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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 - August 23, 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:

On May 21, 2019, Teva Pharmaceuticals USA, Inc. (Teva) issued an Important Drug Warning Letter informing its customers of an important update to safety information that may be absent in the package insert for twenty (20) lots of Hydromorphone Hydrochloride injection 10 mg/mL.(Table 1 in the Appendix). Specifically, the package insert may not include updated safety labeling (boxed warning) concerning the risks associated with concomitant use of opioids and benzodiazepines. Teva learned of the omission on March 25, 2019, when the NDA holder, Hospira, Inc., Lake Forest, IL, notified Teva.  Hospira manufactures and labels all three dosages of this product for Teva.

The purpose of this updated Important Drug Warning Letter is to inform Teva’s customers of two additional lots of product with package inserts missing the subject updated safety labeling. Please refer to Table 2 in the Appendix attached to this letter for information about the two additional lots in question.

 

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 associated 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

 HYDROMORPHONE HYDROCHLORIDE Appendix August 23, 2019

 

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