Update – March 1, 2008 – Actavis, Inc. announced that it will voluntarily recall all lots of Fentanyl transdermal system CII patches sold in the United States. In February, the company initially recalled 14 lots of the Fentanyl patches and now have decided to recall the remaining lots as a precautionary measure.
In February and March of this year, thirty-eight million patches were voluntarily recalled by several manufacturers. An additional eight million were previously recalled in February and April of 2004. The drug has been the recipient of several FDA advisories.
At least one wrongful death verdict has been handed down against Johnson & Johnson’s fentanyl patch, a $5.5 verdict in 2007 involving a 28 year old Florida man.
The medical community has some serious concerns about Fentanyl, particularly after numerous reports of death in patients taking Fentanyl. The FDA issued a Public Health Advisory in July 2005 and is currently investigating these deaths to determine whether the fatalities were the result of the quality of the medication, or the patient’s use.
Fentanyl is a pain relief patch, also known as Duragesic. Fentanyl is very strong and is much more potent than morphine. The patches are intended to relieve chronic pain that requires 24-hour a day treatment and cannot be controlled by other medication. The patches contain Fentanyl in a gel form and can provide up to three days’ relief from severe pain.
Severe drug reactions or overdose can occur when:
- Using this drug with other medications that affect the brain’s function;
- Using medication that can affect the way Fentanyl is broken down in the body;
- Consuming alcohol; and
- Exposed to heat or an increase in body temperature.
Symptoms of a Fentanyl overdose can include:
- Slow or difficult breathing
- Severe sleepiness or sedation
- Cognitive disturbances, and
- Other abnormal reactions.
If you are experiencing any of these symptoms while on the Fentanyl patch, we urge you to seek medical attention immediately. Fentanyl should always be taken as directed by a physician and should never be used anyone without a prescription.
If you or loved one have been injured as a result of taking the above drug, you may have a valid claim. Call Cellino & Barnes now at 1-(800) 888-8888 or contact us.