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In April 2008, the Archives of Internal Medicine published a study related to Fosamax. The study created a lot of media attention and raised a lot of questions among users of the drug. While the findings of the study were discredited only a few months later, the damage to the public opinion of the drug may be irreversible.
What the April 2008 Study Found
In April 2008, the Archives of Internal Medicine published a study conducted by Group Health and the University of Washington. The study found that women who take Fosamax had an 86% increased chance of developing an atrial fibrillation or irregular heartbeat. Atrial fibrillation is a dangerous condition that can cause fainting, congestive heart failure, blood clots and stroke.
The study was conducted because previous studies, including one that was published in the prestigious New England Journal of Medicine, found a possible link between atrial fibrillation and bisphosphonate drugs such as Fosamax. The study examined 719 women with atrial fibrillation and 966 women of the same age without atrial fibrillation and found that there was an 86% higher chance of developing atrial fibrillation while on the drug.
After the study was released some doctors speculated that the increased risk of atrial fibrillation was because bisphosphonate drugs might disrupt the way human bodies regulated protein.
Why the April 2008 Was Discredited
After the April 2008 study was published, Merck & Co. immediately responded by saying that there was not enough evidence to find that Fosamax was dangerous. The company also cited a report in the British Medical Journal that found no link between atrial fibrillation and bisphosphonate use.
Of course, the April 2008 study was not discredited on Merck's words alone. The US Food and Drug Administration (FDA) examined the potential link between atrial fibrillation and bisphosphonates such as Fosamax and found no link between the condition and the drug. Merck found the FDA's findings consistent with their own internal review.
However, while the FDA's statement was meant to reassure the public after the April 2008 study, the FDA did add a caveat to their statement. The FDA said that it would continue to monitor reports of atrial fibrillation and bisphosphonate use and that it would explore the possibility of conducting additional studies on the connection between this condition and this type of drug. The possibility that more research and monitoring is necessary may lead some people to be skeptical that the FDA has issued its final advice on this subject.
The Impact on Public Opinion
Most Americans take medications such as Fosamax on the advice of their physicians. As patients without formal medical training, few of us understand exactly how the drug will treat our condition or what the possible side effects may be. So, when news breaks about potential serious side effects, the public understandably becomes very nervous. The damage may be done whether or not the public later hears that the study which linked the side effect to the drug was discredited.
In the case of Fosamax, patients who were concerned about the potential link to heart problems were likely not comforted by the news that broke on December 31, 2008 and January 1, 2009 that suggested that Fosamax may be linked to esophageal cancer and osteonecrosis, or dead jawbone disease.
Patients who take Fosmax and who have suffered a Fosamax injury should consult their physician for medical advice and a Fosamax lawyer for advice about with a Fosamax suit is warranted.