PITTSBURGH - It's considered a life-saving antibiotic, but, it can also be deadly. Powerful drugs like Levaquin come with a strict warning that you won't find on the label. And Channel 11's Katherine Amenta found out that's not going to change any time soon.
When Diane Powell battled brain cancer, she took the powerful antibiotic, Levaquin.
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She beat the cancer, but now has a disintegrated rotator cuff that she blames on the drug.
“We have got to get the word out,” said Diane Powell.
“We know it increases the risk significantly,” said Dr. Andrew Adams, Division Chief of Internal Medicine at West Penn Hospital.
I sat down with Dr. Adams to find out more about the dangers of antibiotics called fluoroquinolones. They are prescribed to treat serious bacterial infections and work really well. But, Dr. Adams says for some unknown reason, drugs like Levaquin and Cipro, can lead to ruptured tendons, tendonitis, psychotic episodes, nerve damage and even fatal diarrhea known as C diff colitis.
That’s why Dr. Charles Bennett and his drug safety group say they’ve collected thousands of stories from patients describing these adverse effects. The FDA does require labels on these kinds of antibiotics to mention possible permanent nerve damage. But, Bennett is now petitioning the FDA to add an even stronger warning known as a black box warning.
“I don't write a citizen petition light-heartedly...There's too much work and you can't afford to be wrong,” said Dr. Bennett.
In response, the FDA said making a new label raises "complex issues" and they will have to investigate. And Dr. Adams told me, he's not sold that a new label would make that much of a difference.
“I suspect there aren't a lot of doctors who aren't aware of these issues,” said Dr. Adams. “It may raise public awareness but it may not raise prescriber awareness very much.”
Still, everyone agrees, they don't want to see the drug banned -- it saves too many lives.
“They are really effective, lifesaving medications, when used appropriately.”
The company that manufactures Levaquin, Janssen Pharmaceuticals says, "We are aware of (Dr. Bennett's) petition and are evaluating it." They went on to say, "Our first priority is the well-being of the people who use our medicines.”
A dozen companies make these drugs, including the generics and the brand names.
The company behind Levaquin, Janssen Pharmaceuticals, said, "Our first priority is the well-being of the people who use our medicines. We are aware of the [Dr. Bennett's] Citizen Petition and are evaluating it. Levaquin (levofloxacin) is part of the important fluoroquinolone class of anti-infective prescription medications that have been used for more than 20 years to treat infections, including those that may be serious or life threatening. All medicines, including Levaquin, have both benefits and risks. We continually collect and monitor information on the safety and effectiveness of all our medicines, and, in cooperation with the U.S. FDA and other health authorities, we incorporate new data into our product labels so doctors and patients can make informed decisions. Ever since it was first approved by the FDA in 1996, the Levaquin label has provided information to physicians on the risks and benefits associated with the medication, including warnings and precautions. Since 2004, the Levaquin label has informed physicians and patients about possible side effects related to peripheral neuropathy."
CLICK HERE for more information on the Bennett Study/Petition/Warnings
CLICK HERE for more information on the Levaquin Medication Guide