2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC660
Submitter : Mrs. Janell Hope Date & Time: 10/12/2005 06:10:02
Organization : Mrs. Janell Hope
Category : Individual Consumer
Issue Areas/Comments
My comment is this: If there is any doubt about safety of a drug,
age should not even be relevant...I believe this drug is risky, to
say the least...have read of several deaths associated with its use.
My own position is that it should not be available AT ALL, but if it
is, a prescription should always be required, at any age.