A committee of outside experts advising the U.S. Food and Drug Administration recommended June 6 that the FDA ease access restrictions placed nearly three years ago on the diabetes drug Avandia (rosiglitazone), which had been linked to an increased risk of “cardiovascular events, such as heart attack and stroke.” The description of the increased health risks came from the agency’s Sept. 23, 2010, announcement that the distribution controls would be imposed.
The panel’s music to the ears of the manufacturer is a change in perspective, a look at a different side of the science, albeit supposedly without obliterating all safety concerns. Borrowing from a Joni Mitchell hit, the experts have “looked at life from both sides now,” leaving the FDA to determine if they “really don’t know life at all.” The committee’s majority decided to modify Avandia restrictions based on a re-evaluation of the manufacturer’s safety data. GlaxoSmithKline is Avandia’s maker.
The FDA will take under advisement what, if anything, to do about this new perspective on Avandia side effects. In the meantime, rosiglitazone-containing drugs are marketed under the FDA’s risk evaluation and mitigation strategy, or REMS. Using the FDA’s language, Avandia’s restrictions require that the drug “will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class.” Pre-existing users who have been “benefiting from the drug” have been allowed to choose whether to stay on it.
The REMS enrolls participating physicians and pharmacists. Doctors must “attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks.”
If the FDA entirely lifts the REMS, then the golden goose will have done a lot for Teva Pharmaceuticals, which not that long ago, on Jan. 25, obtained FDA approval to produce generic Avandia tablets.
What about Avandia’s victims? What about thousands of people who developed Avandia side effects, such as heart attack and stroke, seemingly without a culprit as plausible as the drug? Thousands of injured patients or their family members have hired counsel and have joined Avandia class action lawsuits that have been centralized before the U.S. District Court for the Eastern District of Pennsylvania.
Avandia settlements are indeed attainable.
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Victims of any bad drug may contact one of the pharmaceutical injury attorneys at Reich & Binstock for a free consultation. The law firm may be reached toll-free at 1-866-LAW-2400. One also may submit the electronic case evaluation request form posted on the law firm’s website, www.reichandbinstock.com.