Levaquin Lawsuits Due to Disabling Achilles Tendon Ruptures

May 22nd, 2009

In 1997, Levaquin, manufactured by Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals, Inc., was approved by the FDA. In 2006, Public Citizen, a citizen advocacy organization, delivered the message to the FDA that a black box warning was needed for Levaquin due to disabling tendon injuries. In July 2008, the FDA demanded that a black box warning be added to the manufacturer’s label. To date, there has not been a Levaquin recall. As Richard Schulte, Attorney at Law, of Dayton, Ohio explains, “The adverse effects of Levaquin may affect the young or the old. It might be a middle aged man with an Achilles tendon rupture that is extremely painful and necessitates a long painful recovery, a youth that may no longer participate in years to come of sporting activities and may be faced with multiple surgeries.” In fact, attorneys have documented bi-lateral Achilles tendon ruptures in those that do not participate in sports which is highly uncommon. As Schulte adds, “Attorneys are concerned that information about the drug was withheld by the manufacturer which prevents doctors from providing accurate risks and benefits information to patients. This disrupts the informed consent process that is crucial for appropriately balanced information.” Other recent injuries reported that are suspected to be associated with Levaquin include: rotator cuff, biceps and hand injuries.

Levaquin Side Effects
• Tendonitis
• Achilles tendon rupture
• Inflammation
• Swelling of the tongue or face
• Hallucinations, nightmares
• Difficulty breathing
• Chest pain
• Vision impairment
• Skin blistering

Levaquin is in a class of drugs called fluoroquinolones. Levaquin is prescribed for the treatment of bacterial infections of the lung, nose, skin, and urinary tract. There have been reports that its’ level of toxicity is far greater than other similar drugs. Select personal injury attorneys are taking on cases to help victims of Levaquin harm to receive financial compensation for their injuries and help better protect the public from pharmaceuticals like Levaquin. As Kate Gillespie, Attorney at Law, of Los Angeles, California explains, “There will be pharmaceutical drugs like Levaquin that injury people. The only means to alleviate the strains caused by such drugs is to have greater support from the government so the FDA has the ability to promptly stop drugs like Levaquin from reaching the public, attorneys that are willing to withstand the years of litigation required for lawsuits to better protect the public, and injured victims that are willing to stand up for their rights.”

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Warning on Tendon Injuries with Fluoroquinolone Antibiotics

February 27th, 2009

Video originally created by FDA -- posted by Lawsuit.com on November 18, 2008

October 2008- FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture. Fluoroquinolones include Cipro (ciprofloxacin), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin) and Proquin (ciprofloxacin hydrochloride).

FDA is concerned that large numbers of tendon problems were continuing to be reported, despite a warning that already appears in the labeling for these drugs. The boxed warning is being added to draw the practitioner’s attention to this information. This can also affect the benefit-risk decisions that are made when these drugs are prescribed.

Certain patients are at greater risk for these injuries, including those over 60, those taking corticosteroids, and patients who have had heart, lung or kidney transplants. Certain tendons are also more likely to be affected. The Achilles is the most commonly affected, but other tendons can also be involved, including those in the rotator cuff, the biceps, the hand and the thumb.

It is important to remember that the risk for injury is not necessarily gone when the drug is stopped. Cases have been reported in which tendon problems occurred up to several months after the drug was discontinued. Also, this increased risk of tendon problems applies only to patients who are getting fluoroquinolones systemically; patients taking eye drops or ear drops are not affected.

Fluoroquinolones may be associated with serious risks other than tendinitis and tendon rupture. These risks are rare but may include convulsions, hallucinations, depression, heart rhythm changes, and serious allergic reactions.

Since fluoroquinolones are vital drugs in treating certain bacterial infections, the practitioner may decide that the benefits of the drug outweigh the risk for a given patient. In these cases, the practitioner should caution patients to watch out for pain, swelling or inflammation in a tendon area, because that could signal tendinitis, and to know the signs and symptoms of a tendon rupture.

If patients experience any of these things, they should avoid using or exercising that area of the body, stop the drug, and see their doctor about the possibility of switching to another type of antibiotic. It is important that patients understand what to look for and what to do, so FDA has asked the manufacturers of fluoroquinolones to develop a Medication Guide containing this information, which will be given to the patient with each prescription.

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