A Federal Drug Administration (FDA) advisory panel decided last month that labels on bisphosphonates - a class of drug used to treat osteoporosis - should be amended to include guidance on how long patients can safely take the drugs.
Fosamax was the first bisphosphonate osteoporosis drug on the American market, and is still one of the most frequently prescribed. Other commonly prescribed bisphosphonates include Aclasta, Actonel, Boniva and Reclast.
The decision comes in the wake of data showing the drugs can have potentially dangerous side effects that may be exacerbated by long-term use.
In 2010, the FDA issued a warning linking the use of the drugs to unusual fractures of the thigh bone. Traditionally, the fractures occurred only in patients suffering severe trauma. However, they are increasingly being reported in patients who experience minor accidents - such as a sudden jolt on a subway ride - but who are taking Fosamax or other bisphosphonates.
The drugs have also been linked with other dangerous side effects including jaw bone death, cardiac arrhythmia and esophageal cancer.
Drugs' Use Has Changed Over Time
When bisphosphonates first came on the market, they weren't initially intended for long-term use. Now, the drugs are routinely used as preventative measures, and it is not uncommon for women to be prescribed Fosamax or other bisphosphonates for periods of five years or more. Studies have shown that Fosamax and its generic form, alendronate, have been linked to spontaneous and low-impact femur fractures in patients taking the drug for more than five years.
Most of the patients who reported unusual fractures to the FDA started taking the drugs in their 50s or 60s. Some testified that their doctors had prescribed the drugs for osteopenia, which means their bone density was below normal, but not low enough to qualify as osteoporosis.
Patients should discuss their concerns with their medical providers, and should be sure to note any new thigh or hip pain. As always, patients should not stop taking any prescribed medication without first consulting with a doctor.
Patients who have been injured by bisphosphonates or other medications may have a right to recover for their injuries. They would be well-advised to consult with a defective drug attorney in their area.
