• Regulatory NewsRegulatory News

    FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included

    The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday. "Because of the potential side effects associated with long-term aspirin therapy...
  • Regulatory NewsRegulatory News

    FDA Issues Labeling Guidance for Aspirin, Acetaminophen

    The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC acetaminophen-containing products. Aspirin: Cardiovascular Advisory For many years the medical community has debated over the benefits and risks of taking low-dose daily aspirin to lower the risk of cardiovascular disease. Last year, the US Preventi...
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    Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk

    The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach. The widely used OTC products already have warnings  about this bleeding risk in their labels, though Dr. Karen Mahoney, Deputy Director and Supervisory Medical Officer in FDA’s Division of Nonprescription Drug Products, noted that a r...
  • Canada: New Safety Labeling Guidance for Aspirin Products

    Newly proposed safety-related revision from Canadian regulators will apply to acetylsalicylic acid (ASA)-containing products, and contains proposed limits for over-the-counter (OTC) use. The product, more commonly referred to as aspirin, is increasingly found in combination products containing, for example, codeine and caffeine. The draft proposal responds to adverse event reports concerning overdoses from products containing ASA, as well as risks to infant health posed...
  • EMA Looks to Open Up Clinical Trial Data After Concerns About Tamiflu Raised

    The European Medicines Agency (EMA) announced it is looking to develop a "way forward for publication of full clinical trial data" after concerns were published about selective publication of Tamiflu efficacy data. Tamiflu, which was stockpiled heavily around 2009 due to fears about swine flu, was recently attacked in the medical journal PLoS Medicine by authors Peter Doshi, Tom Jefferson and Chris Del Mar, who claim the drug overstated its effectiveness by hiding cert...