Romania’s Drug and Medical Devices National Agency will keep the Diane 35 birth control pills on the local market, after the French Drug Safety Agency decided to suspend sale of the birth control pills in the next three months. While the French agency’s decision was based on the link made between the drug and at least 4 deaths from venous thromboembolism (VTE) and 125 other cases of thrombosis over the last 25 years.
In France, Diane 35, produced by Bayer, is approved only for treating acne, but in fact it works as an oral contraceptive. Several other countries in the European Union have approved it for treating acne in women who also want to use it as an oral contraceptive, according to the European Medicines Agency (EMA). The French agency consider that Diane 35 and its generics carry a risk of thromboembolism and that this has been well known for many years, while their effectiveness in treating acne was only moderate and alternative treatments for acne are available.
In Romania, the Drug Agency representatives, quoted by Mediafax, say only one adverse reaction has been registered since 2003, when Diane 35 was licensed in the country. It was only one thromboembolism reaction and the patient recovered. A decision about this product could be taken after the EMA evaluates the risk.
“Although Member States can take unilateral action to suspend the marketing authorization of a medicine, European legislation requires that there is a coordinated European approach in these instances. France has already indicated that it will ask the European Medicines Agency to carry out a European-wide review of Diane 35 and its generics,” according to the EMA.
Pending the outcome of the review, the European Agency advises women who are currently taking Diane 35 or one of its generics not to stop the medicine.
In Romania, the consumption of Diane 35 is estimated at some 300,000 boxes a year.
(photo source: sxc.hu)