Print Consumer Alert: Fentanyl Patches Recalled

February 15, 2008

On February 12, 2008, PriCara announced that patches containing the prescription painkiller "Fentanyl" are being recalled. According to the PriCara Web site, the 25 microgram-per-hour Fentanyl patches are being recalled due to potentially fatal flaws that could result in a lethal overdose to patients.[1] Fentanyl is a potent Schedule II opioid medication, and exposure to Fentanyl gel can lead to very serious adverse events, including respiratory depression and death.[2]

According to the PriCara Web site, the 25 mcg patches recalled may have a cut along one side of the drug reservoir within the patch, potentially exposing patients to a potentially fatal overdose of Fentanyl.[3] The patches have been sold in the United Stated under the brand name "Duragesic" by PriCara.[4] Generic versions were sold by Sandoz, Incorporated. All of the recalled patches have expiration dates on or before December of 2009, and were manufactured by a PriCara affiliate, the ALZA Corporation, which is a division of Ortho-McNeil-Janssen Pharmaceuticals, Incorporated.[5] PriCara, the ALZA Corporation and Ortho-McNeil-Janssen are all subsidiaries of the Johnson & Johnson Company.[6]

Previously, in July of 2005, the FDA issued an advisory emphasizing the limited safe uses of the Fentanyl patch.[7] Despite the advisory, the FDA apparently continued to receive reports of death and life-threatening events in patients who suffered overdoses while using the Fentanyl patches, and the FDA issued an updated advisory on December 21, 2007.[8] In the Advisory, the FDA stated that the Fentanyl patch "is only indicated for use in patients with persistent, moderate-to-severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant."[9]

If you or someone you know has been injured or killed while using the Fentanyl patch and you wish to consult with a lawyer, please send an e-mail by clicking on this link: contact us.

[1] PriCara Web site, available at http://www.pricara.com/pricara/pages/021208_press_release.jsp.
[2] Id.
[3] Id.
[4] Id.
[5] Id.
[6] Johnson & Johnson Website, available at http://www.jnj.com/our_company/family/index.html.
[7] U.S. Food and Drug Administration, Public Health Advisory: Important Information for the Safe Use of Fentanyl Transdermal System (Patch), available at http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_2007HCP.html.
[8] U.S. Food and Drug Administration, Information for Healthcare Professionals: Fentanyl Transdermal System (marketed as Duragesic and generics), available at http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_2007HCP.html.
[9] Id.

+ READ MORE - READ LESS

The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.

Disclaimer