Navigation Links
FDA Restricts Access to Avandia

By Steven Reinberg
HealthDay Reporter

THURSDAY, Sept. 23 (HealthDay News) -- In response to major concerns about heart risks, U.S. health officials on Thursday severely restricted use of the diabetes drug rosiglitazone (Avandia) to patients with type 2 diabetes who cannot control their disease on other medications.

U.S. Food and Drug Administration officials also ordered the drug's manufacturer, GlaxoSmithKline, to get an independent review of a key company-run trial of the drug's heart effects. And they pulled the plug on another company-run trial comparing Avandia to its competitor, pioglitazone (Actos).

"Because of concerns about cardiovascular safety, FDA is announcing regulatory action on medications containing rosiglitazone," FDA Commissioner Dr. Margaret A. Hamburg said during a morning press conference. "FDA is significantly restricting the use of these products by requiring the manufacturer to submit a Risk Evaluation and Mitigation Strategy [REMS]."

The FDA is requiring GlaxoSmithKline to develop a program that will restrict access to the drug to those patients for whom other treatments have not worked.

In addition, doctors will have to state and document a patient's eligibility to use Avandia. They will also have to tell patients about the cardiovascular safety risks associated with Avandia, and patients will have to acknowledge that they understand those risks.

Those currently using Avandia will be allowed to continue taking the drug, Hamburg said. However, once the REMS is in place these patients will also have to have their doctors justify use of the drug.

FDA officials believe this program will significantly reduce the number of people taking Avandia.

According to the agency, there was not enough evidence of Avandia's cardiovascular risks to pull the drug from the market, which is why it opted to restrict its use instead.

But in Europe, the European Medicines Agency has suspended marketing of the drug, forcing patients to find another drug to control their blood sugar. The suspension will remain in place unless there is new data showing that the benefits of the drug outweigh its risks.

Avandia is also sold in combination with other diabetes drugs, with metformin under the brand name Avandamet or with glimepiride under the brand name Avandaryl, the FDA noted.

Avandia belongs to a class of drugs known as thiazolidinediones and is intended to be used along with diet and exercise to control blood sugar in patients with type 2 diabetes.

The FDA has also ordered GlaxoSmithKline to form an independent group of scientists to review the company's clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared with standard diabetes drugs. During the agency's review of the trial, questions came up about bias in identifying cardiovascular events.

"We believe this review will provide additional clarity about this trial and the safety of rosiglitazone," Hamburg said.

As published, the RECORD trial did not show any cardiovascular risk from Avandia, Dr. Janet Woodock, director of the FDA's Center for Drug Evaluation and Research, said during the press conference.

However, "at this time we cannot rely on these results," Woodock said.

In addition, the FDA stopped the company's current trial, called TIDE. This trial compares Avandia with Actos and with standard diabetes drugs. "This study does not meet the criteria for safety studies at this time," Hamburg said.

After the review of the RECORD trial is completed, the FDA may choose to take additional action, officials said.

Dr. Ellen Strahlman, GlaxoSmithKline's chief medical officer, said in a statement that "our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the U.S. have all the information they need to help them understand how these regulatory decisions affect them and their patients."

According to the company, worldwide sales of Avandia in the first half of 2010 totaled $500 million. In the United States, about 600,000 people are currently taking Avandia, Hamburg said.

Dr. Ronald Goldberg, a professor at the Diabetes Research Institute of the University of Miami Miller School of Medicine, said that "given all the evidence pointing to risk, even though it's not conclusive by any stretch of the imagination, it rises to a level to warrant restricting its [Avandia's] use."

Since there is a similar alternative, Actos, that hasn't been shown to increase cardiovascular risk, "you would think there would be very little place for Avandia," he said.

Goldberg said he will no longer prescribe Avandia, except to patients who have been using it for many years. In addition, going through the process to qualify patients for Avandia will deter many doctors from even considering Avandia as a treatment for diabetes, he said.

More information

For more information on diabetes, visit the U.S. National Library of Medicine.

SOURCES: Ronald Goldberg, M.D., professor, Diabetes Research Institute, University of Miami Miller School of Medicine; Sept. 23, 2010, teleconference with Margaret A. Hamburg, M.D., commissioner, Janet Woodock, M.D., director, Center for Drug Evaluation and Research, all U.S. Food and Drug Administration

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Psychologists Say New Jerseys Largest Health Plan Violates Patient Privacy, Restricts Access to Care and Wastes Taxpayer Money
2. Drug that restricts blood supply to prostate tumors delays disease progression
3. New Rural RHIO Aims to Achieve Meaningful Use With Prognosis ChartAccess Comprehensive EMR
4. American Heart Association Rapid Access Journal Report: Study Finds Racial Gaps Continue in Heart Disease Awareness, Low Knowledge of Heart Attack Warning Signs Among Women
5. Bluegiga Expands to Health and Medical Market With the New Bluegiga eHealth Access Point
6. Trade Privacy LLC: Research Concludes Apple Inc. Has Blocked Their Import Records from Public Access
7. Inadequate access to opioid-based pain relief is a human rights issue for cancer patients
8. Survey Finds Access to Mammograms Declining for Women Under Age 50
9. The American Association on Health and Disability (AAHD) and the Susan G. Komen for the Cure Partner to Increase Accessibility for Women with Disabilities at Mammogram Facilities in the DC Metro Area
10. Pew Report Finds Majority of States Fail to Ensure Proper Dental Health & Access to Care for Children
11. Access to Mammograms Drops After Guidelines Change
Post Your Comments:
Related Image:
FDA Restricts Access to Avandia
(Date:11/24/2015)... Salt Lake City, UT (PRWEB) , ... November 24, 2015 , ... ... according to Forbes Magazine. For a business, it is critical that the first impression ... of a business, they are not likely to buy anything or want to return. ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... Reactor System. Brillouin is the developer of renewable energy technologies capable of producing ... reactions (“LENR”), announced today that its WET™ and HHT™ Boiler System reactor core ...
(Date:11/24/2015)... Indianapolis, IN (PRWEB) , ... November 24, 2015 ... ... employee benefits advisory organization, is pleased to welcome Winter-Dent & Company as its ... strive from day one to become a client's most trusted advisor regardless of ...
(Date:11/24/2015)... ... November 24, 2015 , ... The American ... support their local poison centers through donations on Tuesday, Dec. 1, 2015. Since ... “a day that inspires people to collaborate in improving their local communities and ...
(Date:11/24/2015)... MI (PRWEB) , ... November 24, 2015 , ... Serenity ... released a series of recent video interviews with some of the staff members at ... at the residential treatment facility, as well as some of the things that make ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... Nov. 24, 2015 Diplomat Pharmacy, Inc. (NYSE: DPLO) ... of Clinical Services, Education and Human Resources will be presenting ... Oncology Drugs: Health Plan Strategies for a Dynamic Market" on ... Fenrick , a consultant with the Cambridge Advisory Group, where ... The webinar will discuss the rapid growth ...
(Date:11/24/2015)... 2015 iRhythm Technologies, Inc. , a leading digital ... that it will participate in the 27th Annual Piper Jaffray Healthcare ... York, NY . Kevin King , Chief Executive ... 2015 at 8:50am ET. --> ... --> . --> iRhythm is a ...
(Date:11/24/2015)... , November 24, 2015 ... CETP Inhibitors, MTTP Inhibitors, ApoB Inhibitors and PPAR Agonists ... going to grow at the fastest rates? This ... assessing data, trends, opportunities and prospects there. ,  ,Our ... the most lucrative areas in the industry and the ...
Breaking Medicine Technology: