FDA Raises Concerns About Side Effects of Long-Term Use of Bone-Building Drugs

A recent article in The New England Journal of Medicine raises concerns about how long women at risk of osteoporosis should take bone-building drugs such as Fosamax. Fosamax is among a group of drugs known as bisphosphonates that are widely prescribed for osteoporosis, a disease characterized by increasing bone fragility and low bone density.

The concern flagged in the systematic review by the Food and Drug Administration is that bone-building drugs may in rare cases lead to weaker bones in certain women and contribute to adverse side effects, including femur fractures, esophageal cancer and a crumbling of the jaw.

The FDA analysis of industry studies of Fosamax and another drug, Reclast, showed significant reduction in fracture risk during the first three to four years of use but little benefit afterward. In the Fosamax study, 10.6 percent of patients taking Fosamax suffered a fracture during the first three years of use, compared with 21 percent of those in a control group who were not taking the drug.

The FDA review focused on patients who had been taking bisphosphonate drugs for at least three years. It found little or no benefit after three to five years of use.

Many women prescribed Fosamax and other bone drugs have been diagnosed with osteopenia, a lower than ideal bone density that is not low enough to be called osteoporosis. These women are unlikely to benefit from long-term use of the drugs, the article said.

If you have taken Fosamax and have been diagnosed with a femur fracture or Osteonecrosis —a crumbling of the jawbone, you should talk to a knowledgeable lawyer about your legal options.

The Driscoll Firm, LLC, is committed to helping people who have been harmed by dangerous drugs and drug side effects. We have helped thousands of clients nationwide receive full and fair compensation from pharmaceutical companies and medical device manufacturers whose products cause harm. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.

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