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FDA Warning, 6.6.07

in this section: Firm's Press Release, 10.1.07 | Another FDA Warning? 10.24.07 | avandia drug warning | Study Reveals Risks, 6.6.07 | FDA Warning, 5.22.07 | Secret Avandia Vote | Veterans Affairs: Avandia | FDA Approval of Avandia | NEJM Study | Warning Letter, 2001 | Sales Plunge | NEJM Update, 6.5.07 | FDA Safety Information | FDA Warning, 6.6.07 | Scientists Silenced | Dallas Lawsuit | Patients Switch Meds | Avandia Prescriptions Fall | Updated Study, 7.12.07 | Avandia Panel, 7.25.07 | Second Black Box? | Senators Testify | Experts Cite Risks | Black Box Warning | 9.12.07 Study Analysis | Actos Study | Arkansas Lawsuit | Weakens Bones | JAMA Report, 12.7.07 | Avandia Diabetes Pills | Avandia Warning

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FDA Issues Strictest Warning on Prescription Diabetes Drug Avandia

On June 6, 2007, the Food and Drug Administration (FDA) called for the most stringent warning to be added to prescription Type 2 diabetes drug Avandia.

The decision was revealed before a packed Congressional House hearing. It comes, however, more than a year after FDA safety reviewers strongly recommended that the agency take such a step.

In effect, the decision tells GlaxoSmithKline, manufacturer of Avandia, to make the warning about Avandia's heart risks more prominent, by placing it in a so-called "black box."

According to the New York Times, the call for this heightened warning is due to the fact that "despite existing warnings, these drugs [[diabetes drugs Avandia and Actos, the latter made by Eli Lilly]] were being prescribed to patients with significant heart failure."

The article quotes Representative Henry Waxman, a California Democrat who is chairman of the House Committee on Oversight and Government Reform as saying, "Avandia is a case study of the need for reform of our drug safety laws."

If you or a loved one has suffered cardiac complications after ingesting Avandia, you deserve the guidance of an experienced drug attorney. Get a free case review by filling out the form below.

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see also:

Avandia Diabetes Pills Glaxo Failed to Disclose Studies Regarding Avandia Diabetes Pills
FDA wasn't told about safety reports on Avandia Pills--lawsuit info

Veterans Affairs: Avandia Veterans Affairs Severely Limits Use of GlaxoSmithKline's Avandia Drug
Veterans Affairs Limits Use of Glaxo's Avandia Due to Safety Concerns

News & Warnings Avandia Breaking News: Glaxo Warned in 2001 about Misleading Marketing
Bloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001

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