Alert Out from FDA about Osteoporosis Medication

Patients taking bisphosphonates, a class of bone density drugs prescribed for osteoporosis, could suffer from severe, often incapacitating, pain in their bones, joints, and/or muscles, according to an alert the Food and Drug Administration posted Monday.

While there is information in the prescribing information about the drugs of the possibility of such side effects, doctors may tend to not give it much importance, often till such a long time that the patients are incapacitated or require analgesics for pain relief, the alert further said.

The agency alert further said there was no fixed time frame within which the reactions could manifest; it could be anywhere between a few days to a few months after the patient first starts using the drugs. There is also not much information available about the dangers and actual occurrence of musculoskeletal pain, according to the FDA alert.

A post Monday by Med Watch, a health regulator, gave indications of the above, saying, “Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.”

The reports from different patients have been varied. Some of them have reported the pain actually stopping after they took a bisphosphonate, and some others have said the pain either went down very slowly, or did not go down at all, even after taking a bisphosphonate. There are other patients who said they suffered from such severe pain they had to resort to external aids to perform even basic activities such as walking or standing.

Susan Cruzan, a spokeswoman for the FDA, said the drugs were prescribed to millions of osteoporosis. In 2006, there were 37 million prescriptions for bisphosphonates in the U.S. alone, with a total sale value of approximately $4.3 billion, according to data released by health-care information company IMS Health.

Cruzan said the agency was currently in the process of going through reports from hundreds of these patients who complained of pain after bisphosphonate use. Saying that possible side effects are usually under-reported, Cruzan said it would take the FDA about six months to complete the current review.

A number of drugs make the list of bone drugs with the effects mentioned above. These include Didronel, Actonel, Actonel +Ca, all products from Proctor & Gamble; Reclast, Zometa, and Aredia from Novartis; Boniva from Roche Holding AG and GlaxoSmithKline PLC; Foxamax and Fosamax +D from Merck; and Skelid from Sanofi Aventis.

The stance of the drug manufacturers is almost unanimous – cases of such pain are not common, according to them. Data from clinical trials and post-approval reports for Novartis’ Reclast and Zometa showed the number of patients suffering from such incapacitating pain stood at 1 percent, a company statement said. Roche and Proctor & Gamble also said they received infrequent reports of patients suffering from such pain.

Earlier in October last year, the FDA had said another review of bisphosphonates showed the possibility of some connection to atrial fibrillation, a condition wherein the patient suffers from an unusually fast heartbeat. At that point in time, it had stated reviews of that possibility could take up to a year.