Hot on the heels of the media blitz surrounding acetaminophen toxicity due to perceived excessive Vicodin, Percocet and Tylenol use, the United States Food and Drug Administration (FDA) is now turning the spotlight on those pain medications containing propoxyphene (Darvon) and opioid.
The FDA is now requiring manufacturers of propoxyphene-containing products to enhance the label, emphasizing the potential for overdose with these medications. In addition, manufacturers of these pain-relieving drugs will be required to provide a medication guide to patients, containing information regarding the importance of using the drugs appropriately. Such precautions were initiated due to fatal overdoses associated with propoxyphene use.
If propoxyphene manufacturers do not submit the required literature, or if the FDA disagrees with the patient information the pharmaceutical companies propose, then the FDA has the right to issue orders dictating the labeling changes so that there is compliance with the dissemination of the new safety information.
In the midst of all these new requirements due to concerns surrounding pain-relieving medication abuse, the FDA has approved Onsolis, a medication most likely to be used by cancer patients to manage breakthrough pain.
Onsolis delivers the opioid fentanyl through the mucous membrane of the mouth via an absorbable film that attaches itself to the inside of the cheek. As fentanyl is a potential drug of abuse, Onsolis was approved with a concomitant plan for managing the potential abuse risk. Onsolis is thus approved for the management of breakthrough pain in patients suffering from cancer, who are currently using regular dosages of opioid pain medications and who require---and are tolerant of-high dosages of an additional opioid medicine. These are so-called opioid tolerant patients.
For those patients who are not opioid tolerant, the use of Onsolis can lead to overdose, respiratory failure, and death. Hence, Onsolis will only be available through a highly restrictive distribution program. This program is designed so that only prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and obtain Onsolis. Participating pharmacies will send the product directly to the home of the patient.
It will be interesting to see whether one day, most, if not all, drugs with the potential for abuse will be so heavily regulated. Considering the well-publicized concerns recently being voiced by the FDA and other agencies and societies regarding the abuse of many pain-relieving drugs, that day may not be too far in the future.
