BEIRUT: One of Lebanon’s most common acne treatments and contraceptives, Diane-35, could be pulled off the pharmaceutical market following the decision of French health regulators Wednesday to suspend new prescriptions of the medication.
Ziad Nassour, a member of the Syndicate of Lebanese Pharmacists, told The Daily Star that Lebanese Health Minister Ali Hassan Khalil was aware of the withdrawal of Diane-35 and generic versions of the Bayer medication in France, and was in the process of drafting an order to remove all brands from Lebanese pharmacies.
“I think he will take action within hours,” Khalil said.
The minister was in Dubai and could not be reached to comment on his response to the impending ban of Diane-35 in France.
The French National Agency for the Safety of Drugs and Health announced that doctors were no longer permitted to write prescriptions for the contraceptive as of Wednesday, and said it would allow patients three months to switch to an alternative. The decision came after their investigation linked the drug to four deaths caused by blood clots in the last 25 years.
If Khalil follows suit and issues an order to withdraw Diane-35 and the popular generic offshoot, Daphne, from the Lebanese market, the pill could cease to be available in the country in as little as two to three days, Nassour said.
Once the ministry has issued a circular notifying all pharmacies in the country of the order, the drug’s importer, Khalil Fattal and Fils, is responsible for rounding up the rest of the market’s existing stock.
When asked if they were planning to suspend imports of Diane-35, Fattal referred The Daily Star to Bayer’s regional communications manager, Nadine Fanous.
“This decision has not yet been taken,” Fanous said.
“We are quite surprised that this action has been taken [by French health regulators] because we are not aware of any new scientific evidence leading to the change in the positive benefit-risk assessment of Diane.”
Fanous added that Bayer is closely working with the French authorities to respond to any results that emerge from the probe and that no final decision about the fate of Diane-35 had been made in any market yet, despite media reports.
“All I know is that they initiated proceedings to suspend marketing,” she said.
Six different gynecologists and dermatologists contacted by The Daily Star said they were not alarmed by the news that Diane-35 can cause thrombosis or related side effects when it is prescribed as a contraceptive to people prone to blood clots and certain other health risks.
Dr. Fayez Suidan, an associate professor of Obstetrics and Gynecology at the American University of Beirut, has been prescribing Diane-35 and Daphne since the medication was first introduced in Lebanon years ago.
“Unfortunately, it is being used as a contraceptive, when initially it was meant to be used to regulate the cycles of girls with Polycystic Ovary Syndrome and some mild cases of hirsutism,” he said.
“One precaution before prescribing it [is] one should make sure the patient does not have a tendency for thromboembolism,” he added.
Former Lebanese Health Minister and gynecologist Dr. Karam Karam said he was not worried about any new risks associated with Diane-35, but cautioned that it should only be prescribed as an acne treatment to patients who do not suffer from certain medical conditions.
“The medical literature has shown that one of the side effects of medications like Diane-35 is a higher incidence of blood clots and thrombosis,” Karam said.
“I would not give Diane to obese women. I would not give Diane to a lady who is a heavy smoker or a woman who has cold veins ... I would not advise young females with acne to use it, or any other [acne] medications, unless it is debilitating.”