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November 26, 2004

Why Aren't Amiodarone's fatal side effects labeled?

Topics: Clinical Pharmacology

27 Nov 2004. Reported on Medical News Today.

America's heart patients are still not being warned (on labels) about the fatal side effects of Amiodarone.  More than one year ago the FDA said detailed consumer warnings would soon appear on labels.

The plan to include warnings on the labels are just still plans - they are in 'draft stage'.  The draft moves backwards and forwards from the FDA to the manufacturers.

Americans are getting more worried about the FDA's role and effectiveness in protecting patients from the harmful effects of some drugs.  Ever since Vioxx was taken off the market because of serious health risks, many people are wondering how reliable the agency has become.

Karen Muccino wrote to Medical News Today saying 'My father died from Amiodarone Induced Pulmonary Toxicity on February 20, 2004.'

Ms. Muccino believes her father's life may have been saved had warnings been printed on the labels.

...... Amiodarone was prescribed as a last resort drug for ventricular arrhythmias.

Two million Amiodarone prescriptions in the USA have been issued for conditions the FDA had not approved.    Read More at Medical News Today... 

Posted by Hyscience at November 26, 2004 11:17 PM

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