FDA Public Health Advisory: Fentanyl Transdermal Patches and potentially life threatening side effects
In 2005 the FDA had issued a public health advisory about safety warnings regarding the use of the Fentanyl Transdermal (Skin) Patches. The original Public Health Advisory was issued in July, 2005; an updated Public Health Advisory was issued in December, 2007.
In the Public Health Advisory titled “Important Information for the Safe Use of Fentanyl Transdermal System (Patch)” the FDA opened by stating this was being released to alert patients, caregivers, and healthcare professionals of important information regarding the save use of the patch, marketed under the brand name Duragesic, as well as with the generic equivalents of this product.
The FDA stated that they have received continued reports of death and “life-threatening” side effects in patients who use the patch when it was prescribed for inappropriate reasons. Fentanyl is not designed for patients who have short term pain, pain that is not constant, or for pain following a surgical procedure, for example. It is designed for use in patients with chronic pain who are opioid-tolerant (meaning they take regular narcotic medicine for pain and are more resistant to the dangerous side effects of narcotic pain medicine).
The FDA warns that even the lowest dose Fentanyl patch available can cause dangerous side effects in patients who are not opioid-tolerant. These side effects can include respiratory issues (severe trouble breathing or very slow and shallow breathing) and even death.
In this statement the FDA indicates that doctors have been prescribing the Fentanyl patch for patients when it is not an appropriate treatment – patients with acute pain following surgery, for headaches, or other mild pain. It also states that patients are using the Fentanyl patch incorrectly – applying more than is prescribed, or applying a heat source to the patch, for example. This increases the amount of Fentanyl in the bloodstream which makes an overdose more likely.
Important safety information was highlighted by the FDA in this Advisory:
- The patch should be used only for opioid-tolerant patients with chronic pain not well controlled with other medications.
- Healthcare professionals should be aware of the signs of a Fentanyl overdose.
- Patients using the Fentanyl patch should tell their doctor of all the medicines they take.
- Patients and caregivers must be given careful and correct instructions on how to use the patch.
- Heat can increase the amount of Fentanyl in the bloodstream, leading to potentially life-threatening breathing problems and death.
In June, 2007 a $5 million plus jury verdict was awarded to the family of a Florida man who died while using the Fentanyl transdermal patch. The defendants in this case were Johnson & Johnson subsidiaries, Alza Corporation, and Janssen Pharmaceutica Products, the manufacturer of the Fentanyl transdermal patch marketed under the name Duragesic. The Texas law firm of Heygood, Orr, Reyes, Pearson & Bartolomei represented the family of the deceased in this lawsuit, brought in the Federal District Court for the Southern District of Florida, West Palm Beach Division.