FDA Alerts
FDA Alerts Healthcare Providers of Recall by Med Prep Consulting
The US Food and Drug Administration is alerting healthcare providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, NJ, a specialty pharmacy licensed by the state of New Jersey.
Azithromycin (Zithromax or Zmax) and the Risk of Potentially Fatal Heart Rhythms
The US Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.
FDA Issues Draft Guidance to Accurately Label Medical Products Not Made with Natural Rubber Latex
The US Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).
FDA Suspends Pediatric Clinical Trials of Sensipar After Report of Death
The US Food and Drug Administration (FDA) has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial.
FDA Requiring Lower Recommended Dose for certain sleep drugs containing zolpidem
The US Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep medications that contain the active ingredient zolpidem, to lower current recommended doses.
Andy Capp’s Hot Fries Recalled Due To Undeclared Soy Allergen
Today, ConAgra Foods, Omaha, Neb., in cooperation with the US Food and Drug Administration (FDA) is voluntarily recalling a limited number of packages of its Andy Capp’s Hot Fries flavor product that may contain the Andy Capp’s Cheddar Fries flavor, and, therefore, an undeclared allergen—soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no illnesses reported to date in connection with this product.
FDA Proposes New Food Safety Standards
The US Food and Drug Administration today proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act ( FSMA ) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules.
FDA Drug Safety Communication: Xyrem
The US Food and Drug Administration (FDA) is reminding healthcare professionals and patients that the combined use of Xyrem (sodium oxybate ) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression).
FDA approves Signifor, a drug for Cushing’s disease
The US Food and Drug Administration today approved Signifor (pasireotide diaspartate) injection for the treatment of Cushing’s disease patients who cannot be helped through surgery.
FDA Drug Safety Communication: Updated information on intravenous Zofran
The US Food and Drug Administration (FDA) is notifying healthcare professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran ( ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks.