Adverse Effects of Expired Botox

Question

I believe I received botox that had expired 5 months ago. I am having pain & spasms above my left eye. What are the risks of using expired diluted botox?

Kenneth D. Steinsapir, MD · Answer

It is very interesting about the pharmaceutical industry. Those expiration dates probable have much more to do with marketing than product safety. The Navy did a study on drugs because they have to store drugs on big ships and it is very inconvenient to constantly restock drugs. What they learned is that most drugs are still good 10 years after the date of expiration. There are some important exceptions like nitroglycerin for the heart. I think I would want to know that my oral birth control pills have not expired. Busy cosmetic surgery office go through so much BOTOX that is is rare to have any expired product. If the BOTOX had been properly stored and reconstituted within 2-3 weeks of when you were treated, it is improbable that your issues are related to the expiration date on the vial. Again in a busy office, this would not happen because we go through product so quickly. How did you learn that the product was expired? Ultimately, if you are having an issue, I recommend that your get assessed by the appropriate medical specialist.

Kurtis Martin, MD · Answer

I believe the only side effect of expired botox would be loss of potency. Most botox doctors use enough that they never have an expired bottle.

Ron Shelton, MD · Answer

You should contact the manufacturer, Allergan, as their science division might have the best answer for you. Chances are that as long as the product had not been mixed five months ago, and was stored sterilly in the freezer until it was mixed and then given to you, that there probably is no risk. After a long while, possibly years, a product might lose its sterility, but possibly there is a gradual loss of potency. Whether there is degradation of product that could cause a problem needs to be posed to the company but they may not have an answer as this might never have been tested.

	Please only use board certified physicians such as dermatologists or plastic surgeons, ophthalmologists and ENT doctors for botox injections.

Harold J. Kaplan, MD · Answer

Hi Mykr.  The risk of expired Botox would generally not include eye spasms.  It's more likely that if it was reconstituted (mixed) and then was left for 5 months that the chance of infection would be greater.  

	Even more likely than this scenario is that the product simply would not work as well.  Either way, the symptoms you are experiencing are likely not related to the Botox and you should visit your primary care physician.  Good luck.

David Shafer, MD, FACS · Answer

The expiration on Botox is very long.  For instance, Botox in my office right now does not expire until 2012.  However, Botox that has already been reconstituted or diluted should be used within 24 hours.  If you had Botox that was sitting around diluted for 5 months then this is a problem since you are obviously being injected by someone who does not know what they are doing and does not do many Botox injections if they have Botox sitting around for that long.  However, old Botox would be less active, no more active, so most likely your symptoms are coincidental.  However, you should go back and see your doctor for an examination.

	 

	Good Luck.

Andrew Campbell, MD · Answer

As long as the vial was not contaminated, there should be very little risk to using Botox that expired 5 months ago. The most likely side effect from using outdated Botox is that the Botox would be less effective due to degredation of the molecule. I would recommend discussing this with your injector. It would concern me that outdated Botox would ever be used on a patient. There is really no reason this should ever happen. Busy cosmetic practices should be using so much Botox that they never have a chance to expire, and this should be tracked so that no outdated product is ever used on a patient.

Andrew Campbell, M.D.

Board Certified Facial Plastic Surgeon

Andrew Campbell, M.D.

Board Certified Facial Plastic Surgeon

Robert L. Kraft, MD, FACS · Answer

There should be no adverse consequences or risk from expired Botox in terms of pain and spasms unless there has been bacteria formation in the diluted fluid.  Botox should be refrigerated upon reconstitution.  A busy practice with a Botox population would not have expired, open vials.  The problem with an expired medication or injectible is loss of potency.  I would be reluctant to return to a physician who used an expired substance which may have weakened to the point of limited, if any, efficacy.   You should seek treatment from a plastic surgeon or dermatologist who regularly injects Botox and ask to confirm that the expiration date on the vial has not elapsed.

Steven Wallach, MD · Answer

Expired Botox if not reconstituted is probably ok. I doubt that it would cause the problems that you are having.  If it was diluted for the past few months, it would probably have very little effect.

Hugh McLean, MD · Answer

Most drugs are safe for considerable time after expiration and Botox is no exception. Pain is not a likely effect, so you should consult a doctor. Expiration may reduce potency but should not cause harm.

Emily Altman, MD · Answer

The most problematic effect of using Botox diluted 5 months ago is that there may have been bacteria in the liquid.  But the most likely is that the Botox may have lost some of its potency and simply will not work as well.

	Usually Botox is diluted with bacteriostatic saline and is stored in the refrigerator, so if it was reconstituted properly, even the chances of infection are very low.

	All that said, no, Botox should not be used 5 months after expiration and/or dilution.  Please consult your primary care doctor or a board certified dermatologist for an evaluation of your symptoms.

Adverse Effects of Expired Botox

Answers (15)

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