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A fentanyl leak from a Duragesic dermal patch can cause severe respiratory distress or even a fatality. For this reason, millions of Duragesic patches sold recently in the United States and Canada were recalled on February 12, 2008. Johnson & Johnson, the parent company of the manufacturer of Duragesic patches, Alza Corp., voluntarily issued the recall at the behest of the U.S. Food and Drug Administration (FDA).

Fentanyl: A Powerful Narcotic

The fentanyl leak issue has arisen before. Duragesic patches are constructed with a pouch containing fentanyl in gel form, sandwiched between two membranes. A patient wears the patch for hours at a time, to let the fentanyl seep slowly into his or her skin. Fentanyl is a very powerful opioid narcotic, prescribed to alleviate pain in patients who have become tolerant to other narcotic painkillers.

Manufacturing problems have resulted in a Duragesic patch defect that may allow the fentanyl to leak out. Fentanyl is so potent (at least 80 times stronger than morphine) that direct contact with it can cause significant and dangerous symptoms including:

• Dizziness
• Slow or troubled breathing
• Severe sleepiness or sedation

The potential risks is why Duragesic patches are normally prescribed only for patients with intractable, chronic pain that is resistant to other opiate medications. Even so, some doctors have prescribed fentanyl patches for less severe cases of pain, such as that caused by migraine headaches or from surgery.

Recalled Patches

Duragesic patches come in different fentanyl dosage strengths: .25, 12.5, 50, 75, and 100 micrograms. The fentanyl leaked by some .25 mcg patches is the basis of the most recent Fentanyl recall. About 100 lots of .25-mcg Duragesic patches that have an expiration date of December 2009 or sooner, sold by PriCara or Sandoz, are being recalled.

This is the fifth recall of Duragesic patches in the last 15 years. The FDA is monitoring the Duragesic patch recall - again. The FDA has issued several safety warnings about Duragesic and other fentanyl patches to physicians and consumers since the patches were first made available.

Have You Been Harmed by a Fentanyl Leak?

If you've used a Duragesic patch or a generic version and have concerns about your health, contact a Fentanyl lawyer with experience representing victims of defective medical products. Individuals who have been harmed by a Duragesic patch may be eligible for financial compensation.