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…

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…

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…

  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…

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,…

A sampling of drugs, drug classes or therapeutic areas that could benefit from stakeholder collaboration   Long-acting beta agonists (LABA)Some patients who take long-acting beta agonists (LABAs) for asthma experience exacerbations of asthma symptoms, which can result in hospitalizations and death. On June 2, 2010, FDA announced revisions to the prescribing information for LABA labels…

Back to Natural Disaster Response Insulin Storage and Potency Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient’s usual insulin. After a disaster, patients in the affected area may not have access to refrigeration.  According to the product labels from all three U.S. insulin…

Back to Natural Disaster Response Insulin Storage and Potency Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient’s usual insulin. After a disaster, patients in the affected area may not have access to refrigeration.  According to the product labels from all three U.S. insulin…

  Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Data Summary Approved Gadolinium Based Contrast Agents   Safety Announcement [09-09-2010] The U.S. Food and Drug Administration (FDA) is requiring changes in the drug label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition…

Back to Natural Disaster Response The Center for Drug Evaluation and Research (CDER) at the FDA offers the following information on the use of drugs that have been potentially affected by fire, flooding or unsafe water and the use of temperature-sensitive drug products when refrigeration is temporarily unavailable. Drugs Exposed to Excessive Heat, such as…