you have ever had a mental health problem.
  • If you are pregnant or breastfeeding. (Oral steroids like deflazacort can be taken while you are expecting or breastfeeding; however, it is important that your doctor knows about the baby.)
  • If you have any kind of infection at the moment, or if you have ever had tuberculosis (TB).
  • If you have ever had an unwanted blood clot in an artery or a vein.
  • If you have recently had, or are about to have, any vaccinations.
  • If you are taking or using any other medicines. This includes any medicines which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to a medicine, or if you have ever developed muscle pain after taking a steroid medicine.

How to take deflazacort

  • Before starting the treatment, read the manufacturer’s printed information leaflet from inside the pack and any additional information you are given by your doctor. These will give you more information about deflazacort and will also provide you with a full list of side-effects which you could experience from taking it.
  • Your doctor or pharmacist will tell you how many tablets to take for each dose. For an adult, the dose range is usually from ½-3 tablets daily, although it may be higher than this if you are acutely unwell. Take your dose in the morning during breakfast. Swallow the tablet with a drink of water. Children are sometimes prescribed a dose to take on alternate days only.
  • If you forget to take a dose at your usual time, take it as soon as you remember (with something to eat). If you do not remember until the following day, leave out the missed dose. Do not take two doses together to make up for a forgotten dose.
  • Continue to take deflazacort until your doctor tells you to stop. Stopping taking the tablets suddenly can cause problems so your doctor will want you to reduce your dose gradually over a period of time if/when this becomes necessary.

Getting the most from your treatment

  • If your course of treatment is due to last more than three weeks, you will be given a ‘Steroid Treatment Card’ which says that you are on steroids and contains some important advice for you. It is important that you read this card and carry it with you at all times. It also contains details about your dose, how long you have been taking deflazacort for, and who prescribed it for you. Please make sure that this information is kept up to date. If you are having an operation or dental treatment or any treatment for an injury, tell the person carrying out the treatment that you are taking deflazacort and show them your treatment card. This is because your dose may need adjusting.
  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. Your doctor will want you to have tests from time to time to make sure you remain free from some of the unwanted side-effects of treatment.
  • Deflazacort can suppress your immune system, so it is important if you become ill that you make an appointment to see your doctor straightaway. Also, if you come into contact with anyone who has measles, shingles or chickenpox (or anyone who suspects they might have them), you must see your doctor as soon as possible.
  • Some vaccines are not suitable for you while you are being treated with deflazacort. If you need any immunisations, make sure you mention that you are taking an oral steroid.
  • If you buy any medicines, check with your pharmacist that they are suitable to take with deflazacort. This is particularly important if you take a medicine for indigestion (such as an antacid), as indigestion remedies should not be taken during the two hours before you take deflazacort, or for two hours afterwards. This is because antacids interfere with the way deflazacort is absorbed by your body, making it less effective.

Can deflazacort cause problems?

Along with its useful effects, deflazacort can cause unwanted side-effects which your doctor will discuss with you. The benefits of taking an oral steroid usually outweigh the side-effects; however, they can sometimes be troublesome. The table below contains some of the most common ones associated with deflazacort. The best place to find a full list of the side-effects which can be associated with your medicine, is from the manufacturer’s printed information leaflet supplied with the medicine. Alternatively, you can find an example of a manufacturer’s information leaflet in the reference section below.

Although not everyone experiences side-effects, and some will improve as your body adjusts to the new medicine, speak with your doctor or pharmacist if you become concerned about any of the following:

Common deflazacort side-effectsWhat can I do if I experience this?
Tummy (abdominal) pain, indigestion, feeling sick (nausea)Stick to simple foods. If you are sick (vomit) and there is blood present, you must speak with your doctor straightaway
Muscle weakness or feeling tiredDo not drive and do not use tools or machines while affected
Mood or behavioural changes, especially at the beginning of treatmentIf you become confused, or irritable, or start having worrying thoughts about harming yourself, speak with your doctor straightaway
Difficulties sleeping, headache, increased weight, and irregular periods in womenIf any of these become troublesome, speak with your doctor
Increased risk of getting an infectionIf you become ill, make an appointment to see your doctor straightaway
Long-term treatment with deflazacort may cause other unwanted effectsIf you have any symptoms which are causing you concern, you should arrange to see your doctor for advice

Important: you should let your doctor know if you start to experience blurred vision or other vision problems whilst taking deflazacort.

For more information about side-effects which are possible when deflazacort is taken long-term, see the separate leaflet called Oral Steroids.

How to store deflazacort

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

  • Manufacturer’s PIL, Calcort® 6 mg tablets; Neon Healthcare Ltd, The electronic Medicines Compendium. Dated August 2022.

  • Medicines Complete BNF 85th Edition; British Medical Association and Royal Pharmaceutical Society of Great Britain, London.

Deflazacort: View Uses, Side Effects and Medicines

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Information about Deflazacort

Deflazacort Uses

Deflazacort is used in the treatment of Inflammatory conditions, Autoimmune conditions and cancer.

How Deflazacort works

Deflazacort is a corticosteroid. It increases the level of glucocorticoid in the body and works by decreasing the formation of substances that cause inflammation and suppresses immunity to stop self damage to the body by the immune system (auto-immune reactions occurring in organ transplants or cancer).

Common side effects of Deflazacort

Increased appetite, Weight gain, Abdominal pain, Mood changes, Cushingoid syndrome, Excessive hair growth on face, Central obesity, Polyuria, Constipation, Irritability, Fever, Back pain, Erythema (skin redness), Rash, Nausea, Nosebleeds, Stretch marks

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Available Medicine for Deflazacort

DFZIpca Laboratories Ltd

₹15 to ₹4127 variant(s)

Expert advice for Deflazacort

  • Deflazacort helps treat inflammation, severe allergies, flare-ups of ongoing illnesses, and many other medical problems that require either reduction of inflammation or suppression of the immune system.

  • Do not use it more often or for longer than advised by your doctor.
  • Take it with food to avoid an upset stomach.

  • Deflazacort can make it harder for you to fight off infections. Notify your doctor if you have any signs of infection such as a fever or sore throat.

  • Side effects such as mood changes or stomach problems can happen when you start taking Deflazacort. Inform your doctor if this bothers you.
  • Do not stop taking Deflazacort suddenly without talking to your doctor first as it may worsen your symptoms.

Frequently asked questions for Deflazacort

Deflazacort

Q. Is Deflazacort a steroid?

Yes, Deflazacort is a steroid medicine also known as glucocorticoids which occur naturally in the body. These glucocorticoids help to maintain health and wellbeing. Deflazacort increases the corticosteroids levels in the body which helps in treating various illnesses involving inflammation (redness, tenderness, heat and swelling).

Q. What is Deflazacort used for?

Deflazacort has anti-inflammatory and immunosuppressant properties. It is used for treating conditions like allergy diseases, anaphylaxis, asthma, rheumatoid arthritis, inflammatory skin diseases and autoimmune diseases (these diseases happen when your body’s immune system attacks the body itself and causes damage). The medicine also helps transplant patients as it suppresses the immune system so that the body does not reject the organ.

Q. How does Deflazacort work?

Deflazacort is a steroid medicine also known as glucocorticoids which occur naturally in the body. The medicine works by reducing the inflammation which helps in treating many illnesses caused due to active inflammation. Also, it stops the reactions known as autoimmune reactions which occur when your body’s immune system attacks the body itself and causes damage.

Q. Is Deflazacort better than Prednisone?

Clinical studies have shown that Deflazacort has a similar effect as that of prednisone. Moreover, Deflazacort is better tolerated when used in the treatment of inflammatory conditions. However, consult your doctor for the right treatment of your condition.

Q. Is Deflazacort a painkiller?

No, Deflazacort is not a painkiller. It belongs to the class of medicines known as steroids.

Q. Can I take Deflazacort with Tamsulosin?

Yes, Deflazacort can be taken with Tamsulosin. No harmful effects or any other interactions have been reported when they are used together.

Deflazacort instructions – Search for drugs

INSTRUCTIONS
for the use of the drug

Deflazacort

90 003 Form of release

Tablets

Pharmacological properties

Deflazacort – corticosteroid, hormonal
drug that stops muscular dystrophy. Active substance –
a derivative of prednisone with comparable immunosuppressive and
anti-inflammatory effect. The drug, like any other corticosteroid, does not
has an analgesic effect, but it affects the very cause of the pain
– inflammation. By reducing inflammation, Deflazacort indirectly
also has an analgesic effect, since discomfort in the affected
areas decrease or disappear altogether. The drugs in this group are prescribed in
in cases where non-steroidal drugs were ineffective.

Indications

Deflazacort
may be needed to treat Duchenne muscular dystrophy – hereditary
severe pathology causing muscle weakness of varying degrees, and almost
always occurring in boys. The drug is recommended for the treatment of children not
under 5 years old.

Also medicine
effectively used against:

  • Crohn’s disease.
  • Pemphigus.
  • Anaphylaxis.
  • Lymphatic leukemia.
  • Pediatric gangrenosis.
  • Acute interstitial nephritis.
  • Choking.
  • Hemolytic anemia of autoimmune origin.
  • Rheumatoid arthritis.
  • Ulcerative colitis.
  • Bullous pemphigoid (a chronic autoimmune skin disease).
  • Severe hypersensitivity reactions.

Contraindications

Contraindications for use are:

  • Allergy to the main active ingredient.
  • Presence of severely controlled infections.

In addition, you cannot use Deflazacort
long courses if the patient was diagnosed with:

  • Osteoporosis.
  • Glaucoma.
  • Mental pathology.
  • Ulcer.
  • Hypertension.
  • Severe kidney disease.
  • Tuberculosis.
  • Viral infection.
  • Pregnancy.

Dosage and Administration

Follow all
recommendations of the attending physician. Eating food does not affect absorption
drug. If you cannot swallow the tablet whole, crush it and mix
in a spoonful of applesauce. Swallow the mixture immediately without chewing. Don’t Save
it for future use.

Recommended dosages:

  • Adults – prescribe therapy with 0.9 mg/kg of body weight. In the future, gradually increase to 3-18 mg / kg / day. In emergencies, a high dosage is used – up to 120 mg / day.
  • Children – depending on the characteristics of the clinical picture, prescribe 0.25 mg-1.5 mg / kg.

Side effects

Taking
Deflazacort should be prepared for the possible appearance of:

  • urticaria;
  • difficult breathing;
  • swelling of the face/throat;
  • fever;
  • sore throat;
  • burning sensation in the eyes;
  • soreness of the skin.

Storage conditions

At a temperature not exceeding 25°C. Store
out of the reach of children.

Expiry date

Use
Deflazacort is available for 5 years from the date of issue.

First drug for Duchenne muscular dystrophy approved in the USA – Vademecum magazine

Olga Chesnokova

Pharmaceutical industry

February 13, 2017, 11:41 AM

Photo: businesswire.com

10395

The high cost of the drug in the company was explained by the costs of research and development.

In a number of other countries, Emflaza has been on the market since the 90s. In particular, it is approved for use in Canada, Great Britain, Spain, Brazil, Panama, Bangladesh and Honduras. The cost of a course of this drug in the UK is $1,600, in Canada its cost may soon drop to $1 per tablet. Prior to FDA approval, patients self-imported deflazacort from other countries for many years, but this has been banned in the US since the drug was approved. Thus, for patients, the cost of the drug after approval will increase by 6,000%.

Deflazacort is a corticosteroid drug that reduces inflammation and also suppresses the immune system (immunosuppressive effect). Clinical studies of the drug showed positive results in 196 patients aged 5 to 15 years. Already on the 12th week after taking the drug, the functionality of muscle tissue significantly increases in patients. In addition, it has fewer side effects than other similar drugs.

In December 2015, the FDA postponed consideration of the application of the American biopharmaceutical company BioMarin Pharmaceutical Inc regarding the world’s first drug for Duchenne muscular dystrophy, Kyndrisa. The medicine is designed not only to relieve symptoms, but to slow down the development of the disease. The results of clinical studies of the drug presented to the commission did not convince the group of independent FDA consultants of the efficacy and safety of the drug. Thus, FDA experts considered that the statistics obtained in the last stages of clinical trials of the drug do not confirm the results of early clinical trials. In addition, the agency requested a study on delayed side effects of the drug, such as kidney disease or a decrease in the number of platelets in the blood.