HIV drugs may be linked to heart attack risk

FDA may consider changing labels for Ziagen and Videx after data review

updated 3:05 p.m. ET March 27, 2008

WASHINGTON - The Food and Drug Administration said Thursday recent data show patients taking HIV drugs from GlaxoSmithKline and Bristol-Myers Squibb may have increased risk of heart attack.

FDA said data pooled from a 33,000-patient study of HIV patients showed those taking Glaxo's Ziagen and Bristol-Myers' Videx had a greater chance of heart attack than patients on other medications.

Labeling changes could be needed for the drugs, FDA said, though it stressed it is still working with incomplete data. The agency does not have information on heart attack risks of two other drugs in the class of virus-fighting medications.

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In an announcement posted to its Web site, FDA said it would make recommendations on the drugs after it completes its review.

Until then, doctors should weigh the risks and benefits of the drugs for patients, the agency said.

Glaxo and Bristol reviewed their clinical trial data on the drugs and both said they found no increased risk of heart attack.

Company representatives could not immediately be reached by phone.

Shares of Bristol-Myers Squibb Co. rose 15 cents to $21.35 while shares of GlaxoSmithKline rose 58 cents to $42.55 in afternoon trading.