LAWSUITS NEWS & LEGAL INFORMATION

Levaquin and Peripheral Neuropathy FAQ

What is Levaquin?

Levaquin belongs to a class of antibiotics called fluroquinolones and is prescribed to millions of people each year. It is a powerful medication prescribed to treat certain bacterial infections, including pneumonia, bronchitis, sinus, skin, and urinary tract infections.

Fluoroquinolones were originally designed and approved for serious infections that do not respond to traditional antibiotic therapy. Levaquin was originally approved by the FDA in 1996, but since then it has also obtained approval for routine infections that do not warrant such powerful and dangerous antibiotics, and for more specific uses, including for the treatment of certain strains of pneumonia.

Levaquin was also approved for use to fight anthrax, which was the disease that was the subject of several public health scares in recent years.

Are there any Levaquin risks involved?

According to the Levaquin website, and a number of Levaquin lawsuits, fluroquinolones—including Levaquin—are associated with an increased risk of Levaquin tendon rupture and Levaquin tendon problems, such as swelling of the tendon (tendinitis) in all ages. This risk is higher if you are over 60 years of age, are taking steroids (corticosteroid drugs), or if you have a kidney, heart, or lung transplant.

The FDA has received reports from Levaquin users suffering ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability.

I just started taking Levaquin. Should I be worried about Levaquin tendon problems or Levaquin torn tendons?

Tendon rupture can happen while you are taking Levaquin or up to several months after you have finished taking it. Health professionals advise that you get medical help right away if you hear or feel a snap or pop, have severe pain, rapid, or immediate bruising after an accident, or are unable to use the affected area.

What are the Signs and Symptoms of Tendon Rupture?

The tendon most frequently associated to the Levaquin induced ruptures is the Achilles tendon, however Levaquin has also been linked to tendon ruptures in the rotator cuff (shoulder), the biceps, the hand, and the thumb.

Rupture of the Achilles tendon is a severe and serious side effect associated with Levaquin. Symptoms often associated with an Achilles tendon rupture are sudden and severe pain; swelling and bruising; and difficulty walking. If you rupture your Achilles tendon, you must undergo invasive surgery to repair the tendon, followed by (generally) several months of intense physical rehabilitation in order to regain the full range of motion and the ability to move around normally.

I have been taking Levaquin for several weeks. Should I stop taking it?

Before discontinuing any medication, talk with your doctor first. You should watch for any swelling, pain or redness in the joint areas, particularly near the heel, and a more severe problem could be indicated by the loss of any range of motion in those areas of the body.

Are there other Levaquin side effects?

Yes. Levaquin medication can cause side effects that may be serious or even cause death. Here are possible Levaquin side effects (from the Levaquin label):

• Liver damage
• Central nervous system side
• Serious allergic reactions
• Damage to nerves
• An intestinal infection (pseudomembranous colitis)
• Serious heart rhythms changes
• Changes in blood sugar (low blood sugar levels or high blood sugar levels)
• The most common side effects include: nausea, headache, diarrhea, constipation, and dizziness

What steps has the government taken to protect the public from Levaquin side effects?

In 2006, Public Citizen filed a petition with the FDA, requesting that stronger warnings be issued regarding Levaquin tendon rupture side effects. The consumer protection group then filed a federal lawsuit asking the court to require the FDA to act on their petition-- requesting that new warnings be added about side effects of antibiotics--in accordance with the Administrative Procedure Act.

In January 2008, Levaquin lawyers, on behalf of Public Citizen, filed a lawsuit against the FDA in an attempt to compel the agency to order the Levaquin manufacturer, Ortho-McNeil, to include a warning on the Levaquin label regarding the risk of tendon ruptures and other tendon injuries.

In July 2008, the Food and Drug Administration (FDA) ordered that Ortho-McNeil place a black box warning on its Levaquin medicine about the increased risk of developing tendonitis and tendon rupture in patients taking fluoroquinolones.

What can I do if I’ve been harmed by Levaquin?

Contact a Levaquin attorney who can determine whether you have grounds for a lawsuit. As well, experienced Levaquin lawyers can inform you of your egal rights and options, as well as their chances at succeeding in a lawsuit.

Have any Levaquin lawsuits been filed?

Yes, many. Levaquin lawsuits allege that Ortho-McNeil Pharmaceutical did not provide adequate warnings to doctors and patients about the possibility of the drug causing such severe Levaquin side effects.

In September 2008, all federal Levaquin lawsuits were consolidated in an MDL before Judge John R. Tunheim in the U.S. District Court for the District of Minnesota.

A proposed class action lawsuit was filed against Johnson & Johnson and Ortho-McNeil, by a 31-year old woman in East Texas. Lisa Presley, who filed the suit, alleges that during her treatment with Levaquin she began to experience tendonitis and that her resulting injuries became severe and are now permanent.

The suit also argues that, although Levaquin contained a warning regarding the risk for tendon injury and rupture, and included warnings concerning the increased risk for serious side effects if used in conjunction with corticosteroids, the labeling did not accurately portray the risks.

The lawsuit is claiming negligence, strict product liability for manufacturing and/or design defect and for failure to warn, breach of express and implied warranties for the design, manufacture, production, testing, study, inspection, labeling, marketing, advertising, sales, promotion, and distribution of the drug, fraud, unjust enrichment and violation of consumer protection laws.

According to a separate lawsuit filed against Johnson & Johnson, Levaquin can cause a number of problems with Achilles tendons. Such issues have resulted in 1,044 reports of tendon problems, with 282 reports of tendon ruptures from 1997 through 2005 for users of the medication.

Have there been any successful Levaquin Lawsuits?

Yes. To date lawyers have obtained settlements for a number of Levaquin victims and their families to compensate them for their injuries.