|2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC|
|FDA Comment Number :||EC847|
|Submitter :||Dr. Anita Showalter||Date & Time:||12/10/2004 04:12:27|
| I am a board certified OB/GYN and a member of ACOOG. I am opposed to the OTC labeling of emergency contraception for the following reasons:
1. Most contraception is managed now at the annual well-woman exam when STD testing traditionally takes place. OTC labeling will make it less likely that women most at risk for STDs will be obtaining screening.
2. The higher doses of emergency contraception make them potentially more dangerous for side effects such as venous thrombosis than daily hormonal contraception. Since emergency contraception would be easier to obtain, there could be a tendency not to use routine oral contraception (safer) but to use repeated dosing of emergency contraception (more dangerous).
3. While we have been successful in reducing the teen pregnancy rate with various means of contraception, we have seen an explosion of sexually transmitted diseases in this age group as well as cervical cancer. Increasing the ease of purchase without input from a health care professional further puts the most vulnerable group at more risk for these devastating diseases, imparing their future fertility, increasing morbidity and decreasing life expectancy.