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Doctors may miss pain caused by bone density drugs

The FDA warns that patients treated with osteoporosis drugs occasionally develop disabling pain which doctors may not associate with the treatment

In an alert posted on its website, the FDA warns that patients treated with osteoporosis drugs occasionally develop disabling pain which doctors may not associate with the treatment.

Patients have reported pain in the muscles, joints and bones, which is a risk included in the warning labels of GlaxoSmithKline (GSK) and Roche's Boniva (ibandronate), Proctor & Gamble's Actonel (risedronate) and Didronel (etidronate), Novartis' Reclast (zoledronic acid) and Zometa (zoledronic acid), Merck & Co's Fosamax (alendronate), and sanofi-aventis' Skelid (tiludronic acid), which slow or stop bone being reabsorbed.

The FDA has advised doctors to consider if prescribing the drugs, which are known as bisphosphonates, could be the cause of severe musculoskeletal pain and assess if temporary or permanent discontinuation of the drug would be beneficial. The reported pain, which in some cases is described as 'debilitating', sometimes stops when the drug is discontinued, but this is not always the case.

FDA will review hundreds of adverse reports in H1 2008, assuming that doctors are not looking for pain problems, resulting in under-reported, underdiagnosed adverse events.

Bisphosphonates have previously been linked to an inability of jawbone to regrow after oral surgery also known as osteonecrosis of the jaw, and serious, life-threatening irregularly fast heartbeat. The FDA is also reviewing these reports, which could take as long as six months.

According to a 2007 Lead Discovery report, the osteoporosis market is due a major upheaval when market leader Fosamax loses its US patent. The resultant heightened competition will force market players to implement radical lifecycle management strategies to safeguard their franchise revenue.

8th January 2008

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