In response to the swine-flu outbreak, the European Medicines Agency (EMEA) last week authorized the use of Tamiflu (oseltamivir) capsules up to two years after the drug’s prescribed expiration dates. EMEA’s Committee for Medicinal Products for Human Use (CHMP) specifically extended the shelf-life of Tamiflu 75 mg, 45 mg, and 30 mg hard capsules from 5 to 7 years.
Here’s the background: According to the CHMP report, there are currently two classes of antiviral drugs available to treat influenza: adamantane inhibitors (amantadine and rimantadine) and neuraminidase inhibitors (oseltamivir and zanamivir). Studies of the swine-flu virus detected in humans in Mexico and the US were found to be resistant to amantadine and rimantadine, according to the report, so those antivirals were not reviewed. Instead, EMEA focused on oseltamivir, marketed as Tamiflu by Roche, and zanamivir, marketed as Relenza by GlaxoSmithKline. EMEA worked with the drug manufacturers and other experts to review drug safety reports before making their decision. The goal, according to the report, was to avoid a shortage of potentially effective influenza treatments by making sure expired or soon-to-expire capsules were not discarded. Tamiflu’s potential shortage was most imminent, according to the report.
EMEA’s shelf-life extension of Tamiflu does not extend to the pediatric version of the drug. CHMP, therefore, still plans to investigate the drug’s usage for children under age 1 and for pregnant and breastfeeding women, but in case of emergency, has given guidelines for using Tamiflu to treat these patients. Relenza, which is indicated for treatment of influenza in patients over age 5, according to the document, is also still being researched although it was noted as acceptable for use in pregnant women in the case of a full-blown pandemic.
CHMP also noted that storage conditions for Tamiflu are important for maintaining stability. The capsule boxes must remain stored below 25 °C (77 °F).
I’m glad EMEA made this move—to quickly research and make a decision that could potentially save lives. But it also makes me wonder how many other products’ expiration dates could be extended. From time to time, I’ve been known to take an Advil or Tylenol from my medicine cabinet even if it had expired a few weeks before. I figure the drug can’t go that bad just a few weeks after the expiration date, besides, how many people forget to double-check expiration dates? But looking ahead, maybe some money could be saved here. If drugs last longer than we think they do, we wouldn’t have to throw out unused—and potentially still safe and effective—medication. This possibility may be worth looking into even when a pandemic isn’t present.
See FDA’s viewpoint on these antivirals.