GREENSTONE BRAND HYDROCORTISONE
NADF is aware that there have been sporadic issues obtaining Greenstone generic hydrocortisone tablets recently. The Foundation would like to note that while we don’t have a shortage of hydrocortisone in the US, we understand that when your preferred brand is not available to you, it can feel very distressing.
In 2021, Pfizer sold its authorized generic business, Greenstone, LLC—and merged it with Mylan to form Viatris Inc. As a result, Viatris is now the manufacturer of the legacy Greenstone hydrocortisone, and NADF will attempt to learn more about their production plans. In the meantime, please consider these options:
1. The other two manufacturers of generic hydrocortisone are Strides and Amneal; both are in supply.
2. If these are not options for you, speak to your physician about prescribing the Cortef brand; please check with your insurance on the out of pocket cost for you to access this branded product before making a change with your pharmacy.
3. Your physician may also offer another corticosteroid in the interim, such as prednisone, or may help you arrange to obtain a customized formulation from a compounding pharmacy.
Please be assured that NADF is continuing to monitor and investigate the situation and will share additional information as it becomes available.
In 2021, Pfizer sold its authorized generic business, Greenstone, LLC—and merged it with Mylan to form Viatris Inc. As a result, Viatris is now the manufacturer of the legacy Greenstone hydrocortisone, and NADF will attempt to learn more about their production plans. In the meantime, please consider these options:
1. The other two manufacturers of generic hydrocortisone are Strides and Amneal; both are in supply.
2. If these are not options for you, speak to your physician about prescribing the Cortef brand; please check with your insurance on the out of pocket cost for you to access this branded product before making a change with your pharmacy.
3. Your physician may also offer another corticosteroid in the interim, such as prednisone, or may help you arrange to obtain a customized formulation from a compounding pharmacy.
Please be assured that NADF is continuing to monitor and investigate the situation and will share additional information as it becomes available.
CORTISONE ACETATE
December, 2022
The FDA provided an update on availability of cortisone acetate 25mg. Hikma Pharmaceuticals USA, Inc. (formally West-Ward) made a business decision to discontinue manufacture of this product. Hikma was is the sole manufacturer of cortisone acetate tablets in the US.
Most people in the US are no longer using cortisone acetate. If you were, please talk to your physician about a transition to hydrocortisone, the recommended steroid to use. It is recommended to split your Hydrocortisone dose into two or three divided oral doses per day. Higher frequency regimens and size-based dosing may be beneficial in individual cases.
See the Corticosteroid Comparison Chart here
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Cortisone Acetate Tablets
Status: Discontinuation
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 10/12/2022)
Company Contact Information:
800-631-2174
Presentation: 25 mg, bottles of 100 (NDC 0143-9700-01)
Posting Date: 10/12/2022
Related Information: Business decision to discontinue manufacture of this product.
The FDA provided an update on availability of cortisone acetate 25mg. Hikma Pharmaceuticals USA, Inc. (formally West-Ward) made a business decision to discontinue manufacture of this product. Hikma was is the sole manufacturer of cortisone acetate tablets in the US.
Most people in the US are no longer using cortisone acetate. If you were, please talk to your physician about a transition to hydrocortisone, the recommended steroid to use. It is recommended to split your Hydrocortisone dose into two or three divided oral doses per day. Higher frequency regimens and size-based dosing may be beneficial in individual cases.
See the Corticosteroid Comparison Chart here
____________________
Cortisone Acetate Tablets
Status: Discontinuation
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 10/12/2022)
Company Contact Information:
800-631-2174
Presentation: 25 mg, bottles of 100 (NDC 0143-9700-01)
Posting Date: 10/12/2022
Related Information: Business decision to discontinue manufacture of this product.
ORDERING GREENSTONE HYDROCORTISONE
April 8, 2022
If you need to order Greenstone (vs other generic hydrocortisone), be sure to let your doctor and pharmacy know. The NDC order info:
If you need to order Greenstone (vs other generic hydrocortisone), be sure to let your doctor and pharmacy know. The NDC order info:
- Hydrocortisone oral tablet, Greenstone, 10 mg, bottle, 100 count, NDC 59762-0074-01
- Hydrocortisone oral tablet, Greenstone, 20 mg, bottle, 100 count, NDC 59762-0075-01
- Hydrocortisone oral tablet, Greenstone, 5 mg, bottle, 50 count, NDC 59762-0073-01
update on greenstone hydrocortisone
Pfizer is transitioning its generic Greenstone hydrocortisone products to a new company called Viatris.
There is still a locate service but instead of using the online process, patients need to call Viatris (the new company) and speak with a customer relations representative. They will take the information and help locate supply in your area. They are still in the process of transitioning from Pfizer and expect to have an improved service in December. The Customer Relations Locate Team can be reached at 1.800.796.9526 between 8 AM- 5 PM EST, Monday-Friday. Choose customer relations, press 2
Also, on a positive note, according to the FDA Shortage Database, hydrocortisone tablets (both Generic and Cortef Brand) are in better supply, with less lags in inventory.
There is still a locate service but instead of using the online process, patients need to call Viatris (the new company) and speak with a customer relations representative. They will take the information and help locate supply in your area. They are still in the process of transitioning from Pfizer and expect to have an improved service in December. The Customer Relations Locate Team can be reached at 1.800.796.9526 between 8 AM- 5 PM EST, Monday-Friday. Choose customer relations, press 2
Also, on a positive note, according to the FDA Shortage Database, hydrocortisone tablets (both Generic and Cortef Brand) are in better supply, with less lags in inventory.
update on strides hydrocortisone tablets
The National Adrenal Diseases Foundation (NADF) contacted the Strides/Vensun pharmaceutical company regarding issues patients with adrenal insufficiency were experiencing when they started the Strides/Vensun generic hydrocortisone due to the shortage of the Greenstone generic. In response, the company conducted a detailed analysis and concluded that the medication is safe and effective.
However, many of you have indicated that you have had symptoms of low cortisol when you switched.
However, many of you have indicated that you have had symptoms of low cortisol when you switched.
- If you do have any issues, please work with your individual doctors about adjusting their dose. http://bit.ly/NADF_med_bio
- Please be proactive about reporting any adverse events or issues with the generic via the FDA MedWatch or directly to the company. You can find the link here: https://www.fda.gov/media/76299/download
FDA drug shortage website updated their information regarding availability of hydrocortisone
September 9, 2021
Most Current FDA Shortage Information can be found here:
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydrocortisone+Tablets&panels=1&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery
Most Current FDA Shortage Information can be found here:
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydrocortisone+Tablets&panels=1&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery
NADF HYDROCORTISONE SURVEY RESULTS
Since last year, Greenstone hydrocortisone tablets have been in short supply and many are taking Strides/Vensun generic hydrocortisone as a replacement.
Based on a recent NADF survey, this shortage has been causing unwanted side effects for many people.
Based on a recent NADF survey, this shortage has been causing unwanted side effects for many people.
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The Vensun product from Strides is available but many are reporting issues.
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59% of the respondents say they cannot get their usual hydrocortisone tablets: Greenstone 5mg and 10mgs. Although the product is still limited, those that can get Greenstone have used Greenstone’s locator service or their pharmacy has located the Greenstone product.
Most respondents say they have not felt as well on the replacement. Most common side effects noted when their usual brand was replaced by Strides/Vensun included nausea, weakness and fatigue. |
There are things you can do!
- When you experience an adverse event, fill out the FDA MedWatch form 3500 to report it. This is the best way to get information to the FDA on product issues.
- You may need to adjust your hydrocortisone dose. Please read Dr. Margulies’ statement on medication bioequivalency here.
- Be sure to let your pharmacy know if you need help locating Greenstone or any other specific product. They are often very helpful!
reporting adverse events
If you have had problems with how a drug worked after switching brands, please submit a MedWatch form so the FDA can investigate. MedWatch – Form 3500 for reporting to the FDA (pdf file)
