What happens when a pharmaceutical drug does more harm than good? These stories about the Avandia diabetes drug may answer that question.
"Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas...in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach...?" A fascinating article recently discussed the increasingly common practice of performing clinical drug trials outside of the United States for drugs planned to [...]
This week, Honorable Cynthia M. Rufe of the U.S. District Court for the Eastern District of Pennsylvania rejected GlaxoSmithKline's (GSK) request to exclude three plaintiff experts from testifying about the health risks associated with taking the diabetes drug, Avandia. The national Avandia multidistrict litigation is coordinated in front of Judge Rufe. Multidistrict Litigation (MDL) is [...]
A segment on 60 Minutes discussed the story of Cheryl Eckard, who was the global quality assurance manager at GlaxoSmithKline (GSK). Her job was to inspect plants to make sure drugs were manufactured properly and met government standards for purity. In 2002, Ms. Eckard was assigned to GSK's important Cidra, Puerto Rico, plant where 900 [...]
For decades, the Brandi Law Firm has represented victims of defective pharmaceutical drugs and medical devices when their use has been shown to be unreasonably dangerous to users. One similarity in all of these cases it that the adverse affects of these drugs was found after FDA approval through a high incidence of side effects. [...]
The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and [...]
The FDA announced in September that they are placing severe restrictions on the continuing use and prescription of Avandia. The European Medicines Agency (Europe’s version of the FDA) went even further, banning the advertising, marketing, or sale of Avandia. Under the FDA’s restrictions, a doctor will have to certify that their patient has tried all [...]
Studies Show Avandia Increases Risk for Cardiac Problems Type two diabetics with high blood sugar levels are prone to serious health problems, such as hypertension, obesity, stroke, heart attack and heart disease. Avandia (generic name rosiglitazone maleate) has been given to many type two diabetes patients to keep their blood sugar levels below dangerous levels. [...]