The French government called off clinical trials of an experimental drug in 2012, in part due to that drug’s link to Stevens Johnson Syndrome.
The drug, masitinib, is an experimental drug currently being developed as a treatment for certain cancers, inflammatory diseases, and diseases of the central nervous system.
Although other countries have allowed clinical trials of masitinib to go forward, French regulatory authorities from the National Agency for Drug Safety ordered masitinib’s manufacturer AB Science to stop conducting clinical trials for masitinib, based on reports of “serious and severe adverse events that have the potential to be fatal.”
These events included instances of Stevens Johnson Syndrome, according to the agency. The agency determined the risk of SJS and other side effects is too high in cases where the illness being treated isn’t immediately life-threatening.
Bloomberg News reported on the agency’s 2012 order based on documents received only recently via a public records request. More recently, the agency says it still has not authorized clinical trials of masitinib.
Paris-based AB Science had been in the process of conducting nine clinical trials to evaluate the safety and efficacy of masitinib as a treatment for conditions as diverse as asthma, Alzheimer’s disease, rheumatoid arthritis, multiple sclerosis, painful bladder syndrome, and chronic obstructive pulmonary disease.
Masitinib has been approved by U.S. and European regulatory authorities for veterinary use. However, in over 12 years of developing the drug, AB Science has yet to earn approval of the drug for use in humans. The European Union rejected AB Science’s application for approval of masitinib to treat cancers of the pancreas and stomach.
AB Science maintains that masitinib’s side effects are manageable.
Stevens Johnson Syndrome
Stevens Johnson Syndrome, the masitinib side effect cited by the French agency, is a potentially life-threatening condition in which the top layer of skin peels away from the lower layer. SJS symptoms may first present as flu-like symptoms such as headaches, body aches, cough, and generally not feeling well.
Then areas of rash develop on the skin. Within those areas of rash, blisters may form. As the rash and blisters progress, they may coalesce into large sheets of skin that peel away.
A case of SJS may be referred to as toxic epidermal necrolysis, or TEN, if the affected area of skin increases to 30 percent or more of the body’s surface. SJS may also cause blisters and ulceration on the mucous membranes inside the eyes, mouth, or digestive tract.
Although SJS is rare, when it does occur it most often happens as a side effect of a drug – and masitinib is only one of many different types of drugs with the potential to cause SJS.
Drugs that can be associated with SJS include:
- Antibiotics such as ciprofloxacin (Cipro), moxifoxacin (Avelox), gemfloxacin (Factive), and levofloxacin (Levaquin). Sulfa antibiotics like Septra and Bactrim can also be linked to SJS. Zithromax has also been linked to SJS.
- Antiepileptic drugs, also known as anticonvulsants. These include phenytoin (Dilantin), lamotrigine (Lamictal), valproate, carbamazepine, and phenobarbital.
- Allopurinol (sold as Aloprim or Zyloprim) and other medicines used to treat gout.
- Common over-the-counter pain relievers such as acetaminophen (Tylenol), ibuprofen (Advil), or naproxen sodium (Aleve).
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Stevens Johnson Syndrome attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, SJS lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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Help for Victims of Stevens Johnson Syndrome
If you or a loved one were diagnosed with Stevens Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) after taking a prescribed or over-the-counter medication, you may be eligible to take legal action against the drug’s manufacturer. Filing an SJS lawsuit or class action lawsuit may help you obtain compensation for medical bills, pain and suffering, and other damages. Obtain a free and confidential review of your case by filling out the form below.
An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.
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- Were you, or a loved one, medically diagnosed with Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis?*
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- What year(s) were you or your loved one diagnosed with Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis?*
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