• Regulatory NewsRegulatory News

    Senator Seeks More Info From Mallinckrodt on Price Increases of Acetaminophen Injection

    • 24 May 2017
    Sen. Claire McCaskill (D-MO) late last week sent a letter to the CEO of Mallinckrodt seeking more information on price increases of its injectable version of acetaminophen as hospitals reported millions in increased costs. McCaskill, who says in the letter that she’s recently begun an investigation into the manufacturers of the top five opioids by 2015 worldwide sales, notes that BJC HealthCare hospital system in Missouri saw an additional $2.16 million in costs as...
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    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    The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC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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    FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen

    The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of some over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours. The guidance, which was initially issued in 2012 , helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirh...
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    FDA Orders New Warnings on OTC Acetaminophen Drugs

    A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions. Background The new guidance, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions , follows a 2013 warning by FDA that ...
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    Three Years After Warnings, FDA Bans Last High-Dose Aceptaminophen Products

    All prescription drugs containing high doses of acetaminophen have officially been withdrawn from the market, the US Food and Drug Administration (FDA) indicated in a regulatory filing this morning. Background In January 2011, FDA requested that manufacturers discontinue marketing high-dose versions of acetaminophen—defined as doses higher than 325 mg—due the drug causing severe liver failure in some patients. "Overdose from prescription combination products containi...
  • FDA Issues New Draft Guidance for Products Containing Acetaminophen

    The US Food and Drug Administration (FDA) has released new draft guidance pertaining to over-the-counter drug products containing acetaminophen, saying it will allow exceptions to a labeling rule under limited circumstances. Acetaminophen is commonly used in internal analgesic, antipyretic and antirheumatic (IAAA) drugs to relieve pain, but had also been associated with liver injury and stomach bleeding if used at high dosages. As a result of the associated adverse event...