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FDA MEDWATCH ALERTS

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May 20, 2013

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

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All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility

May 14, 2013

Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

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Zolpidem Containing Products Drug Safety Communication

May 09, 2013

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

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The Compounding Shop FDA News Release Lack of Sterility

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FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy

Wednesday, February 20, 2013

Safety Announcement

[2-20-2013] The U.S. Food and Drug Administration (FDA) is updating the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). Deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following a tonsillectomy and/or adenoidectomy. Codeine is converted to morphine by the liver. These children had evidence of being ultra-rapid metabolizers of codeine, which is an inherited (genetic) ability that causes the liver to convert codeine into life-threatening or fatal amounts of morphine in the body. Read the full announcement.

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