FDA Shortage database update on SOLU-CORTEF®
August 15, 2023
See details here: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydrocortisone%20Sodium%20Succinate%20Injection&st=c
See details here: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydrocortisone%20Sodium%20Succinate%20Injection&st=c
List of extended use dates to assist with drug shortages
https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages#table - search for hydrocortisone to see a list with extended dates for Solu-Cortef®
UPDATE ON GREENSTONE HYDROCORTISONE TABLETS
As of September 7th, 2023, all Greenstone hydrocortisone, 5 mg, 10 mg and 20 mg are now available!
The Viatris Customer Relations Team can be reached at 1.800.796.9526 between 8 AM-5 PM EST, Monday-Friday.
The Viatris Customer Relations Team can be reached at 1.800.796.9526 between 8 AM-5 PM EST, Monday-Friday.
pfizer's august 3rd report provides the current status of SOLU-CORTEF® AND SOLU-MEDROl®
See details here: pfizer_solucortef_shortage_reporting_as_of_august_3_2023.pdf
SOLU-CORTEF® update
May 2023
This letter is a notification of Emergency Date Extension for Solu-Cortef® (hydrocortisone sodium succinate for injection, USP) 100 mg/2 mL (50 mg/mL) ACT-O-VIAL™ Single Dose Vial. There are 32 lots listed in the table included at the end of the letter from Pfizer that have been extended by five months beyond the labeled 36-month expiry by the FDA. The estimated recover date is December 2023. Refer to: https://www.pfizerhospitalus.com/sites/default/files/news_announcements/5-4-23%20Solu-Cortef%20Emergency%20Date%20Extension.pdf
This letter is a notification of Emergency Date Extension for Solu-Cortef® (hydrocortisone sodium succinate for injection, USP) 100 mg/2 mL (50 mg/mL) ACT-O-VIAL™ Single Dose Vial. There are 32 lots listed in the table included at the end of the letter from Pfizer that have been extended by five months beyond the labeled 36-month expiry by the FDA. The estimated recover date is December 2023. Refer to: https://www.pfizerhospitalus.com/sites/default/files/news_announcements/5-4-23%20Solu-Cortef%20Emergency%20Date%20Extension.pdf
solu-cortef® availability
May 25, 2023
NADF has been in touch with the FDA to obtain an update on the shortage of Solu-Cortef®. They have confirmed with Pfizer that they expect adequate availability of supply to meet demand by late June. Pfizer will ensure the product is available for emergency situations. If you have any difficulty obtaining the product using the process provided by Pfizer, please send us a note with the details of your situation, including all contact information.
Please see March 23rd letter from Pfizer regarding the current availability of Solu-Cortef®:
https://www.pfizermedicalinformation.com/sites/default/files/attachments/solu-cortef_supply_update_3-22-23_0.pdf
Please contact us here: https://www.nadf.us/contact-us.html
NADF has been in touch with the FDA to obtain an update on the shortage of Solu-Cortef®. They have confirmed with Pfizer that they expect adequate availability of supply to meet demand by late June. Pfizer will ensure the product is available for emergency situations. If you have any difficulty obtaining the product using the process provided by Pfizer, please send us a note with the details of your situation, including all contact information.
Please see March 23rd letter from Pfizer regarding the current availability of Solu-Cortef®:
https://www.pfizermedicalinformation.com/sites/default/files/attachments/solu-cortef_supply_update_3-22-23_0.pdf
Please contact us here: https://www.nadf.us/contact-us.html
UPDATE ON GREENSTONE HYDROCORTISONE TABLETS (US)
May 23, 2023
Greenstone Hydrocortisone Availability (as of May 23, 2023)
Note that the resupply dates continue to be updated, and are subject to change.
The Viatris Customer Relations Team can be reached at 1.800.796.9526 between 8 AM-5 PM EST, Monday-Friday. They update their information each Tuesday afternoon, so the best day to call is on Wednesday-Friday.
Greenstone Hydrocortisone Availability (as of May 23, 2023)
Note that the resupply dates continue to be updated, and are subject to change.
- 5mg tablets are are still on backorder with anticipated product release timing in August
- 10mg tablets are now available.
- 20 mg tablets were never on backorder, so these have been available
The Viatris Customer Relations Team can be reached at 1.800.796.9526 between 8 AM-5 PM EST, Monday-Friday. They update their information each Tuesday afternoon, so the best day to call is on Wednesday-Friday.
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
____________________
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)
