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Patients Should Wait Until 2010 to Take Osteoporosis Drug Boniva, Public Citizen Reveals on WorstPills.org Web Site

Oct. 2, 2006

Patients Should Wait Until 2010 to Take Osteoporosis Drug Boniva, Public Citizen Reveals on WorstPills.org Web Site

“Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

WASHINGTON, D.C. – Patients should wait until 2010 to take Boniva (ibandronate) because it is a relatively new osteoporosis drug, and no evidence exists to prove Boniva is any more therapeutic than older drugs, Public Citizen writes in a new October posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the August 14 issue of The Medical Letter on Drugs and Therapeutics.

Since Boniva has been on the market for only three years, it is impossible to know whether there are any previously unknown, potentially harmful adverse effects. Public Citizen recommends waiting seven years before taking a newly approved drug, unless it is a breakthrough drug, which is a drug that offers documented advantages in healing over older, proven drugs. Many new drugs have been taken off the market during the first seven years they were available, because they have proven dangerous to patients. By relying on older, safer drugs, patients can minimize risk.

Boniva is available in oral and injected form. The tablet is taken once a month, while the injected form of the drug is given once every three months. Though the injection received the Food and Drug Administration’s (FDA) approval in January 2006, currently there are no studies available that show the effectiveness of injected ibandronate in reducing bone fractures in women. In fact, the FDA’s approval was meted out on the basis that injected Boniva was “not inferior” to the drug’s oral form.

“New drugs are tested only in small numbers of people prior to FDA approval, and serious adverse effects or drug interactions often show up only after thousands of people take the drug,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “Patients should make sure a drug is as risk-free as possible before they take it.”

The October updates to the WorstPills.org Web site also give consumers information about why consumers should not use Internet-sold dietary supplements for erectile dysfunction, how migraine drugs and antidepressants may cause life-threatening interactions as well as how birth defects can be caused by antidepressants alone. These latter articles contain the caveat: Do not stop any antidepressant medication without first consulting your physician.

Worst Pills, Best Pillsis a monthly newsletter available in print and electronic formats through Public Citizen’s Web site, www.WorstPills.org. The article about ibandronate will be available free on the site for the next seven days. The site has other searchable information about the uses, risks and adverse effects associated with prescription medications, including all the information contained in Public Citizen’s best-selling book, Worst Pills, Best Pills.

Worst Pills is an unbiased analysis of information from a variety of sources, including well-regarded medical journals and unpublished data obtained from the FDA that allow Public Citizen to sound the alarm about potentially dangerous drugs long before they are banned by the federal government. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol and Propulsid years before they were pulled from the market.