Raptiva Recalled in U.S. Due To Link With Fatal Brain Infection, Progressive Multifocal Leukoencephalopathy (PML) (Posted by Tom Lamb at DrugInjuryWatch. On April 8, 2009 Genentech Inc. — which was just acquired by Roche Holding AG in March 2009 — issued a press release announcing a phased voluntary withdrawal of psoriasis drug Raptiva (efalizumab) from the U. UPDATE: On April 8, 2009 Genentech (the manufacturer of Raptiva) announced a nationwide recall of Raptiva, a medication for treatment of psoriasis due to reports of patients developing progressive multifocal leukoencephalopathy (PML). April 8, 2009 – The psoriasis drug Raptiva has been voluntarily pulled from the market, drugmaker Genentech announced today. Raptiva suppresses the haywire immune responses that cause psoriasis.
This recall notice came just two months after the Food and Drug Administration issued a public health advisory to warn doctors and patients about the link between Raptiva and PML. Raptiva is a once-a-week injection first sold by Genentech in 2003 for the treatment of chronic plaque psoriasis. Raptiva Recalls and Withdrawal from the U.S. Market. However, on April 8, 2009, Genentech announced that it is voluntarily withdrawing Raptiva from U. This prolonged withdrawal period is scheduled to allow doctors and Raptiva patients to work together to find a suitable alternative psoriasis drug. RAPTIVA – Medication for the treatment of psoriasis sold by Genentech, Inc. The FDA announced a withdrawal of Raptiva on April 8, 2009, due to the risk of patients developing the risk of a viral infection that damages the protective sheath surrounding nerves.
Raptiva will no longer be available after June 8, 2009. Genentech has begun a voluntary, phased withdrawal of its psoriasis drug efalizumab (Raptiva) from the U. This recall includes RY-Tann and D-Tann CT caplets; D-Tann CT, AT, CD, and DM suspensions; Ben-Tann suspension; B-Vex and B-Vex D suspensions; Brom-Tann, 8-mg/DM Tann, 60-mg/PSE Tann, 90-mg suspension; DM-Tann, 30-mg/PE Tann, 25-mg/Brom Tann, 10-mg suspension; and PE Tann, 20-mg/CP Tann, 4-mg suspension. Source: FDA, April 2 and April 9, 2009. Source: Core Essence, April 8, 2009. June 8, 2009. EU-wide Recall of Raptiva (efalizumab) to be Initiated. WEDNESDAY, April 8 The troubled psoriasis drug Raptiva is being withdrawn from the U.S. market, California-based drug maker Genentech announced Wednesday.
While Raptiva has certainly benefited some people who suffer from psoriasis, it has nonetheless been shown to cause severe and sometimes life threatening complications, such as:. Raptiva, also known as Efalizumab, is a medication administered by injection on a weekly basis to people who suffer from a condition known as plaque psoriasis. Ultimately, on April 8, 2009, the FDA announced that Genentech voluntarily recalled the drug, due to its association with serious infections and other life threatening conditions. Specifically, the drug was pulled after reports surfaced of a reported increased risk of Raptiva PML (progressive multifocal leukoencephalopathy), a rare progressive neurologic disease that is often fatal. That lawsuit was filed by the family of Stephen Johnson and alleges the businessman died of PML after taking Raptiva for approximately five years to treat psoriasis, Bloomberg (1/26/12) reports. When the FDA announced the voluntary recall of Raptiva, it noted that the risk of developing PML was rare and associated with long-term use. There is no known effective treatment for PML, (4/8/09). Genentech Inc., RG 10-494957. A second MS drug, Avonex, is also manufactured by Biogen and was used jointly with Tysabri as an MS treatment during clinical trials. In April of 2002, Anita Smith was enrolled in a clinical trial of Tysabri. Earlier this month, on April 9, the biotech company Genentech announced that it was withdrawing its psoriasis medicine Raptiva from the market because it can cause PML. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. In fact, more than one-third of the global total of all M&A deals in 2009 are in healthcare. The Boston Area Chapter is proud to announce a new and exciting resource – a Career Exchange Web site providing Members with access to current job openings in the life sciences industry. If the drug does not work, analysts say, Genentech’s shares might fall below 70.