Ectopic pregnancy risk when contraception fails. A review.
OBJECTIVE
To alert clinicians to the risk of ectopic pregnancy when certain contraceptive methods fail by summarizing data from trials reviewed by the U.S. Food and Drug Administration (FDA).


METHODS
The review focuses on 7 contraceptive drug products with an increased risk of ectopic pregnancy when the method fails. Data were extracted from reviews of clinical trials submitted to the FDA to support marketing applications and from the medical literature. Data on 6 other contraceptive drug products and published data for tubal ligations are used for comparison. This review does not include medroxyprogesterone acetate injections because the FDA reviews for this method did not include any pregnancy outcome information.


RESULTS
The results are presented in a table and are compared to postmarketing surveillance reports and published literature, when available. The proportion of ectopic pregnancies among all pregnancies ranged from 1:2 to 1:21 for intrauterine devices, tubal ligations, progestin-only implants and progestin-only oral contraceptives. Although the confidence intervals for the proportions were large in trials with few pregnancies, both postmarketing surveillance reports and published literature support proportions calculated from clinical trial data.


CONCLUSIONS
Pregnancies in women using progestin-only oral contraceptives, progestin-only implants, intrauterine devices and tubal ligations are more likely to be ectopic than pregnancies in the general population.
Furlong
Lesley-Anne
LA
U.S. Food and Drug Administration, HFD-580, 5600 Fishers Lane, Rockville, MD 20857, USA. furlongl@cder.fda.gov
D002986:Clinical Trials as Topic; D003270:Contraceptive Agents / Q000009:adverse effects*; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects; D017277:Drug Approval; D005260:Female; D006801:Humans; D007435:Intrauterine Devices, Copper / Q000009:adverse effects; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects; D016912:Levonorgestrel / Q000009:adverse effects; D009640:Norethindrone / Q000009:adverse effects; D009644:Norgestrel / Q000009:adverse effects; D011247:Pregnancy; D011271:Pregnancy, Ectopic / Q000209:etiology*; D011358:Product Surveillance, Postmarketing; D011374:Progesterone / Q000009:adverse effects; D017211:Treatment Failure; D014481:United States; D014486:United States Food and Drug Administration
D003270:Contraceptive Agents; D003280:Contraceptives, Oral, Synthetic; D009644:Norgestrel; D011374:Progesterone; D016912:Levonorgestrel; D009640:Norethindrone