UAE MoH suspends sale of ‘Diane 35’ after French agency confirms related deaths of 15 women

Published Tuesday, February 05, 2013

By Bindu Suresh Rai

The UAE’s Ministry of Health has suspended the usage and sale of the acne drug, ‘Diane 35’, effective immediately, following France’s decision with studies confirming the related deaths of 15 women.

Last week, France banned the sale of Diane 35 after four related deaths were reported, which have occurred over 25 years.

This came close on the heels of Canada confirming the death of 11 women, linked to this drug, which is used alternatively for acne and birth control.

Following the recommendations by the French drugs agency ‘ANSM’, MoH has issued the suspension across all medical districts, including public and private hospitals and all clinics, with studies indicating its usage may cause blood clots.

Diane 35 is made by Bayer and is currently sold in 116 countries.

At a press conference last week, Dominique Maraninchi, Bayer’s Director, said: “This drug is not licensed for use as a contraceptive. But it is being used as such, in this secondary role.”

Dr Amin Hussein Al Amiri, Assistant Undersecretary for Medical Practices and Licensing and Chairman with the MoH, spoke to Emirates 24|7, saying: "The suspension of Diane 35 sales and prescription is with immediate effect, and pharmacies are being informed to comply from today itself.

"Even the importation and marketing of the drug will be suspended until the final evaluation of the product is done by the European drugs authorities.”

When quizzed, Dr Amiri clarified this suspension would be implemented just on the above-mentioned drug, and not on similar products in the market.

He said in statement earlier that patients using the drug should also not stop using the medicines by themselves but consult their doctor.

Dr Al Amiri did emphasise that doctors must not prescribe new prescriptions or renew the prescription of the medicine, effective immediately.

However, when Emirates 24|7 contacted several pharmacies in Dubai, all of them confirmed they were still offering Diane 35 over the counter, which retails at approximately Dh25.

When quizzed over the suspension, the pharmacists across the outlets said they were unaware of the order.

With the 15 deaths reportedly linked to the usage of Diane 35 in Canada, along with reports of over 200 women suffering from long-term, possibly life-threatening side effects, the French drugs agency decided to suspend this product.

The UAE Ministry has also requested UAE residents who might be suffering from possible side-effects to fill out an online form available on the website, Cpd-pharma.ae.

Dr Amiri added: "It is imperative for everyone's health and safety that people who believe they are suffering from side effects, to come forth and report it."

The MoH has confirmed that the European Drugs Authority is currently examining and studying the product in its laboratories and coordinating with the UAE MoH regarding to the continuation of the product or withdrawing it completely from the markets.

The French ANSM has reported that approximately 315,000 women across the country have been prescribed the medication. The number of women prescribed the drug in UAE was not immediately available.

(Home page image courtesy Shutterstock)

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