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

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
By DUFF WILSON

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. 

Drugs causing the problems they're supposed to prevent

From the NYTimes:

"In the past month, the Food and Drug Administration has concluded that in some cases two types of drugs that were supposed to be preventing serious medical problems were, in fact, causing them.
One is bisphosphonates, which is widely used to prevent the fractures, especially of the hip and spine, that are common in people with osteoporosis. Those drugs, like Fosamax, Actonel and Boniva, will now have to carry labels saying they can lead to rare fractures of the thigh bone, a surprising new discovery that came after another surprise — that they can cause a rare degeneration of the jawbone.
The other is Avandia, which is widely prescribed for diabetics, whose disease puts them at risk for heart attacks and heart failure. Two-thirds of diabetics die of heart problems, and a main reason for taking drugs like Avandia is to protect them from that..."

They then go on to quote experts who feel that the FDA doesn't do enough to track drugs after they've been turned loose on the (unsuspecting) public. Since drugs only undergo a relatively short testing period, it would, of course make sense to continue tracking drugs once on the market. Where that money will come from I have no idea in this political climate, especially since the FDA has shown to be infiltrated with people from the drug industry with a vested interest. (See blog post "When oversight means overlook")
Given the shortcomings, and lack of oversight in the FDA I think it makes utmost sense as a health care consumer to wait at least 7 years before taking any newly released drug. Let others be the guinea pigs and if possible, take the version of any medication that is tried and true if given a choice. It's often cheaper, too.
I like to think that attitudes are changing among physicians, and that they're less willing to prescribe newly minted drugs, but I'm not sure if there is any evidence for that. I understand the drug companies rushing drugs to market, after all there is a boat load of money to be made. But I'm not sure I understand the eagerness of physicians to enable them. It could be pressure from patients themselves, who knows. But they should remind themselves of their oath to "first do no harm" and consider counseling weight bearing exercise and dietary changes before bisphonphonates and Avandia.

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