Experts to Consider Whether Patients Need a ‘Holiday’ From Bone Drugs

Two scientific panels will consider on Friday whether some patients taking bone-building medications known as bisphosphonates should take a break — or a “drug holiday” — from the treatment.

The drugs are widely used to prevent hip and other bone fractures associated with osteoporosis, a bone-thinning disease most common among women over the age of 50 and men over 70. As MedPage Today reports, about seven out of every 100 people in the U.S. in 2008 received a prescription for a bisphosphonate.

The medications include the brand-name medications Fosamax, Boniva, Actonel, Atelvia and Reclast, as well as many generics that have been available over the past three years.

But, as pointed out in new briefing documents prepared for Friday’s joint meeting of two Food and Drug Administration advisory panels, there are unresolved questions about whether the drugs have rare but damaging side effects. The panel members will examine whether the drugs are linked to unusual breaks of the femur or thighbone, to jawbone deterioration or to esophageal cancer.

What’s more, the panelists will weigh those possible side effects against findings by FDA reviewers that women don’t benefit from taking the drugs beyond five years. As The New York Times reports, the demonstrated advantages of the drugs show up in patients taking them for three years.

As a result, the FDA panelists will consider whether a “drug holiday” may be warranted for women who have taken the drug for long periods. Yet the benefits of such a break are murky, too. As the briefing materials point out, “There are no substantial data available to inform decisions regarding the initiation or duration of a drug holiday.”

Related Posts:
Amid a Wave of Lawsuits, Doctors Debate When to Prescribe Osteoporosis Drugs
When Drugs Are Taken for the Long Term, the FDA May Fall Short in Ensuring Safety

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One comment to “Experts to Consider Whether Patients Need a ‘Holiday’ From Bone Drugs”

  1. Kevin Costner

    Your article is a good example of why the American public is ignorant
    about the facts concerning why we have a large budget deficit. No place
    in the story does it mention the FACT that Republicans created Medicare part D and refused to allow Medicare to negotiate drug prices. The article simply says congress voted
    for it.

    http://goo.gl/Polve

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