Avandia is an oral diabetes medicine that help control blood sugar levels. Avandia is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes. Avandia may also be used for purposes other than those listed in Avandia's medication guide.
Avandia History
A report was developed over the last 2 years by U.S. Senate Committee on Finance investigators who reviewed over 250,000 pages of documents provided by Avandia’s pharmaceutical drug maker GlaxoSmithKline, the FDA, the University of North Carolina, and others. Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA, and anonymous whistleblowers.
Committee staff began this investigation in May 2007 after a study was published in the New England Journal of Medicine, showing a link between the diabetes drug Avandia (rosiglitazone) and heart attacks. However, the reviewed evidence suggests that GSK knew for several years prior to this study that there were possible cardiac risks associated with Avandia.
As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.
When an independent scientist sought to publish a study in 2007 pointing out the cardiovascular risk of Avandia, GSK acquired a leaked copy of that study from one of its consultants prior to the study being published. The company’s own experts analyzed the study, found it to be statistically reliable, and then attacked the soundness of that study in press releases and public comments.
GSK also sought to counter the study’s findings by quickly releasing preliminary results from its own study on Avandia, even though the company’s internal communications established that its study was not primarily designed to answer questions about cardiovascular risk.
FDA Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines [such as Avandia]
The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.
The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)—a program FDA may require to manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on September 23, 2010.
Facts about rosiglitazone
• Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
• From January 2010 through October 2010, around 460,500 patients filled a prescription for a rosiglitazone-containing product from outpatient retail pharmacies. The projected number of patients filling a rosiglitazone-containing product declined by 50% from 235,500 patients in January 2010 to around 119,000 in October 2010.
FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products. The REMS, called the Avandia-Rosiglitazone Medicines Access Program, limits the use of rosiglitazone medicines to:
• Patients already being successfully treated with these medicines.
• Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines. After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies. Patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program.
FDA Report: Take Avandia Off the Market
Two officials from the Food and Drug Administration are recommending that diabetes drug Avandia be pulled from the market because of its potential to harm the heart, the New York Times reports. Agency reports suggest that if every diabetic taking Avandia switched to a different medication, about 500 heart attacks would be averted each month. And in the third quarter of 2009, Avandia was linked to 304 deaths, the Times reports. Avandia's heart risks came to light following a 2007 study by the Cleveland Clinic, but later studies failed to show a definitive link. An FDA advisory committee is being assembled to assess whether or not Avandia should continue to be sold.
Doctors Claim Glaxo Dismissed Worries on Avandia
Drug Maker Tried to Make Physician at Maryland Hospital Stop Talking About Concerns; Company Defends Its Effort
A ruckus erupted last year when reports surfaced that Glaxo was accused of intimidating John Buse, a University of North Carolina researcher who, years earlier, questioned the safety of its Avandia diabetes pill, which was linked to heart problems. However, he wasn’t the only one the drug maker tried to stifle.
Pharmaceutical Giant GlaxoSmithKline to Suffer More Setbacks in Avandia Battle
Pharmaceutical giant GlaxoSmithKline is about to suffer more setbacks in the ongoing battle of opinions concerning the safety of its much touted diabetes drug Avandia. The American Diabetes Association has accepted for publication in its prestigious medical journal, Diabetes Care, a study by Harvard researchers that shows users of the diabetes drug Avandia have more than double the risk of a heart attack compared to other diabetes drugs. Further, a jointly sponsored study by both GlaxoSmithKline and i3 Drug Safety, an independent drug-safety firm, will appear in the journal Clinical Therapeutics showing that Avandia users have a 35-41% increased risk of a heart attack over users of Actos, Avandia's main competitor.
Public Citizen Petitions FDA to Ban Diabetes Drug Avandia, According to Avandia Plaintiffs Attorney Group
National non-profit organization documents upsurge in negative clinical data associated with use of Avandia, urges FDA commissioner to remove drug from U.S. market immediately Thus, it is urgent for the FDA to immediately ban rosiglitazone (Avandia).
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