Vancouver, B.C. (PRWEB) July 1, 2005 -- Over a year after the maker of Duragesic issued an urgent recall for the defective pain patches that were associated with 120 fatal reports, the FDA issues a health advisory and the drug company revises the drugs warning label.
Duragesic (fentanyl transdermal system CII) is an adhesive "pain patch" that is prescribed to persons suffering from chronic and/or debilitating pain such as arthritis. This pain medication or analgesic delivers a steady dose of fentanyl, a powerful opiate, to alleviate pain over an extended period of time (24-72 hours).
The drugs new black box warning label states, Since the peak fentanyl levels occur between 24 and 72 hours of treatment, prescribers should be aware that serious or life threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period. The FDA states that the abuse, misuse, or diversion of this pain patch could result in fatal respiratory illness and/or fatal cardiac arrest.
Negative effects and symptoms of a fentanyl overdose can occur when interacting with CNS Depressants or CYP3A4 Inhibitors, alcohol or drugs, or use of damaged or cut patches. Symptoms may include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency.
The maker of Duragesic, Janssen L.P., specializes in pain management medication and developed this pain medication with their parent company, Johnson & Johnson and their pharmaceutical R&D department. Johnson & Johnson is the worlds largest manufacturer of health care products with $47 billion in annual sales.