Levaquin, also known as Levofloxacin, is a fluoroquinolone antibiotic made by Orth-McNeil. It is used to treat a multitude of infections including pneumonia, skin infections, and urinary tract infections. In fact, it is the only respiratory fluoroquinolone that the Food and Drug Administration approves for use in cases of nosocomial pneumonia. It was released in 1993 after fifteen years of testing proved it to be safe.
As with most medication, Levaquin has some side effects, although it is believed to be generally well tolerated. Some of the more common side effects are nausea, diarrhea, itching, abdominal pain, dizziness, flatulence, rashes, and vaginitis (in women). Some patients may experience blistering sunburns after being exposed to sunlight or the ultraviolet light from tanning salons. Your doctor will suggest that if you suffer any severe side effects, that you immediately quit taking Levaquin and contact him or her.
Now, some groups think that Levaquin may cause serious tendon damage as one of the side effects. Ortho-McNeil has stated that taking Levaquin may cause ruptures of the shoulder, hand, thumb, or Achilles tendon. They suggest in their literature that if you develop pain, swelling, or rupture of a tendon, that you quit taking Levaquin and immediately contact your doctor. Scientists are not sure why some patients taking this drug suffer ruptures, but believe it may be because the drug is toxic to tendons and decreased the blood supply to areas that are already receiving a limited amount of blood.
On July 8, 2008, the Food and Drug Administration (FDA) ordered Ortho-McNeil to put a “black box” warning on Levaquin warning patients of the potential risks as well as creating literature that stresses the risks associated with taking Levaquin. But, the FDA allowed the drug to remain on the market and did not issue a recall.
But, is the warning too late for some? The Public Citizen and Illinois Attorney General tried to get the FDA to add the “black box” warning on Levaquin in August 2006. An earlier petition had been filed in 1996 by a nonprofit group, asking for the same warnings. While the FDA did grant the 1996 petition, the chance of ruptures was merely added to the list of possible side effects and not emphasized as a serious risk. The FDA has stated that the benefits of the class of fluoroquinolone drugs like Levaquin outweigh any potential risks.
While it is believed that patients and doctors may be able to prevent the tendon ruptures with awareness of early warning signals such as tendon pain, there are still a large number of patients taking Levaquin who are reporting this problem. An FDA database shows reports of 262 cases of tendon ruptures, 259 cases of tendonitis, and 272 cases of additional tendon disorders. Of the cases reported to the FDA, 61% of the patients were taking Levaquin.
If you have been taking Levaquin and feel you have suffered tendon damage due to the drug, you may want to contact a lawyer to see what legal recourse you have.