Kentucky Injury Lawyers

Should Levaquin Have Stronger Warning Labels?

Published on Jan 9, 2015 at 9:30 am in Dangerous Drugs.

A 54 year-old woman in Arizona had only taken Levaquin for seven days before she wound up in the emergency room after she became dizzy and couldn’t breathe. Within a few weeks, Jenny Frank’s ankles swelled and her knees ached. Her joints started making crunching sounds when she moved. Gastrointestinal problems, muscle spasms, and fatigue followed.

Frank was diagnosed with peripheral neuropathy, a form of nerve damage, which is a known side effect of Levaquin. Last summer, the FDA issued a warning that Levaquin and the other drugs in the class of fluoroquinolones, had potentially serious side effects, including peripheral neuropathy. The FDA found drug makers were not adequately documenting these risks in their labeling and required stronger warnings.

Due to Frank’s nerve damage, she had to wear braces on her elbows, wrists and knees, and use a cane to help her walk. “Every single day, something else in my body fell apart,” she told USA Today. Three years later, she has mostly recovered. But some cases can be permanent.

Her case and others have patients and drug safety experts working to educate consumers and calling on the FDA to do more. Patients who have suffered side effects are talking through online forums. They are also sharing information and research.

A citizens’ petition has been submitted to the FDA asking for stronger warning labels on the drugs and further investigation into adverse-event reports . The petitions were drafted by Dr. Charles Bennett, who is a pharmaceutical safety expert. Bennett sees a need to educate doctors more about the side effects of this drug and told USA Today the goal of the petitions is to get stronger warning labels that will help doctors refrain prescribing the potent antibiotic in cases where weaker drugs can be effective.

The labeling is intended to advise both doctors and patients. Patient advocates stress that consumers can’t rely on the government to protect them and need to become aware of the side effects of the drugs they are prescribed.

“A lack of education among consumers and physicians exists, coupled with widespread marketing of drugs,” Dr. Ray Woosley, of Oro Valley, Arizona, told USA Today. “Although the FDA regulates drugs and attorneys general have taken legal actions against large pharmaceutical companies, antibiotics are far more frequently prescribed and their use grows so quickly that government can’t keep up.”