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Acetaminophen Information
Acetaminophen Safety Information January 13, 2011 FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure 1/13/2011 Questions and Answers about Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit 1/13/2011 FDA limits acetaminophen in prescription combination…
FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References  Safety Announcement [1-12-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Lantus is a long-acting modified version of human insulin (insulin analog) used…
Safe Use Initiative: FDA-Sponsored Stakeholder Meeting on Surgical Fire Prevention
 On October 22, 2010, the Food and Drug Administration held a workshop to discuss FDA regulated products implicated in surgical fires and challenges in eliminating fires. The workshop was organized by the Center for Drug Evaluation and Research’s Safe Use Initiative team and the Center for Devices and Radiological Health Division of Patient Safety…
FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary  Safety Announcement [12-22-2010] The U.S. Food and Drug Administration (FDA) is informing the public that results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and…
FDA Drug Safety Communication: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)
   Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [12-17-2010] The U.S. Food and Drug Administration (FDA) is informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult…
FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age
 Safety AnnouncementAdditional Information for Patients and CaregiversAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [12-14-2010] The U.S. Food and Drug Administration (FDA) is warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. Benzonatate is a prescription drug approved for relief…
FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References Safety Announcement [11-19-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has…
Safe Use Initiative: Expert Roundtable on Pain Management in Older Adults
On September 30, 2010, CDER’s Safe Use Initiative team convened a roundtable of more than forty experts from academia, health care management, consumer advocacy and government to address the safe use of pain medications in older adults. Background Millions of Americans suffer from chronic pain. In a study of 1000 community dwelling seniors (median age…
FDA Drug Safety Communication: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [10-21-2010] The U.S. Food and Drug Administration is notifying the public that new risk information has been added to the label of the antiviral drug Invirase (saquinavir), describing a potential change in the electrical activity of the heart when Invirase is used with…