OTC bronchodilator drugs - sale of theophylline-containing non-prescription drugs is illegal, and those containing ephedrine may soon be illegal because of health hazards - Brief Article

FDA Consumer, Oct, 1995

Over-the-counter bronchodilator drugs containing theophylline can no longer be sold in the United States, and those containing ephedrine may soon follow suit.

In July, FDA banned the sale of OTC theophylline-containing combination bronchodilators because evidence failed to show that the products are safe and effective. These products had been on the market for decades.

The agency cited data showing that the therapeutic dose for these drugs may be toxic to some people, causing life-threatening events and death. Studies also show no evidence that the ingredients in these OTC products contribute to the claimed therapeutic effects or that the dosage of each component is safe and effective for a significant number of patients.

The ban does not include theophylline-containing OTC inhalers.

At the same time, FDA proposed banning OTC bronchodilators containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine hydrochloride because of abuse and misuse. According to the U.S. Drug Enforcement Administration, ephedrine is being used to make illegal drugs. And, FDA has found that some drug manufacturers promote ephedrine for unapproved uses, such as weight control and muscle enhancing.

People with asthma who have been using ephedrine will have several OTC alternatives containing other drugs, including epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. These are sold as metered-dose inhalers. Prescription options exist, as well.