Raptiva Lawsuit
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Raptiva Lawsuit Information
Raptiva is an anti-psoriasis medication developed by Genentech and marketed in conjunction with Merck Pharmaceuticals. The drug was approved by the FDA in 2003. Raptiva is an autoimmune suppressant, restricting the growth of T-cells, an important component of the immune system. Patients who have been treated with Raptiva have developed side effects that are going to result in lawsuits.
Psoriasis is caused by false demands from the immune system for additional epidermal cells - which in turn causes the inflamed and flaky skin that is a primary symptom of psoriasis. Raptiva is administered with weekly injections and has shown some success in reducing psoriasis symptoms. Suppression of the immune system can lead to development of infection, particularly in persons of fragile health and who are in the latter stages of life. In October of 2008 the FDA directed Genentech to include a "black box" warning on all packaging for Raptiva, warning of the possibility of infection development due to the use of the drug.
Among the infections noted by the FDA is a rare brain affliction called progressive multifocal leukoencephalopathy, or PML. This infection impacts the central nervous system, causing severe weakness, lack of coordination and difficulty speaking. There is no known cure for PML, which is very likely to be fatal.
On February 19th the FDA issued a public health warning about Raptiva, explaining that they had received notification of three Raptiva users who had been afflicted with this rare condition, and a fourth case that was possibly PML. Two of the confirmed cases and the patient who may have developed PML have died.
There are 7.5 million Americans who have psoriasis. The drug generates about $120 million a year in sales, principally in the United States; many patients who have had adverse effects from Raptiva are conferring with attorneys about lawsuits against Genentech. The FDA's announcement on packaging dating from October of 2008 noted that: "The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy [PML] and other opportunistic infections."
Four months later, the FDA has issued a public health advisory notifying consumers and medial professionals of the possible link between Raptiva and PML. The FDA's advisory states, in part:
The FDA is reviewing this latest information. The agency will take appropriate steps to:
- ensure that the risks of Raptiva do not outweigh its benefits;
- that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
- that health care professionals carefully monitor patients for the possible development of PML.
Attorneys representing Raptiva patients are reviewing cases and are engaged in research to determine whether Raptiva patients who have suffered adverse effects are due compensation. If you or a family member has been treated for psoriasis and has developed infections or illnesses as possible side effects, contact our offices and we will do that research for you.
