OTC Tamiflu? I’ve Got Some Questions.

Should the FDA approve OTC Tamiflu?

OTC Tamiflu may be a reality in the near future. Sanofi has purchased the over-the-counter rights for Tamiflu and is pursuing approval from the FDA. I do have some potential concerns with this medication becoming an over-the-counter option. For the pharmacology, adverse effects, drug interactions, and more on Tamiflu (oseltamivir), take a listen to this podcast.

Will OTC Tamiflu Discourage Vaccination?

Vaccination programs are incredibly important in trying to reduce the impact of influenza. This is probably my major concern with Tamiflu gaining over-the-counter status. There is an easy temptation to avoid vaccination if we have a potential treatment for something. It is simply human nature to want to delay preventative measures and deal with it when it actually happens. I think that lower influenza vaccination rates are a significant possibility because of a greater ease of obtaining a treatment option for influenza.

Will Patients Use It Appropriately?

Patients with renal impairment need to have dose adjustments. Will patients appropriately be able to dose Tamiflu themselves. Or will they appropriately recognize that they have renal issues and discuss the appropriate dose with their pharmacist or other provider? That is a big question.

Another question about appropriate use is whether the drug will be started on time. Many patients try to tough out symptoms and do not recognize they have some more serious than a head cold. Tamiflu is ideally started within 48 hours of symptoms to show its maximal benefit. Having Tamiflu available as an OTC medication will allow for quicker access to the drug, but this ease of access may allow for a lot of patients who may be in the late stages to start taking the medication. Telling the difference between the effectiveness of the drug and the beginning of the end of the regular course of the disease may be difficult for patients to recognize.

What Will The Cost Be?

OTC status would allow for easier access to the drug…or would it? If cost is prohibitive, it may prevent a substantial number of patients from being able to obtain the drug. What the OTC price of Tamiflu is set at would be a big question mark and will make a big impact as far as patient utilization.

What do you think? Should Tamiflu be available OTC or not?

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1 Comment

  1. Zubair Amin, PharmD

    You present valid concerns but you are missing one: the potential for resistance. All selective anti-microbial agents carry the potential for resistance, oseltamivir is no exception (see: N Engl J Med 2005; 353:2633-2636). I think this reason in itself (and it’s public health implications) should be the biggest argument against de-restriction.


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Written By Eric Christianson

December 25, 2019

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