Last week the FDA gave nine pharmaceutical manufacturers 60 days to stop making unapproved painkillers, which included high concentrate morphine sulfate oral solutions, and immediate release tablets and oral solutions containing morphine sulfate, hydromorphone and oxycodone. My first thought when I read that was, “How could so many companies have gotten by with manufacturing unapproved drugs to begin with?” So I did some digging.
It turns out that many of these drugs were developed long ago, before FDA approval was required. The FDA has known about these medications all along. Then in June 2006 they began an initiative to require all marketed drugs to either seek FDA approval or stop production. They classified groups of drugs according to their potential risk to the public and sought to remove those posing the greatest risk first. Apparently the time has come to address the opioid painkiller category.
The FDA insists that there are enough approved medications with the same ingredients on the market to meet consumers' needs. I hope they're right. But since there is already a shortage of oxycodone, I can't help but think this will only make it worse.
At least the FDA did respond to the concerns of hospice experts and this week agreed to allow the high concentrate morphine sulfate oral solution to remain on the market until an approved version or equivalent therapy becomes available. The high concentrate morphine is often crucial for relieving pain in terminal patients who have difficulty swallowing, because it only takes a few drops in the mouth to be effective.
While I appreciate the need to ensure that our medications are safe, I think the FDA could have addressed these unapproved painkillers one at a time rather than taking so many off the market at once. That would give patients more time to make sure they could still get their prescriptions or to ask their doctors to switch them to another medication. After all, patients have been taking these drugs safely for many years. It's not like we're suddenly facing a huge risk. And I particularly think the FDA should have postponed this action for oxycodone until the current shortage is resolved. They're only making a bad situation worse. But they didn't ask my opinion.
If you are taking immediate release morphine sulfate, hydromorphone or oxycodone tablets, check with your pharmacist to see if your prescription is one that will be affected. If so, ask whether an equivalent alternative will be available or you will need to see your doctor for a different prescription.
Published On: April 11, 2009