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Diabetes Treatment - Update on Avandia - Double Jeopardy!

Thursday, July 15, 2010
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A medicine for diabetes control could well lead to heart problems and death, so what was meant as a panacea for one health problem could well be the cause for another.

Patients, who are on Avandia a drug for blood sugar control, seem to be more prone to Heart failure Stroke and higher risk of death. From 1995-2006 Diabetologists prescribed Avandia to control blood sugar. It seemed like a wonder drug, formulated by a reputed pharma company-GlaxoSmithKline. The drug worked by increasing the body's sensitivity to insulin similar to another drug `Actos, made by Pharma "Takeda" - Avandis was approved by FDA and was a high selling drug in 2006 at $3.4 million.

The storm then raged in 2007 - The chairman of cardiology, Cleveland, Dr. Steven E. Nissen, chairman of cardiology found a 43% increase of Heart attack and around the same time the FDA also got similar reports. Subsequently with more and more doctors expressing concern, two major independent studies with two different methodologies published their findings in well-accepted medical journals, with only one conclusion-To withdraw the drug-Avandia which clearly and drastically increased heart risks in these patients.

Dr David Graham a FDA researcher who along with his team extensively studied over 227,571 records of patients who were put on either on Avandia or Actos between 2006 -2009. He found that more than 47,000 people who were on Avandia, suffered heart attack, heart failure stroke or premature death but would have been spared the same if they were on Actos.

 

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User Comments

26 October, 2010 | Namrata Singhal | Reply

Namrata Singhal I am glad that India has also taken tough stand on this drug. India is touted as diabetes capital of the world and has over 50 million diabetics. According to the newspaper report (The Hindu, 8th oct 2010), this drug is being used by an estimated 7—10 million diabetics in India.

09 October, 2010 | Vijayalakshmi Iyengar | Reply

Vijayalakshmi Iyengar At last India has decided to ban the widely prescribed diabetes pill -AVANDIA (Rosiglitazone) with immediate effect. The decesion was taken by the health ministry expert committee on 7th Oct 2010. They banned both the import of fresh stocks and manufacturing of the drug in India.

According to the drug regulator along with a panel of experts "Banning of rosiglitazone is more important in Indians since they as an ethnic group are highly pre disposed to early and severe custering of CVD risk factors-syndrome X and heart attacks."
They feel giving this drug to a diabetic may actually increase the risl manifold of getting strokes & heart problems. So by banning Avandia, they may save many lives endangered by this drug
While Europe has already taken the drug off the shelves lat month, US has announced only a tight regulation.

11 October, 2010 | Sangeetha Narayana Swamy | Reply

Sangeetha Narayana Swamy Yeah finally the health ministry has decided to ban the drug. I too was glad to see the report in the newspapers the other day.

Now its the duty of the doctors who are treating diabetics to check for their patients who are on this drug and review their medical status and also put them on a different drug that would be helpful in controlling their glucose and also help their health and not harm it.

28 September, 2010 | Rahul Sinha | Reply

Rahul Sinha Europe has banned the sale and USFDA has placed stringent restriction on the sale of this controversial drug. It’s high time that India should also make its stand clear. It has been reported (Times Of India- 28\9\10) that estimated 5 million diabetics in India are using this drug, mainly in smaller cities where doctors are not aware of the drug’s serious side effects.

28 September, 2010 | Mrinal | Reply

Mrinal Yes, Rahul, you are right.

Last week the United States FDA and European regulators took steps to officially ban the controversial diabetes drug - Avandia.

Effective immediately Avandia’s sales were suspended entirely in Europe, while in the United States patients could continue to receive limited quantities only if they had clearly been made aware of the drug’s serious heart risks.

Cleveland Clinic cardiologist Dr. Steven Nissen, brought attention to Avandia's heart attack risks - meanwhile between 1999 - 2009, more than 47,000 people on Avandia suffered a major, life threatening heart attack, stroke or heart failure, or died.

What measures have been proposed to begin ensuring a ban on Avandia globally?

In India, has the Ministry of Health held any discussions - have they made any announcements?

Is there a will to ban it from within the diabetic industry ranks?

28 September, 2010 | Rahul Sinha | Reply

Rahul Sinha Hi Mrinal,
According to the same TOI report, In February 2010, Indian government had set up a six member committee of experts on the advice of the Drug Technical Advisory Board to decide whether to ban sale of this drug, however, no decision has been taken as yet.
I think this matter should be dealt with much more seriousness as well as urgency by the health ministry and prompt decision should be made and implemented too.

24 September, 2010 | Kanika Jain | Reply

Kanika Jain There is report in Times of India Delhi edition today and other leading online news portals too that the European Medicines Agency has called for the suspension of the use of controversial drug Avandia.
Also, the Food and Drug Administration placed stringent restrictions on its use in the United States, saying heart attack risks associated with the drug are too great a safety concern to continue its use for most people. The FDA said new patients will be able to get a prescription for Avandia, but only if they can't control their blood sugar with other medications. Doctors will have to document that their patients are eligible to receive the drug and have been briefed on its risks.

09 September, 2010 | Vijayalakshmi | Reply

Vijayalakshmi Medical experts in Uk have urged a ban on AVANDIA because it increases the risks of heart attacks. The commission in Human medicines said the `risks of Rositglitazone (Avandia) outweigh its benefits' and has called for prompt action. Yoon Loke of The University of East Anglia estimated that the drug causes around 1000 extra heart attacks a year in Britian.

Report in TOI. Bangalore Sept 07/2010

16 July, 2010 | Mrinal Jhangiani | Reply

Mrinal Jhangiani The results of the ruling are in - Twelve panelists voted to remove Avandia from the market, while ten voted to allow sales but after beefing up warning labels and adding restrictions on its use - such as allowing only certain physicians to prescribe it or requiring special education for doctors and patients.
The remaining 10 have settled for stronger warnings.

I think the new obesity drug called Qnexa and developed by Vivus was today rejected by the FDA as a result of passions running high post the Avandia fallout.
There is much greater scrutiny of studies, claims by companies and management as well as reports from Physicians involved during the trials.

17 July, 2010 | Sunitha Chelar | Reply

Sunitha Chelar Honestly, why are the 10 panellists against not prescribing Avandia? It beats me, am I missing something?

17 July, 2010 | Mrinal | Reply

Mrinal Sunitha,
My thoughts exactly upon reading and hearing the report, but it might be cynical or presumptious of me to assume it might be political on the part of these ten panelists. I know The Obama administration is definitely for stricter regulations and more transparent clinical studies.

I think we havent seen the last of this.
What is your take on it?

16 July, 2010 | Janet | Reply

Janet What a mixed bag of decisions. The Panel voted both ways for Avandia.
I would have preferred a straight forward ban on all Avandia sales.

Lets see how the FDA moves on this one.
Lets keep the pressure on.
Get active.

16 July, 2010 | Sunita, Ahmedabad | Reply

Sunita, Ahmedabad Some one needs to control these companies.
Hope they remove it from the market.

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