Tacrolimus Manufactured by Accord Healthcare

[Okralove]

The U.S. Food and Drug Administration (FDA) published a report about tacrolimus oral capsules manufactured by Accord Healthcare Inc. Tacrolimus is a medication that helps prevent organ rejection in transplant patients.

If you are taking tacrolimus, do not stop taking it, even if you are taking the Accord product. You can find out if you are taking the Accord product by calling your pharmacy. You might also find this information on the label on your prescription bottle.

According to the FDA, if you are taking the Accord product, your trough levels, which is what we measure with routine lab testing, will be unchanged and the risk of rejection is not increased. However, there could be an increased risk of side effects.

Mayo Clinic recommends that you ask your pharmacy for a non-Accord product. If you are not experiencing any new or worsening side effects since your last refill, this can be at your next scheduled refill of your prescription. If you experience new or worsening side effects, ask your pharmacist to assist you in getting an early refill of a non-Accord product as soon as possible.

Continue to take the Accord product until another product is available for you, even if you are experiencing side effects. Stopping your tacrolimus for even a short period of time will increase your risk for rejection. If your pharmacy cannot give you tacrolimus manufactured by another company, please let your Mayo coordinator know. They will help you in the next steps to get your prescription.

New or worsening side effects to watch for may include an increase compared to normal of headache, tremor, blood pressure, or in very rare cases, seizure.

You can read more information about the FDA report on the FDA website. If the link doesn’t work, go to fda.gov and search for search tacrolimus or Accord Healthcare.

[Herewegoagain12]

Thanks for the information. I take tacrolimus and have quite a few side effects.

[Okralove in reply to Herewegoagain12]

Please check with your pharmacy and or nephrologist. We did the same day and my husband is good.

[PuggyWuggy]

😱Thank you so much for this very important info/warning! My current MFR is Glenmark. Since a pharmacy could change manufacturers at any time, I will be sure to check each time I get a refill.

[Okralove in reply to PuggyWuggy]

I know we will check each month. Just wanted to share. When we receive a warning from Mayo we take it seriously!!

[Bax509]

thank you so much - this is the first I heard about it and recently refilled my Tac and it was a new capsule. Called my pharmacy and sure enough had been on the one from Accord since transplant in 2021 (with a lot of side effects). Hopefully they abate on the new one. Thanks again!

[Okralove in reply to Bax509]

Please check with your nephrologist also. My husbands transplant was done at the Mayo Clinic so we take it seriously when we are contacted by them. Felt like we needed to share the information.

[LibraEmpath]

🫶🏽Thank you so very much for this information. I just went to check , and my MFG is SANDOZ. I’m in the Bay Area and my kidney transplant was performed at UCSF medical center. Once again, thank you 🫶🏽

[Transplant2014]

This information is about 5 or 6 months old. I reported it to my specialty pharmacy in September and now they supply tacrolimus manufactured by Sandoz.

[LBatl]

Thank you so much for this valuable information!

[Pesh77]

I appreciate you posting this. I am putting this story on my social media to make other transplant patients aware. When did you receive the warning from Mayo Clinic? Asking as I haven't received anything from my transplant hospital. Thank You.

[Okralove in reply to Pesh77]

Received it January 19th.