13 September, 2010
FDA officials in favor of an Avandia recall claim drug safety advisory committee panelists were biased in favor of the diabetes drug.
FDA drug safety experts Dr. David Graham and Dr. Kate Galperin sharply criticized the agency for including consultants who were biased against an Avandia recall on a 2010 FDA drug advisory panel. This most recent criticism of FDA Avandia review was published in the British Medical Journal on September 7, 2010. Continue reading Drug safety expert at FDA: Avandia panel had anti-recall bias
Category: Avandia FDA | Avandia News | Avandia Recall9 September, 2010
Concerns over Avandia side effects has led an independent panel of drug safety experts in England to call for an Avandia recall.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the Brittish counterpart to the U.S. FDA. Avandia side effects risks outweigh its benefits, the regulators were advised by the panel. Continue reading Drug experts call for UK Avandia recall due to side effects
Category: Avandia News | Avandia Recall | Avandia Safety | Avandia Side Effects28 August, 2010
A new study comparing heart side effects risks of rival diabetes drugs Avandia and Actos suggests both treatments carry similar risks of heart attack, acute heart failure and death.
Researchers at health insurance company WellPoint reviewed the claims records of over 29,000 diabetic clients who took either of the drugs between 2001 and 2005. The study was published on August 24, 2010 in the medical journal, “Circulation: Cardiovascular Quality and Outcomes.” Continue reading Avandia heart risks similar to Actos claims new study
Category: Avandia Cardiovascular Risk | Avandia Lawsuit | Avandia News | Avandia Safety | Avandia Side Effects31 July, 2010
Avandia increases the risk of fractures in women over 50 and in men who also take loop diuretics, according a new study published in the Journal of Clinical Endocrinology & Metabolism.
The new study examined diabetes treatments and fractures using data from the TRIAD study of diabetic patients in managed care settings. Continue reading New study links TZDs Actos and Avandia to fracture risk
Category: Avandia News | Avandia Safety | Avandia Side Effects27 July, 2010
FDA puts Avandia drug safety TIDE trial on clinical hold pending Avandia side effects risks review.
The FDA has given notice to Avandia drug manufacturer GlaxoSmithKline that the TIDE trial has been put on clinical hold pending review of Avandia safety information presented at the FDA Advisory Committee meeting on Avandia drug safety held July 13 and 14, 2010. The complete FDA statement is set out in full. Continue reading FDA Statement on Avandia TIDE Trial
Category: Avandia FDA | Avandia News22 July, 2010
While Avandia side effects data are being reviewed by the FDA, Avandia lawsuit settlements are being reached, and an Avandia recall still is being considered, the FDA has barred new diabetes patients from participating in the TIDE trial. Continue reading FDA Avandia news on TIDE: New patients barred
Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Side Effects21 July, 2010
GlaxoSmithKline statement in response to FDA announcement on TIDE trial
GlaxosmithKline’s press release in response to FDA Avandia news that a “partial clinical hold” barring new diabetes patients from enrolling in the TIDE trial had been issued while Avandia side effects data are reviewed. Continue reading FDA Avandia news on TIDE trial: GSK's press release response
Category: Avandia FDA | Avandia News16 July, 2010
Avandia lawsuits have been filed by diabetics and their families against drug manufacturer GlaxoSmithKline to collect financial compensation for personal injury and wrongful death damages.
Avandia lawsuit attorneys claim GSK intentionally misled doctors and the public about the drug’s safety and efficacy. Lawyers also claim Glaxo was negligent. Please contact us for the latest Avandia lawsuit 2010 news. Continue reading Avandia Lawsuit 2010 Information
Category: Avandia Lawsuit | Avandia News14 July, 2010
On July 14, 2010, the joint FDA drug advisory panel on Avandia safety voted NOT to recall Avandia, GlaxoSmithKline’s controversial Type 2 Diabetes medicine.
How did the 33 members of the FDA advisory committee vote when asked what regulatory action should be taken on Avandia by the U.S. Food and Drug Administration? Here are the number of votes received for each of the options: Continue reading FDA Panel Vote NO AVANDIA RECALL, Revise Warning, Restrict Use
Category: Avandia FDA | Avandia News | Avandia Recall11 July, 2010
Avandia FDA Advisory Committee Briefing Document Abbreviations
AE Adverse event ACR Albumin creatinine ratio ACS Acute Coronary Syndrome BARI 2D Bypass Angioplasty Revascularization Investigation 2 DiabetesCategory: Avandia FDA | Avandia News