Rosiglitazone, an ingredient in popular Type II diabetes drugs such as Avandia, Avandamet, and Avandaryl, has been shown to increase the risk of a heart attack and other cardiovascular problems. The U.S. Food and Drug Administration will soon restrict access to these medicines by requiring patients and their doctors to enroll in a special program to use them.
After mid-November of this year, patients will not be able to get these medicines at a neighborhood pharmacy. The Avandia-Rosiglitazone Medicines Access Program will allow patients to get the medicine by certified, mail-order pharmacies. This special program is for patients who have successfully used these medicines and cannot control their blood sugar with other anti-diabetic medicines.
“There are multiple and conflicting signals of cardiovascular ischemic risk related to rosiglitazone,” said Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research. “The current cardiovascular safety database for Rosiglitazone does not provide an assurance of safety at the level set out in FDA’s guidance for marketed anti-diabetic drugs. There are not similar signals pertaining to the only other drug in the TZD class available in the US, pioglitazone.”
As to the FDA’s decision regarding the marketing and future sales of rosiglitazone, it found that current meta-analytic findings do show the increase of heart attacks and the risk of “…cardiovascular death and all-cause death, when compared to placebo or non-TZD diabetes drugs.” Most of the drug trials only lasted a year or less, and thus the chances for a serious event or death occur in a short timeframe after use. The European Medicines Agency already decided to halt sales and marketing of rosiglitazone, and patients must find alternative medications.
Chicago personal injury lawyer Robert I. Briskman, Esq. has decades of experience investigating and prosecuting claims on behalf of individuals and their loved ones. As the facts show with Rosiglitazone, the FDA once thought that the drug could be used by the wider population. Now that drug-related injuries and deaths have affected people nationwide, they are finally making it tougher to prescribe. If you or your loved one used this or any other drug and suffered undue harm, you have the right to legal counsel to discuss your situation. The Chicago personal injury attorney team at Briskman Briskman & Greenberg is accomplished in product liability, medical malpractice, and wrongful death lawsuits. To learn more, visit http://www.briskmanandbriskman.com or call 877-595-HURT (4878).
Briskman Briskman & Greenberg
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Robert Briskman is a Chicago personal injury lawyer and Chicago personal injury attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.
