Product News and Recalls

Public Citizen Calls for Black Box Warning for Fluoroquinolone Heart Rhythm Problems

criticism for fluoroquinolones over heart rhythm problemsPublic Citizen, a prominent consumer advocacy group, has called for a black box warning on the labels of fluoroquinolone antibiotics like Levaquin, Avelox, and Cipro indicating the risk of heart rhythm complications due to the drugs’ side effects.

Fluoroquinolone antibiotics, which are frequently used to treat urinary and respiratory infections, have already been linked to a slew of other health risks. In 2008, the U.S. Food and Drug Administration (FDA) ordered manufacturers to include a boxed warning indicating fluoroquinolones’ link to tendon damage and rupture. Then in 2013, the agency requested stronger safety label warnings that drugs such as Levaquin, Avelox, and Cipro may cause severe and potentially permanent nerve damage, known as peripheral neuropathy.

An FDA advisory panel convened recently to hear testimony from patients who suffered from Fluoroquinolone-Associated Disability, or FDQ, as well as pharmaceutical and medical experts. Public Citizen founder and advisor Dr. Sidney Wolfe spoke before the panel. He stated that in addition to significant overprescription and buried health risk information, fluoroquinolones lacked a strong warning about the heart rhythm complications they have been shown to sometimes lead to. Citing the recommendation of FDA reviewer Dr. Andrew Mosholder, Wolfe called for fluoroquinolone producers to include a black box warning about drugs’ QTc-prolonging effects.

Over 200 Levaquin lawsuits, Avelox lawsuits, and Cipro lawsuits have already been transferred to a multidistrict litigation in the U.S. District Court for the District of Minnesota. Plaintiffs who have filed fluoroquinolone lawsuits claim the companies behind the drugs failed to adequately warn patients and practitioners of the nerve and tendon damage they can cause. Several thousand fluoroquinolone lawsuits are expected to accumulate over the coming months.

Speak to your doctor if you have any questions about the side effects of your medications. If you or someone you know experienced tendon rupture, heart rhythm problems, or peripheral neuropathy after being treated with fluoroquinolones, contact the lawyers at Lopez McHugh for a free legal consultation.