23 September, 2010
The FDA announced today that it will put tight restrictions on Avandia use while the EMA announced a European Avandia recall.
Under new FDA Avandia restrictions, the diabetes drug will be available in the U.S. 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.” Continue reading FDA: Avandia restricted severly; Europe: Avandia recallCategory: Avandia FDA | Avandia News | Avandia Recall
18 September, 2010
The FDA has begun reviewing the safety of the diabetes drug Actos (pioglitazone), after receiving early results from research evaluating the drug’s bladder cancer risk.
While early data from a long-term study demonstrates an increased risk of bladder cancer in patients with the longest exposure and in those having taken the highest cumulative dose of Actos, the FDA has not concluded that Actos increases the risk of bladder cancer. The FDA has no clinical information associating Avandia with bladder cancer. Continue reading FDA reviewing safety of Avandia's rival diabetes drug ActosCategory: Avandia FDA | Avandia News | Avandia Safety | Uncategorized
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 biasCategory: Avandia FDA | Avandia News | Avandia Recall
10 August, 2010
A new law has been been proposed to give the FDA authority to recall dangerous drugs.
Currently, the FDA can only require warnings, issue safety alerts and recommend that a dangerous drug be recalled. The Drug Safety and Accountability Act of 2010 would give the FDA power to recall drugs it determines to be unsafe. Continue reading New law would give FDA drug recall powerCategory: Avandia FDA | Avandia Recall | Avandia Senate Report
27 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 TrialCategory: Avandia FDA | Avandia News
22 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 barredCategory: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Side Effects
21 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 responseCategory: Avandia FDA | Avandia News
14 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 UseCategory: Avandia FDA | Avandia News | Avandia Recall
13 July, 2010
Endocrinologic and Metabolic Drugs Advisory Committee
Drug Safety and Risk Management Advisory Committee
Hilton Washington DC North/Gaithersburg
July 13 – 14, 2010
A list of 47 experts at the joint FDA drug advisory committee meeting to evaluate Avandia safety data, cardiovascular/heart risk, side effects and an Avandia recall. Continue reading FDA Avandia Safety Joint Advisory Committee Meeting Roster - ExpertsCategory: Avandia FDA | Avandia Recall | Avandia Safety | Avandia Side Effects | Avandia Warning
11 July, 2010
Advisory Committee Briefing Document: Cardiovascular Safety of Rosiglitazone
Prepared by GlaxoSmithKline for the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
Meeting on July 13-14, 2010 Continue reading FDA Advisory Committee Briefing Document: Cardiovascular Safety of Avandia