Diabetes Treatment – Update on Avandia

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The study showed older people with diabetes on Avandia compared to patients taking Actos, showed 27% higher risk of stroke

25% higher risk of heart failure
14% higher risk of death

For every 60 plus patients who take Avandia instead of Actos for one year, there would be one extra heart attack, heart failure, stroke, or death. Is this risk big enough? Dr Graham also categorically said that even if a person was on Avandia currently and nothing untoward has happened till date it was advisable if they shift to Actos and reduce further risk. Why prescribe 'Avandia' when a safer alternative was there? Why prescribe a drug that would either land you in a hospital or the cemetery?

The second study, co-written by Dr. Nissen, after updating his 2007 also conclusively brought home the fact that Avandia increased the risks of heart attack by 39 percent and the risks of heart-related death by 46 percent.

However the pharma in question viz GlaxoSmithKline contradicted the claim and said after 6 much better studies, Avandia neither increased the over all risk of heart attack nor lead to stroke or death.

The question on everybody's lips are -why is AVANDIA still prescribed especially with Actos giving similar benefits with fewer repercussions?

Compiled by
Vijayalakshmi Iyengar
Sr. Dietitian: NutritionVista.com

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User Comments

26 October, 2010 | Namrata Singhal | Reply

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

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

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

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

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

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

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

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

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

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

17 July, 2010 | Mrinal | Reply

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

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

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

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