What’s the deal with Diane-35?
IN recent years there has been much controversy surrounding the continued use of Diane-35, a popular contraceptive drug, as the product has previously been banned in France and heavily scrutinised in other countries such as Canada and the United States.
Gynaecoloist Dr Charles Rockhead explained to All Woman that the review of Diane-35 and its generics was triggered in 2013 by the French medicines agency, National Agency for Medicines and Health Products Safety (ANSM), following its decision to suspend Diane-35 and its generics in France within three months.
“The French decision followed a national review of the medicine by ANSM. This review highlighted serious thromboembolic (formation of blood clots in the blood vessels) events and extensive off-label use of these medicines as a contraceptive only,” Dr Rockhead said.
As it relates to no decision about the use of the drug locally, Dr Rockhead said that’s an issue the pharmaceutical society would have to deal with.
“We have our own pharmaceutical society. They guide the Ministry of Health as to what should and shouldn’t be removed in Jamaica,” he said.
Moreover, he pointed out that at the time of conceptualisation, Diane-35 was intended to be an oral contraceptive, but was later found out to be an effective treatment for hirsutism and acne.
Dr Rockhead explained that as a result, improper usage of the drug began.
“People abused it and used it for acne. When you have mild to severe acne it should be treated by a dermatologist. These medicines should be used solely in the treatment of moderate to severe acne related to androgen sensitivity or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age. Furthermore, Diane-35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed,” he said.
“Since Diane-35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives. Concomitant use of Diane-35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism,” Dr Rockhead said.
He added: “If you are using these medicines for other conditions, you should make a non-urgent appointment with your doctor to review your treatment. You should not stop taking these medicines before speaking to your doctor. Diane-35 and its generics act also as hormonal contraceptives, and stopping them means that you will have to use another form of contraception to prevent unwanted pregnancies.”
The gynaecologist further stated that the risk of thromboembolism occurring with these medicines is low and well known.
But, to minimise the risk, further measures should be implemented in addition to the updated product information, which include providing educational materials to prescribers and patients highlighting the risks of thromboembolism.
“You should always read the package leaflet and be aware that there is a low risk of blood clots with these medicines. The risk of blood clots in the veins with these medicines is 1.5 to two times higher than for combined oral contraceptives containing levonorgestrel, and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone,” he said. “You should be aware that there are factors that can increase the risk of blood clots in blood vessels, such as increasing age, smoking, obesity and prolonged immobility. You should immediately report any relevant symptoms to your doctor, such as pain and swelling in the legs, or breathlessness and a sharp pain in the chest.”
Dr Rockhead said important factors to consider include:
1. Diane-35 and its generics should only be used for the treatment of moderate to severe acne related to androgen sensitivity (with or without seborrhoea) or hirsutism in women of reproductive age.
2. For the treatment of acne, these medicines should only be used after topical therapy or systemic antibiotic treatment has failed.
3. Since Diane-35 and its generics act also as hormonal contraceptives, they should not be used in combination with other hormonal contraceptives.
4. Doctors should review patients on Diane-35 and generics in line with these recommendations at their next scheduled appointment.
5. Doctors should discuss with their patients the risk of thromboembolism and risk factors such as increasing age, smoking, obesity and prolonged immobility.
