The problems with FDA and Merck regards Fosamax date back 10 years. For example, in July 1997, (see NDA: 20-560), Merck was advised that its marketing tactics for Fosamax contained false information about osteoporosis and that Merck was overstating the population eligible for therapy with Fosamax.

So it seems that selling the drug was more important than getting the facts right.

DDMAC (FDA's division for marketing) ordered Merck to stop the dissemination of this false information.

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A recent study published in the American Journal of Managed Care (November 2006) revealed that physicians and patients rarely talk about how much prescription medicines will cost. (Read more)

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A recent study of over 33,000 postmenopausal women showed that among patients newly prescribed one of the two most popular osteoporosis treatments, patients taking Actonel (risedronate sodium) were approximately half as likely to
sustain a hip fracture as those taking alendronate (Fosamax) in the first year
of treatment. These Actonel and Fosamax results were published in the peer-reviewed
journal Osteoporosis International.

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In a letter to the editor in the Washington Post, a reader writes that it’s a travesty to advertise certain drugs on TV especially Boniva and Fosamax based on the problems they present with jawbone death and unknown repercussions of long term use. (Washington Post)

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In the summer of 1995, the FDA approved a class of drugs known as bisphosphonates, the most familiar of which is sold under the brand name Fosamax. Fosamax was hailed as a miracle drug that would work against the degeneration of bone density mass.

Read More: Fosamax May Not Be the Best Way to Treat Osteoporosis

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American Dental Association following a small but growing number of reports linking bisphosphonate drugs like Fosamax, Boniva, and Actonel to incidences of osteonecrosis of the jaw (dead bone tissue), believes that dentists should discuss ONJ risks with dental patients who are taking Fosamax, Boniva, and Actonel when performing tooth extraction or doing implants.

A failure to do so could constitute Dental Malpractice. Dentists and their patients should carefully consider these procedures and discuss alternative dental therapies.

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Fosamax, a bisphosphonates, is now linked to the death of jaw bone tissue. Two other Bisphosphonates are more likely to cause this tissue death: Zometa and Aredia.

Fosamax, Actonel, and Boniva are used to treat osteoporosis, but also raise the risk of jaw necrosis.

Bisphosphonate drugs block the normal ``turnover" of bone cells. Because bone is not turning over, infections in the mouth (which is loaded with bacteria), may not heal properly, further damaging the jaw.

According to the May Annals of Internal Medicine, researchers from Brigham and Women's Hospital linked jaw necrosis to bisphosphonates.

Patients are suing Merck & Co., the maker of Fosamax. But the company on its website noted that as of March 2006, jaw necrosis probably occurs in less than one in every 100,000 patient-treatment years. Last year, the US Food and Drug Administration asked Merck and the other makers of oral bisphosphonates to mention the jaw necrosis risk on its product labels.

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Since 2003, more than 3,000 published cases of osteonecrosis of the jaw (ONJ) have been reported from taking bisphosphonates. While most of the cases involve cancer patients who take the intravenous versions of the drug; a few years ago, ONJ began turning up in healthy women taking Fosamax to increase bone density.
Most documented cases have been in people who have had a tooth extraction. (Read more about Fosamax ONJ)

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