Study Questions Advisability of Taking a Break from Osteoporosis Drugs

The drugs Fosamax, Boniva and Actonel are prescribed for people with osteoporosis, the bone-thinning disorder that leaves patients vulnerable to fractures that can be life-threatening.

A new study examined the wisdom of taking a break from these drugs, known as bisphosphonates, in order to reduce the likelihood of the terrible side effects for which they’re known. (See our blogs, “Osteoporosis Drugs Might Carry Risk of Atrial Fibrillation,” “Fosamax Warning Renewed” and “Do Bone-Building Drugs Cause Femur Fractures?”)

The practice of going off your meds is unusual in medicine; most drug regimens for chronic conditions require consistency to be the most effective, and some can be dangerous if they’re not taken as prescribed.

The so-called bisphosphonates “drug holiday” often is recommended to reduce the risks associated with their long-term use, primarily jaw bone decay and atypical femur fractures. The fractures, as we’ve described previously, occur for no apparent reason – you can stand up from a chair, and fracture your femur (thigh bone). So taking a drug break is believed to reduce the risk of Fosamax side effects, while still helping to prevent fractures associated with osteoporosis.

As explained on AboutLawsuits.com, the research presented in the journal Endocrine Practice was a retrospective review of patients who took a bisphosphonate drug holiday between 2005 and 2010. It analyzed bone mineral density (BMD, or markers of how well bone replaces itself), levels of vitamin D and reports of fractures.

Unfortunately, the study showed that taking a Fosamax holiday to prevent femur fractures could leave patients, who often are elderly, at risk of several types of fractures.

In the study, 11 of the 209 patients developed a bone fracture during the four years of follow-up. All of the patients who took the drug holiday showed increased levels of an enzyme that was particularly pronounced in the group that suffered fractures. Also, the BMD of neck bones also declined significantly after two years of drug holiday.

This was a fairly small study, and researchers said more research was needed on the risks and benefits of taking a Fosamax drug holiday.

Last year, as we wrote, the FDA issued new recommendations for taking Fosamax, Actonel and Boniva. The feds suggested that users should consider limiting them to a three- to five-year period. That interval, the thinking went, would provide bone-protection but reduce the risks of side effects from longer-term use.

One study in November 2013 showed that the increased risk of bone fractures with bisphosphonates might have a genetic component, which would explain why some patients experience atypical femur fractures.

These drugs clearly are powerful and potentially dangerous. But the body of science about how to achieve the optimal balance of use and nonuse is slim.

Even if drug holidays aren’t a good idea, something needs to be done to address the record of truly terrible side effects from bisphosphonates. Merck, the manufacturer of Fosamax, is facing more than 4,000 femur fracture lawsuits, according to AboutLawsuits.com. Plaintiffs allege that the company failed to provide adequate warnings for consumers or the medical community about the risk of atypical fractures.

In late 2010, the FDA required Merck to add new label warnings about the risk of bone fractures. They included the importance of recognizing new hip or groin pain, which could occur before an atypical fracture of the femur.

If you take these drugs, and have experienced such pain, contact your doctor immediately. In some cases, it might make sense to take a break from the meds, but it might not. The bedeviling results of the new study only make this decision more difficult, and only a full airing of all the risks and benefits between you and your doctor can determine what course of action you should take.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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