Novartis: Criminal Cover-Ups and Jawbone Damage from Zometa and Aredia

In a devastating blow to Novartis, a federal judge denied a bid to overturn a verdict in which a jury decided the drugmaker failed to adequately warn about the risks that its Zometa and Aredia bone-strengthening meds caused severe jaw bone damage. And in making his decision, he writes that the jury was shown sufficient evidence to conclude a cover-up was undertaken with “the knowledge and approval of high-ranking officials.”
Read article at pharmalot.com

Novartis Downplayed Bone Drugs' Risks, Lawyer Told Jurors

Novartis AG officials downplayed risks that the drugmaker’s bone-strengthening medicines Aredia and Zometa could destroy patients’ jaws, a lawyer for a woman suing the company told a North Carolina jury. Officials of the Basel, Switzerland-based drug company got reports from doctors as early as 2002 that Rita Fussman and other cancer patients taking Aredia and Zometa to prevent bone loss during treatment suffered irreplaceable jawbone damage, Bob Germany, a lawyer for Fussman’s family, said in opening statements in a trial over the medicines.
Read article at Bloomberg.com

Bisphosphonates alert! - Adverse side-effects of prescribed drugs.

Information on Bisphosphonates
(marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

Extract:

"FDA ALERT [1/7/2008] - FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown."