Psoriasis Drug Raptiva Gets “Black Box” Warning – Associated Risk of Infection and PML

Just this week, the psoriasis drug Raptiva received a “black box” warning, the FDA’s strongest, regarding progressive multifocal leukoencephalopathy (PML) and other potentially fatal infections. Raptiva, manufactured by Genentech, is a medication given via weekly injection to treat moderate to severe plaque psoriasis in adults only. Raptiva is a biologic drug that works to suppress the immune system with the goal of fewer psoriasis flare-ups. However, as with any immunosuppressant, the use of Raptiva compromises the immune system to such an extent that it increases the risks of serious infections, some fatal, and other malignancies.

Most of these infections are opportunistic ones, meaning that they lay dormant in the body until precisely that time when the immune system is severely weakened before attacking the body.

While the warning label for Raptiva previously made mention of the risk of infections, the addition of the “black box” warning is a significant admission as to the severity of the risks presented by the drug. Additionally, the “black box” warning also includes new information regarding the risk of PML associated with the drug, never before disclosed on the label. PML is a very serious, rare, and progressive neurological disease. The brain infection steadily worsens, attacking multiple locations in the brain simultaneously, until the patient dies. The most common presentation of PML included visual problems, loss of coordination, and other mental impairment. Currently, there is no effective treatment for PML, only the possibility of slowing its progression, primary by attempting to strengthen the immune system by discontinuing the patient’s use of all immunosuppressants.

This is not the first instance where an immunosuppressant has been liked to serious infections and PML, so the delay by Genentech in providing this “black box” warning on Raptiva is questionable at best. If you or a loved one were taking Raptiva and have since been diagnosed with PML or have since been experiencing the early symptoms of the disease as described above, please contact our office via our website at www.pbmattorneys.com for a free consultation so that we can work with you to protect your rights.