FDA Advisory Panel Says OK to a Non-Prescription Tagamet

A panel of scientists unanimously urged a Food and Drug Administration committee on Monday to allow the popular ulcer drug Tagamet to be sold without a prescription to treat heartburn.

However, the members of the advisory committee recommended that the over-the-counter boxes for the drug include warnings that the drug might interact with blood thinners and with certain prescription medicines for lung diseases and seizures.

The FDA is not obligated to follow the recommendations of its advisory committees, but it usually does.

The non-prescription version of the drug would be taken at much lower doses--200 milligrams a maximum of twice a day. That amount has proven modestly effective at easing heartburn.

Just last year, the committee rejected Tagamet as an over-the-counter medicine, citing concerns that it would interact with certain prescription drugs.

Manufacturer SmithKline Beecham did chemical analyses of the way Tagamet affects one of the drugs of most concern, theophylline, which is widely prescribed for asthma and lung diseases.

The studies showed no significant danger from Tagamet at the lower doses. Company officials said they wanted warnings on the labels, and the committee agreed.

Committee members noted that the company studied the drug’s interactions only in healthy people, which means sicker people could suffer adverse effects.