Archive for April, 2010

Avandia recall threat takes financial toll on GlaxoSmithKline

30 April, 2010

Heart side effects concerns and the possible recall of Avandia have led to a significant drop in sales of the popular diabetes drug.

Despite earnings and revenue being up 9% and 17%, respectively, a possible FDA Avandia recall leads financial analysts describe Glaxo’s first-quarter report as “gloomy.” Continue reading Avandia recall threat takes financial toll on GlaxoSmithKline

Category: Avandia FDA | Avandia News | Avandia Recall

Progress made toward Avandia lawsuit settlements, Glaxo Q1 profit over $2 billion

28 April, 2010

GlaxoSmithKline Q1 profits beat analysts’ estimates as progress is made toward settlement of Avandia lawsuits.

Without specifically mentioning Avandia, the diabetes drug manufacturer stated that legal costs for the quarter increased by over $319 million due to “the progress we are making towards settlement of a number of existing cases.” Over 2,000 Avandia lawsuits have been filed against Glaxo following a 2007 New England Journal of Medicine article linking Avandia to an increased risk of heart attack. Continue reading Progress made toward Avandia lawsuit settlements, Glaxo Q1 profit over $2 billion

Category: Avandia Lawsuit | Avandia News | Avandia Settlements

Assessment of Avandia Safety at July FDA meeting to lead to TIDE Trial decision

24 April, 2010

Avandia safety assessment at July meeting of joint FDA committees to lead to TIDE Trial decision.

When the FDA convenes a joint meeting of its Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory committees in July, the agency will assess the cardiovascular safety of Avandia and decide whether the controversial TIDE… Continue reading Assessment of Avandia Safety at July FDA meeting to lead to TIDE Trial decision

Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report

FDA may suspend Avandia safety study, could lead to Avandia recall

21 April, 2010

An Avandia safety study called the TIDE trial may be suspended by the FDA over Avandia heart attack risks.

Calls for an Avandia recall have been renewed over concerns that the diabetes drug increases heart risks. In February, a critical Senate report on Avandia was released following a two-year Senate Finance Committee investigation… Continue reading FDA may suspend Avandia safety study, could lead to Avandia recall

Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report

Scientists with positive opinion of Avandia safety were paid by Glaxo, reports New York Times

16 April, 2010

Authors of articles with favorable opinions of Avandia’s safety received money from Glaxo, reports The New York Times.

The New York Times reports that an analysis of Avandia research finds a “slant in articles” on the safety of the diabetes drug:

A new analysis of reviews and articles about the controversial diabetes drug… Continue reading Scientists with positive opinion of Avandia safety were paid by Glaxo, reports New York Times

Category: Avandia Cardiovascular Risk | Avandia News | Avandia Safety

FDA Drug Safety Review of Avandia to be Completed by July 2010

5 April, 2010

FDA is reviewing RECORD study Avandia heart risks data submitted in August 2009 – FDA Drug Safety Assessment of Avandia to be released July 2010

[02-23-2010] The Food and Drug Administration (FDA) is reviewing data submitted in August 2009 from a large, long-term study on possible heart-related risks with the diabetes drug Avandia (rosiglitazone)… Continue reading FDA Drug Safety Review of Avandia to be Completed by July 2010

Category: Avandia FDA Alerts

FDA Drug Safety Announcement: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety

5 April, 2010

Avandia Drug Safety Announcement: 2/22/2010

FDA Avandia Safety Announcement

[02-22-2010] The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia* (rosiglitazone). The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of… Continue reading FDA Drug Safety Announcement: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety

Category: Avandia FDA Alerts

Avandia FDA Alert – New Black Box Warning of Avandia Heart Risks

5 April, 2010

FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug AvandiaAgency says drug to remain on market, while safety assessment continues

[11-14-2007] The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed… Continue reading Avandia FDA Alert - New Black Box Warning of Avandia Heart Risks

Category: Avandia FDA Alerts

Avandia FDA Warning – Heart Failure Risk added to Avandia Black Box Warning

5 April, 2010

Avandia FDA Alert: 8/14/07

This Alert highlights important revisions to the full prescribing information for rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl). The updated information includes a new BOXED WARNING, and additional updated WARNINGS, PRECAUTIONS and CONTRAINDICATIONS to emphasize that rosiglitazone may cause or exacerbate heart failure, particularly in certain patient populations. The… Continue reading Avandia FDA Warning - Heart Failure Risk added to Avandia Black Box Warning

Category: Avandia FDA Alerts

Avandia FDA Warning – Heart Attack Risk added to Avandia Black Box Warning

5 April, 2010

FDA Safety Alert on Avandia Issued May 21, 2007

The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of… Continue reading Avandia FDA Warning - Heart Attack Risk added to Avandia Black Box Warning

Category: Avandia FDA Alerts
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