8 December, 2011
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Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report | Avandia Settlements | Avandia Side Effects | Avandia Warning | Congestive Heart Failure16 October, 2011
A federal judge presiding over Avandia litigation denied drug maker GlaxoSmithKline’s motion to dismiss 60 Avandia lawsuits on statute of limitations grounds. GSK attempted to convince the judge that the claims were filed too late. Continue reading Avandia statute of limitations ruling allows new lawsuits to proceed
Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Settlements | Avandia Side Effects17 February, 2011
The New Zealand Ministry of Health will withdraw Avandia from the market due to heart risks. The Avandia recall is scheduled for April 29. Drug regulators at the U.S. FDA have fallen short of ordering an Avandia recall. 2011 Avandia settlements have been reached in thousands of cases. Avandia lawsuits continue to be filed across the United States. Continue reading Avandia recall in New Zealand: 2011 Avandia settlements in U.S.
Category: Avandia FDA | Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Settlements24 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 Avandia
Category: Avandia FDA | Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Settlements15 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 restrictions
Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Warning23 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 recall
Category: Avandia FDA | Avandia News | Avandia Recall13 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 Effects10 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 power
Category: Avandia FDA | Avandia Recall | Avandia Senate Report22 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 Effects