Diabetes Self-Management Blog

The US Food and Drug Administration has ordered GlaxoSmithKline (GSK), maker of the controversial diabetes drug Avandia, to halt enrollment in the TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) trial, designed to compare the cardiovascular safety of Avandia to that of the diabetes drug Actos in people with Type 2. This decision comes a week after an FDA advisory panel voted to allow Avandia to remain on the market, but with a majority of the panelists calling for label revisions and restrictions on the drug.

Under the partial clinical hold, no new participants may be enrolled in the trial until further notice from the FDA, but those who are already enrolled will be allowed to continue to participate. The trial, which was requested by the FDA, is being conducted by an independent research group and aims to study 16,000 people in 14 countries before the year 2015. As of last week, about 1,100 people had volunteered for the trial.

The FDA has instructed GSK to update researchers, review boards, and ethics committees involved in the trial with regard to safety data and votes from last week’s meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Committee. (The panel voted 19–11 in favor of keeping the trial open if Avandia remains on the US market.) This new information could be used to revise the informed consent forms for those currently enrolled in the trial.

According to an announcement on the FDA Web site, “The FDA is evaluating available information on Avandia’s safety and the discussions of the recent advisory committee meeting. The FDA will update the public on the outcome of its review and its implications for Avandia and the TIDE trial when the review is complete.”

In a joint statement, the American Diabetes Association, the Endocrine Society, and the American Association of Clinical Endocrinologists noted that the FDA’s announcement is specific to the TIDE trial, and urged people with questions about their diabetes treatment to speak with their health-care providers.

For more information, see the article “FDA Orders Enrollment Freeze on Rosiglitazone Trial” or see the statement posted on the FDA’s Web site.

POST A COMMENT       
  

Comments
  1. Seems to me if they halt trials without a good reason, how will we know if the drugs are safe

    Posted by Gary E Kolb,DO |
  2. THEY ALREADY KNOW THE DRUG IS CAUSING PROBLEMS….no more trial needed…period…do you remember FenFen…..these people are crazy for allowing Avandia as long as they did.

    Posted by Deirdre Helms |
  3. Avandia is not a silver bullet due to the contrary belief of SKG. I don’t why the FDA is still allowing them to continue on with any more distribution.

    To all who may read this, don’t let your doctor foist this drug upon you until all the results are in!

    Posted by David Tearle |
  4. There seems to be an inconsistency in this. The FDA did not ban it but bans more research. Is there evil in this ?

    Posted by calgarydiabetic |
  5. More medical system disconnect. No doubt a victim of the a ‘Devil is in the details’ reason that the medical establishment for some reason does not want to devulge. Meanwhile, concerned citizens are left looking for answers from medical
    establishment leadership and finding none.

    Posted by S. Printz |

Post a Comment

Note: All comments are moderated and there may be a delay in the publication of your comment. Please be on-topic and appropriate. Do not disclose personal information. Be respectful of other posters. Only post information that is correct and true to your knowledge. When referencing information that is not based on personal experience, please provide links to your sources. All commenters are considered to be nonmedical professionals unless explicitly stated otherwise. Promotion of your own or someone else's business or competing site is not allowed: Sharing links to sites that are relevant to the topic at hand is permitted, but advertising is not. Once submitted, comments cannot be modified or deleted by their authors. Comments that don't follow the guidelines above may be deleted without warning. Such actions are at the sole discretion of DiabetesSelfManagement.com. Comments are moderated Monday through Friday by the editors of DiabetesSelfManagement.com. The moderators are employees of Madavor Media, LLC., and do not report any conflicts of interest. A privacy policy setting forth our policies regarding the collection, use, and disclosure of certain information relating to you and your use of this Web site can be found here. For more information, please read our Terms and Conditions.


Type 2 Diabetes
Insulin for Type 2 (07/14/14)
Rutgers Recruiting for Type 2 Diabetes Study (07/03/14)
One in Ten Heart Attack Patients Has Undiagnosed Diabetes (06/19/14)
Sleep Apnea Increases Type 2 Diabetes Risk (06/06/14)

Oral Medicines
New SGLT Drugs Coming (07/23/14)
Metformin More Effective in African-Americans (07/10/14)
FDA Panel Votes in Favor of Inhalable Insulin; Diet Drug Recalled (04/09/14)
Many Americans Taking Meds That Work Against Each Other (03/14/14)

Diabetes Research
Whey Protein to Prevent After-Meal Blood Sugar Spikes? (07/18/14)
Metformin More Effective in African-Americans (07/10/14)
Diabetes Distress and Depression (07/09/14)
Researchers Successfully Test "Bionic Pancreas" (06/26/14)

Diabetes News
Whey Protein to Prevent After-Meal Blood Sugar Spikes? (07/18/14)
Metformin More Effective in African-Americans (07/10/14)
FDA Approves Inhalable Insulin (07/03/14)
Diabetes Distress and Depression (07/09/14)

Diane Fennell
Whey Protein to Prevent After-Meal Blood Sugar Spikes? (07/18/14)
Metformin More Effective in African-Americans (07/10/14)
FDA Approves Inhalable Insulin (07/03/14)
Remembering Jan Chait (07/01/14)

 

 

Disclaimer of Medical Advice: You understand that the blog posts and comments to such blog posts (whether posted by us, our agents or bloggers, or by users) do not constitute medical advice or recommendation of any kind, and you should not rely on any information contained in such posts or comments to replace consultations with your qualified health care professionals to meet your individual needs. The opinions and other information contained in the blog posts and comments do not reflect the opinions or positions of the Site Proprietor.


Blood Glucose Self-Monitoring — Part 1: The Gear
Blood glucose self-monitoring is one of the keys to diabetes control. Here are the tools you need to carry out this task.

Perfectionism: An Impossible Goal in Diabetes Management
Striving for good self-care is important, but perfectionism can make diabetes care — and life — more difficult.

Recipes for Spring
Enjoy recipes for Baked salmon on beet greens, Tofu and snow pea slaw, Radish and cucumber salad, Spinach pinwheels, Beet salad with citrus dressing, and Stuffed berries.

Complete table of contents
Get a FREE ISSUE
Subscription questions