Many folks have had sticker shock at the pharmacy when going to refill their inhalers, the same inhalers they have been on for years. You must have questions; here are some answers about what is going on.
What is albuterol?
Albuterol is an inhaled beta agonist which works to relax smooth muscle and dilate or “open up” the airways. It is a short acting bronchodilator.
How long has albuterol been on the market?
Albuterol was originally approved by the FDA in 1981 and has been sold as many different brand names: Proventil, Ventolin, Volmax among others.
With the banning of CFCs was albuterol the only inhaler affected?
Yes, albuterol is the most common metered-dose inhaler (MDI) which used a propellant-driven chlorofluorocarbon (CFC) delivery mechanism for inhalation.
Have other countries banned CFC?
Yes, in fact most aerosols (hairsprays, etc) dropped the use of CFC propellants more than 25 years ago. Countries worldwide signed an International treaty called “The Montreal Protocol on Substances That Deplete the Ozone Layer” which called for banning CFC propellants. The U.S. ended production and importation of CFCs for all commercial applications in 1996 but because there was no alternative for the asthma inhaler Albuterol, they were allowed to stay on the market until December 2008.
When did you hear that the albuterol inhaler would be taken off the market?
In 2004 when the Proair HFA was released most Physicians realized this was the beginning of the transition from CFC inhalers to HFA inhalers.
Have there been any complaints?
What are the most common? Cost is by far the most common complaint with the HFA inhalers as there is no generic option. This means patients are paying a much higher copay. Patients also report the HFA inhalers have a slightly different smell and taste and the mist is a little less forceful and warmer coming out of the inhaler. Additionally, you must prime and clean HFA-propelled inhalers to prevent buildup of the drug in the inhalation device, which can block the medicine from reaching the lungs. Each HFA inhaler has different priming, cleaning, and drying instructions.
Would you know why the decision was made to make HFA Albuterol (pro-air) a brand drug as opposed to a keeping it as a generic?
If the drug is the same, why would a different propellant change the status of a drug from generic to brand? ProAir HFA, Proventil HFA and Ventolin HFA are all albuterol with HFA as the propellant and yes, the Albuterol ingredient is the same but the HFA inhalers still had to be tested for safety and efficacy like any new drug, and apply for approval from the FDA just like any new drug.
How long does it take for a brand drug to become generic?
It depends on the drug and the indication for the drug but between 5 and 7 years for most drugs.
Is there any hope of seeing albuterol return as a generic drug any time soon?
ProAir HFA was approved in 2004 and will go generic in late 2009 (early 2010 possibly) and many drug companies will make a generic form of ProAir HFA at that time.
As a Physician, how do I feel about the situation?
To go from inhalers that cost 5 dollars to 60 dollars especially for those who don’t have prescription drug coverage has been awful. There are a couple things that do help: drug samples at the doctor’s office, the nebulizer solution is still generic so some have started using nebulizer treatments at home, and drug companies have set up some help for those in financial need with no drug coverage through the Partnership for Prescription Assistance (PPA) at 1-888-477-2669, or visit them online.