Sanofi has halted all clinical trials and is discontinuing development for its blood cancer drug fedratinib (SAR302503) due to a link between the drug and an increased risk of the brain disease Wernicke’s encephalopathy.
FDA Probes Fedratinib Trials
According to PMLive, the FDA had previously ordered Sanofi to place a partial hold on clinical trials for fedratinib after discovering a relationship between the experimental cancer drug and the brain disorder.
However, follow-up analysis by the FDA, Sanofi and independent experts suggested that the risks associated with the drug outweighed the benefits resulting in Sanofi decision to scrap all development for the drug and shelf any filing plans indefinitely.
The drug was in development as a possible treatment for several types of blood cancer including phase III trials for myelofibrosis and early stage trials for polycythemia vera and essential thrombocythemia.
About Wernicke’s Encephalopathy
- Wernicke’s encephalopathy, also known as Wernicke’s disease, is a brain disorder which can lead to vision and eye problems, loss of coordination and memory loss.
- The disease is estimated to affect around 2 percent of the world’s population, and is most often associated with alcohol abuse in malnourished individuals.
- Physicians may have trouble positively diagnosing Wernicke’s encephalopathy as a patient may only exhibit a few of the symptoms associated with the disease.
- Patients who participated in clinical trials for fedratinib are urged to consult with their physicians should they experience changes in vision, impaired memory, confusion or changes in personality.
Contact an Experienced Drug Recall Attorney
Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.