MIAMI (CBSMiami) – Andrea Siani 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.
“It was a prescription for 10 days. On the ninth day both my arms went numb. That night I woke up around midnight, and it felt like flames were coming out of my elbows,” said Siani.
Thousands of patients have reported similar reactions to Levaquin, one of a powerful family of antibiotics known as Flouroquinlones.
So just how powerful is this class of drug? Two of the prescribed uses are for anthrax and the plague.
Levaquin has a black box warning from the Food and Drug Administrtation for increased risk of tendon ruptures, muscle weakness and impacts on the central nervous system.
Dr. Marylee Worley is a professor at Nova Southeastern University’s College of Pharmacy.
“A black box warning is the most serious warning that a medication can get before really being pulled from the market,” explained Worley.
“It is powerful,” said Dr. Charles Bennett. He is one of the nation’s leading watchdogs for prescription drugs. He said the big problem with flouroquinolones is inappropriate use.
“We are talking about going into the physicians office, having a little sniffle, walking out with an antibiotic and shortly after having these kinds of problems,” Bennett said.
He has filed two citizen’s petition with the FDA seeking to expand the black box warning to include mitochondrial toxicity, meaning damage can occur within a patient’s cells.
The second petition wants to highlight the potential for serious psychiatric events.
Caroline Eagan was given Levaquin to treat a sinus infection. Eight years have passed and the former daycare provider has never been the same.
“One day I can be okay, 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,” said Eagan.
Levaquin is made by a subsidiary of Johnson and Johnson. In a statement, they said the antibiotic, “Has been used for more than 20-years to treat infections, including those that might be serious or life threatening. When used according to the product labeling, Levaquin has been proven to be a safe and effective medication.”
Dr. Worley has a word of caution for people considering taking it.
“We know this class of anitibiotics is being overly prescribed. If you start experiencing pain, especially around your ankle, call your doctor immediately,” advised Worley.
Eagan regrets her doctor didn’t give her any warning.
“You don’t be normal and then three days after taking a medication, and it was the only medication I was on, you can’t walk,” said Eagan.
In a statement, an FDA spokesperson said the agency is reviewing the citizen’s petitions, adding they consider drug labels living documents so they can be updated, as new safety information becomes available.