ALERT: Antibiotic Levaquin Linked to Peripheral Neuropathy, Tendon Injury
November 2015: Health regulators are growing increasingly concerned about the serious side effects associated with Levaquin and other fluoroquinolone antibiotics, including peripheral neuropathy and tendon injury. On November 6th, the U.S. Food & Drug Administration (FDA) convened a joint meeting of its Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the safety of Levaquin and other fluoroquinolone antibiotics in the treatment of sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary disease. The committees ultimately voted 21-0 to recommend stronger warnings for sinusitis; 18-2, with one abstention, on bronchitis; and 20-1 regarding urinary-tract infections. While the FDA is not required to enact the recommendations of its advisory panels, it usually does so.
What are Fluoroquinolone Antibiotics?
Fluoroquinolone antibiotics are used to treat a wide range of bacterial infections. Drugs in this class include:
- levofloxacin (marketed as Levaquin)
- ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
- ciprofloxacin extended release (Cipro XR and Proquin XR)
- moxifloxacin (marketed as Avelox)
- gemifloxacin (marketed as Factive)
- norfloxacin (marketed as Noroxin)
- oxfloxacin (marketed as Floxin and generic ofloxacin)
Levaquin and Peripheral Neuropathy
Since 2004, the labeling for Levaquin and other fluoroquinolone antibiotics has noted peripheral neuropathy as a potential side effect. However, in 2013, the FDA ordered the drugs’ manufacturers to strengthen those warnings after the agency determined that the labels did not adequately describe the potential for rapid onset of the condition or the possibility of permanent nerve damage.
“The onset of peripheral neuropathy after starting fluoroquinolone therapy was rapid, often within a few days. In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms,” the FDA noted.
Signs and Symptoms of Peripheral Neuropathy
Peripheral neuropathy is a type of nerve damage that affects the nerves that send sensory information back to the brain and spinal cord. The peripheral nerves also carry signals from the brain and spinal cord to the muscles to generate movement. Damage to the peripheral nervous system may result in the following signs and symptoms:
- Change in sensation to light touch, pain or temperature, or the sense of body position
According to the FDA, peripheral neuropathy associated with the use of Levaquin and other fluoroquinolones can occur at any time during treatment and can last long after the drug is stopped or be permanent. Levaquin patients who develop any symptoms of peripheral neuropathy should tell their health care professionals right away.
Levaquin and Tendon Injuries
July 2008: The FDA is notifying manufactures of fluroquinlolone antimicrobial drugs (Levaquin, Cipro and others) that they need to add a Boxed Warning to the product’s labeling that warns consumers of the increased risk of tendonitis and tendon rupture in patients who take these drugs. The FDA also asked drug companies to provide patients with a Medication Guide that describes these potential Levaquin side effects. The strengthened FDA warnings apply to fluoroquinolones for systemic use (e.g., pills, tables, capsules and injectable formulations).
What are the Signs and Symptoms of Tendon Rupture?
Tendons connect your muscles to your joints. Tendinitis and tendon rupture most frequently involve the Achilles tendon (back of your ankle), but have also been repoted in the shoulder (rotar cuff), the hand, the biceps, and the thumb. Serious cases oftendor rupture may require surgical repair.
The FDA reports that the risk of developing fluoroquinolone-associated tendonitis and tendon rupture is higher in patients who are over the age of 60, those who are taking steriods (corticosteriods) and in kidney, heart and lung transplant recepients.
Symptoms of Tendon Rupture May Include:
- pain, swelling or inflammation in a tendon area
- a snap or pop in a tendon area
- bruising right after an injury in a tendon area
- inability to move the affected area or bear weight
Patient Reports of Tendon Rupture to the FDA
Between November 1997 and December 2005, the FDA received reports of 262 cases of tendon ruptures, 258 cases of tendonitis, and 274 cases of other tendon disorders associated with the use of fluoroquinolone antibiotics, with 175 of those occurring since the beginning of 2003. From January 2006 through March 31, 2007 the FDA adverse events database received 74 additional reports of tendon ruptures, for a total of 336 cases of tendon rupture reported since November 1997.
Injured by Levaquin?
If you were injured by a fluoroquinolone antibiotic, contact Bernstein Liebhard’s experienced Levaquin attorneys to learn more about your legal rights. Free and confidential case evaluation can be obtained by calling (877) 779-1414 or by clicking here.
About Bernstein Liebhard
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