NEWS: February 19, 2009 FDA ALERT FOR RAPTIVA:
FDA has just issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva.
In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.
The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML. The Public Health Advisory provides recommendations for h ealthcare providers and patients when treatment with this product is considered.
Read the MedWatch safety summary, including links to the Public Health Advisory and News Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Raptiva
October 24, 2008
Raptiva is a drug that’s given to help treat psoriasis, and it’s generally given once per week to patients. It’s administered via an injection, and its main function is to suppress the patient’s immune system somewhat in order to alleviate the symptoms of their existing psoriasis. It’s generally been viewed in a positive light in terms of its results, but recent reports have prompted the FDA to issue the statement at issue here.
Raptive Side Effect Problems
Reports have surfaced in which patients have complained of the following side effects and symptoms while using Raptiva:
* Fever or chills
* Sore throat
* Coughing
* Congestion or other signs of infection
* Redness, pain, or swelling of a skin wound
* Burning or difficult urination
FDA Warning for Raptiva.
These symptoms have been found to potentially lead Raptiva users to develop the following conditions as a result of using this medication:
* Bacterial sepsis
* Viral meningitis
* Invasive fungal disease
* Progressive multifocal leukoencephalopathy (PML)
Specifically, one report seems to have prompted the FDA into action. It was the case of a 70-year-old man who had been using Raptiva for four years, or almost since the date it was originally approved for use. He developed a case of PML, which is a viral condition that attacks the brain progressively, and he ultimately was killed as a result.
In reaction to these reports, the FDA has recently issued a public alert that’s designed to help provide notice to medical professionals and the public at large. In furtherance of this notice, the FDA will now require a warning label to be affixed to every container of Raptiva that warns of the potential for these side effects.
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