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Fentanyl Recall

Date Added: February 14, 2008 03:54:24 AM

On February 12, 2008 Johnson & Johnson voluntarily recalled pain patches containing the prescription painkiller fentanyl, because of a flaw that could cause patients to overdose.

Sold under the brand name Duragesic, the recall includes all 25-microgram-per-hour fentanyl patches with expiration dates on or before December 2009.

The defect is believed to be a cut in the lining of the internal reservoir of fentanyl patch. If the gel leaks it could cause a patient to come into direct contact which could result in;

  • Impaired breathing
  • Reduced blood pressure
  • Coma
  • Death

In addition to defects, other factors that could cause a fentanyl overdose and potentially death including;

  • Heat (which causes a rapid release of the drug)
  • Inappropriate Use

It is estimated that out of every one million included in the recall two patches have the defect and leak.

Fentanyl Patches - Recent History

In July 2005, the Food and Drug Administration issued an alert stating that the agency was looking into reports of deaths from Duragesic and fentanyl overdose. As a result it was required that an increased warning be added to the drug’s labeling.

One year later, in July 2006, a jury decided that the Duragesic patch was responsible for the death of a Texas woman.. Johnson & Johnson was forced to pay nearly $1 million in damages.

This past year, the family of a Florida man has won a $5.5 million wrongful death verdict against two subsidiaries of pharmaceutical giant Johnson & Johnson in the nation's first federal trial involving a patch form of the narcotic painkiller fentanyl.

Finally in December 2007, the FDA issued its last warning about the dangers of fentanyl.

The FDA is currently investigating at least 120 deaths related to defective Duragesic patches.