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Diane 35, prescribed for acne and contraception, has been temporarily suspended in the UAE following links to life-threatening side effects reported in France. Fatima Al Marzooqi / The National
Fatima Al Marzooqi Photographer
Diane 35, prescribed for acne and contraception, has been temporarily suspended in the UAE following links to life-threatening side effects reported in France. Fatima Al Marzooqi / The National

Prohibited skin pills linked to deaths still on sale in UAE despite ban

The popular acne drug has been temporarily suspended in the UAE by health authorities after medical reports in France linked it to fatal side effects.

Pharmacies in the UAE are continuing to sell a popular acne drug that was temporarily suspended by the Ministry of Health after medical reports in France linked it to severe side effects.

The ministry has ordered doctors to stop prescribing Diane 35, used to treat skin diseases caused by hormones.

Doctors have also been ordered not to renew any prescriptions.

The decision was made based on the recommendations of the French drug agency ANSM.

The drug has been linked to the deaths of four women in France. There have also been possible connections to  life-threatening side-effects in more than 100 other women.

On Monday a circular was sent to health authorities, pharmacies, hospitals and all medical agencies, said Amin Al Amiri, assistant under secretary for medical practices and licensing at the Ministry.

But the drug, a prescription-only medication, was still being dispensed by pharmacies in Dubai and Abu Dhabi yesterday, even without a prescription.

Dr Al Amiri requested that any pharmacy found dispensing the drug be reported to the ministry so it  can take action.

He also said there had been no reported problems with the drug in the UAE so far.

The ministry is awaiting a decision by the European Medicines Agency (EMA) on whether or not the medicine should be pulled off the shelves.

“The ministry recommended the temporary suspension of the drug and all similar products, in addition to the importation and marketing of the drug, until the final evaluation is done by international health authorities,” Dr Al Amiri  said.

He added that patients who were already using the drug should consult their doctors.

A confidential report from ANSM obtained by the French newspaper Le Figaro showed that the drug, which in France is used for acne treatment, was also largely prescribed as a form of contraception.

It showed there were seven deaths linked to the drug since it came on the market in 1987. Six of the women took Diane 35 and one took its generic.

The document showed 125 cases were registered in which women who were taking the drug or its generics  experienced blood clots.

On Sunday the French agency partly confirmed the document, stating that four deaths were attributed to vein clotting linked to Diane 35.

It said the other three cases were linked to underlying diseases that played an essential role in the women’s deaths and the drug alone was not the main cause.

Diane 35 is authorised in 135 countries and commercialised in 116.

Largely, the drug is indicated for the treatment of acne or androgen-dependant diseases. In some countries it is prescribed for use in contraception.

In the UAE, Diane 35 is prescribed for acne, unnatural excessive facial or body hair and androgen-related hair loss.

The leaflet for the drug states that although Diane 35 also has a contraceptive effect, it should not be used exclusively for the purpose.

Dr Amiri said the drug could be used as an off-label contraception at the discretion of the prescribing doctor.

Gynaecologists in the UAE had mixed feelings about the developments.

“All similar types of medication carry the same risks,” said Janeta Atanassova, a gynaecologist at Infinity Health Clinic in Dubai.

“We can’t remove a drug from the market  because of a few cases over such a long period of time.

“We must also look at the benefits the drug has provided many patients over the years.”

Dr Atanassova said although the amount of oestrogen in the drug was a little higher than other contraceptive pills, it worked well for treating acne in children and teenagers who did not have risk factors such as smoking.

“We’ve been working with this drug for nearly 30 years and to remove it from the market because of this is ridiculous,” she said.

Several studies have shown that third and fourth-generation contraceptives, those introduced in the 1990s and in the past decade, are more likely to cause blood clots than their predecessors.

Dr Al Amiri said that while the product was registered in the UAE, it did not stop the ministry using “correct safe and healthy procedures in case any side-effects appear due to the use of any medicine”.

Radio France Internationale said the German pharmaceutical company Bayer, which also made the Yasmin and Yaz contraceptives, spent €560 million (Dh2.78 billion) to settle nearly 3,500 lawsuits with claims of deep-vein thrombosis or pulmonary embolism.

An estimated 3,800 more lawsuits remain to be settled, as well as nearly 5,000 claims over other types of ailments allegedly caused by the pills.

mismail@thenational.ae

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