In light of the mega million-dollar lawsuit filed against the makers of the quinolone, Levaquin, the FDA has recommended that healthcare providers should not empirically prescribe these agents. Quinolones use to treat both gram- positive and gram-negative infections. Most of these antibiotics have been in use for over 3 decades.
However, over the years warnings were given out that these drugs could cause rupture of tendons or ligaments. Now there is a medical malpractice lawsuit against Johnson & Johnson. The suit claims that ligament ruptures occurred in some elderly patients who were prescribed Levaquin.
A similar lawsuit has been filed against doctors in the past but this is the first time that Big Pharma has been taken to court. In addition, the suit claims that the FDA has always been aware of tendon injuries caused by Levaquin but never reinforced the warning on the label..
The exact numbers of people who have to develop ligamentous injury or tendon rupture with these agents are unknown. The plaintiffs are arguing that there are many people who have suffered ligamentous injuries but that the Pharmaceutical company has just hidden the raw data.
The defendants argue that these numbers are small and the adverse effects are not the sole cause of the injury. The case has just come to trial and will continue for a few more weeks,
In the meantime, The FDA has stated that the labels for these antibiotics should warn the healthcare provider about the risk of tendon rupture, tendonitis, peripheral neuropathy, QT prolongation and exacerbation of myasthenia gravis.
These events can occur either singly or in combination. The FDA has further stated that the new labels should clearly indicate the serious risk of the quinolones far outweigh the benefits especially in patients with urinary tract infections, bronchitis, and sinusitis. Doctors should instead use other antibiotics to treat these conditions.
At the moment in the USA, the currently FDA approved quinolones include the following
- Moxifloxacin (Avelox, Merck)
- Ciprofloxacin (Cipro, Bayer HealthCare)
- Ciprofloxacin extended-release
- Gemifloxacin (Factive, LG Life Sciences, Inc)
- Levofloxacin (Levaquin, Janssen Pharmaceuticals Inc)
- Moxifloxacin injection
- Ofloxacin (available only as a generic)
Orthopedic surgeons are being urged to report any adverse effects of these antibiotics by calling 1-800-FDA-1088; by fax at 1-800-FDA-0178; or at the FDA website
In the meantime, to be safe, orthopedic surgeons should refrain from using these antibiotics.