- AACE PATIENT SAFETY EXCHANGE -

AACE Patient Safety - News

FDA Alert RE: Levemir 2009-06-15 08:52:36 Submitted by: AACE The FDA has issued the following Public Health Advisory regarding Levemir Insulin: The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared an Read More FDA Imposes Restrictions on Coast IRB due to Violations 2009-04-15 09:20:27 Submitted by: FDA News The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human Read More Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful 2008-12-17 16:04:45 Submitted by: FDA News A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable informa Read More FINAL RULE ISSUED FOR PATIENT SAFETY ORGANIZATIONS 2008-11-21 11:11:42 Submitted by: AHRQ Public Affairs The U.S. Department of Health and Human Services has issued a final rule for Patient Safety Organizations (PSOs). Read More FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes 2008-11-06 11:52:20 Submitted by: Daniel S. Duick, MD, FACP, FACE - AACE President The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needl Read More Byetta and Patient Safety 2008-08-20 16:20:11 Submitted by: Richard Hellman, MD, FACP, FACE The FDA has reported the receipt of six cases of hemorrhagic pancreatitis in patients taking the drug Byetta (exenatide). In all cases the Byetta was discontinued. Two of the patients died, and all six patients required hospitalization. Read More CT Scans May Cause Medical Device Malfunctions 2008-07-18 08:07:35 Submitted by: Richard Hellman, MD, FACP, FACE On July 15 , 2008, the FDA released a report stating that direct x-ray exposure from CT scanning has been reported to not only cause malfunction of cardiac pacemakers and defibrillators, but also to affect other devices, including neurostimulators and impl Read More A Lethal Mistake – a misread prescription for propylthiouracil (PTU) 2008-07-16 12:13:44 Submitted by: Jeffrey R. Garber, MD, FACP, FACE A soon to be released FDA edition of "Drug Topics" will report that a pregnant woman with hyperthyroidism was given Purinethol (mercaptopurine) instead of propylthiouracil, which was prescribed as "PTU 50 mg tid". Read More AACE Calls For New Standards for Safer Insulin Pump Use 2008-05-24 15:56:18 Submitted by: Richard Hellman, MD, FACP, FACE JACKSONVILLE, FL - "The American Association of Clinical Endocrinologists applauds the FDA's efforts to protect the safety of children and adolescents who are using insulin pumps," said Dr. Richard Hellman, the Association's President. Read More A First Step Toward Improving Drug Surveillance – The Sentinel Initiative 2008-05-24 15:54:33 Submitted by: Richard Hellman, MD, FACP, FACE The Food & Drug Administration (FDA), in conjunction with the Department of Health & Human Service (HHS) and the Centers for Medicare & Medicaid Services (CMS), has just launched an effort, the Sentinel Initiative, to develop a post-market drug and device Read More