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…
Warning Letters 2010
2010 Warning Letters and Untitled Letters to Pharmaceutical Companies      These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page.  Some of the letters have…
Questions and Answers on Unapproved Chelation Products
The U.S. Food and Drug Administration (FDA) advises consumers to be wary of so-called “chelation†products that are marketed over-the-counter (OTC) to prevent or treat diseases. Companies are marketing unapproved OTC chelation therapy products to patients with serious and incurable diseases, including autism spectrum disorders and heart (cardiovascular) conditions. 1. What is chelation? Chelation involves…
FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [10-13-2010] The U.S. Food and Drug Administration (FDA) is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be…
FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [10-8-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of Meridia (sibutramine) because this drug may pose unnecessary cardiovascular risks to patients. FDA has requested that Abbott Laboratories—the manufacturer of Meridia—voluntarily withdraw this drug product from…
New and Generic Drug Approvals
Visit Drugs@FDA to search Drug Approval Reports by Month. October 06, 2010 Aridol (mannitol) Inhalation Powder, Pharmaxis, Inc., Approval Eligard (leuprolide acetate) Injectable Suspension, sanofi-aventis, Labeling Revision October 05, 2010 Atomoxetine Hydrochloride Capsules, TEVA Pharmaceuticals, Approval Carbidopa, Levodopa and Entacapone Tablets, Sun Pharmaceutical, Tentative Approval COMBIVIR (lamivudine/zidovudine) Tablets, GlaxoSmithKline, Labeling Revision DURAMORPH (morphine sulfate) Injection,…