FDA warns of heart risk with HIV drug combination

Feb 23, 2010 By MATTHEW PERRONE , AP Business Writer

(AP) -- The Food and Drug Administration issued a warning Tuesday about potential heart risks when combining two HIV drugs.

The agency said preliminary data suggest Roche's Invirase and Abbott Laboratories' Norvir can affect the electrical activity of the heart when used together. Changes to the heart's electrical activity can delay the signals that trigger heart beats.

In some cases the problem can cause irregular heart rhythms, leading to lightheadedness, fainting, and even death.

The FDA made its announcement after reviewing data submitted by Roche about the heart activity of patients using its drug with Abbott's Norvir. The agency said its review is ongoing and patients should not stop taking Invirase without talking to their doctor.

Doctors should review patients' heart health and current medications to determine if they should continue taking Invirase, the agency said in a statement posted online.

Invirase was approved in 1995 and is marketed by , the biotech unit of Swiss drugmaker Roche.

The drug is used in combination with Norvir and other anti-viral drugs to control HIV in adults. Norvir is given at a low dose to boost the level of Invirase in the body.

The FDA previously asked Roche and all makers of protease inhibitor drugs, which includes Invirase, to conduct studies of the heart side effects of their products.

A spokeswoman for Genentech said the company has submitted new drug labeling to Invirase which is under FDA review.

"The safety of patients is of the utmost importance to Genentech, and we continue to monitor and report to FDA adverse event reports from patients and physicians," Tara Cooper said in a statement.

A spokesman for Abbott, based in North Chicago, Ill., could not immediately provide comment.

HIV attacks the body's immune system, eventually causing AIDS. Just over 1.1 million Americans are estimated to have and 232,000 do not know it, according to the Centers for Disease Control and Prevention.

The FDA issued Tuesday's warning under its so-called early communication program, which seeks to alert the public to a potential side effect with a drug immediately, even if no direct link has been established.

Explore further: Evidence lacking for long-term opioid use in low back pain

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

Related Stories

FDA approves antiretroviral drug

Aug 07, 2007

The U.S. Food and Drug Administration has approved the antiretroviral drug maraviroc for use in adult human immunodeficiency virus patients.

FDA to review Vytorin results

Jan 26, 2008

The U.S. Food and Drug Administration said it is conducting a review of the cholesterol drug Vytorin based on preliminary results from a recent study.

Recommended for you

Study recalculates costs of combination vaccines

5 hours ago

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

9 hours ago

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

Pyridoxine-doxylamine drug safety data lacking

Apr 16, 2014

(Medical Xpress)—The most commonly prescribed drug for pregnant women suffering from morning sickness in their first trimester does not prevent birth defects even though drug safety data says it does, according to research ...

User comments : 0

More news stories

Turning off depression in the brain

Scientists have traced vulnerability to depression-like behaviors in mice to out-of-balance electrical activity inside neurons of the brain's reward circuit and experimentally reversed it – but there's ...

Hackathon team's GoogolPlex gives Siri extra powers

(Phys.org) —Four freshmen at the University of Pennsylvania have taken Apple's personal assistant Siri to behave as a graduate-level executive assistant which, when asked, is capable of adjusting the temperature ...

Better thermal-imaging lens from waste sulfur

Sulfur left over from refining fossil fuels can be transformed into cheap, lightweight, plastic lenses for infrared devices, including night-vision goggles, a University of Arizona-led international team ...