Discontinuation and Reformulation of Vicodin®

Why is my Vicodin changing? Upon advisory by the United States Food and Drug Administration, drug manufacturers have been asked to limit the strength of acetaminophen in prescription drugs to 325mg acetaminophen (APAP). This advisory includes acetaminophen combination products containing opiates such as Vicodin®.

The reasonings behind this reformulation roots from a nationwide effort to reduce incidence of liver injury from acetaminophen overdosing. This transition involves the discontinuation of current formulations of Vicodin®, and a new distribution of the reformulated medication with a safer dosing of APAP.

What does this mean for you? Abbott, the makers of Vicodin, have already discontinued the manufacturing of the current (pre June 2012) formulation. This does not mean that it will be immediately unavailable, but it does mean that prescribers will be declining their issuance of the pre June 2012 formulation. Replacement therapies will include:

  • Vicodin® (hydrocodone bitartrate and acetaminophen tablets, USP 5mg/300mg);
  • Vicodin ES® (hydrocodone bitartrate and acetaminophen tablets, USP 7.5mg/300mg); and,
  • Vicodin HP® (hydrocodone bitartrate and acetaminophen tablets, USP 10mg/300mg)*

*these are FDA approved and indicated for the relief of moderate to moderately severe pain.

These new formulations of Vicodin® by Abbott will be introduced into distribution in the thrid quarter of 2012, July 1st of this year.

Here is the FDA Consumer Health Information Packet on Acetaminophen and Liver Injury

In an effort to monitor the safety of Vicodin, you can report any adverse events to Abbott at 1 (800) 633-9110, or to the FDA MedWatch system at 1 (800) 332-1088, online at www.fda.gov/medwatch, or by mail at MedWatch, HF-2, 5600 Fishers Ln, Rockville MD, 20852-9787.

By:

Jeremy KW Spiewak, Pharmacy Intern, CPhT, MA RPhT, BA Chemistry, Doctor of Pharmacy Candidate at Massachusetts College of Pharmacy and Health Sciences

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References:

Global Medical Communications. (2012). Reformulation and Discontinuation Announcement. Abbott Park, IL 60064: Abbott Laboratories.

United States Department of Health and Human Services. (2011). FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure. WEB. [accessed June 2012]

United States Food and Drug Administration. (2011). Acetaminophen Information. WEB. [accessed June 2012]


Original Published:June 2012

Revised:June 2012