FDA steps up Cipro warnings

-courier-journal.com

09/18/2008- After the anthrax attacks of 2001 Cipro became a household word when it was identified as a drug that could fight that deadly bacteria.

Recently, Cipro was in the spotlight again as federal regulators imposed their most urgent safety warning on Cipro and similar antibiotics because of increased risk of tendonitis and tendon rupture.

The U.S. Food and Drug Administration ordered makers of fluoroquinolone drugs -- a class of antibiotics prescribed for gastrointestinal, urinary tract and respiratory infections -- to add prominent "black box" warnings to their products.

It also ordered the drug companies to develop new literature for patients emphasizing the risks.

Drugs covered by the order are Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Avelox (moxifloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin) and Floxin and generic ofloxacin.

The FDA, in a statement issued July 8, gave the manufacturers a month to develop new warning labels and literature to go with the drugs.

"The warnings came about because of a lawsuit," explained Bob Oakley, director of pharmacy at Baptist Hospital East. "The current language wasn't strong enough."

The consumer group Public Citizen had petitioned and then later sued the FDA for such warnings.

According to the Los Angeles Times, Public Citizen said that after the drugs were marketed, 407 tendon ruptures and 341 cases of tendinitis were reported by the end of last year.

No one knows the connection between the drugs and tendon ruptures. One theory is that the drugs are toxic to tendon fibers and decrease the supply of blood to tendons.

Side effects reported

Pre-market clinical trials of a drug may only involve a few thousand people, Oakley explained. Later, additional and unexpected side effects may show up because the drugs are being more widely used in the general population. There is a program through which physicians, pharmacists and consumers can report what they consider unusual side effects.

In its announcement July 8 asking for the "black box" warnings, the FDA said it had conducted a new analysis of the "available literature and post-marketing adverse events reports."

Dr. Renata Albrecht, who heads the FDA division of special pathogen and transplant products, estimated that spontaneous tendon ruptures occur in about one in 100,000 people, it was reported by WebMD. The fluoroquinolone drugs triple or quadruple the risk.

The risk of developing tendinitis or tendon rupture is "further increased in people older than 60, in those taking corticosteroid drugs and in kidney, heart and lung transplant recipients," an FDA statement said.

Painful joints

Julie Payne of Louisville said she was treated with Levaquin pills a few years ago for an ear infection. She developed pain and aching in her knee and elbow joints that lasted two to three months. Her physician sent in a report, she said.

Then in January of this year when she developed an eye infection, a different doctor prescribed an eye drop with ciprofloxacin. When asked if she was "allergic to Cipro," she said "not that I know of." But Payne was unaware that Levaquin is in the same drug family.

By the third day of using the drops, the joints in her legs and arms were swollen. She called the doctor and was told to immediately stop using the medication.

Later, while still experiencing pain and swelling, she heard something tear in the back of her left leg.

The recent "black box" warning requirement for fluoroquinolones doesn't apply to fluoroquinolones used in ear or eye drops, which concerns Payne.

Some of a drug in eye drops can be absorbed systemically through the tear ducts, Oakley said.

"But when used in the ears and eyes, only trace amounts of most drugs are absorbed, whereas 90 percent is absorbed when a drug is taken orally," he added.

For Payne, just a little bit was enough to cause trouble, she said.

If you or a loved one have experienced serious side effects or injury as a result of Fluoroquinolone antibiotics such as tendonitis, torn ligament, or ruptured tendons, you may be entitled to compensation. Contact one of our Fluoroquinolone lawyers today for more information regarding your legal rights. For more information about a potential Fluoroquinolone lawsuit, or Fluoroquinolone side effects, fill out our free case evaluation form or call the toll-free number listed below.