Raptiva
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Raptiva is a drug developed, manufactured and sold by Genentech that is designed to treat psoriasis. It is an autoimmune suppressant, meaning that is purposely impacts the immune system to reduce psoriasis symptoms. Psoriasis develops as a result of the immune system sending false signals that more skin cells are needed. The excess cells that develop lead to the red, itchy and flaky spots symptomatic of psoriasis.
Raptiva attacks the T-cells in the body, an active component of the immune system. By suppressing T-cell activity, the medication reduces the body’s demands for generation of more epidermal cells. Autoimmune suppression is a technique used for a number of diseases, but it always increases the possibility of the patient developing additional medical problems.
In the case of Raptiva, the most dangerous additional medical problem that may be associated with it is progressive multifocal leukoencephalopathy, or PML. This infection attracts the brain and the central nervous system, resulting in symptoms such as unexplained weakness, lack of physical coordination, difficulty speaking and in many cases, death.
In October of 2008 the FDA issued a labeling request to Genentech directing that a "black box warning" be printed on all Raptiva packaging materials "to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance."
Four months later on February 19th of 2009, the FDA issued a public health warning about the use of Raptiva possibly being linked PML. The FDA had established that three users of Raptiva and a possible fourth individual had developed PML. Three of these people have died. The public health warning states, in part, that "Raptiva increases the risk of PML."
Genentech's public position is that they are reviewing their research and the information that the FDA has developed. The company acknowledges in its own letter to healthcare professionals that "RAPTIVA increases the risk for PML. Prolonged exposure to RAPTIVA or older age may further increase this risk."
Genentech also notes in its website information on the drug that "The most serious adverse reactions observed during treatment with Raptiva are serious infections including PML, malignancies, thrombocytopenia, hemolytic anemia, psoriasis worsening and variants, and neurologic events."
For further information on the adverse effects incurred by patients during Genentech's clinical trials, consult their website: www.gene.com. For information on possible legal action against the company for health damage caused by this drug, contact us immeadiately.
