Duragesic Pain Patch
There is growing controversy about the adequacy of warnings for Duragesic, a skin patch system containing the pain killer fentanyl. Overdoses have allegedly resulted from the simple accident of the patient's skin becoming hotter, which increases absorption, as well as from differences in patient age. There are also questions concerning the ease with which the patch can be used for "recreational" purposes.
In July 2005, the FDA issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product. After a review of fatalities reported to the voluntary adverse event reporting system, the FDA noted that establishing whether the overdose was unintentional was difficult because the information provided in the report was incomplete and patients who were being treated with the fentanyl patch often had underlying diseases or conditions that could have contributed to their deaths (such as cancer). Factors identified as possibly related to unintentional overdose included: use of high doses of the fentanyl patch and/or multiple patches (sometimes in combination with other drugs), possible medication errors, accidental exposure (e.g., coming in contact with a discarded patch), application of a heat source to the patch possibly resulting in increased fentanyl absorption, injection or ingestion of the patch contents, and suspected transdermal patch malfunction. Some patients have also warned of poor adhesion of the patch. In July 2005, Janssen and FDA also notified healthcare professionals of changes to the BOXED WARNING/WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Duragesic to indicate use only for the management of persistent, moderate and severe pain for opioid-tolerant patients who require continuous, around-the-clock opioid administration for an extended period of time, and whose pain cannot be managed by other means. The FDA also warned that a patient using the fentanyl skin patch may have a sudden and possible dangerous rise in their body level of fentanyl or have a stronger effect from fentanyl if they: use other medicines that affect brain function; drink alcohol (beer, wine or distilled spirits); have an increase in body temperature or are exposed to heat; or use other medicines that affect how fentanyl is broken down in the body.
A recently introduced oral version (mainly for pediatric population) called Oralet has been heavily criticized for its attractive form, rather than the adequacy of warnings.
If you are someone you know has been injured because of a Duragesic Pain Patch call the Law Office of Harold D. Thompson right away. Let our experienced team of attorneys properly evaluate your case. 619.615.0767
In July 2005, the FDA issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product. After a review of fatalities reported to the voluntary adverse event reporting system, the FDA noted that establishing whether the overdose was unintentional was difficult because the information provided in the report was incomplete and patients who were being treated with the fentanyl patch often had underlying diseases or conditions that could have contributed to their deaths (such as cancer). Factors identified as possibly related to unintentional overdose included: use of high doses of the fentanyl patch and/or multiple patches (sometimes in combination with other drugs), possible medication errors, accidental exposure (e.g., coming in contact with a discarded patch), application of a heat source to the patch possibly resulting in increased fentanyl absorption, injection or ingestion of the patch contents, and suspected transdermal patch malfunction. Some patients have also warned of poor adhesion of the patch. In July 2005, Janssen and FDA also notified healthcare professionals of changes to the BOXED WARNING/WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Duragesic to indicate use only for the management of persistent, moderate and severe pain for opioid-tolerant patients who require continuous, around-the-clock opioid administration for an extended period of time, and whose pain cannot be managed by other means. The FDA also warned that a patient using the fentanyl skin patch may have a sudden and possible dangerous rise in their body level of fentanyl or have a stronger effect from fentanyl if they: use other medicines that affect brain function; drink alcohol (beer, wine or distilled spirits); have an increase in body temperature or are exposed to heat; or use other medicines that affect how fentanyl is broken down in the body.
A recently introduced oral version (mainly for pediatric population) called Oralet has been heavily criticized for its attractive form, rather than the adequacy of warnings.
If you are someone you know has been injured because of a Duragesic Pain Patch call the Law Office of Harold D. Thompson right away. Let our experienced team of attorneys properly evaluate your case. 619.615.0767