Washington, DCThe US Food and Drug Administration (FDA) issued a warning late last week with regard to Videx, an antiretroviral medicine introduced in 1991 and manufactured by Bristol-Meyers Squibb. Videx, along with a delayed-release version known as Videx EC that was approved in 2000, are used in combination with other antiretroviral drugs to treat the HIV infection in children and adults.
The FDA is concerned about the potential for non-cirrhotic portal hypertension, a rare but serious liver disorder that has been reported by some HIV patients taking Videx/Videx EC (didanosine).
The agency says it has received a total of 42 adverse reaction reports related to non-cirrhotic portal hypertension over an 18-year period. A total of four patients have died from bleeding or liver failure as a result of taking Videx/Videx EC.
Non-cirrhotic portal hypertension occurs when blood flow in the portal vein—a major vein in the liver—slows and leads to severely enlarged veins in the esophagus. These enlarged veins, known as esophageal varices, are thin and can break open, resulting in serious and potentially fatal bleeding.
The FDA maintains that the clinical benefits of the drug continue to outweigh the risks. However, product labels have been revised in an effort to better inform health care professionals and patients about the signs and symptoms of non-cirrhotic portal hypertension. According to an Associated Press report, the new label stresses that patients "should be monitored for early signs of portal hypertension during routine medical visits."
Bristol-Myers Squibb issued a statement revealing that the FDA has also requested the design of a medication guide detailing the risks of Videx, Videx EC or the two drugs used in combination. "As with all our medicines, we work closely with the FDA to monitor safety events," stated the Princeton, New Jersey-based company.
Use of didanosine treatment can range from months, to years before the emergence of the rare, non-cirrhotic portal hypertension.