Information Needed to Determine the Side Effects of Fosamax

A lot of conflicting studies, reports and statements have recently been published regarding Fosamax. Serious concerns about irregular heartbeats, dead jawbone disease and esophageal cancer have been raised and refuted. So, how are physicians and patients supposed to make sense of the information presented and how are they supposed to make safe and medically beneficial decisions regarding treatment for osteoporosis? The simple answer is that more studies and more research must be done to provide doctors with the information that they need to protect patients.

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The Conflicting Information About Fosamax

In just the past year, three major health concerns about Fosamax have been raised by professionally published studies and letters. First, in April 2008 the Archives of Internal Medicine published a study that indicated that users of Fosamax had an 86% increased risk for developing an irregular heartbeat. That study was later refuted by the FDA who found no link between atrial fibrillation, or an irregular heartbeat, and Fosamax use. However, the FDA did indicate that further studies might be needed to definitively rule out the connection between the condition and the drug.

Then, came news in the form of a letter published by an FDA official in the New England Journal of Medicine that 23 cases of esophageal cancer have been linked to Fosamax use. While those 23 cases of esophageal cancer may be connected to Fosamax use, they represent a very small percentage of the millions of people who have used Fosamax over the past 13 years. That said, the Fosamax warning label is clear that damage the esophagus is a potential side effect of the drug.

While news of possible esophageal cancer was breaking, so was news from the Journal of the American Dental Association that a University of Southern California School of Dentistry study found a link between osteonecrosis of the jaw (or death of the jawbone) and Fosamax. The study was not the first to find a link between the painful condition of osteonecrosis and Fosamax. In fact, the FDA first requested Merck and other manufacturers of bisphosphonate drugs to add a warning about osteonecrosis of the jaw to the drugs' warning labels in 2005. Merck complied with the FDA's request but responded to the Journal of the American Dental Association publication with very specific words that, "In controlled clinical trials involving more than 17,000 patients, contributing as much as 10 years' date with alendronate [Fosamax] there have been no reports of [osteonecrosis of the jaw]." If that statement by Merck is true then why did it comply with the FDA's 2005 request and why do the FDA and the American Dental Association believe that there is a connection between the drug and osteonecrosis of the jaw?

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Additional Studies Are Needed

The conflicting information makes it very difficult for patients to feel confident taking Fosamax and for doctors to make the best possible decisions regarding prescribing Fosamax to osteoporosis patients. Additional studies are needed to rule out the link between bisphosphonate drugs, of which Fosamax is one, and osteonecrosis of the jaw as well as other possible medical conditions that may or may not be linked to bisphosphonate drug therapy.