AMSTERDAM, March 4 (Reuters) - Doctors should not prescribe Bayer’s acne pill Diane 35 and its generic versions to new patients, the Dutch medicines watchdog said, the second country to act since European authorities started to investigate safety concerns.
The European Medicines Agency last month started a formal safety review of the German drugmaker’s pill, which is also used as a contraceptive, following a request by France.
French authorities suspended sales of the medicine in January after four deaths over the past 25 years were linked to its use. Bayer said at the time it was “surprised” by the move.
The Dutch Medicines Evaluation Board (CBG) on Monday advised doctors not to prescribe Diane 35 and generic versions to new patients.
“It seems to me now that we have to recommend not prescribing this drug to new patients because the risk, especially when starting using it, seems to have risen,” CBG head Bert Leufkens was quoted as saying in Dutch newspaper Trouw. A CBG spokesman confirmed his remarks.
The spokesman declined to comment when asked what existing users of Diane 35 should do, saying the agency would issue a statement at 1500 GMT.
In February, the medicines watchdog asked doctors, pharmacists and patients to pass on any reports of side effects from Diane 35 to the Netherlands Pharmacovigilance Centre, Lareb, an independent body that collects and analyses reports of adverse reactions to medicines and vaccines.
CBG uses Lareb’s data to help make its recommendations.
Lareb said on its website it had received 10 reports of deaths that possibly involved the use of Diane 35 or one of its generic versions.
Bayer’s Dutch unit said it knew of no new scientific evidence that had any bearing on the risks associated with using Diane 35.
A spokeswoman declined to give an immediate response to Lareb’s findings. She also declined to comment on whether Bayer would appeal against the CBG’s advice that doctors should not give Diane 35 to new patients.
No-one at Bayer’s German headquarters was immediately available to comment.
The European watchdog said last month the risk of blood clots with the medicines was low but well known. It urged patients currently taking Diane 35 or one of its generics not to stop and to consult their doctors if they were concerned.
Leufkens was quoted as saying on Monday that he expected the results of the European safety review in May. (Reporting by Gilbert Kreijger and Thomas Escritt; Editing by Erica Billingham)