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:12/8/2016)... PLAINS, N.Y., and JENNERSVILLE, Pa. (PRWEB) , ... ... ... to announce that Penn Medicine Southern Chester County, a Property owned by an ... The $23 million, 72,000 square foot Penn Medicine Southern Chester County ambulatory care ...
(Date:12/8/2016)... Boston (PRWEB) , ... December 08, 2016 , ... ... shareholders with global law firm Greenberg Traurig, LLP, will speak at DeviceTalks West, Dec. ... sponsor of the DeviceTalks series, and attorneys from the firm’s global Life Sciences & ...
(Date:12/8/2016)... N.J. (PRWEB) , ... December 08, 2016 , ... ... delivery technologies and development solutions for drugs, biologics and consumer health products, today ... PSCI was set up in 2006 as a non-profit organization to unite pharmaceutical ...
(Date:12/8/2016)... Peachtree City, Ga (PRWEB) , ... December 08, ... ... and moving as soon after surgery as possible. With this in mind, SIGVARIS ... vein thrombosis (DVT or blood clot) during bed rest and provide the benefits ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... services from offices headquartered in Hamilton County, is embarking on a charity drive ... specializes in finding new homes for orphaned or neglected senior dogs in the ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... ANGELES , Dec. 8, 2016  Hanson ... manufacturing of dissolution testing and diffusion testing instruments ... been acquired by Teledyne Instruments, Inc. ("Teledyne"). The ... long-proven line of precision testing instruments, as well ... accelerating development of new products and services. ...
(Date:12/8/2016)... 2016  Haemonetics Corporation (NYSE: HAE ) has ... an innovative software suite designed to help customers drive efficiency ... of NextGen DMS 4 improves core features and introduces innovations ... liter of plasma collected, enhancing quality and regulatory compliance and ... ...
(Date:12/8/2016)... Inc . has announced regulatory approval by CFDA and product launch in ... (GERD). Continue Reading ... ... by Professor Jun Liu, Director of Endoscopy at Wuhan Union Hospital ... "We are very pleased that Mederi products are now available in ...
Breaking Medicine Technology: