Anti-Psoriasis Drug Raptiva Removed from Market

After the death of some patients and countless others suffering from a deadly brain infection (PML), Genentech, manufacturer of Raptiva, has removed the drug from the United States market. The removal of Raptiva (Efalizumab) from the market comes mainly as a reaction to its link to a number of reported cases of progressive multifocal leukoencephalopathy (PML) in Raptiva users. A statement released by Genentech said they anticipated Raptiva being unavailable in the United States by June 8, 2009. As a result of the recall, physicians and healthcare professionals were asked to stop prescribing Raptiva and begin alternative treatment methods for patients already using Raptiva.

The FDA originally approved Raptiva (Efalizumab) in 2003. Raptiva is prescribed as a weekly injection. The drug was designed to treat psoriasis, a chronic condition that causes skin irritation and thick, red, scaly skin. While the cause of Psoriasis is unknown, we do know that it is a disorder affecting the joints and skin and can range in severity from mild to severe. Plaque psoriasis is the most prevalent type of psoriasis, accounting for 80-90% of cases. In patients suffering from plaque psoriasis, the skin lesions are typically found on the elbows, knees, scalp, and lower back.

Raptiva treats psoriasis by suppressing the immune system to prevent inflammation of the skin. It blocks the triggering of T cells (immune cells), and the traveling of those cells to the skin. However, this can be very dangerous because this blockage also suppresses the body’s natural defense system. By suppressing the natural defense system, Raptiva increases the body’s risk of developing life-threatening infections.

Potential infections Raptiva users may contract are:

Of the aforementioned infections, PML (progressive multifocal leukoencephalopathy) is the most severe. PML is caused by the JC virus, which attacks the body when the immune system is weakened. Due to Raptiva suppressing the body’s defense system, the JC virus activates. This results in PML attacking the brain and central nervous system.

The prognosis for this brain infection is often very serious. According to the National Institute of Health, patients usually suffer from PML for several months. Sadly, over 80% of PML patients die within the first six months. For the remainder of their lives, patients suffering from PML continue to experience irreversible neurological problems, including loss of coordination/movement, memory loss, and vision problems.

Unfortunately, Raptiva is not the only drug linked to PML. Other drugs linked to PML risk are Rituxan, Tysabri, Campath, and Cellcept. For more information on PML (progressive multifocal leukoencephalopathy), CLICK HERE.

After four reports of Raptiva users, two of which died, being diagnosed with progressive multifocal leukoencephalopathy (PML), Genentech finally recalled Raptiva. The FDA reported that all four users had been prescribed the drug for more than three years. They sent a letter to healthcare professionals and physicians, advising them that Raptiva patients were at risk of getting the fatal brain infection, PML. Furthermore, they declared that the dangerous risks associated with Raptiva called for its’ recall from the market.

Although Raptiva was eventually recalled, there were several indications that the drug should have been removed from the market sooner. In October 2008, Raptiva received the highest warning possible by the U.S. Food & Drug Administration (FDA). A black box warning is the strongest warning the FDA will give a drug. This means that medical studies indicated Raptiva has a significant risk of adverse side effects including death. The warnings were added as a result of the life-threatening infections caused by Raptiva. The FDA released a statement along with its black box warning. In the statement, the FDA informed Raptiva users of the symptoms of the PML infection, which include: weakness, and problems with vision and speech.

While Raptiva was facing scrutiny in the United States following the FDA’s black box warning, the drug’s manufacturer faced more serious trouble in Europe. In February 2009, The European Medicines Agency issued a recommendation to the European Commission to stop all prescriptions of Raptiva in the European Union. After reviewing the drug, they concluded that Raptiva’s benefits no longer outweighed its risks.

Finally, the recall and warnings on Raptiva are too little, too late. Many people have already been injured from using this anti-psoriasis drug. If you believe that you or a loved one has suffered as a result of taking Raptiva, you may want to speak with an attorney regarding a potential claim.

Please CLICK HERE for a free consultation.