Product News and Recalls

Fluoroquinolones to Get Stronger Warning Labels

fluoroquinolones get tougher warning labelsAs fears of a surge in antibiotic resistant bacteria continue to grow, one class of drugs has been drawing attention for more immediate reasons. The drugs, known as fluoroquinolones, or FLQs; and marketed under familiar names like Levaquin, Cipro, Avelox, and Factive, have been linked to increased instances of peripheral neuropathy and other serious injuries.

Peripheral neuropathy is generally referred to as nerve damage. Patients experiencing peripheral neuropathy can suffer from a wide variety of symptoms; including sharp pains shooting through their extremities as well as weakness, burning or itching sensations, and extreme sensitivity to touch or temperature.

This is not, however, the only risk associated with the use of FLQs. Other studies have linked the drugs to tendon ruptures and aortic aneurysms – a potentially fatal occurrence that involves massive amounts of internal bleeding. Patients in one Canadian study were 3.13 times more likely to experience a tendon rupture and 2.72 times more likely to experience an aortic aneurysm when taking fluoroquinolones.

Given the risk-benefit profile of this series of drugs, the FDA has recently announced that it only recommends the use of FLQs in the most dire of circumstances. Illnesses like anthrax, plague, and bacterial pneumonia may warrant an FLQ response. Others, however, can be left to drugs that do not carry the same potential risks.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” says FDA director of the Office of Antimicrobial Products at the agency’s Center for Drug Evaluation and Research. “”It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

Patients had previously been administered FLQs under vastly less-severe circumstances. Sinusitis, chronic bronchitis, and a simple urinary tract infection may have led to an FLQ prescription. However, in a classic case of the cure being worse than the disease, some of these patients wound up suffering far worse side effects.

FLQs already carry a black box warning – among the highest warning levels that the FDA can require for a medication. Under this latest action, the warning will be updated and patients will be given information specifically related to the safety issues surrounding the drug.