Zometa Linked to Progressive Destruction of Patients' Jawbones | Shapiro, Washburn & Sharp

Missoula, Montana (MT) resident Peggy L. Stevens could know by the end of this week whether the maker of the drug she took to prevent the loss of bone mass will be held liable for failing to warn prescribers and patients that the medication could actually destroy jawbones. Stevens’ suit against Novartis, which markets Zometa (zoledronic acid), is the first of more than 500 similar claims to receive a court hearing.

Stevens and the other plaintiffs developed a painful, progressive and incurable condition called osteonecrosis of the jaw after receiving injections of Zometa. People with osteonecrosis of the jaw lose teeth, gum tissue and bone in the lower jaw. They cannot wear dentures. The condition is often triggered by dental work, and patients receiving Zometa or injections other bone-strengthening medications classified as bisphosphonates while also undergoing cancer treatments have the greatest risk for developing osteonecrosis of the jaw.

The U.S. Food and Drug Administration approved Zometa in 2001, but Novartis did not add warnings about the medication’s osteonecrosis risk until 2005. The other FDA-approved bisphosphonates are Actonel (risedronate from Procter & Gamble), Aredia (pamidronate from Novartis), Boniva (ibandronate from Roche), Didronel (etidronate from Procter & Gamble), Fosamax (alendronate from Merck), Reclast (zoledronic acid from Novartis) and Skelid (tiludronate from Sanofi-Aventis).

I’ve written before that no patient should face a greater risk from a medication than they face from their disease. This may, however, be the situation with Zometa, Yaz/Yasmin (drospirenone and ethinyl estradiol from Bayer) and several other drugs. Patients need to be protected from dangerous drugs. I hope Stevens and patients like her receive such protection, even if belatedly.

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