What Levaquin Can Tell Us about the FDA's Adverse Events Reporting System

Did you or a loved one take the drug Levaquin (generic name Levofloxacin) and experience a tendon rupture, severe joint or muscle pain, or a psychotic episode? If so, you may be one of the thousands of Americans who has suffered from an adverse drug reaction to fluoroquinolones, popular antibacterial drugs used to treat serious bacterial infections.

Levaquin is one of the most popularly prescribed fluoroquinolones, known as quinolones for short. In 2010, sales of Levaquin totaled $1.3 billion, and in the first quarter of 2011 alone, the drug has generated $422 million in revenue for Ortho-McNeil-Janssen, its manufacturer.

In 2008, the Food and Drug Administration (FDA) required all manufacturers of quinolones to add a black box warning about the risk of patients developing tendonitis or a tendon rupture after taking the drug. The black box warning is the most serious action the FDA can take on a drug, short of pulling the drug off the market completely.

Researchers are unsure why so many people have experienced tendon ruptures while on Levaquin, but some argue that because the drug is initially tested on only a small percentage of the general population, more adverse effects like this do not show up until the general public also starts taking the medication.

Perhaps even scarier for consumers is the fact that the United States has no accurate way to track adverse drug reactions. Although the FDA has an Adverse Events Reporting System (AERS) for tracking adverse drug reactions, the system catches only an estimated 10 percent of these reactions. That means a staggering 90 percent of all adverse drug reactions go unreported, which means that the number of deaths due to adverse drug reactions also goes unreported. Researchers estimate that adverse drug reactions are the fourth leading cause of death and that between 1997 and 2010, nearly 2500 deaths were caused by or linked to quinolones.

In a recent report on PBS's News Hour, the FDA commented on quinolones, saying there is "no ‘common thread' of negative evidence that would lead the agency to remove quinolones from the market." But even with the black box warning, patients who are prescribed these drugs may not fully understand the risks because they are usually unaware of these warnings. In fact, serious warnings like this may not be provided in the information given to patients.

Even more troublesome is the fact that quinolones are being overprescribed to patients who do not have serious bacterial infections. When this happens, these powerful drugs can cause severe damage to patients.

Plaintiffs across the country have brought claims against Ortho-McNeil-Janssen and its parent company Johnson & Johnson for failing to properly warn them that the drug could cause tendon ruptures. In one case, Johnson & Johnson was forced to pay $1.1 million in punitive damages after the jury found that the company acted with deliberate disregard for the safety of patients taking the drug.

Many patients who have taken the drug have reported not only tendon ruptures, but also severe joint and muscle pain, which has kept them from living their once active lives. Some patients have even had to quit their jobs and have lost their homes because they are unable to work. Others have reported having psychotic episodes within the first few days of taking the drug.

Despite all of the problems that have been reported with Levaquin, the FDA has recently given 12 manufacturers approval to market a generic form of Levaquin. If the generic form of the drug ends up causing as many adverse drug reactions as Levaquin has, patients taking the generic form who suffer from an adverse reaction will have no recourse against the generic manufacturers in a state tort action, thanks to the recent Supreme Court decision in Pliva, Inc. v. Mensing.

We can't reverse the pain that some consumers have suffered from taking Levaquin, but we can learn from these adverse reactions and develop a system that accurately tracks adverse drug reactions.

If you or a loved one has taken Levaquin and has suffered from a tendon rupture or severe joint and muscle pain, contact consumer advocate and dangerous drug attorney Kay Van Wey today by calling 800-489-5082 or 214-329-1350.

Don't hesitate to contact Kay Van Wey at (800)489-5082 for a free, no obligation consultation.

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