Levaquin Recall Lawsuit And Side Effects

Levaquin (levofloxacin) is a fluroquinolone antibiotic used to treat bacterial infections (such as skin infection, respiratory tract, sinus, urinary tract infection, pneumonia, chronic bronchitis, and kidney infection). Levaquin is manufactured by Ortho-McNeil Pharmaceuticals, and was approved by the FDA in 1997. Levaquin is only available with a prescription.

Levaquin has been linked to tendon ruptures, damage and other injuries. As of this writing, 794 cases have been reported to the FDA (and these may make up only 10%).
Complications from taking Levaquin can include tendon damage, tendon injury, Achilles tendon, inflammation, tendon rupture, tendonitis, and injury to the rotator cuff (shoulder), biceps, hand and thumb. These injuries can leave patients incapacitated, in need of extensive surgery, and incurring large medical bills.

There has not been a recall on Levaquin yet. In 2006, the consumer advocacy group Public Citizen petitioned the FDA to add black box warnings (this is the strongest warning that is can be placed on prescription medicine) to the labels. When the FDA declined, Public Citizen filed a federal lawsuit asking the court to require the black label warning. On July 8, 2008, the FDA finally ordered the manufacturer to add the black box warning. They have also required that a guidebook be provided to patients warning about the possible side effects. These blackbox warnings apply to pills, tables, capsules and injectable formulas.

Levaquin side effects have been reported by the FDA. Side effects include Achilles ruptures, tendon ruptures in the biceps, shoulder, hand and thumb. The FDA has advised people taking Levaquin to discontinue use at the first sign of pain. If you have had trouble walking, bruising or swelling in a tendon area, severe pain that comes on suddenly, or inability move or bear weight, you may have a claim.

According to the FDA database: 262 reported cases of tendon ruptures, 274 cases of other tendon disorders, 259 cases of tendonitis, 61% of tendon ruptures caused by Levaquin. Tendon rupture is higher in patients over age 60 (especially those taking steroids). These numbers are expected to continue to grow.

How do you know if you have had a Tendon Rupture? Some symptoms of a Tendon Ruptures include: an inability to move, bruising in the affected area, popping or snapping sound in the tendon area, or severe pain or swelling in the tendon area.
Tendon ruptures associated with Levaquin could be prevented if the public were more aware of the early warning signs and switched to a safer antibiotic.

On July 8, 2008, The FDA ordered the manufacturer of Levaquin, Ortho McNeil, to place a black box warning on the drug. A black box warning (also referred to as a black label warning or boxed warning) is the strongest warning available for prescription drugs. Such a warning means that the drug carries significant risk.

Although Levaquin has not yet been recalled, the FDA has also ordered Ortho McNeil to provide a guidebook to patients with information about the possible side effects associated with Levaquin.

Many Levaquin users are wondering if there is a Class Action lawsuit against the manufacturer, Ortho-McNeil Pharmaceuticals. Currently, Levaquin lawsuits are being filed by individuals and families throughout the United States. No class actions have been filed, however that may change given the potential number of victims and the fact that the drug is still being prescribed.

Multidistrict litigation and class action litigation may ultimately be the answer in order to efficiently handle the growing number of cases. People who have suffered injuries from taking Levaquin should be treated fairly and compensated for their losses (whether it be medical bills, lost wages, loss of quality of life and independence, or pain and suffering).

By:
Shirley Mayer

Elizabeth Seiler is author of this article on Levaquin Lawsuit. Find more information about Levaquin Ruptured Tendon here.