The FDA says a popular HIV drug combination can be life-threatening. The label for Roche's Invirase has been updated to include the fact that pairing it with Abbott Laboratories' Norvir increases the risk of cardiac abnormalities, particularly in patients with underlying heart conditions.
The new labeling comes after a February warning from FDA that the drug combo could cause heart-rhythm changes, which in turn may lead to fainting and lightheadedness, and in some cases, a life-threatening ventricular fibrillation. FDA is also requiring a medication guide to be distributed to Invirase patients.
The agency emphasized that the benefits of the drugs outweigh their risks, but advised patients to talk to their doctors. As the Los Angeles Times points out, Norvir helps boost the effectiveness of Invirase, so the two meds are often taken together.