Regulatory Focus™ > News Articles > CHMP Says Combined Hormonal Contraceptives Still Safe on Balance, Mirroring Earlier Assessments

CHMP Says Combined Hormonal Contraceptives Still Safe on Balance, Mirroring Earlier Assessments

Posted 22 November 2013 | By Alexander GaffneyRF News Editor

After an extensive and lengthy review of the evidence, European regulators have announced the results of their investigation into combined hormonal contraceptives, saying that they believe the products' benefits continue to outweigh their risks.

Background

Combined contraceptive medications, such as Bayer's Yasmin (drospirenone and ethylestradiol), have long been associated with "very rare" thromboembolisms, and are closely monitored by both EU and US regulators.

In April 2012, the US Food and Drug Administration (FDA) issued a warning regarding all drospirenone-containing products, saying the hormone might be associated with a higher risk of thromboembolisms than was previously known. It was not able to control the risk of drospirenone relative to the risk of other birth control products, it said, and was continuing to study the issue.

EU regulators, however, initially hedged on the possibility of there being an elevated risk. In a statement released on 11 January 2013, the European Medicines Agency (EMA) said it was aware of "no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today."

A Shift to Study the Issue

However, shortly after releasing the statement, EMA said it would launch an investigation into third- and fourth-generation contraceptives at the urging of French regulators, who said they were concerned about risks associated with Diane-35 (cyproterone acetate), an acne drug that is also used as a contraceptive.

"France has made this request amid recent initiatives to reduce the use of third- and fourth-generation combined oral contraceptives by French women in favor of using second-generation oral contraceptives," EMA wrote in an online post announcing the review.

EMA's announcement noted the already-established risk of patients developing blood clots, but said its Pharmacovigilance Risk Assessment Committee (PRAC) would review the contraceptives to "give its opinion on whether the currently available product information provides the best information possible for patients and doctors to take appropriate healthcare decisions."

The review was seen as being especially notable because it was the first time a member state had requested a review and recommendation under the EU's 2012 pharmacovigilance legislation.

PRAC and CHMP Weigh in

In October 2013, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) announced that it had found no basis to restrict the availability of combined contraceptives, saying the products still offered a net benefit to patients despite the elevated risk of blood clots.

"There is no reason for women who have been using CHCs without any problem to stop taking the medicines on the basis of this review," PRAC wrote. "It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive."

Now a second EMA committee, its Committee for Medicinal Products for Human Use (CHMP), has come to the same conclusion.

In a 22 November 2013 announcement, CHMP nearly mirrored the comments made by PRAC in its October statement.

"EMA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small," it wrote.

However, unlike PRAC, CHMP made specific recommendations that the product information on the contraceptives be updated to better inform prescribing decisions.

The unanimous recommendations now move to the European Commission for a final decision.


CHMP Statement


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