I-Team: Patients Say Popular Drug Caused Devastating Side Effects
BOSTON (CBS) - Fluoroquinolones are among the most widely prescribed type of antibiotics. Many patients say instead of helping them heal, however, these powerful drugs have made them sicker.
The most widely known version is Levaquin. The Food and Drug Administration is being pushed to increase the warnings about how these drugs should be used.
Andrea Siani is on crutches and has a hard time getting around her Concord house. She was treated with a generic version of Levaquin after coming down with pneumonia last winter.
After nine days on the drug, she says her arms went numb during the day. "That night I woke up, around midnight, and if felt like flames were coming out of my elbows."
Just a week before, she had been skiing at Tuckerman's Ravine in New Hampshire.
Today she is counting her steps, trying to conserve what little energy she has left. "The limitations are extreme. My life has become very small," said Siani. "I can't go out and do errands. I can't food shop."
Thousands of patients have reported similar reactions to Levaquin. The I-Team found one case which had been filed at the US District court in Boston. A Martha's Vineyard man sued the drug manufacturer, saying he suffered severe and debilitating tendon injuries.
Today, 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.
A black box warning is the most severe safety advisory before a drug is pulled from the market altogether. Two of the recommended uses for Levaquin involve anthrax and the plague.
"It is powerful," said Dr. Charles Bennett of the South Carolina College of Pharmacy, one of the nation's leading watchdogs for prescription drugs. Dr. Bennett believes the big problem with fluoroquinolones 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 has filed two citizen's petitions with the FDA seeking to expand the black warning to include mitochondrial toxicity, meaning damage can occur within a patient's cells, and possibly manifest years later as Parkinson's disease, Alzheimer's disease, or ALS.
Dr. Bennett theorizes the most likely patients to suffer these problems are those who have 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," he added.
The second petition wants to highlight the potential for serious psychiatric events.
Caroline Egan of Framingham took Levaquin eight years ago for a sinus infection and has never been the same. She has suffered from depression, anxiety, had ruptured tendons, and joint problems.
The former daycare provider said, "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."
Levaquin is made by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. In a statement, they told the I-Team 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. Liudvikas Jagminas of Beth Israel Deaconess Plymouth said the use of these drugs is a real concern for physicians. He said this is a tough balancing act because so many antibiotics don't work like they once did. "Unfortunately we don't have whole lot of potential drugs that we can use. Obviously if we can use another drug, we certainly would."
Carolyn regrets she didn't get any warning about Levaquin's side effects. "You can't be normal and then three days after taking a medication, and it was the only medication I was on, you can't walk."
In a statement, an FDA spokesperson told the I-Team the agency is reviewing the citizen's petitions. He added the agency considers drug labels living documents so they can be updated as new safety information becomes available.
This is a link to the Citizen's Petitions: http://www.regulations.gov/#!docketDetail;D=FDA-2014-P-0856
Send tips for the I-Team to iteam@cbsboston.com or call 617-779 TIPS
