EMA: Diane-35 Acne Drug's Benefits Outweigh Blood Clot Risks

The European Medicines Agency (EMA) has stated that the benefits of the hormonal acne treatment Diane 35 and its generics outweigh the risks of the drug, provided that several measures are taken to minimize the chance of thromboembolism, the chance of a blood clot. The announcement is a boon to women who are unresponsive to other acne treatments.

Diane-35 has widely been prescribed "off label" as an oral contraceptive in the past because it halts ovulation. Yet after the deaths of four women over 25 years from blood clots linked to the drug, France banned the use of Diane-35, according to The Huffington Post. Officials from Canada, in turn, began a safety review in order to assess the drug.

EMA's Pharmacovigiliance Risk Assessment Committee finally announced its review of the product; it should only be used to the treatment of moderate-to-severe acne related to androgen-sensitivity or hirsutism in women of reproductive age, according to MedScape. In addition, it should only be used when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed.

Yet these aren't the only warnings the agency has released. It also cautions that the drug and its generics are hormonal contraceptives. This means that women should not take them in combination with other hormonal contraceptives since it would expose them to a higher dose of estrogen and, in turn, increase the risk of a blood clot.

Blood clots are a relatively rare side-effect of hormonal products. Yet this risk can increase with smoking, being overweight or having a family history of blood clots.

The EMA has already acknowledged that there is a need to take further measures to better address and minimize the risks of blood clots associated with these medicines. More specifically, the agency has pointed out that efforts should be made to raise awareness of the risks and the signs that a patient may be suffering from thromboembolism.