Cipro and Levaquin Black Box Warning added by FDA
On Tuesday, the FDA announced that they are requiring the makers of fluoroquinolone antibiotics, such as Cipro and Levaquin, to add a black box warning about an increased risk of tendinitis and tendon ruptures. They are also requiring that patients receive a Medication Guide highlighting the possible tendon side effects. The lawyers at Saiontz & Kirk, P.A. have been investigating potential Cipro and Levaquin lawsuits against the manufacturers as a result of their failure to warn about the risk of the debilitating tendon ruptures. The failure to provide this detailed warning sooner has likely resulted in thousands of preventable and unnecessary injuries.
>>FDA LINK: Cipro and Levaquin Black Box Warning
The warnings apply to fluoroquinolone antimicrobial drugs, which are prescribed for treatment or prevention of infections caused by bacteria. The increased risk of tendon ruptures and tendon damage have been associated with the following drugs:
- Levaquin (levofloxacin)
- Cipro and generic ciprofloxacin
- Cipro XR (extended release ciprofloxacin)
- Proquin XR (extended release ciprofloxacin)
- Factive (gemifloxacin)
- Avelox (moxifloxacin)
- Noroxin (norfloxacin)
- Floxin and generic ofloxacin
PRIOR REQUESTS FOR CIPRO AND LEVAQUIN BLACK BOX WARNING
In August 2006, the consumer group Public Citizen filed a petition with the FDA requesting the black box warnings for Levaquin, Cipro and the other antibiotics, about the risk of tendon ruptures. At that time, they also urged the FDA to require that all patients receive a pamphlet with every bottle describing the risk so that users would know they should immediately stop using the drugs and contact their doctors if they experience symptoms of a tendon rupture, such as pain or inflammation.
Because the FDA failed to act on Public Citizen’s petition for two years, the consumer advocacy group filed a lawsuit against the drug regulatory agency in January 2008, alleging that their petition had been ignored. The lawsuit indicated that providing patients with more detailed information about the risks could allow them to substantially reduce the risk of a tendon rupture by discontinuing the medication if problems developed.
TENDON RUPTURE BLACK BOX WARNING
In yesterday’s announcement, the FDA indicated that a new analysis confirmed that the use of Cipro, Levaquin and other fluoroquinolone antibiotics is associated with an increased risk of tendon rupture. Although the warning labels already contained information about the possibility of tendon ruptures, large numbers of tendon problems continue to be reported, causing the FDA to finally require the “Black Box” tendon rupture warning and patient information guide.
A “Black Box” warning is the strongest warning that can be placed on a prescription medication. The new language will be placed prominently on the label in a bold black box, indicating that the drug has been associated with an increased risk of tendonitis and tendon rupture. It will also indicate that the risk could be increased among those over age 60, in kidney, heart and lung transplant patients, and with the use of concomitant steroid therapy.
The FDA has indicated that users should be urged to watch for signs of tendon pain, swelling or inflammation. Physicians have been instructed to tell their patients that if tendon problems develop they should call their doctor, stop taking the antibiotic, avoid exercise and use of the injured area. Taking these steps could help avoid an actual rupture of the tendon, which often requires surgical repair and results in permanent injury.
CIPRO AND LEVAQUIN TENDON RUPTURE LAWSUITS
The lawyers at Saiontz & Kirk, P.A. are reviewing Cipro lawsuits, Levaquin lawsuits and other legal claims for users of fluoroquinolone antimicrobial drugs who experience a tendon rupture. The problems most frequently involve the Achilles tendon, but reports of ruptures have also been seen in the shoulder, the hand, the biceps and the thumb.
To review a potential claim and determine if financial compensation may be available for a ruptured tendon, request a free consultation and claim evaluation.