USA

Notice to Healthcare Professional Regarding Safety Information That May Be Absent in the Package Insert for HYDROMORPHONE HYDROCHLORIDE

Teva Pharmaceuticals USA, Inc.
URGENT: Important Drug Warning Letter - May 21, 2019


HYDROMORPHONE HYDROCHLORIDE injection, USP, 10 mg/mL CII
HYDROMORPHONE HYDROCHLORIDE injection, USP, 50 mg/ 5 mL (10 mg/mL) CII
HYDROMORPHONE HYDROCHLORIDE injection, USP, 500 mg/ 50 mL (10 mg/mL) CII

Notice to Healthcare Professional Regarding Safety Information That May Be Absent in the Package Insert

Dear Healthcare Professional:


Teva Pharmaceuticals USA, INC. is writing to inform you of an important update to safety information that may be absent in the package insert of HYDROMORPHONE HYDROCHLORIDE injection, USP lots listed in Table 1 in the Appendix. Teva Pharmaceuticals USA, INC. became aware of the omission on March 25, 2019, when the NDA holder, Hospira, Inc., Lake Forest, IL notified Teva. Hospira manufactures and labels these products for Teva Pharmaceuticals USA, INC.

Refer to Table 1 in the Appendix for product information.


Summary of Updated Safety Information:

Package inserts for HYDROMORPHONE HYDROCHLORIDE injection, USP in your possession may not include updated safety labeling (boxed warning) concerning the risks with concomitant use of opioids and benzodiazepines. The updated package insert is available at https://dailymed.nlm.nih.gov/dailymed/ and https://www.pfizer.com/products-list (under product HYDROMORPHONE HYDROCHLORIDE: HYDROMORPHONE HYDROCHLORIDE, Vial (manufactured for Teva) U.S. Physician Prescribing Information Revision date: 07/2017).

The updated important safety information missing from the boxed warning for the product(s) in your possession is provided below. All other information in the boxed warning is current:


WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.5), Drug Interactions (7)].
 Reserve concomitant prescribing of Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
 Limit dosages and durations to the minimum required.
 Follow patients for signs and symptoms of respiratory depression and sedation.
See full prescribing information for complete boxed warning.


Refer to https://dailymed.nlm.nih.gov/dailymed/ for the most current labeling for the drug product that contains the complete safety instructions for the product.

Wholesalers/Distributors/Retailers, if you have further distributed the product, please notify your sub accounts of the important update to safety information.

Please use below contact information for any medical related questions or comments on the information provided in this letter. 


CONTACT INFORMATION

Medical-related Questions or to report an Adverse Event:

Contact Medical Information at: 888-838-2872, option 3, then, option 4

Live calls received: Monday-Friday, 9:00AM-5:00PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week

Product availability and Customer Service-related Questions:

Contact Teva Customer Service: 888-838-2872, option 2 (Hours of Operation: Live calls received: Monday-Friday, 8:30AM-5:00PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week).

FDA contact information for reporting adverse events/quality complaints:

Online at www.fda.gov/medwatch/report.htm or call FDA at 1-800-FDA-1088

Sincerely,
Regulatory Compliance
Teva Pharmaceuticals USA, Inc.

Appendix
Table 1 – Product Information

Product Name

NDC Number

Product Lot Number

Expiration Date

HYDROMORPHONE HCL INJ 10 MG/ML 1x50 ML

0703-0018-01

780603F

05/2019

HYDROMORPHONE HCL INJ 10 MG/ML 1x50 ML

0703-0018-01

780853F

05/2019

HYDROMORPHONE HCL INJ 10 MG/ML 1x50 ML

0703-0018-01

790103F

06/2019

HYDROMORPHONE HCL INJ 10 MG/ML 1x50 ML

0703-0018-01

880953F

03/2020

HYDROMORPHONE HCL INJ 10 MG/ML 1x50 ML

0703-0018-01

900153F

05/2020

HYDROMORPHONE HCL INJ 10 MG/ML 1x50 ML

0703-0018-01

910253F

06/2020

HYDROMORPHONE HCL INJ 10 MG/ML 1x50 ML

0703-0018-01

910403F

06/2020

HYDROMORPHONE HCL INJ 10 MG/ML 10x1 ML

0703-0110-03

811053F

08/2019

HYDROMORPHONE HCL INJ 10 MG/ML 10x1 ML

0703-0110-03

811103F

08/2019

HYDROMORPHONE HCL INJ 10 MG/ML 10x1 ML

0703-0110-03

881203F

03/2020

HYDROMORPHONE HCL INJ 10 MG/ML 10x1 ML

0703-0110-03

881103F

03/2020

HYDROMORPHONE HCL INJ 10 MG/ML 10x1 ML

0703-0110-03

901353F

05/2020

HYDROMORPHONE HCL INJ 10 MG/ML 10X5 ML

0703-0113-03

801003F

07/2019

HYDROMORPHONE HCL INJ 10 MG/ML 10X5 ML

0703-0113-03

811403F

08/2019

HYDROMORPHONE HCL INJ 10 MG/ML 10X5 ML

0703-0113-03

840153F

11/2019

HYDROMORPHONE HCL INJ 10 MG/ML 10X5 ML

0703-0113-03

881153F

03/2020

HYDROMORPHONE HCL INJ 10 MG/ML 10X5 ML

0703-0113-03

891003F

04/2020

HYDROMORPHONE HCL INJ 10 MG/ML 10X5 ML

0703-0113-03

891103F

04/2020

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