FDA Delays Relaunch of Onsolis as Concerns Linger Over Safety of Fentanyl Pain Patches
The U.S. Food and Drug Administration has delayed the relaunch of Onsolis, a pain patch that features the potent opioid fentanyl. Other fentanyl pain patches, including those manufactured under the Duragesic brand name, have become the subject of scrutiny after numerous patients suffered complications while using one of these products.
Earlier this month, BioDelivery Sciences International, Inc. announced that it would postpone the relaunch of Onsolis to modify the product formulation based on appearance issues raised by the FDA. Onsolis is thin patch that is used to deliver a specific dose of fentanyl through the skin. Onsolis was originally approved in 2009.
The first fenanyl pain patches were approved by the FDA in 1990 to treat patients suffering from moderate to severe chronic pain. that does not respond to other medications. Fentanyl is an extremely potent narcotic drug that is 80 to 100 times stronger than morphine. The pain patches typically feature an adhesive backing and a permeable top layer, which allows the fentanyl gel to be absorbed through the skin over an extended period of time.
The Duragesic pain patch, marketed by Janssen Pharmaceutica, has been the target of numerous FDA safety warnings. In 2005, the FDA issued an updated safety communication advising patients and health care providers that numerous deaths had been linked to the fentanyl patches. A second safety warning was issued in 2007 after additional deaths were reported. Specifically, the 2007 safety advisory warned against using the patches to treat occasional or mild pain or pain following surgery. The FDA also warned against exposing the patches to heat sources, such as heating pads, hot tubs or electric blankets, as the additional warmth could potentially speed the rate at which the fentanyl is absorbed into the body, leading to an overdose.
Numerous cases of fentanyl overdose have been reported to the FDA and a number of wrongful death lawsuits have been filed against Janssen and Johnson & Johnson in connection with the Duragesic pain patches. Patients who use fentanyl pain patches are urged to be aware of the warning signs that they may be experiencing an overdose. These symptoms include:
- Shallow breathing
- Difficulty breathing
- Slowed heartbeat
- Extreme drowsiness
- Clammy skin
- Trouble walking or talking
- Feeling faint
Patients who experience any of these symptoms while using a Duragesic pain patch are urged to seek medical treatment as quickly as possible.
If you or a loved one suffered serious side effects, including a fentanyl overdose, after using a Duragesic pain patch you may be entitled to compensation for your medical bills, lost wages and pain and suffering. Contacting an experienced California pain patch attorney is the first step in protecting your legal rights.
Nadrich & Cohen, LLP is currently investigating Duragesic pain patch claims in all 50 states. For more information on filing a fentanyl overdose lawsuit, call 1-800-718-4658 to begin your free initial case evaluation. There is never a fee unless damages are recovered on your behalf.