Critics demand stronger warnings for potent antibiotics

A powerful antibiotic prescribed to cure strep throat may have been more debilitating for one woman than her sickness ever was.

Jenny Frank, 54, of Glendale, Ariz., was seven days into her regimen of Levaquin, a brand in a class of antibiotics known as fluoroquinolones, when she became so dizzy that she could not breathe. She ended up at an emergency room.

A few weeks later, her knee started hurting. Then, her ankles swelled up. Her joints made crunching sounds like Rice Krispies when she moved. Panic and anxiety attacks, gastrointestinal issues, muscle spasms, fatigue — the list of problems went on and on.

Her deteriorating health, especially relating to nerve damage, eventually forced her to take a leave from work. She wore elbow, wrist and knee braces and used a cane.

"Every single day, something else in my body fell apart," said Frank, who has now mostly recovered from the worst of her pains, which began three years ago. She suffered from peripheral neuropathy, or nervous-system damage, a known side effect of the drug.

Although it is unclear if all of Frank's symptoms were directly linked to the antibiotic, the federal Food and Drug Administration has documented side effects, including peripheral neuropathy from fluoroquinolones, and requires certain label warnings.

Now, a citizens petition conceived in Phoenix is asking the FDA to expand its warnings, alerting physicians and consumers about potentially broader consequences of fluoroquinolones.

Patients such as Frank have created online forums, blogs, movies, books and articles on fluoroquinolone side effects. They have formed an information-exchange network across the country, providing emotional support and sharing research.

Like all drugs, antibiotics have known side effects. This is especially true with fluoroquinolones, one of the best-selling classes of antibiotics, because they have grown so popular that they are often inappropriately prescribed or overused, experts say.

Fluoroquinolones are intended for serious infections. They can be life-saving for patients with sepsis, blood infections, infections that are resistant to conventional drugs, or hospital-acquired pneumonia.

But doctors now prescribe the medicine for everything from sinus congestion to urinary-tract infections. And it is in many of those cases that patients have reported serious side effects such as nervous-system damage.

"They're so active, they're the drug of choice for illnesses when they shouldn't be," said Dr. Ray Woosley, founder and president of CredibleMeds, an Oro Valley, Ariz.-based independent research and education non-profit that advocates for medication safety.

"There is no question we need these drugs," Woosley said. "But when you're giving it to somebody with sinusitis (or other non-bacterial infections) ... we're going to lose them because of overuse."

Spokeswomen for Bayer Corp. and Janssen Pharmaceuticals Inc., two manufacturers of fluoroquinolones, said their companies report any known side effects to the FDA as required.

At least six FDA-approved fluoroquinolones are commercially available: Levaquin, Cipro, Noroxin, Avelox, Factive and the generic ofloxacin. For more than a decade, the FDA has studied and identified potential side effects that patients reported, prompting it to publish warnings and change labeling on some brands.

But some advocates want additional labeling to include other reported side effects.

This summer, a researcher submitted a citizens petition on behalf of a Phoenix resident and other patients who suffered side effects from taking fluoroquinolones, mainly Levaquin and Cipro. They asked the FDA to further investigate adverse-event reports relating to the drug and to add a warning that the drug may cause permanent damage to the mitochondria in cells.

The FDA has studied this theory, but its report did not draw a conclusion about mitochondrial toxicity.

"We are aware of the citizen petition, and we are evaluating it," said Jennifer Norton, spokeswoman for Janssen, the pharmaceutical unit of Johnson & Johnson. "(Levaquin) is part of an important 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. When used according to the product labeling, Levaquin has been proven to be a safe and effective medication."

Last week, the same group petitioned the FDA for an additional warning about potential psychiatric side effects related to nerve damage.

FDA labeling is a continuous process. Although the agency does not track how frequently it relabels drugs based on outside requests, a spokeswoman said the agency works with drug companies regularly to update labeling as new safety or efficacy information becomes available.

"Think of drug labels as living documents," said Stephanie Yao, FDA spokeswoman.

A 2013 FDA review of reported side effects examined the extent of damage to patients with peripheral neuropathy, which is listed as a side effect on the antibiotic label.

The FDA found the antibiotic's labeling is inconsistent with details of risk of peripheral neuropathy, or how damage may potentially be permanent. Based on the report's recommendations, the FDA this past fall issued a drug-safety announcement warning consumers that nerve damage from fluoroquinolone antibiotics may be permanent.

The petitioners want to see more. Dr. Charles Bennett, a pharmaceutical-safety expert whose research focuses on improving drug safety and minimizing side effects, drafted both citizens petitions after three years of research. If successful, additional warnings will educate physicians and help them act more judiciously in prescribing it to patients, Bennett said.

The debate over fluoroquinolone labeling highlights a larger problem of drug regulation and overprescription of serious drugs, Woosley said.

A lack of education among consumers and physicians exists, coupled with widespread marketing of drugs. Although the FDA regulates drugs and attorneys general have taken legal actions against large pharmaceutical companies, antibiotics are far more frequently prescribed and their use grows so quickly that government can't keep up, Woosley said.

That means the onus falls on consumers to research drug side effects.

The FDA releases drug-safety announcements online and sends safety updates in patient and physician newsletters and other safety alerts. Physician education is separate and usually is conducted by the drug manufacturer, Yao said.

Learn more

• U.S. Food and Drug Administration's drug safety info

• Centers for Disease Control and Prevention's antibiotics guide