Table 2. Rates of Pregnancy-Related Adverse Events.
| Event | Year 1 (2006), %a | Year 3 (2008), %b | Year 4 (2009), % | Year 5 (2010), % |
|---|---|---|---|---|
| Rate of Events per Total No. of Isotretinoin Prescriptions Among Females of Childbearing Potential | ||||
| Pregnancy (total) | 0.3113 | 0.1490 | 0.0747 | 0.1050 |
| Pregnancy while taking contraception | 0.0143 | 0.0133 | 0.0083 | 0.0029 |
| Abortion (total) | 0.0994 | 0.0602 | 0.0154 | 0.0337 |
| Therapeutic abortion | 0.0619 | 0.0511 | 0.0100 | 0.0274 |
| Fetal defects (total) | 0.0049 | 0.0019 | 0.0004 | 0.0004 |
| Rate of Events per Total No. of Females of Childbearing Potential Registered in iPLEDGE | ||||
| Pregnancy (total) | 0.6486 | NA | 0.3347 | 0.5144 |
| Pregnancy while taking contraception | 0.0042 | NA | 0.0371 | 0.0142 |
| Abortion (total) | 0.2072 | NA | 0.0690 | 0.1649 |
| Therapeutic abortion | 0.1290 | NA | 0.0449 | 0.1343 |
| Fetal defects (total) | 0.0102 | NA | 0.0017 | 0.0022 |
Abbreviation: NA, not available.
a
Calculated based on monthly prescriptions from December 31, 2006, to February 28, 2007.
b
The number of patients registered is only available cumulatively since 2006; thus, the number of females of childbearing potential enrolled in 2008 is unknown. Total number of prescriptions to females of childbearing potential: 2006, 245 404; 2008, 481 364; 2009, 519 641; and 2010, 448 625. Total number of females of childbearing potential enrolled in iPLEDGE: 2006, 117 784 (approximated from 14-month period); 2009, 115 925; and 2010, 91 556.