Ethics in Medicine

Bisphosphonates require caution, new labelling for Fosamax, Actonel, and Boniva

Kristen Sparrow • September 14, 2011

To file under “Beware of Blockbuster Drugs.”  See previous post entitled :Drugs causing the problems they’re supposed to prevent

Stronger Cautions Backed on Bone Drugs for Women

Two advisory panels to the Food and Drug Administration on Friday recommended increasing the cautionary language on the product labels of bone-building drugs taken by more than five million women in the United States.

But they stopped short of specifying what the safety warnings should say and did not recommend limiting use of the drugs to a proposed five years. About 11 percent of women 55 and older take the drugs to prevent bone fractures…
The benefits of the drugs have only been proven for three to five years, not longer, F.D.A. staff members said, warning about links to those rare conditions after longer use….

Several women who have suffered the unusual fractures testified at the meeting.

Dr. Jennifer P. Schneider, whose thigh broke as she was standing in a New York subway, presented her own review of 111 cases.

Almost all took the drug for more than five years, most for a pre-osteoporosis condition called osteopenia, she said. Many felt pain in the thigh before the bone suddenly broke.

The first such drug, Fosamax, was marketed by Merck in 1995. Others include Actonel and Atelvia from Warner Chilcott and Boniva from Roche Therapeutics. Worldwide sales last year were $7.6 billion.

At a conference at UCSF last year, “Controversies in Women’s Health,”  I was very interested in the topic of bisphosphonates which was on the agenda.  The professor who gave the talk made light of any nasty side effects, but he also had published conflicts of interests.  He had done some of the initial work funded by the pharmaceutical industry.