19 November, 2010
Health Canada, the national drug regulatory agency, has put tight new restrictions on the use of Avandia (rosiglitazone), Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimepiride).
To get a new Avandia prescription, diabetes patients will be required to sign an informed consent form confirming that they have read and understand consumer information about the drug’s heart-related risks and discussed with their physician other diabetes treatment options. In addition, A new boxed warning has been added to the package insert. Continue reading Canada puts new restrictions on diabetes drug AvandiaCategory: Avandia Cardiovascular Risk | Avandia News | Avandia Side Effects | Avandia Warning | Congestive Heart Failure
14 November, 2010
The State of Utah has filed a fraud lawsuit against Avandia drug maker GlaxoSmithKline claiming the company made illegal misrepresentations in the marketing of the Type 2 diabetes drug.
The lawsuit claims GSK misrepresented to the public and the FDA that “wonder drug” Avandia was more effective than other less expensive diabetes drugs and would reduce cardiovascular risks. Continue reading Utah v. GSK, fraud lawsuit filed over diabetes drug AvandiaCategory: Avandia Lawsuit | Avandia News
2 November, 2010
Please contact us for the latest Avandia litigation 2010 news updates.
Many diabetics who have suffered Avandia heart attack, stroke, or congestive heart failure (CHF) are unaware that the diabetes drug caused their serious heart problems. Continue reading Avandia litigation 2010 newsCategory: Avandia Lawsuit | Avandia News | Avandia Settlements | Avandia Side Effects
24 October, 2010
Avandia drug maker GlaxoSmithKline is under investigation by federal and state law enforcement officials, the company announced in a press release issued on October 21, 2010:
[GSK] is in the process of responding to a US Department of Justice (DOJ) subpoena relating to the development and marketing of Avandia. Continue reading GSK under state, federal criminal investigations of AvandiaCategory: Avandia FDA | Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Settlements
15 October, 2010
A FDA Avandia news conference was held on September 23, 2010 to announce the FDA decision on Avandia and for FDA drug safety officials to take questions from the media.
The following is a complete transcript of the news conference. FDA Commissioner Margaret Hamburg, FDA Principal Deputy Commissioner Joshua Sharfstein and Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA all were in attendance. Continue reading FDA Avandia news conference: 2010 rosiglitazone restrictionsCategory: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Warning
8 October, 2010
In May 2007, Cleveland Clinic cardiologist Dr. Steven Nissen published an Avandia study in the New England Journal of Medicine that would mark a turning point for the diabetes drug Avandia.
Dr. Nissen found that Avandia use was linked to a 43% increased risk of heart attack. and has been a vocal critic of Avandia ever since. Dr. Nissen reacts to the September 23, 2010 FDA Avandia restrictions. Continue reading FDA Avandia heart attack news, Avandia critic reacts to FDACategory: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Safety | Avandia Settlements | Avandia Warning
30 September, 2010
Last week, an Avandia recall in Europe was announced as the FDA put tight new restrictions on Avandia use in the United States.
Avandia has been on the market in the U.S. to treat type 2 diabetes since 1999. How long have drug maker GlaxoSmithKline and the FDA been aware of Avandia side effects risks? According to a lead Senate investigator, the answer is shocking. Continue reading Avandia Recall News: GSK hid Rosiglitazone side effects risksCategory: Avandia FDA | Avandia Lawsuit | Avandia News | Avandia Senate Report | Avandia Settlements | Avandia Side Effects
25 September, 2010
FDA stops Avandia TIDE trial due to unjustified risk of stroke and cardiac events.
Act now to make you Avandia settlement claim. FDA drug safety experts concluded that the TIDE trial subjected participants to an unjustified risk of heart disease. All of the regulatory deadlines set by the FDA for completion of the trial have been rescinded. Continue reading FDA stops Avandia TIDE trial due to unjustified heart risksCategory: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Safety
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