Arava: Side Effects: FDA Warns Users
The federal Food & Drug Administration issued a safety alert on July 13, 2010 to patients and doctors about a new boxed warning. Boxed warnings are the toughest warnings the FDA issues and indicate that a drug has serious and possibly deadly side effects.
The Arava boxed warning was precipitated by an FDA review of Arava side effects from 2002 to 2009. That review identified 14 deaths and at least 49 cases of severe liver injury.
According to the FDA, the side effects from taking Arava include:
* Jaundice
* Encephalopathy, or brain disease
* Coagulopathy or blood clotting problems
* Joint disorders
* Blistering on the inside of eyelids, nose, or mouth
* Chest pain
* Peeling or blistering skin
* And many other serious side effects
The FDA has issued a warning that patients with pre-existing liver disease or with elevated liver enzymes should stop taking Arava immediately and contact their doctor.
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