Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -47

Accepted - Volume 6

Comment Record
Commentor Mrs. Dorothy Glavin Date/Time 2000-06-27 21:02:17
Organization housewife - retired
Category Individual

Comments for FDA General
1. General Comments Regarding an article I read in the local newspaper about prescriptions may be sold over the counter: It was giving an example about cholestral medicine - ex. Mevacor or Pravachol. I do not think this should be allowed to sell over-the-counter because I had been on Pravachol for some years and while going to a Dr. for a checkup, he discovered a liver enlargement by probing my stomach area. Asked if I drank, if so, how much - to which I replied very little & sent me to a Gastroentrologist for further testing. The results of the test & over a period of 30 days, was - the Pravachol medicine enlarged my liver. After not taking it & changing to another medicine, Cholestramine, which is not a statin, everything is fine. Now, if I had bought that medicine over-the-counter and just thought I was getting muscle aches (which was what I was getting, but I wasn't associating it with Pravacol), then more than likely, I never would have done a thing about it. I therefore, don't believe this medicine should be allowed to be sold without a Dr.'s supervision. I was, and still am, being tested for blood work every 3 - 6 months. This would not take place if I were getting this at the local Drugstore without a prescription. I realize all these medicines are costly, but isn't it better to be safe than sorry?

EC -47