Legal news for New Jersey product liability attorneys — The Food and Drug Administration announced safety risk of HIV drug.
Princeton, NJ (NewYorkInjuryNews.com) –The U.S. Food and Drug Administration (FDA) www.fda.gov announced January 29, 2010 that several people treated for HIV with a certain drug have developed a rare liver disorder.
There were reports of certain HIV patients who developed non-cirrhotic portal hypertension, which is a rare and serious liver disorder. The patients were given the drug Videx/Videx EC (didanosine), which is an antiretroviral medication. The FDA first accepted the drug in 1991, which was used to treat children and adults with HIV.
Forty-two patients who underwent treatment with Videx/Videx EC since the drug was approved, developed cases of this rare liver disorder has been reported to the FDA. Four of the patients, who were taking Videx/Videx EC, died from liver failure or bleeding during an Adverse Event Reporting System.
The FDA’s evaluation of the drug still states that the pros outweigh the adverse potential side effects. The drug company, marketed through Princeton, New Jersey firm, Bristol-Myers Squibb, has revised their labels to include the liver disorder as a potential side effect.
The liver disorder, non-cirrhotic portal hypertension, occurs when blood flow in a major vein in the liver slows down, which then leads to dangerously enlarged veins in the esophagus. These enlarged veins in the throat are thin and can burst resulting in severe bleeding. For more information regarding this and other product warning news, visit www.fda.gov.
Bridget Hom
www.NewYorkInjuryNews.com