Levaquin (also known as levofloxacin) is a popular antibiotic that has been used for years for the treatment of upper respiratory infections, urinary tract infections, prostatitis, and bacterial infections.  It is part of a class of drugs known as fluoroquinolones, which were first marketed in the United States in 1997.  The fluoroquinolone class of drugs also includes the widely-prescribed antibiotics Cipro, Floxin, and Noroxin.  There have also been some notable fluoroquinolones that have been withdrawn from the market due to safety concerns, including Trovan (liver failure); Omniflox (low blood sugar; kidney failure, and anemia); Raxar and Zagam (prolonged QT syndrome); and Tequin (severe blood sugar reactions).

For several years, there have been rising concerns about adverse events associated with use of fluoroquniolones, especially Levaquin.  According to documents filed in the Levaquin litigation, being coordinated in the United States District Court in Minnesota, the Japanese company (Daiichi Pharmaceutical Co. Ltd.) that developed both Levaquin and Floxin knew prior to approval of Levaquin for sales in the United Sates that the drug was likely to cause Achilles tendon ruptures . This risk was well documented in the early years after introduction as it was marketed throughout Europe and began to cause harm to patients.

The warning label for Levaquin has included mention of the possibility of tendon ruptures in the past, but such labels were obscure and never adequately warned patients or prescribing physicians of the magnitude of the risk or the fact that Levaquin was more toxic than other, similarly effective drugs.  Other than placing a warning in December of 2001, based on postmarketing surveillance reports in the PDR, indicating that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly, the manufacturer did not provide any special label precautions. The manufacturer fell far short in their warnings, regarding the higher risks faced by older patients or those concomitantly taking steroids.

This is most unfortunate because deleterious effects of fluoroquinolones on tendons have been well documented since the 1980s .

Finally, in 2008, after more than 1,000 reports of serious tendon injuries and ruptures to the FDA, a Black Box warning (the highest level of warning) appeared on the label confirming that patients taking Levaquin are at greater risk for suffering a ruptured Achilles tendon.   Unfortunately, the label still fails to alert physicians and patients that Levaquin is more toxic than other similar drugs .

Levaquin is particularly risky for patients who are over the age of 60 and taking corticosteroids at the same time as Levaquin.  Studies conducted by the manufacturer  indicated that Levaquin was more toxic than Cipro; for example the study that Ortho McNeil completed in 2001, one that Johnson & Johnson completed in 2006 and another By Johnson & Johnson completed in 1993. Unfortunately, none of the studies conducted by these manufacturers were published in any noted journals . Undoubtedly, if this information were known to physicians in the Untied States, prescribers would have evaluated the risk differently and chosen one of a number of other antibiotics for treatment of their patients. As a result, doctors might have avoided subjecting their patients to the unnecessary pain and suffering associated with an Achilles tendon rupture and a host of other adverse events.

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Merck’s nightmare over Vioxx continues.  This is one that has cost the company dearly – on Wall Street, among physicians, in scientific circles, in the judicial system, and in the court of public opinion.  The latest blow came from the New England Journal of Medicine which published additional information regarding the APPROVe study, one of two studies that led to the recall of Vioxx in September of 2004.  This study included 2,586 patients who ingested Vioxx or a placebo.  After three years of use of these drugs, the study concluded that Vioxx users had a 3.6% incidence of thrombotic events (heart attacks and strokes) versus a 2% incidence in the placebo group.  The study further concluded that the increased risk of heart attacks and strokes associated with Vioxx emerged after just 18 months of use. 

As has been highly publicized, more than 50,000 patients who suffered heart attacks, strokes or died after ingesting Vioxx are now participating in a nearly $5 billion settlement program being administered through the federal court in New Orleans.  This settlement was announced after more than a year of secret negotiations and more than a dozen trials.  Just prior to announcement of the settlement, Merck faced the prospect of spending far more than $5 billion in order to continue its win-at-all-costs litigation tactics.  The Vioxx claims were submitted to a Claims Administrator over the Summer and partial payments began in August of 2008.  It is expected that all of the qualifying Vioxx claimants should have their claims reviewed and paid in full within the next 18 months.

A novel lawsuit is winding its way through the courts in St. Louis.  Thirty Missouri hospitals are pursuing claims against Altria (the parent company of Phillip Morris) and other tobacco manufacturers for the costs of medical care provided to patients with tobacco-induced diseases who were uninsured or unable to pay for their treatment.  The lawsuit has been pending for more than a decade and has had many twists and turns along the way.  Initially, the plaintiff hospitals sought more than $8 billion in damages for medical expenses incurred as far back as 1954.  The judge overseeing the case pared the claims down to include only costs incurred since 1993, which are still substantial.  It is anticipated that the case could go to trial as early as January of 2010. 

A recent study published in Kidney International, the journal of the International Society of Nephrology, noted increasing concerns over the use of gadolinium-based contrast agents in patients with renal or liver disease.  In this article, researchers from the Oregon Health and Science University urged the use of ultrasmall superparamagnetic iron oxides (USPIOs) as a safer alternative to the highly toxic gadolinium.  The scientists noted that USPIOs provided enhancement of MRI images similar to that experienced with the use of gadolinium.  This substance, which has been safely used in the past in patients with chronic kidney disease for iron supplementation therapy, was determined to be a safer alternative to the gadolinium therapies currently in use which have been repeatedly implicated as the cause of nephrogenic systemic fibrosis (NSF) in patients with pre-existing renal and liver disease.