Public Citizen Warns Against Teriparatide for Osteoporosis Daniel J. DeNoon April 4, 2003 — First, Public Citizen warned the U.S. Food and Drug Administration (FDA) not to approve teriparatide (Forteo), a new kind of drug for osteoporosis. Now the consumer group is warning patients not to take it. The reason: The drug appears to cause osteosarcoma in lab rats. No such cancers were seen in human tests of the drug. But Larry Sasich, PharmD, MPH, research analyst for the Public Citizen Health Research Group, worries this may be only a matter of time. "We think this animal data is very, very compelling," Dr. Sasich told Medscape. "On our staff we have a former FDA toxicologist, who reviewed this part of the data for us. This is what she did at the FDA for 13 years — she reviewed animal study data. These teriparatide findings were very compelling and concerning to her." An FDA advisory panel reviewed these findings in November 2002, but still recommended that the drug be approved. However, approval came with a list of restrictions that are unusual for a new drug: The drug carries a "black box" safety warning, the FDA's highest warning level, which highlights the concern over the association between teriparatide and osteosarcomas in animal studies. Every time a teriparatide prescription is filled or refilled, pharmacists must give patients an FDA-approved information sheet. These "Medication Guides" are required when drugs present significant health problems or when patients need extra information to use a drug in the safest and most effective way. Eli Lilly and Co., the drug's manufacturer, must pay for a 10-year study to see whether patients using teriparatide get osteosarcoma. Lilly also agreed not to advertise teriparatide directly to consumers, to restrict free samples of the drug, and to limit its sales force marketing the drug to doctors. Lilly also agreed to do a physician education program. The idea is to make sure doctors prescribe teriparatide only to patients at high risk of osteoporotic fractures. All of this simply means that Lilly is working hard with both patients and doctors to make sure they know about teriparatide's benefits and risks, said Lilly spokesperson Debbie Davis. "Public Citizen's criticism simply doesn't square with extensive clinical trials and FDA review of teriparatide," Ms. Davis told Medscape. "More than 2,000 people participated in teriparatide clinical trials, none have any signs of osteosarcoma." Public Citizen publishes a book and web site called "Worst Pills, Best Pills." In its April 2003 edition, teriparatide became the newest member of its "Do Not Use" list. Dr. Sasich says that there's no good reason for patients to run the risk of osteosarcoma with teriparatide, because there are other drugs for osteoporosis — and they are more convenient and far less expensive. There's simply no other drug like teriparatide, Ms. Davis notes. While other osteoporosis drugs slow bone loss, teriparatide stimulates bone growth. "Certainly teriparatide does work by a new mechanism of action. But drugs that work in new ways have new ways of being toxic we didn't have before," Dr. Sasich said. "The sword cuts both ways." "Their argument isn't valid," Ms. Davis said. "All around, we believe very strongly in teriparatide and what it can provide for patients. I personally have talked to patients who believe this drug is providing them hope." Reviewed by Gary D. Vogin, MD Source: Medscape, 4/03 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.