-April 10, 2008
U.S. health regulators are reportedly investigating whether or not two transplant medications could be associated with a rare central nervous system disorder.
Both of the drugs are manufactured by Switzerland’s Roche Holding AG and Novartis AG.
FDA Conducts Review
According to reports, the FDA is conducting a review to determine whether or not the two drugs, Roche’s CellCept and Novartis’ Myfortic could potentially trigger a fatal illness known as progressive multifocal leukoencephalopathy or PML.
Both drugs are reportedly used to prevent organ rejection during organ transplants.
Reports of Patient Harm
The FDA says they have received at least 16 reports of PML in patients using CellCept since 1995.
FDA spokesman Christopher Kelly also says that the agency has received reports of deaths linked to the medications.
Drugs Used Worldwide
More than 500,000 patients have reportedly used CellCept worldwide and in 2007 the drugs brought in about $2 billion for the company.
“Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system,” says the FDA.
(Source: Reuters)
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