FDA liver risk warning for Bristol-Myers HIV drug

Feb 01, 2010

(AP) -- Federal health officials say patients taking a Bristol-Myers Squibb drug for HIV have reported a rare, but potentially fatal liver disorder.

The says it received 42 reports of the disorder since Videx was approved in 1991. Four patients died from bleeding or liver failure after developing the problem, known as non-cirrhotic portal .

The problem involves dangerously slow blood flow though the liver, which can cause veins in the esophagus to swell. These veins are thin and can cause burst, causing potentially deadly bleeding.

FDA says it is keeping the drug on the market because its benefits outweigh its risks. The agency added warnings to the drug's label about the signs of the liver disorder.

Explore further: Determine patient preferences by means of conjoint analysis

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA OKs drug to treat bleeding disorder

Apr 30, 2007

The U.S. Food and Drug Administration has approved Humate-P for the treatment of a specific bleeding disorder called von Willebrand disease.

FDA questions safety of Glaxo kidney cancer drug

Oct 01, 2009

(AP) -- Federal regulators said Thursday an experimental kidney cancer drug from GlaxoSmithKline may cause liver problems, potentially outweighing its ability to slow the disease.

FDA toughens warnings on over-the-counter painkillers

Apr 29, 2009

The Food and Drug Administration said Tuesday that it is asking drugmakers to more prominently display safety warnings on the labels of some of the most widely used over-the-counter pain and fever remedies.

Recommended for you

Determine patient preferences by means of conjoint analysis

12 hours ago

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

User comments : 0