Home -> Law Blog Directory -> Disability Law Blogs -> Personal Injury and Social Security Disability Blog
(866) 635-2689 for Personal Injury or (866) 635-9402 for Criminal Defense
Find a Local Lawyer
Divorce (866) 635-6190
Personal Injury (866) 635-2689
Criminal Defense (866) 635-9402
Disability Law
: Personal Injury and Social Security Disability BlogRegulators Impose Tight Restrictions on Diabetes Drug Avandia
By Robert Kraft

In a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, will no longer be widely available.
The drug?s sales will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug?s substantial risks to the heart. Patients currently taking Avandia may continue to do so.
The Food and Drug Administration?s decision shows that the Obama administration is taking a harder line on drug safety issues even in the face of scientific uncertainty. Along with its announcement, the agency for the first time immediately posted on its Web site memorandums from top agency staff members that in some cases offered entirely contradictory advice. Dr. Margaret Hamburg, the agency?s commissioner, said that passions within the agency had run high on the Avandia decision.
?As F.D.A. commissioner, my job would be infinitely easier if we had consensus and full scientific clarity,? she said.
Dr. Steven Nissen, a Cleveland Clinic cardiologist whose studies highlighted Avandia?s heart attack risks, said that the decision brought an end to ?one of the worst drug safety tragedies in our lifetime,? adding that it was ?essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.?
One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure or died.
Full post as published by Personal Injury and Social Security Disability Blog on September 23, 2010 (boomark / email).
Mitchell Report Summary
Report on Steroid Drug Use in Major League Baseball by Senator George Mitchell
Florida, USA
alleging restrictions too tight on Medicaid recipients.
Avandia
alleging heart attacks, increased fracture risk that may have been caused by Avandia.
Cressi Scuba Regulators Recalled Due to Risk of Drowning
Scuba Regulators Recalled Due to Risk of Drowning
Drug Manufacturer Rebates
Caremark Corp. agrees to pay $38.5 million settlement after convincing doctors to switch drug brands.
FDA Review of Prostate Cancer Treatment Prompts Warning of Risk for Diabetes
Prostate Cancer Treatment FDA Review Prompts Warning of Risk for Diabetes
Seroquel
Data on Diabetes Buried

GSK Diabetes Drug Avandia May be Unsafe, Near Recall
Avandia Roundup: Sales Drop, GlaxoSmithKline Cut Jobs
Avandia Experiment may have Killed Mom
Medical groups advise against using GlaxoSmithKlines Avandia








