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Keyword: blackboxwarning

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  • FDA adds a warning to Covid-19 vaccines about risk of heart inflammation [ myocarditis ]

    08/12/2021 9:34:27 PM PDT · by NoLibZone · 12 replies
    CCP vetted then CNN ^ | June 26,2021 | By Lauren Mascarenhas
    The US Food and Drug Administration added a warning about the risk of myocarditis and pericarditis to fact sheets for Moderna and Pfizer-BioNTech Covid-19 vaccines Friday. The warning notes that reports of adverse events following vaccination – particularly after the second dose – suggest increased risks of both types of heart inflammation. The FDA said at the time it would update the fact sheets the reflect the findings.
  • Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection

    11/18/2004 12:15:15 AM PST · by neverdem · 7 replies · 521+ views
    ROCKVILLE, Md., Nov. 17, 2004 - The Food and Drug Administration (FDA) announced today that a "black box" warning, highlighting prolonged use may result in the loss of bone density, will be added to the labeling of Depo-Provera Contraceptive Injection, an established injectable drug approved for use in women to prevent pregnancy. Although Depo-Provera Contraceptive Injection has been used for decades for birth control throughout the world and remains a safe and effective contraceptive, FDA and Pfizer, the drug's manufacturer, are taking this action to ensure that physicians and patients have access to this important information. The black box warning...