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FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)
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FDA Drug Safety Communication: FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)
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FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine
Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data SummaryTable Safety Announcement [04-14-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being…
FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events
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Pediatric Exclusivity Statistics
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Written Requests Issued
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FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies
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FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References Safety AnnouncementPublic Health Advisory warning about methemoglobinemia with the use of benzocaine sprays during medical procedures. Since then, FDA has received 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine sprays, bringing the total to 319 cases…
FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
Safety AnnouncementAdditional Information for Consumers and CaregiversAdditional Information for Healthcare ProfessionalsData Summary References Safety AnnouncementDrug Safety Communication on Benzocaine Sprays). These products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums. Methemoglobinemia has been reported with all strengths of benzocaine gels and…