FDA wants asthma drug withdrawn

Jan 26 2006

An FDA advisory panel has advised that an over-the-conter (OTC) asthma drug should be withdrawn.

The panel believe that the inhaled drug Primatene Mist offers no health benefits to patients and has the added disadvantage of depleting the ozone layer.

The Nonprescription Drugs and Pulmonary-Allergy Drugs advisory committees which initially met to discuss the use of the ozone-depleting propellant, focused on whether mild asthma is a condition for which OTC treatments should remain available.

Several panelists pointed out that asthma is a doctor-diagnosed condition, and people who self-medicate often use products incorrectly.

According to Dr Steven Gay, of the University of Michigan, even doctors sometimes have difficulty distinguishing what is mild asthma, and for patients to do this puts them at significant risk.

Gay, himself a panel member, says the hallmark of asthma treatment is clearly, controlled medication that requires anti-inflammatory therapy.

Many panelists agreed that asthma treatment has improved significantly with Rx anti-inflammatory inhalers since Primatene Mist was first approved for OTC use in 1956.

Also Primatene Mist only treats symptoms for an average of 23 minutes, while Rx inhalers can provide relief for up to six hours.

Drug manufacturer Wyeth however maintains that 90% of consumers who use Primatene Mist have had their condition diagnosed by a physician, and while many asthma sufferers have prescriptions for Rx inhalers, they use Primatene when they do not have access to their other medication.

Wyeth also says that Primatene provides asthma treatment to those who cannot afford health insurance.

However, NDAC Chair Alastair Wood, MD, says there is "zero safety and efficacy data" on the product, and has expressed "concern" over "a system which says that undeserved populations should be assigned to drugs for which there's no evidence of efficacy and/or safety."

Wyeth has been advised that they undertake a label comprehension study in order to provide more information on whether consumers can correctly self-treat with Primatene.

It seems Wyeth is in the process of developing an alternative epinephrine MDI that does not contain CFCs, and has requested that Primatene remain available for sale in the interim.