Offices:

Washington DC Office
1101 Pennsylvania Ave.
Suite 600
Washington DC 20004
Telephone: 202-756-2972

Miami Office
1111 Brickell Avenue
11th Floor
Miami, FL 33131
Telephone: 305-913-7199

Fort Lauderdale Office
110 E. Broward Blvd.
Suite 1700
Fort Lauderdale, FL 33301
Telephone: 954-315-3934

Avandia Heart Risks News

GSK Revises US Avandia Label To Include New Restrictions On Use

- WSJ.com

02/08/2011 - GlaxoSmithKline PLC, a pharmaceutical and healthcare company announced Monday it has revised its U.S. prescribing information and medication guides for all rosiglitazone-containing medicines, like Avandia, Avandamet and Avandaryl to include additional safety information and restrictions on the use of these medicines.

MAIN FACTS:

-The new label content reflects the U.S. Food and Drug Administration's or FDA review of cardiovascular event data in type 2 diabetes patients treated with Avandia, and follows a meeting of the joint Advisory Committees in July 2010 and a decision in September 2010 by the FDA to restrict access to these medicines.

-The revised labels restrict use to patients already taking a rosiglitazone-containing medicine or to new patients who are unable to achieve adequate glycemic control on other diabetes medications and to those, who in consultation with their healthcare provider, have decided not to take Actos (pioglitazone) or other pioglitazone-containing medicines for medical reasons.

-Patients should consult their healthcare professional for advice on the benefits and risks of Avandia.

-Other revisions to the label content include changes to the Boxed Warning, Indications and Usage, Dosage and Administration, and Warnings and Precautions.

-As part of the September decision, the FDA had required GSK to establish a Risk Evaluation and Mitigation Strategy or REMS program which will restrict availability of these medicines.

Avandia Side Effects Cases Still Being Accepted:

The lawyers of Ennis & Ennis, P.A. are still accepting Avandia side effects cases and have extensive experience representing plaintiffs in Avandia lawsuits nationwide.

If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia lawyers of Ennis & Ennis, P.A. today about an Avandia lawsuit. Call us toll free for a free, confidential case evaluation or fill out our online Avandia case evaluation form

Case Evaluation Form
*Required

Your Full Name:*

E-mail address:*

Mailing address:*

City:*

State:*

Zip:* (5 digit Zip Code)

Phone number:*
(123-123-1234)

Age:*

When did you begin and end using Avandia?

Please list any injuries:

If you have been injured as a result of Avandia side effects we recommend that you notify the FDA
FDA MEDWATCH FORM