Raptiva Recall 2009

Raptiva recall 2009.

Raptiva is an immunosuppressant that was designed to be received as a once per week injection, for the treatment of moderate to severe plaque psoriasis. This drug suppresses the immune system, and results in a weakened immunity, and a temporary improvement of psoriasis.

History of Raptiva (reversed chronological oder - easier to read from the bottom):

June 8,
2009

Raptiva is no longer available.

From 2003 (Raptiva approval) to 2009 (Raptiva recall), about 46,000 psoriasis sufferers around the globe received treatment with Raptiva.

April 8,
2009

Raptiva recall - the drug is being voluntarily removed from the U.S. market by the manufacturer (Genetech).

Genetech starts Raptiva withdrawal due to a rare and very serious brain infection PML, caused by suppressed immunity of the people taking the drug. PML is caused by a virus, results in the irreversibly declined neurological function and death, and has no known treatment for it. The risk of this neurological disease is rare, and is linked to a prolonged use of Raptiva.

Doctors are notified not to prescribe Raptiva to new patients, and to find an alternative treatment for the patients who are taking the drug at the time of its withdrawal (about 2,000 patients).

February 19,
2009

FDA notes 3 deaths of people taking Raptiva, all associated with the development of a rare brain infection (PML, progressive multifocal leukoencephalopathy). All three people had been treated with efalizumab for 3+ years, with no use of other immunosuppressants.

October 16,
2008

Raptiva gets a "black box" warning - the sternest warning that can be issued by the FDA, due to the discovered risk of the following life-threatening infections: viral meningitis (brain infection), rare brain infection, bacterial sepsis (blood infection affecting body organs), and invasive fungal disease (body-wide fungal infection).

October 27,
2003

Raptiva (efalizumab) is approved by the FDA.

If you have received Raptiva in the past, you need to be monitored by your doctor for any signs of neurological disease or infection. The symptoms include:

- Possible symptoms of PML: confusion, dizziness, difficulty talking/walking, and impaired vision.

- Possible symptoms of Anemia: weakness, jaundice, and dizziness upon standing.

- Possible symptoms of Thrombocytopenia: bleeding gums, bruising, tiny red dots under the skin.

- Possible signs of a Nervous System Disorder: tingling, numbness, weakness in the arms/legs/face.

Undecided Did you try Raptiva? Were you thinking of giving it a try? Or did you not have trust is Biologics? Please, share your opinion below.

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Last Updated ( 11.10.2009 )
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