Maryland Raptiva Bad Drug Product Lawyers
Bad Product Drug Lawyers, Greenberg & Bederman, serving MD, DC and VA

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RAPTIVA IS WITHDRAWN FROM THE MARKET!

Raptiva, manufactured by Genentech, has been pulled from the market by the FDA. If you have been getting once weekly injections from Raptiva for moderate to severe psoriasis ,there is a rare but dangerous reaction to Raptiva, called Progressive Multifocal Leukoencephalopathy, or PKL. This rare reaction is a brain infection usually affecting people with a low immune system. It also usually affects those who have been taking Raptiva for an extended period of time.

To learn more about the Raptiva withdrawal, read Raptiva Withdrawal.

PML:

PML is a rare disease of the central nervous system that can lead to severe disability or death. The John Cunningham (JC) virus, which is latent in about 80% of healthy adults is activated by PML, although is not fully understood how. PML is most commonly found in persons with low immune systems, such as HIV patients, or cancer patients. A recent report of a healthy 70 year old developing PML from Raptiva has contributed to the FDA removal of the drug Raptiva from the market.

Psoriasis:

Psoriasis is a chronic disease of the immune system that appears on the skin, usually in the form of thick, red, scaly patches. Up to 30 percent of people with psoriasis also develop psoriatic arthritis. Psoriasis is associated with other serious conditions such as diabetes, heart disease and obesity. According to the National Institutes of Health, as many as 7.5 million Americans have psoriasis. Plaque psoriasis is the most common type of psoriasis. The skin is red and covered with silvery scales and is inflamed. Patches of circular to oval shaped red plaques that itch or burn are typical of plaque psoriasis. The patches are usually found on the arms, legs, trunk, or scalp but may be found on any part of the skin. The most typical areas are the knees and elbows.

Raptiva:

Raptiva is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis. In October 2003, Raptiva received U.S. Food and Drug Administration approval for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. Raptiva can be self-administered by patients as a single dose, once-weekly, subcutaneous injection after proper training by a healthcare professional.

The most common adverse reactions from Raptiva include headache, chills, fever, nausea, and myalgia within 48 hours following the first two injections. These events were largely mild to moderate when a first dose of 0.7 mg/kg was given. Less than one percent of patients discontinued Raptiva treatment because of these adverse events.

The most serious adverse reactions from Raptiva were serious infections, malignancies, immune-mediated thrombocytopenia, immune-mediated hemolytic anemia, arthritis events, and psoriasis worsening and variants.

DOW JONES NEWSWIRES

Genentech Inc. announced a phased voluntary withdrawal of its psoriasis drug Raptiva from the U.S. market Wednesday because it is associated with a higher risk of developing a rare and often fatal brain infection.

The withdrawal follows a February warning from the U.S. Food and Drug Administration of the drug's dangers and the recommendation of Europe's main medical regulator that Raptiva be withdrawn from the European market.

But Swiss drug maker Roche Holding AG (RHHBY), which completed its $46.8 billion acquisition of Genentech last month, said the withdrawal won't have a significant impact on its net income. The company expects to post a charge of about $125 million in the first half of the year.

U.S. sales of Raptiva were about $108 million in 2008. Genentech estimates about 2,000 patients in the U.S. may be receiving Raptiva for chronic plaque psoriasis. Since FDA approval in 2003, about 46,000 people worldwide have been treated with Raptiva.

Effective immediately, the biotechnology giant said doctors shouldn't issue prescriptions for Raptiva for new patients and should contact those taking the drug to assess alternatives.

Raptiva will no longer be available after June 8. Because severe psoriasis could worsen if patients stop taking Raptiva abruptly, the company said patients should talk to their doctor before stopping treatment.

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Site Disclaimer

Neither by accessing this site or by reviewing its contents has an attorney-client relationship been formed or established; and nothing contained in this site shall constitute the giving or rendering of legal advice or be construed as a legal opinion, or guarantee of a particular resolution of a legal problem. Information is provided as a public service, and is not intended to be a substitute for competent legal counsel. The information provided is general in nature and may not apply to your circumstances, particularly if you are not in the State of Maryland (MD), Virginia (VA) and the District of Columbia. Under no circumstances should you make legal decisions solely based upon the information provided on this web site. You should consult an attorney before making any important decision involving a legal matter.

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