Proquin XR

Proquin XR Linked to Tendinitis & Tendon Rupture - FDA Issues “Black Box” Warning

On July 8. 2008 the U.S. Food & Drug Administration (FDA) notified all manufacturers of fluoroquinolone antimicrobial drugs including Proquin XR (ciprofloxacin extended release) that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

All fluoroquinolone antimicrobial drugs are affected by this warning (not recall) and are as follows:

• Cipro and (ciprofloxacin)
• Cipro XR and Proquin XR (ciprofloxacin extended release)
• Factive (gemifloxacin)
• Levaquin (levofloxacin)
• Avelox (moxifloxacin)
• Noroxin (norfloxacin)
• Floxin (ofloxacin)

Background

Public Citizen: As far back as August 29, 2006 Public Citizen and the Illinois Attorney General petitioned the FDA to add a black box waring to Proquin XR.

“The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The FDA must act and require black box warnings and patient information guides.”
Public Citizen’s petition follows a 1996 petition the nonprofit group filed seeking a warning on the label of Proquin XR. The FDA that year granted the petition, but the warning is buried in the list of possible adverse reactions and so has been inadequate.

In April 2005, the Illinois Attorney General’s office petitioned the FDA to place a black box warning on Proquin XR, but the FDA has never responded substantively to the petition. A black box warning is in bold type and surrounded by a black box to make it stand out.

Link to 2006 Petition: http://www.citizen.org/pressroom/release.cfm?ID=2262

FDA Black Box Warning Letter

On July 8. 2008 the U.S. Food & Drug Administration (FDA) notified the manufacturers of Proquin XR that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks.

“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. “The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysis reconfirms that use of Proquin XR is associated with an increased risk of tendon rupture. It also demonstrates that despite the current warning of tendon rupture in the labeling for Proquin XR, large numbers of tendon-related adverse events continue to be reported.

Link to FDA Black Warning: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.html

Do I Have a Lawsuit?

If you or a loved one have taken Proquin XR and suffered an adverse event such as Tendonitis or Tendon Rupture, you should contact and Injury Help Network attorney immediately. You may be entitled to compensation by filing a lawsuit and law firms can help.

Please use the form below to contact a Proquin XR lawyer for a free confidential case evaluation. You may also call toll free 24 hrs/day (866) 879-3040.