In the News: Transdermal System Medication Recalls: Duragesic, Fentanyl, Icy Hot

Several February MedWatch releases have a direct impact on patient care within the community based care delivery setting.  These releases were targeted for pain management specialists, other health care professionals and patients.  Two of these FDA MedWatch releases were focused on transdermal pain medication administration delivery systems. Duragesic® and Fentanyl transdermal, available by prescription only, are used to manage persistent, moderate to severe chronic pain that needs to be treated around the clock.

Duragesic® patches were recalled nationwide by PriCara and Sandoz Inc for all lots of 25 mcg/hr Duragesic® Patches distributed within the United States and Canada.  This recall was due to the possible direct release of Fentanyl gel to patient’s or caregiver’s skin. The patches appeared to have a cut along one side of the drug reservoir, that is contained within the patch. Because the medication, fentanyl, is a potent opiod, concerns that serious adverse effects, such as respiratory depression and potential fatalities, might occur from the potential for an overdose. Individuals who come in direct contact with the fentanyl gel are cautioned to thoroughly cleanse the skin with large quantities of water and are further cautioned to not use soap when cleansing the skin area exposed to the fentanyl gel.

Any patches with expiration on or before December 2009, manufactured by ALZA Corporation, were included in this recall.  The US Food and Drug Administration complete 2008 MedWatch Safety Summary of this release is available at www.fda.gov/medwatch/safety/2008/safety08.htm#Duragesic. And the firm’s recall release is available at www.fda.gov/oc/po/firmrecalls/pricara02_08.html. Additional information regarding Duragesic can be found at www. DURAGESIC.com.

Shortly following the PriCara and Sandoz recall, Actavis Inc. also announced a nationwide recall. This Fentanyl transdermal system CII patch recall included only certain lots, which were distributed and sold under either an Abrika or Actavis product label.  This product was also found to have a defect that had the potential to allow the fentanyl gel to leak from the patch onto the skin resulting in direct skin exposure.  Patients and caregivers are being alerted to remove the recalled lots from use and inventory.  This recall covered a range of dosages from 25, 50, 75 and 100 mcg/hr and included 14 specific lots.  This recall directed end users to dispose of affected patches that may be damaged or compromised in any way, using extreme caution in handling, with suggested disposal being to flush the patches down the toilet.  Further, this company’s press release cautioned that these patches with the potential to leak gel would not provide effective pain relief.  A complete and specific listing of product lots included in this recall is available through accessing the complete MedWatch 2008 safety summary, including a link to the firm's press release, at www.fda.gov/medwatch/safety/2008/safety08.htm#Fentanyl.

Links to home numbers for directly contacting each of these companies is also available at the www.fda.gov/medwatch web location.

A third recall of transdermal products was released by Chattem, Inc.  This company announced a voluntary nationwide recall of its Icy Hot Heat Therapy products. This also included its 3-oz Aspercreme product. The recall occurred as a result of consumer’s reporting skin irritation, as well as first, second and third degree burns from the use of this product.  The following Icy Hot Heat Therapy products, all sizes, all lots are recalled:

Icy Hot Heat Therapy Air Activated Heat - Back
Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal - Arm, Neck, and Leg [single consumer use]

Aspercreme Pain Relieving Cream promotional samples

Consumers are instructed to discard or return these products to the manufacturer.  The complete MedWatch release for this product recall is available at www.fda.gov/medwatch/safety/2008/safety08.htm#Chattem

Resources/References:

www.fda.gov/medwatch