Archive for the 'bisphosphonates – Fosamax' Category

FDA Panel Backs Limits on Osteoporosis Drugs

An advisory committee to the U.S. Food and Drug Administration (FDA) has suggested the agency limit how long patients can remain on bisphosphonate therapy for their osteoporosis. The committee was unable, however, to agree on what that limit should be, said ABC News.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee discussed if the FDA should change its label to indicate that the drugs should not be used long term. The Committee agreed a label change is in order, but, despite 17-to-6 votes for, said ABC News, the Committee was unable to agree on a timeframe, claiming insufficient data. (more…)

Osteoporosis Drugs Like Fosamax Can Stop After Five Years

Following its review of Fosamax, the U.S. Food and Drug Administration (FDA) has determined that women taking Fosamax and other bone strengthening medications known as oral bisphosphonates can, for the most part, safely stop taking the drugs within five years.

According to the FDA staff report, said the New York Times, which has been released prior to meeting of two of its scientific advisory committees, research reveals that while osteoporosis medications offer benefits in fracture prevention in the first three years of treatment, the benefits diminish after five years. As a matter-of-fact, continuing to take medications such as Fosamax after five years does not offer benefits over no drug treatment, according to the report, said the Times. (more…)

Fosamax, Other Bone Drugs Set for FDA Review

Drugs called oral bisphosphonates, including Merck & Co.’s osteoporosis medication Fosamax, are scheduled for review by a U.S. Food and Drug Administration (FDA) advisory panel over concerns about serious adverse events. Among other things, the panel will recommend whether or not long-term used of the drugs should be limited due to their association with a rare type of femur fracture.

It was once believed that Fosamax and similar medications could be taken indefinitely. Oral bisphosphonates are widely used in the treatment of post-menopausal women at risk for osteoporosis,especially those diagnosed with low bone density, said the Wall Street Journal.Oral bisphosphonates are also prescribed for the treatment of bone diseases such as Paget’s disease. Other drugs in this class include Actonel, Boniva, Atelvia, Didronel, and Skelid. (more…)