Tuesday, Feb 05, 2013
Abu Dhabi: The sale and prescription of Diane-35, an acne pill that has been linked to the death of four women in France, was temporarily suspended by the UAE Ministry of Health on Tuesday.
The ministry called upon local health authorities, directors of medical districts, as well as public and private hospitals and clinics to abide by the decision that was issued as a result of the suspected side effects of the drug. These side effects include an elevated risk of blood clotting, as mentioned in the patient package insert for Diane-35.
“The ministry recommends the temporary suspension of the drug, in addition to its import and sale, until the final evaluation of the product is done by international health authorities,” said Dr Ameen Al Amiri, assistant undersecretary for medical practices and licensing, and chairman of the higher committee for registration and pricing, at the MoH.
Dr Al Amiri also said doctors must not prescribe the drug or renew prescriptions for it.
Patients, however, should not stop using the medicine without consulting their doctors. Therefore, people with existing prescriptions may still purchase the drug at pharmacies, but are urged to consult with their doctors first, the official told Gulf News.
Diane-35, produced by German chemical and pharmaceutical firm Bayer, is a hormonal treatment usually prescribed to treat acne, excess oil secretion and excessive hair growth, which are often symptoms of polycystic ovarian syndrome (PCOS). Although it is not licensed as an oral contraceptive, Diane-35 is also often prescribed for birth control because it stops ovulation.
Last week, reports from France linked the drug to four female deaths during the last 25 years, as well as blood clots in about 100 others. Consequently, the National Agency for the Safety of Drugs and Health Products in France (ANSM), suspended its sales on January 30.
“[In the UAE], the product is registered by the MoH according to the rules and regulations of the drugs registration operations and processes. However, in case of the appearance of any side effects, this does not prevent the ministry from implementing procedures aimed at enhancing public health and safety,” the MoH official said.
The statement also said that the ministry is coordinating with the European Drugs Authority, which is currently examining the drug. Based on these studies, a final decision will be taken by the MoH about its eventual continuation or withdrawal in the UAE.
When contacted, many pharmacy representatives told Gulf News that Diane-35 was still available at their stores, and that they were not aware of the MoH temporary suspension.
“As soon as we receive the official notice from MoH, we will withdraw all available packs from our shelves, and also contact patients who may have purchased the medicine over the last week,” said Dr Lamya Al Barasi, director of Al Noor Pharmacies.
When asked, doctors said that the pill was widely prescribed.
“Nearly all gynaecologists will have some experience in prescribing Diane-35, especially as it is used to treat certain symptoms of PCOS, which is common in women in the UAE,” said Dr Aruna Kumari, obstetrics and gynaecology consultant at Burjeel Hospital in Abu Dhabi.
She added that gynaecologists run preliminary checks on patients before prescribing these pills to ensure that other risk factors are not present.
“Medicines are also prescribed only for three months at a time. So patients need not worry if they are being monitored regularly,” she said.
Patients, however, said that they were dismayed to hear of the temporary suspension.
“I have been using Diane-35 for nearly 16 years, and it is most effective in dealing with the acne and excess oil secretions that result from my PCOS. Every time I have stopped using it, the symptoms have returned very quickly,” said a 31-year-old nurse from Brazil.
“I am aware of the possible side effects of Diane-35, but I believe the key is to check back with your doctor regularly. Perhaps the women who died did not follow medical instructions or took other products at the same time. So I do hope they will not ban the drug in the UAE. In all these years, I have not found an effective alternative treatment, and I do not want to suffer from the symptoms of my disease just because I cannot acquire Diane-35 here,” she added.
By Samihah Zaman Staff Reporter
Gulf News 2013. All rights reserved.
