If you are experiencing serious side effects from a medication or an injury from a defective product you should first speak with your doctor. Then contact Brent M. Cordell for a free initial consultation and case evaluation. Our attorneys also represent family members of those who died a wrongful death due to dangerous drugs or defective products.
Brent M. Cordell,
Attorney at Law
1445 North Loop West,
Suite 700 Houston, TX.77008
Voice: (713) 248-5265
email: bcordelllaw@gmail.com
In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) was subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications.
In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.
The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product.
DURAGESIC® (fentanyl transdermal system)
The Duragesic patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs. Only patients who are already tolerant to opioid therapy and require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is made by Janssen Pharmaceutica and available by prescription only.
In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications. Over 400,000 patches were included in the recall. In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.
In July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.
See your doctor if you suffered an adverse side effect while using the Duragesic patch. The following lot numbers are affected: NDC no. 50458-035-05 Lot Control nos. 0327192, 0327193, 0327294, 0327295, and 0330362