Thursday, February 17, 2011

The Dubious Levaquin Study

People in Pittsburgh, Pennsylvania that have been prescribed Levaquin will be interested to know that Levofloxacin (the generic name for Levaquin) was introduced in Europe by Aventis Pharmaceuticals under the trade name Tavanic. Report of peculiar tendinopathy and tendon rupture began to surface in early 2001. This raised concerns that European authorities would require heightened warnings on the medication that Levaquin was more tendon toxic than other fluoroquinolones increasing patients’ risk for tedinopathy and tendon rupture.

Not surprisingly, Johnson & Johnson and the other manufacturers of Levaquin became concerned that these warnings would impact sales of and profits from Levaquin in the U.S. Court documents have stated that members of J & J met with Aventis and assumed control of the company’s response to the injuries in Europe. One of their efforts in damage control consisted of sponsoring a study conducted by Ingenix, a division of United Health Care, to counter other epidemiologic studies and evidence that had found a significantly heightened risk of tendinopathy and tendon rupture with Levaquin and Floxin compared to other fluorquinolones- particularly in the elderly and those concurrently using corticosteroids.

Discovery in the Levaquin lawsuit has revealed that Johnson & Johnson and the other defendants to the case were intimately involved in the design of the Ingenix study that purported to find no difference in risk between fluorquinolones. The Plaintiffs in the Levaquin lawsuit allege that the study was so fundamentally flawed that its results had no scientific validity. What caused even more eyebrows to raise was the fact that the underlying source documentation from the study was destroyed immediately following its publication so no verification or criticism of the results could be undertaken.

Despite the study, in 2008, the FDA found, based on a new analysis of existing data, that the warning label concerning tendon disorders previously provided by the makers of Levaquin, was inadequate. The FDA, in turn, required a black box warning for fluoroquinolones regarding tendinopathy and tendon rupture, particularly for the elderly and those simultaneously taking corticosteroids. As of today, the makers of Levaquin still have not warned doctors about the increased risk of Levaquin causing tendon disorders as compared to other fluoroquinolones on the market. Read more about Levaquin and Pittsburgh here. Share this post :
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