AACE Patient Safety - News

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Patient Safety Alert: Falsely Elevated Glucose Monitor Readings in Patients Receiving Icodextrin (Extraneal) Peritoneal Dialysis Solution
2012-06-12 14:14:10
Submitted by: Submitted by Sara Alexanian, MD
Glucose has been the traditional osmotic agent used in peritoneal dialysis (PD) solutions. However, osmotic agents, including a glucose polymer called icodextrin, are now available and pose a safety Read More


"Does Calcium Supplementation Increase CHD Risk?"
2012-05-30 15:15:00
Submitted by: Nelson Watts, MD
As covered in recent news reports in the lay press, Li et al (Li K, et al. Associations of dietary calcium intake and calcium supplementation with myocardial infarction and stroke risk and overall cardiovascular mortality in the Heidelberg cohort of the Eu Read More


The Food and Drug Administration (FDA) Issues a Safety Label Change for Statin Drugs
2012-03-06 10:26:00
Submitted by: AACE
The Food and Drug Administration (FDA) issued a safety label change for statin drugs. Of principal concern to endocrinologists are the changes related to increases in blood glucose and the dosage warning related to lovastatin. Read More


“No Significant Change in Recommendations for Calcium and Vitamin D": Conclusion from an analysis of a meta-analysis.
2010-09-24 16:01:47
Submitted by: Daniel L. Hurley, MD, FACE
Mark Bolland and colleagues have recently published a meta-analysis of studies in the British Medical Journal (http://www.ncbi.nlm.nih.gov/pubmed/20671013) to investigate whether calcium supplements increase the risk of cardiovascular (CV) events. Read More


FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events
2010-06-11 14:23:43
Submitted by: Alan J. Garber, MD, PhD, FACE
AACE Liaison to the FDA and Editor, AACE Patient Safety Exchange

The U.S. Food and Drug Administration (FDA) is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan) had a higher rate of death from a cardiovascular cause compared to pat Read More


FDA Statement on Thyrogen
2010-05-26 16:59:45
Submitted by: Daniel Einhorn, MD, FACP, FACE
AACE President

Alan J. Garber, MD, PhD, FACE
AACE Liaison to the FDA and Editor, AACE Patient Safety Exchange

As a consequence of previous concerns raised regarding contamination resulting from particulate material in Thyrogen, the FDA and Genzyme have entered into a legal settlement which will limit the availability of a drug used in the treatment and diagnostic Read More


FDA MedWatch - Orlistat (marketed as Alli and Xenical): Labeling Change
2010-05-26 14:22:22
Submitted by: Food and Drug Administration (FDA) MedWatch
The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. Read More


FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil
2010-05-04 08:56:36
Submitted by: Food and Drug Administration (FDA) MedWatch
The FDA Safety Information and Adverse Event Reporting Program

The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism, to include information about reports of severe liver injury and acute liver failure, some of which have Read More


GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer-Possible increased risk of diabetes and certain cardiovascular diseases
2010-05-04 08:51:32
Submitted by: Food and Drug Administration (FDA) MedWatch
The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals and patients of FDA's preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists Read More


Response to oral bisphosphonates news reports
2010-03-11 11:44:53
Submitted by: Steven M. Petak, MD, JD, FACE, FCLM
President, American College of Endocrinology

During the past 24 hours, a number of news articles have reported on a potential link between oral bisphosphonates and increased fracture risk. The following is a quote from the FDA response to these news reports:
Read More


OneTouch SureStep Test Strips: Recall-Test strips may provide falsely low results when glucose level is over 400 mg/dL
2010-03-01 13:49:39
Submitted by: Alan Garber, MD, PhD
Editor, AACE Patient Safety Exchange

LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. Read More


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


 

 

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