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The FDA and Tagamet

© Adelle Vancil Tilton

Every so often, a prescription medication, is released as an Over-The-Counter (OTC) medication. This is often received with mixed reaction. Patients are usually thrilled - it saves a trip to the doctor (and therefore added medical bills, especially if medical insurance is absent or will not pay as in the case of Medicare with prescriptions). It seems a great time saver - no waiting for doctors who aren't on schedule, no waiting for a prescription to get filled, and no fainting when you have to pay the bill. But some people, amongst them physicians, are not as thrilled about prescription medications going OTC. Believe it or not, this is not because they are losing an office call. It is because of the potential dangers and the problems caused by these drugs. These problems often bring people back into the medical clinic anyway, because of the issues brought about by these drugs.

A good example of this is Tagamet. Advertised widely as a heartburn "cure", it is bought by millions of people. Pepcid and Zantac were also released OTC, but with Tagamet we have a different story. Let's trace back and then return to the Tagamet problem.

When it is Over-The-Counter, anyone can buy something, anytime and as often as they wish. People can buy many things in this manner: aspirin, acetaminophen (Tylenol), Tums, allergy medications...the list is virtually endless. The television is telling us constantly about these medications and how they can make us feel better. Most of them are safe. There probably is no safer drug than aspirin, used as directed of course. Being able to buy aspirin freely is a beneficial thing to society. Can you even imagine the rush into physician's offices everytime someone needed a prescription for 30 aspirin. That would be totally impractical.

The assumption is that if you can buy it at the grocery store, if it is an OTC, it is safe. Many people do not even report the OTC drugs they take to their physician when they do visit for a check up, or for a chronic condition. It's an OTC. It doesn't count.

Now back to Tagamet. The FDA released Tagamet as an OTC in June of 1995. They required the packaging state that if they take oral asthma drugs (Theo-Dur), Coumadin or seizure medications, they should contact their physician before use. They were also required to state on the packaging if they were in doubt if their medications contained those ingredients they should contact Smith-Kline. Smith-Kline is the manufacturer of Tagamet and people are to call them? Not their physician? The problem

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