QuarterWatch™ Reports January 2018

Safety Profiles of Newer Contraceptives

In this issue of QuarterWatch™, we compare and contrast the safety profiles of five leading pharmaceutical approaches to birth control: copper-releasing intrauterine devices (IUDs), emergency contraception pills, long-acting etonogestrel implants, levonorgestrel IUDs, and combination oral contraceptives. We used 43,342 adverse event reports–two full years of the most recent data–to identify the leading safety issues reported to the US Food and Drug Administration (FDA).

Table 1. Adverse event reports for 5 contraceptive methods, 2 years ending June 2017
Method Frequent Brand Name Serious Non-serious Total
Copper IUD Paraguard T 380 A 2,481 3,698 6,179
Emergency contraception pill Plan B One-Step 595 6,973 7,568
Etonogestrel implant Nexplanon 1,747 8,186 9,933
Levonorgestrel IUD Mirena 8,166 7,731 15,897
Oral combination Yaz* 1,770 1,995 3,765
Total   14,759 28,583 43,342
* > 200 oral combination products listed

Key Findings

  • The overall safety record for these five pharmacological contraceptive methods was strong. Even though an estimated 15 million women were exposed, we identified only 72 reported deaths over 2 years, 316 reports of life-threatening events, 217 events that required intervention to prevent harm, and 1,491 cases that resulted in hospitalization.
  • Unintended pregnancies were reported for all five methods, but the proportion of these reports was highest for oral estrogen combinations, because of missed doses, and lowest for the levonorgestrel IUDs.
  • Psychiatric symptoms were 4-7 times more likely to be reported with contraceptives providing sustained doses of sex hormones compared to the non-hormonal copper IUD.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.