FDA Considering Ban of Primatene Mist

If you're one of the 3 million Americans who use Primatene Mist to manage your asthma, you may have to look for an alternative. The Pulmonary-Allergy Drugs Advisory Committee voted 11 to 7 in favor of removing Primatene Mist from drugstore shelves because of the harmful chemical it contains.

Primatene Mist Contains Ozone-Depleting Chemical

Primatene Mist, manufactured by Wyeth Consumer Healthcare, contains chlorofluorocarbon (CFC) which facilitates the propulsion of the medication (epinephrine) from the inhaler canister. CFC has been used in many aerosolized products in the past, but its use has been phased out because of its effects on the Earth's ozone layer. CFC depletes the ozone layer that provides protection against the Sun's harmful rays. (Read more about ozone and your health.)

No OTC Alternatives for Primatene Mist Users

Currently, there are no epinephrine-based inhalers on the market that use hydrofluroalkane (HKF), the environmentally safe aerosol propellant, and there are no epinephrine-based prescription inhalers on the market. Therefore, if the ban could leave no OTC alternatives for asthmatics.

CFC-Containing Prescription Inhalers Banned

Prescription inhalers containing CFC are being phased out. In March 2005, the FDA ruled that all prescription inhalers containing CFC will be banned by the end of 2008, forcing drug manufacturers to use an alternative, environmentally safe aerosol propellant.

Health Concerns Have Many Doctors in Favor of the Ban

Many doctors are in favor of the ban, but mainly for health-related reasons. Doctors are concerned that many of the users of Primatene Mist are self-diagnosing and self-treating, i.e. they are not seeking medical treatment for their asthma, or what they believe is asthma. Since Primatene Mist contains epinephrine, there is also concern that consumers may suffer cardiac side effects.

Some Doctors Believe Primatene Mist is Unnecessary

"Asthmatics can be better treated with albuterol", says Dr. Richard Ahrens, allergist, pediatric pulmonologist, professor at the University of Iowa and former chair of the Pulmonary-Allergy Drugs Advisory Committee. Dr. Len Horovitz, pulmonary specialist at Lenox Hill Hospital in New York City stated, "Anybody who thinks they have asthma should consult a physician and get on a daily maintenance regimen so they have no need for a rescue inhaler like Primatene. Using a rescue inhaler means that the asthma is not under control."

Asthmatics to be Affected by the Primatene Mist Ban

Approximately 700,000 asthmatics use Primatene Mist because 1) they can't get a prescription for the proper asthma treatment, or 2) they lack the health insurance they need to pay for the medication. So where will this ban leave these 700,000 asthmatics?

Wyeth Requests Primatene Mist Ban be Delayed

Wyeth has requested that the Food and Drug Administration (FDA) delay the ban of Primatene Mist until they can develop an asthma inhaler that is free of CFC. However, a replacement may not be available until 2010.

The FDA's Decision to Ban Primatene Mist

Although the Pulmonary-Allergy Drugs Advisory Committee has voted in favor of the ban, it is the FDA that will make the final ruling. The FDA must decide if the continued use of Primatene Mist is "essential", i.e. it's medical benefits outweigh the risks of its continued use on the environment.

_{Sources: forbes.com; money.cnn.com; seattlepi.nwsource.com}