3rd & 4th gen oral contraceptives: risk factors and media hype
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3rd & 4th gen oral contraceptives: risk factors and media hype Specific risk factors for the development of venous and arterial thromboembolic ADRs associated with third and fourth generation oral contraceptives have been further characterised in a recently published overview analysis conducted by Lareb, the Dutch Pharmacoviligance Centre.1 After assessment of data from follow-up questions on 175 case reports, it was found in the main that risk factors such as hereditary disposition were not completely or well documented. The reported incidences of positive family history such as Factor-V-Leiden deficiency, decreased protein-S or -C levels, and increased homocystein levels were relatively minor. Lareb also discovered that the rate of thromboembolic ADR reporting was effected by ‘notoriety bias’, or increased media attention to the ADR. Following the media attention on the association between thromboembolic ADRs and the use of third and fourth generation oral contraceptives (such as Diane-35), Lareb received a high number of reports about these drugs, but the majority of cases were very old (dating as far back as 1993) and in some cases sporadic. Lareb warned that an unstable reporting system such as this may lead to misleading comparisons about the rate of thromboembolic ADRs related to this drug class.
Benefits continue to outweigh risks At its November meeting, the EMA’s CHMP agreed with the Pharmacovigilance Risk Assessment Committee’s (PRAC’s) earlier determination* that the benefits of combined hormonal contraceptives, in terms of preventing unwanted pregnancies, continue to outweigh the risks.2 The CHMP concluded that the well-known risk of venous thromboembolism associated with all combined hormonal contraceptives is small. The risk of arterial thromboembolism is very low, and there is no evidence of a difference in risk in products containing different types of progestogen. Product information will be updated, however, to help women and their healthcare professionals make informed decisions about their choice of contraception. The committee’s opinion will now be sent to the European Commission for the adoption of a legally binding decision. * see Reactions 1475 p2; 803094833 1. Lareb. Overview of the analysis of reports of thromboembolic adverse drug reactions associated with third and fourth generation oral contraceptives. Lareb Quarterly Report : 39-48, No. 3, 18 Jul 2013. Available from: URL: http:// www.lareb.nl. 2. EMA. Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks -- CHMP endorses PRAC recommendation. Internet Document : [4 pages], 22 Nov 2013. Available from: URL: http://www.ema.europa.eu. 803096492
0114-9954/13/1480-0001/$14.95 Adis © 2013 Springer International Publishing AG. All rights reserved
Reactions 30 Nov 2013 No. 1480
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