Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -93

Accepted - Volume 6

Comment Record
Commentor Dr. Maria Hornquist Date/Time 2000-07-04 15:13:36
Organization Dr. Maria Hornquist
Category Health Professional

Comments for FDA General
Questions
1. General Comments I would like to register my opinion about certain medications that are being considered for OTC status. I have been a pharmacist for 6 years and currently work in Minnesota. 1. Antihistamines: I believe that non-sedating antihistamines should definately be OTC. They have been proven safe and effective and are perhaps safer than the OTC sedating antihistamines currently available. 2. Oral Birth control: I strongly oppose making OC's OTC. Although the side effects of stroke, thrombosis, etc. are rare, they are life threatning. Women, especially young, would not be as compliant with anual exams which can detect rises in blood pressure, migraines and other side effects that could predict the CV adverse effects. Dr's could also monitor smoking habits which could help them determine whether it is safe for a woman to continue the OC's. OC's do not protect women from AIDS and other STD's, and OTC OC's could decrease safe sex practices. And finally, parents should have the right or at least an opportunity to be the minor's first educator on sex and all that it entails. If OC's are made OTC, they should definately not be made available to those under 18, just as cigarettes have an age restriction. 3. Emergency contraception: Again, I oppose this due to the safety reasons. The incidence of the above mentioned life threatning side effects can only increase.(See Preven Webpage for stats). There are many women in which the morning after pill is contraindicated due to the increase chance for stroke or thrombosis (due to high blood pressure, migraines, etc.). The safety of repeated use of this high dose OC's has not been determined. How many times a year can you take it safely? And with out a Dr's supervision? The FDA would be very irresponsible to approve this OTC switch. 4. statins: I also believe due to the safety issues and the necessary monitoring that these agents remain Rx. Again, I believe compliance to liver function tests would decrease or cease all together. How will patients know they are taking the correct dose? This will also decrease the Dr's recommendation for diet and exercise first. Thank you for your consideration on these very important issues, Maria T. Hornquist, Pharm.D.




EC -93