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Don't Use Forteo, Consumer Group Urges
April 4, 2003 -- First, Public Citizen warned the FDA not to approve 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 a kind of bone cancer 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," Sasich tells WebMD. "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 Forteo findings were very compelling and concerning to her."
An FDA advisory panel reviewed these findings but still recommended that the drug be approved. That happened in November 2002. However, approval came with a list of restrictions that -- especially for a new drug -- are unusual:
- The drug carries a "black box" safety warning, the FDA's highest warning level, which highlights the concern over the association between Forteo and bone tumors (called osteosarcomas) in animal studies.
- Every time a Forteo 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 Forteo get bone cancer.
- Lilly also agreed not to advertise Forteo directly to consumers, to restrict free samples of the drug, and to limit the sales force marketing the drug to doctors.
- Lilly also agreed to do a "physician education" program. The idea is to make sure doctors prescribe Forteo only to patients at high risk of osteoporosis fractures.
All of this simply means that Lilly is working hard with both patients and doctors to make sure they know about Forteo's benefits and risks, says Lilly spokeswoman Debbie Davis. Lilly is a WebMD sponsor.
"But Public Citizen's criticism simply doesn't square with extensive clinical trials and FDA review of Forteo," Davis tells WebMD. "More than 2,000 people participated in Forteo clinical trials, [and] none have any signs of [bone cancer]."
Public Citizen publishes a book and web site called "Worst Pills, Best Pills." In the April 2003 edition, Forteo became the newest member of its "Do Not Use" list.
Sasich says that there's no good reason for patients to run the risk of bone cancer with Forteo. He notes that there are other drugs for osteoporosis -- and that they are more convenient and far less expensive.
Davis notes that there's simply no other drug like Forteo. And she's right. While other osteoporosis drugs slow bone loss, Forteo stimulates bone growth. Doctors call that a new "mechanism of action."
"Certainly Forteo 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," Sasich says. "The sword cuts both ways."
"Their argument isn't valid," Davis says. "All around, we believe very strongly in Forteo and what it can provide for patients. I personally have talked to patients who believe this drug is providing them hope."
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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