Home : Unsafe Drugs : Levaquin : Articles : Levaquin Issued Black Box Warning by FDA
Levaquin Issued Black Box Warning by FDA
Levaquin (levofloxacin), maufactured by Ortho-McNeil, is among a family of drugs that has been issued a "black box" warning from the FDA - the most severe warning given to medications on the market - due to an increased risk of tendon rupture and tendonitis.
Levaquin Side Effects Reported to FDA
The U.S. Food and Drug Administration (FDA) will require certain popular antibiotics to carry a "black box" warning on all labels alerting patients and doctors of potential tendon ruptures and tendonitis. This is the harshest warning the FDA can issue without demanding a recall.
All fluoroquinolone drugs, which include the popular medications Cipro, Levaquin, Avelox, Noroxin and Floxin, will be required to carry warning labels and distribute a medication guide alerting patients of possible risks.
The warning came after the FDA was sued by consumer watch group Public Citizen, which had previously asked in 2006 that the medications carry the black box warning.
Although the organization is pleased with the FDA requirement, they are concerned the FDA may not be protecting consumers to the best of its ability from unnecessary tendon rupture.
Tendon rupture and tendonitis can occur once in about 100,000 patients, however fluoroquinolone drugs can increase the risk three to four times according the FDA. Patients who are over 60, or who have had a kidney, lung or heart transplants are more at risk, however ruptures have occurred in all ages groups.
Ruptures most frequently involve the Achilles tendon, although ruptures have been reported in the biceps, shoulder, hand and thumbs, according to the FDA. Often patients do not have symptoms prior to a rupture.
The FDA has advised patients to quit taking the antibiotics if they show signs of tendon pain, avoid exercise and contact their doctor.
Do You Need Legal Advice Regarding Levaquin?
Oftentimes, patients pursue a Levaquin lawsuit to seek monetary compensation to cover medical treatments due to tendon rupture or tendonitis. If you or a loved one has questions regarding a potential Levaquin law suit, you may contact one of our experienced Levaquin law firms. A Levaquin lawyer can provide you with updates on Levaquin side effects or a possible Levaquin recall. Contact a Levaquin attorney using the form at the top of the page.
