Valtoco FDA Alerts

Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use

ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

RECOMMENDATION:

Health Care Professionals

• Consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction.
• Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.
• Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.
• Take precautions when benzodiazepines are used in combination with opioid addiction medications.

Patients, Parents, and Caregivers

• Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.
• Take benzodiazepines and all medicines exactly as prescribed by your health care professional
• Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.
• Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.
• Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.

Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Source: FDA

Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates

including Auto-Injectors for

Atropen (atropine)
DuoDote (atropine/pralidoxime chloride)
morphine sulfate
pralidoxime chloride
diazepam

[Posted 11/22/2013]

ISSUE: FDA is aware of a disruption in supply to health care providers and emergency response personnel of Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors manufactured by Meridian Medical Technologies, a Pfizer Inc. company. FDA and Meridian are working together to resolve the disruption as quickly as possible, but it is unclear how long this disruption may persist.

FDA concluded that it was scientifically supported that certain lots of DuoDote can be used for an additional year beyond the manufacturer’s original labeled expiration date. FDA is continuing to assess whether these identified lots of DuoDote can receive further expiration date extensions if needed, and whether additional lots of DuoDote that were not listed in FDA’s September 5, 2013, memo can have their expiration date extended.

FDA is currently reviewing data for the potential use of Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors beyond their labeled expiration dates in order to mitigate any potential shortages of these medically necessary drugs.

RECOMMENDATIONS: FDA will provide additional information about use of these products beyond the labeled expiration date in the coming weeks. Until FDA provides additional information, these expired auto-injectors may be used for patient care under emergency situations when no other product is available.

Health care providers and emergency response personnel who have any of the auto-injectors manufactured by Meridian identified above that are nearing or beyond the labeled expiration date should retain the products until FDA is able to provide additional information regarding the continued use of these products.

[11/22/2013 - Drug Safety Statement - FDA]
[09/05/2013 - Memorandum to Pfizer/Meridian Medical Technologies - FDA]