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Alan Khadavi, MD, APC
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March 13, 2022 by Alan Khadavi

Does Expired Albuterol work?

Does expired albuterol work?  Expiration dates of pharmaceutical products are important to know. They are based on stability studies conducted by manufacturers. Expiration dates imply that the medications no longer retain their potency and should be discarded once its reached, but in facts, the post expiration residual drug strength is usually undetermined.  In fact in a previous blog we discussed how expired Epipens still worked much past their listed expiration dates.

Does an expired Epipen work?

The financial impact of expired medications is substantial. Many “expired” medications still retain enough strength to make the therapeutically beneficial. A recent study investigated expired albuterol and expired Singulair even 20 years past their expiration dates. They support the notion that expired medications may be useful and shouldn’t be wasted.

Active drug levels have to be within 90% to 110% of the label strength, which is the acceptable quality control range of pharmaceutical products.

The results of the study showed:

  • All expired Singulair were within the quality control range, around 95%, some of them had greater than 10 year expiration dates.
  • Albuterol solutions had a similar quality of 98%, except 2 samples (85% and 88% of label strength). These 2 products were from multi dose vials and not single-dosage sealed vials like the rest of the products.
  • Albuterol inhalers had larger variability (approximately 87%). The investigators attributed the lower amounts in the difficulty of capturing the medication from the dispensing puffs into the capturing device (balloon).
  • The expiration dates from the above medications ranged from March 2001 to January 2021.

On the basis of these results, solid dosage forms and most liquid forms of singulair and albuterol retain their strength over extended periods of time, even 20 years. This is in line with other published studies.

The FDA has extended expiration dates for many drugs based on past studies. This will result in a marked reduction in replacement costs for drugs.

Based on this current study, the authors concluded:

  • Expired medications should be stored at normal conditions of temperature, light and humidity so they retain their strength.
  • Solid dosage medications are usually most stable.
  • Individual expiration dates for medications are variable based on their molecular structure. For example, aspirin, caution must be advised.
  • Biologic products will need to be investigated as a different class and has yet to be determined.

So in conclusion, expired albuterol most likely will retain most of its potency if kept in optimal climate conditions. If you are having an asthma attack, it is best to used expired albuterol then no albuterol at all.  This most recent study has shown that even many years past its expiration date, expired albuterol still retains a significant amount of its potency. In general though, it is best to get a non expired medication, but if there are difficulty obtaining medications because of drug cost, speak to your doctor about what is right for you.

Filed Under: Allergy Medicine, Asthma, Blog

alan-khadavi
Dr. Alan Khadavi
Allergy & Asthma Specialist

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