By Stephanie Stahl

By Stephanie Stahl

PHILADELPHIA (CBS) —  The FDA is evaluating, a popular antibiotic that patients say is making them sicker.

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Andrea Siaini doesn’t get around her home like she used to, not since she was treated for pneumonia last winter. She was prescribed the generic version of Levaquin, a powerful antibiotic. After nine days, it felt like her arms were numb.  “.. it felt like flames were coming out of my elbows,”  Andrea says.

Thousands of patients have reported similar reactions to Levaquin, one of a family of antibiotics known as Flouroquinolones. Levaquin has a black box warning from the Food and Drug Administration for increased risk of tendon ruptures, muscle weakness, and impacts on the central nervous system.  Dr. Charles Bennett with South Carolina College of Pharmacy says, “It is powerful.”  Dr. Bennett is one of the nation’s leading watchdogs for prescription drugs.  He says the big problem with flouroquinolones is inappropriate use.  “We are talking about going into the physician’s office, having a little sniffle, walking out with an antibiotic, and shortly after having these kinds of problems,” Dr. Bennett says.

He has filed two citizen’s petitions with the FDA. One seeks to expand the warning to include mitochondrial toxicity, meaning damage can occur within a patient’s cells, and possibly manifest years later as Parkinson’s, Alzheimer’s, or ALS.  “Potentially, a genetic predisposition to be a poor metabolizer of the drug, so it’s not what you take it for, it’s who you are,” Dr. Bennett explains.  The second petition wants to highlight the potential for serious psychiatric events.

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Patient Caroline Eagan took Levaquin for a sinus infection.  Eight years have passed and she says she’s never been the same.  “One day, I can be OK on focus and another day, I can’t even talk to anybody because they are not making sense.  It sounds like they are not speaking English,” Caroline says.

Levaquin is made by Janssen, a subsidiary of Johnson & Johnson. In a statement, they say the antibiotic: “Has been used for more than 20 years to treat infections, including those that may be serious or life threatening.  When used according to the product labeling, Levaquin has been proven to be a safe and effective medication.”

An FDA spokesperson says the agency is reviewing the petitions, adding that they consider drug labels living documents so they can be updated as new safety information becomes available.

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Stephanie Stahl