FDA requires Strongest Warning Label on Nausea Drug

On Thursday September 17th the Food and Drug Administration required that the strongest warning label be placed on a nausea drug known as Phenegran. This new warning label is due to the fact that after Diane Levine took this drug through an IV push for migraine related nausea and it then led to infection and gangrene. This caused her to have to have her lower right arm amputated. She sued the drug company Wyeth claiming that the warning label was not sufficient enough to warn against the effects of this drug especially in an IV push. This case made it to the Supreme Court and won Diane 6.7 million dollars. This then led to the FDA requiring this strong warning. This will warn users and medical professionals about the possibility of gangrene and also to let them know that IV drugs should be used in low doses and low concentration. This warning is the FDA’s strongest and is called a “black box” warning. The Court agreed that having the Food and Drug Administration’s approval and new warnings help cut down on medical device lawsuits.

For more information on Food and Drug Administration and  improper warning labels you may visit:

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If you or a loved one have experienced a situation similar to this or have been injured due to a medical device or product, please contact a defective product lawyer right away. They will help you fight for your rights to be heard and get the care you or loved one  deserve.

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