Avandia FDA Alerts

New FDA Avandia restrictions: 9-23-2010 FDA News Release

23 September, 2010

The attorneys at AvandiaRecallNews.com no longer are accepting new Avandia cases.

FDA significantly restricts access to the diabetes drug Avandia

Makes regulatory decisions on RECORD and TIDE trials

[09-23-2010] The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with… Continue reading New FDA Avandia restrictions: 9-23-2010 FDA News Release

Category: Avandia FDA Alerts

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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