Navigation Links
Monitoring of high-risk medications unchanged despite FDA warnings
Date:1/12/2010

PORTLAND, Ore. A new study concludes that many doctors appear to have largely ignored a Food and Drug Administration warning to screen users of new antipsychotic drugs for high blood sugar and cholesterol, which poses risks to their health and raises questions about the efficacy of warning protocols in general.

The research analyzed about 109,000 Medicaid patients taking "second generation" antipsychotic drugs, which can cause increases in blood sugar, cholesterol and significant weight gain, as well as other symptoms significantly raising the risk of diabetes. It was done by health researchers from Oregon, Colorado, Georgia and Missouri, and just published in the Archives of General Psychiatry.

It found that most doctors never changed their level of baseline screening for blood sugar and cholesterol, despite a warning in 2003 from the FDA and two other organizations that these antipsychotic drugs could raise the risk of diabetes in a patient population that already was at higher risk for this disease.

"The existing baseline screening and ongoing monitoring of glucose and lipid levels in these patients was already pretty low, and the FDA warning really had no impact in changing that," said Daniel Hartung, an assistant professor of pharmacy instruction in the College of Pharmacy at Oregon State University.

"The side effects that can be caused by these new types of antipsychotic medications, some of which were first approved in the 1990s, are not trivial," Hartung said. "Increases in blood sugar, cholesterol and body weight can lead to diabetes in some cases, and this patient group already has a problem with diabetes that's almost twice that of the general population."

By 2003, Hartung said, enough evidence of these problems had accumulated that the FDA, along with the American Diabetes Association and the American Psychiatric Association, issued formal statements and warnings about the issue, and recommended baseline metabolic testing and ongoing monitoring for anyone beginning these medications.

In this study group that examined more than 100,000 patients in California, Missouri and Oregon it never happened.

There were no significant changes in the level of baseline testing for blood sugar and cholesterol. There was some movement toward one drug that posed less metabolic risk, the study found, but much of that could have been caused by the elimination in California, around the same time, of required prior authorization for that drug.

Second-generation antipsychotic drugs, such as olanzapine, aripiprazole and others, are very powerful medications and were originally developed for treatment of schizophrenia, Hartung said. They were largely prescribed at first only by psychiatrists, but their use has now expanded widely into treatment for problems such as bipolar disorder and less serious mental health problems such as depression, and they are often administered by general practitioners.

The study noted that individuals with serious mental illness often have a higher risk of diabetes and cardiovascular disease, and as such are already a vulnerable population. Since the new drugs can significantly increase those risks, monitoring blood sugar and cholesterol is very important, experts say.

"Part of the problem may be that simply sending doctors a letter about these issues, which come up every now and then with medications, is just not getting the job done," Hartung said. "With this group of medications, at least, it clearly wasn't effective, and it does raise questions about whether new approaches are needed. Part of the problem may also be people moving from one doctor to another, and inaccurate assumptions about testing being made."

"Also, changes in behavior are always slow," he said.

Anyone taking these medications, Hartung said, may wish to discuss with their physicians what type of metabolic screening they've had, and consider glucose and lipid testing if it has not already been done. If there are problems with high blood sugar, cholesterol or body weight, it may need to be considered by the physician in choosing the best treatment, he said.


'/>"/>

Contact: Daniel Hartung
hartungd@ohsu.edu
503-494-4720
Oregon State University
Source:Eurekalert

Related medicine news :

1. Mobile bushfire monitoring
2. Blood glucose self-monitoring: No benefit for non-insulin-dependent patients with type 2 diabetes
3. New Mexico VA Health Care System Selects Sensotech Wireless Temperature Monitoring System
4. Bedside Exam Trumps Scan for Post-Brain Surgery Monitoring
5. Partnership for a Drug-Free America(R) Responds to 2009 Monitoring the Future Study Results
6. AIDS Drugs Dont Need Routine Lab Monitoring
7. Ageing Demographic Boosts Uptake of Wireless Patient Monitoring Devices Across Europe, Finds Frost & Sullivan
8. Masimo Receives FDA Clearance for Masimo Rainbow SET(R) Acoustic Respiration Rate Monitoring
9. Parental Monitoring Can Curb Teen Marijuana Use
10. Greater certainty in monitoring 3 therapeutic medications is facilitated by new CRMs
11. The straight dope: Studies link parental monitoring with decreased teen marijuana usage
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/26/2017)... ... 26, 2017 , ... ODH, Inc.™ announced today it will exhibit and ... Pentagon City Hotel in Arlington, VA. ODH’s director of medical strategy, Candace Saldarini, M.D., ... improve Medicaid population health management. , ODH will also have an exhibit booth where ...
(Date:2/25/2017)... ... February 25, 2017 , ... FCPX users now have the ability ... Film Studios. With ProSharpen Color users have total control over sharpening amount, sharpening radius, ... range. With color spectrum tools users can visually see the color range effected with ...
(Date:2/24/2017)... ... February 24, 2017 , ... Only two months after the official release of ... in Cannes (France), XO Private has initiated a second print-run of its lavish luxury ... a metre across when open, weighs in at more than six kilos, retails at ...
(Date:2/24/2017)... , ... February 24, 2017 , ... ... of Liberty University, has officially announced the appointment of Peter A. Bell, DO, ... of Osteopathic Medicine (LUCOM), beginning April 10. Dr. Bell comes to Liberty ...
(Date:2/24/2017)... , ... February 24, 2017 , ... ... hearing disabilities, it is so critically important that we all are aware of ... is why Mediaplanet is proud to announce the launch of its newest edition ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... NEW YORK , Feb. 23, 2017 ... gives comprehensive insights on the various drugs ... The report covers all the drugs that ... Preclinical & Clinical). The pipeline focuses on ... small molecules, antibodies, stem cell therapies, recombinant ...
(Date:2/24/2017)... Research and Markets has announced the addition of the ... report to their offering. ... The latest research Urinary Incontinence Drugs Price Analysis and ... global Urinary Incontinence market. The research answers the following questions: ... for Urinary Incontinence and their clinical attributes? How are they positioned ...
(Date:2/23/2017)... LG Innotek hat heute die weltweit erste ... das 1,5-fache des 45-mW-Moduls der Konkurrenz. UV-C ... und 280 nm und eignet sich damit für Sterilisationsaufgaben. Es ... zerstört. Das Produkt von LG Innotek erzeugt UV-Strahlung im ... ...
Breaking Medicine Technology: