Bone Drugs Recommendations Incomplete

Two advisory panels to the Food and Drug Administration on Friday recommended that the cautionary language on the product labels of bone-building drugs taken by more than five million women in the United States be updated, but did not specify the exact language to be used or recommend that women should stop taking the drugs after five years, as anticipated.  The drugs under review included Fosamax from Merck, first approved in 1995, Boniva from Roche Therapeutics, and generic copies.  Prior to the review, the FDA had never conducted a broad review of the long-term safety and efficacy of the drugs.  Known as bisphosphonates, the widely used meds have also generated reports concerning thigh-bone fractures, jaw-bone damage and various other ailments.

In a quarterly report from Merck, the pharmaceutical giant noted that it is facing over 1,000 lawsuits regarding jaw damage and over 500 for unusual femur fractures and other bone injuries, alleged to be associated with bone drug usage.  Merck lost an $8 million verdict in June last year for jaw damage caused by its bone drug, after winning its first case

The FDA announced in July that it would convene a joint meeting of advisory committees on drug safety and reproductive health to reconsider osteoporosis drugs after evidence surfaced linking long-term use with unusual breaks of the femur or thigh bone, bone death in the jaw, and possibly esophageal cancer.

In an FDA staff report prior to the scientific advisory committee recommendations, studies had suggested that “no significant advantage of continuing drug therapy beyond five years” were demonstrated.  While the studies did show that the drugs had proven benefits in preventing osteoporosis fractures for the first three years of treatment, any additional time on the drugs did not provide an added benefit.  Women who stopped taking the drugs after five years had similar levels of increased bone density and reduced fracture risk as those who continue taking them according to the report.

None of the panel members from Friday’s meetings recommended firm restrictions on longer-term use.  No suggestions were made to include a black box warning for the bone drugs, as some former patients have requested.  Several advisers said the new label needed to be much more specific about benefits during the first three to five years and about the uncertainties after that. 

Jury selection also began this week for a Fosamax trial in the United States District Court for the Southern District of New York after a judge had narrowed the scope of the original complaint brought forth by a patient allegedly injured through use of the bone drug (Seacrest v. Merck, No. 06-6292).  In a 42-page decision allowing only a design defect claim to stand for trial, the judge noted that there was no evidence that the patient’s prescribing doctor would have told her to stop using Fosamax in 2004 and 2005, at the time of her alleged injury, had Merck included a warning on its label.  The judge also said punitive damages were inappropriate because no reasonable jury could conclude that Merck breached any legal duty either intentionally or with a “conscious disregard or indifference” to its customers’ health.

While the decision of the advisory panels to not specify language for updated warnings for bone drugs is surprising, the ongoing litigation and scientific reviews have heightened consumer awareness.  Doctors and patients should consider a variety of factors while individually considering longer-term use of the drug.