FDA panel backs new labels for osteoporosis drugs

[September 10, 2011]  TRENTON, N.J. (AP) -- Food and Drug Administration advisers voted Friday to require makers of widely used osteoporosis drugs to clarify how long patients should take them for the greatest benefit and least risk.

The FDA itself will later decide what the new label wording should say for each of the drugs: Fosamax, Boniva, Actonel, Atelvia and Reclast. The agency could require wording that recommends limiting how long each drug is taken, but it's unclear how long that would be for each drug.

A few patients have suffered serious complications, including jawbone destruction, unusual thighbone fractures and cancer of the esophagus, generally after several years taking the medicines.

The drugs stop and reverse dangerous thinning of bones in many people, preventing much more common hip and spine fractures that cause pain and can result in hospitalizations, nursing home stays and early death.

But after several years, it's unclear whether the drugs, a class called bisphosphonates, do more harm than good.

More than 10 million Americans, mostly women over age 50, have osteoporosis, and 34 million more have low bone mass that could lead to osteoporosis, in which the body breaks down bone tissue faster than it rebuilds it.

Some patients suffering jaw damage and hip fractures have sued the drugs' makers, and law firms aggressively advertise for plaintiffs. Publicity about the complications and the lawsuits have alarmed many patients.

So experts have been reviewing data to try to provide better advice on whether patients should stop the drugs totally, or perhaps temporarily, after several years. The drugs include daily, weekly and monthly pills and longer-acting intravenous treatments.

At a daylong meeting Friday in Adelphi, Md., a panel of outside advisers to the FDA reviewed details of many studies compiled by FDA staff.

The staff report states few patients have been followed for a decade, but that data seems to show "no further increase in fracture benefit after 3-4 years of therapy." It notes jaw destruction appears more prevalent with four or more years of use, that data suggest the drugs are associated with thighbone fractures, but that the esophageal cancer link is in question.

Panel members also heard public comment and presentations from the drugs' makers.

Fosamax maker Merck & Co. said data show benefits outweigh the risks of taking Fosamax for a decade -- in patients who remain at risk of an osteoporotis-related fracture. Merck's Dr. Arthur Santora, heads of endocrinology research, said the company believes each patient's doctor should determine whether long-term treatment is needed.

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The panel then voted 17-6 to recommend that the product labels, or detailed package inserts, be changed to better clarify the best duration of use.

Currently, each drug's label states how many years patients taking it have been studied. That's followed by: "The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis."

Some panel members said companies need to be more specific, including defining "periodic," but left wording changes up to the FDA.

The recommendation could vary for each drug, according to how long patients taking it have been followed and other factors.

Since Merck started selling Fosamax in 1995, more than 225 million prescriptions have been filled in the U.S. for these drugs. Rates of spine and other fractures in patients with thinning bones have since declined, despite the fact that our population is aging -- a major risk factor for osteoporosis.

U.S. sales of osteoporosis drugs totaled about $4.2 billion last year, down from a 2007 peak of about $6 billion. The decline is because Fosamax got generic competition early in 2008. That wiped out most Fosamax revenue and cut into sales of newer, competing drugs.

The number of prescriptions dispensed also has declined a bit, down to about 37 million in the U.S. last year. Many patients have switched from monthly to three-month prescriptions of the pills, or to an intravenous infusion of Boniva once every three months or of Reclast every one or two years.

The drugmakers said after the hearing that they back the safety of their products and will work with the FDA to address the panels' recommendations.

[Associated Press; By LINDA A. JOHNSON]

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