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Consumer Health Advocates Warn Against Osteoporosis Drug

April 1, 2003

Consumer Health Advocates Warn Against Osteoporosis Drug

Forteo May Lead to Bone Cancer in Humans, Risk Outweighs Benefit

WASHINGTON, D.C. – Public Citizen’s Health Research Group has recommended that patients not take teriparatide, a drug approved by the U.S. Food and Drug Administration (FDA) in November 2002 for treatment of osteoporosis. Teriparatide, marketed by Eli Lilly under the name Forteo, has led to bone cancer in laboratory animals, a risk that far outweighs the drug’s benefit.

Public Citizen issued a “Do Not Use!” warning in the April issue of Worst Pills, Best Pills News, an online service and monthly newsletter that contains information on drug safety and effectiveness, dangerous dietary supplements, drug-induced symptoms and drug interactions. In the past, Public Citizen’s Do Not Use! warnings have preceded safety-related withdrawals of drugs such as Baycol, Propulsid and Rezulin by months, sometimes years. The Health Research Group has listed more than 200 drugs as Do Not Use! over the past 15 years.

In July 2001, Public Citizen recommended against the FDA approval of teriparatide when it learned of the unusually high incidence of osteosarcoma, or malignant bone tumor, in laboratory animals. Although osteosarcomas are generally rare among laboratory animals, rats given teriparatide developed tumors even at the lowest doses tested, and higher exposures shortened the time before tumors developed and the animals died.

The FDA has already mandated a series of warning labels for the drug because of its known risks. The package insert includes a “black box” warning describing the studies on rats. The government also requires that pharmacists distribute patient information leaflets with new and refill prescriptions, a requirement made by the FDA for only a handful of drugs. Also, Eli Lilly has agreed to restrict its promotion of teriparatide, refraining entirely from direct-to-consumer advertising.

“The warnings and restrictions the government has put in place are significant, but the safety hazards are so serious, we do not believe any patients should be taking the risk of ingesting this drug,” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. “That’s especially true because there are safer alternatives.”

The FDA approved teriparatide to treat osteoporosis in postmenopausal women who are at high risk for fractures and to increase bone mass in men with osteoporosis. There are no data showing that the drug reduces the risk of fractures in men. In women, there are data showing reduced fracture risk, but the reduction is not large, and alendronate, marketed as Fosamax, appears to offer a similar level of risk reduction. Public Citizen recommends that neither men nor women take teriparatide.

Teriparatide is also extremely expensive and must be injected daily. A 30-day supply of teriparatide costs $515.79 at drugstore.com, while a 30-day supply of alendronate costs $65.16.

The article warning readers to not take teriparatide is on the Worst Pills, Best Pills site at www.worstpills.org; reporters can obtain a complimentary subscription to the online newsletter by calling the Public Citizen press office.