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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
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