The US Food and Drug Administration (FDA) confirmed that the Decemember 31st 2011 ban on Chlorofluorocarbon (CFC) based asthma inhalers will go into force. The ban is part of the Montreal Protocol on substances that deplete the Ozone Layer., which dates back to international agreements made in the late 1980s. Since the protocol went into force in 1989 many products that use large amounts of CFC, such as refrigerators and deodorants have gone out of production.
Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research. Confirmed :
"If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma."
More importantly the ban will affect over the counter Epinephrine based inhaler marketed by Armstrong Pharmaceutical Inc. called Primatene Mist. This OTC product allows those with only mild asthma to treat themselves as and when they see fit. However it is the only FDA approved OTC product available on the market for asthma, leaving those who have been relying on it, needing to seek a doctor's prescription for an alternative product.
Public discussions have been in progress since 2006, in regards to the CFC epinephrine inhalers and while most manufacturers have switched to the new hydrofluoroalkane (HFA) as an aerosol propellant in asthma inhalers, there is no product with HFA to replace the CFC based Primatene Mist.
The FDA has encouraged Armstrong Pharmaceutical Inc. to inform its consumers and Primatene Mist now carries alerts to warn consumers that it will be discontinued at year end. However as the deadline approaches it is obviously important to make sure the transition occurs without incident, as Asthma suffers that have been relying on the product will now need prescriptions. Doctors should be careful to alert patients to the changes.
More information is available on these links :
Phase Out of Epinephrine CFC Metered-Dose Inhalers
Epinephrine CFC Metered-dose Inhalers - Questions and Answers
Consumer Update: Primatene Mist with Chlorofluorocarbons No Longer Available After Dec. 31, 2011
Written by Rupert Shepherd BSc.