Product News and Recalls

Prescription Opioids to Receive Enhanced Warnings

fda moves to implement black box warnings on opioidsA recent piece of news posted to Time’s website sings the praises of recent FDA action to impose stronger labels on incredibly powerful narcotic painkillers like OxyContin. The technical name for these drugs is opioids and they have dominated medical news in recent months.

Most medical professionals in the United States will not hesitate to call the state of prescription opioid abuse in this country an epidemic. When someone can walk into a doctor’s office complaining of knee pain and walk out with a prescription for some of the most powerful painkillers available, it might be time to take a closer look at how the medical community is managing patient pain.

There is, arguably, a right way and a wrong way to try to undo the damage done by a system that has already failed so many. Indeed, law enforcement is already seeing the effects. As opioids become more difficult to obtain, addicts are turning to dealers for heroin as a substitute. In many cases, the drug is easier to obtain and cheaper than a prescription narcotic. And, while the legislative branch of the US government would like the public to think that they are doing something about the problem, recent legislative efforts have merely served as a bandage.

A bill that recently moved through the Senate provided only a reaction to a problem that requires a proactive solution. While increasing funding for monitoring programs and the availability of an anti-heroin overdose medication carried by law enforcement and emergency medical personnel, the bill does nothing for the millions that are already addicted and trying to find a way out. In fact, when senators tried to amend the bill to provide such funding, that amendment was met with such opposition that the senators were forced to drop it or risk killing the entire bill.

While the failure of the US legislature on this matter has been one of epic proportions, the FDA (so wholly praised in the Time article) is not without its own share of blame. Time would have done well to remind its readers that this FDA that is “reassess[ing] its approach to opioid medications” in order to “reverse this epidemic” is the same FDA that approved the use of OxyContin in children as young as eleven just last year.

The move caught the attention of one US senator who was so appalled that he called into question the very independence of the entire agency. “Given the extraordinary public health crisis that we are facing and the well-documented damage that dangerously additive drugs like OxyContin can do to a developing brain,” says West Virginia Senator Joe Manchin, “it is difficult to believe that an independent panel of experts would have recommended the approval of this drug in children.”

Epidemic. Crisis. The words on their own prompt feelings of alarm and urgency. Epidemics can strike anyone anywhere. They affect the lives of millions, including our friends, family, and even ourselves.

One has to wonder how then much more talking will be done before this epidemic finally sees the decisive action it so desperately requires.