Doctor petitions FDA for more warnings about commonly prescribed medications

Taking Action

RICHMOND, Va. (WRIC) — There’s a new push to add more warnings to some commonly prescribed antibiotics. 8News has been reporting on serious side effects linked to fluoroquinolones for years now. Fluoroquinolones include- Cipro, Levaquin, Avelox and their generics.

Doctor Charles Bennett and SONAR, the Southern Network For Adverse Reactions, have filed a citizen petition urging the Food and Drug Administration (FDA) to add additional warnings that these antibiotics can cause one to be permanently disabled.

Dr. Bennett successfully petitioned the FDA to add a black box warning to the label once before. A black box warning is the most serious of drug label warnings.

The latest citizen petition claims these drugs, can result in hearing, vision and nervous system disabilities that can result in one’s inability to conduct a normal life. 8News has heard some of those complaints from patients in the past, some telling us they now struggle to carry on a conversation or even tie their shoes.

The petition also asks that a warning be added, that the antibiotics can be linked to psychiatric issues, including suicide. In addition, the petition requests a requirement for patients to give written consent to take a fluoroquinolone after a doctor has fully described all the adverse events, risks, and benefits.

The manufacturers of these drugs have repeatedly told 8News that these drugs have been used for nearly 20 years to treat a range of bacterial and life-threatening infections. In a statement the FDA told 8News:

The FDA is reviewing the petition and will respond directly to the petitioner. It is important that health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use. For some serious bacterial infections, including bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for these antibacterial drugs to remain available as a therapeutic option.  More information about fluoroquinolones can be found on FDA’s web site here.

-FDA

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