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Drugs & Devices > Levaquin

Generic Name:  Levofloxacin

Levaquin, manufactured by Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals, Inc., has been linked with side effects that could increase risk of tendon ruptures and permanent damage of the tendon.

What Is Levaquin?

Levaquin (levofloxacin) is an antibiotic that is part of a group of drugs known as fluoroquinolones. It is prescribed to prevent infection by stopping the reproduction of bacteria.  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.

Approved by the FDA in December 1996, Levaquin has become one of the more commonly prescribed antibiotics. In 2005, annual sales exceeded $2.3 billion.

Serious Side Effects of Levaquin

If you experience any of the following serious side effects of Levaquin (Generic: levofloxacin), seek emergency medical attention or contact your doctor immediately.

The use of Levaquin has been associated with an increased risk of tendon ruptures, tendon damage and tendonitis, which has left many users permanently disabled after taking the drug.  Ortho-McNeil has stated that taking Levaquin may cause ruptures of the shoulder, hand, thumb, or Achilles tendon. Some researchers 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.

If you or a loved one have been injured from the dangerous side effects of Levaquin, contact us immediately at 1-800-214-1600 or fill out the free case evaluation form for an immediate review of your case.

FDA Issues Black Box Warning For Levaquin:

In July 2008, the FDA announced that the makers of all fluoroquinolone antibiotics, including Levaquin, will add more prominent language about the risk of tendon damage to a “black box” on the label. In addition, the manufacturers will provide a medication guide which better informs users about the potential side effects of the drugs, and that they should consult with a doctor at the first sign of tendon pain.

In August 2006, the consumer advocacy group Public Citizen filed a petition with the FDA requesting that these stronger warnings be provided, but the drug makers and FDA failed to take steps at that time to warn users. In January 2008, a Levaquin lawsuit was filed against the FDA alleging that their petition had been ignored.

Risk of Tendon Rupture from Levaquin

The risk of tendon ruptures has been associated with all fluroquinolone antibiotics, but the risk appears to be greater with Levaquin. According to reports received by the FDA, Levaquin tendon ruptures accounted for 61% of all fluoroquinolone-associated ruptures between November 1997 and December 2005. However, the drug only accounted for about 45% of all prescriptions written for fluoroquinolones during that time.

A tendon rupture is a very painful injury that often requires surgery to repair the tendon damage. Symptoms associated with a Levaquin induced tendon rupture could include swelling, inflammation or pain.  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.

The most frequently ruptured tendon with Levaquin is the Achilles tendon, in the heel. However, reports have also indicate Levaquin side effects could cause tendon ruptures of the shoulder, biceps, hand and thumb.  The risk of Levaquin tendon rupture side effects is said to be higher among those who are 60 years of age or older.  This risk is further increased in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy.

Lawsuits filed on behalf of Levaquin users who have suffered tendon ruptures or tendon damage allege that Johnson & Johnson failed to provide adequate warnings about the potentially debilitating side effects of their antibiotic. The claims indicate that if consumers and the medical community had been properly informed of the Levaquin tendon side effects, actual ruptures may have been prevented.

All Levaquin tendon rupture lawsuits filed in federal court have been consolidated and centralized in the U.S. District Court for the District of Minnesota before Judge Tunheim for pre-trial litigation as part of a procedure known as an MDL, or multidistrict litigation.

Under the federal procedure, the cases are all handled together to during discovery and pretrial litigation to efficiently move the mass tort cases through the court system. The MDL rules normally require that cases be returned to the original jurisdiction where they were filed for trial.

In pharmaceutical litigation involving claims for drug side effects, the first trials scheduled are considered “bellwether” cases, which are selected to be representative of the issues which will be presented throughout the litigation, and to help establish potential values for various groups of similar cases.

Woman Says Levaquin Caused Tendon Damage
A 31-year-old woman is suing Johnson and Johnson, Ortho-McNeil Pharmaceuticals Inc. and Johnson and Johnson Pharmaceutical Research and Development LLC, claiming that she suffered from Achilles tendonitis after taking Levaquin, an antibiotic that is marketed as a first-line therapy for common bronchitis and sinusitis infections... Read More
Levaquin Linked to Tendon Damage
Texarkana, AK – Three recent lawsuits filed in East Texas and West Arkansas state that antibiotic Levaquin causes a higher rate of tendon injuries... Read More
J&J, Ortho-McNeil and Walgreen Sued over Levaquin
Twenty plaintiffs are suing the makers and seller of Levaquin, an antibiotic used to treat various infections, for violating the Consumer Fraud Act. Four lawsuits have been filed against the companies... Read More

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