Last April, the FDA ordered pharmaceutical manufacturers to stop making unapproved painkillers. These were drugs that were developed long before FDA approval was required and included morphine sulfate immediate release tablets and oral solutions, hydromorphone and oxycodone. You can read more about that here: FDA Orders Halt to Production of Unapproved Painkillers – Gives One a Reprieve
This week the first of these drugs came back on the market when the FDA approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.
This is the only FDA approved morphine sulfate oral solution currently available at this concentration. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now.
This action is part of the FDA’s unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product, Roxane Laboratories, to ensure that there is enough drug available for patients. The FDA says it will also be working with patient organizations and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability.
“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” said Douglas Throckmorton, M.D., deputy director for the FDA’s Center for Drug Evaluation and Research. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”
According to the FDA, one benefit of this approval process is a requirement for manufacturers to provide sufficient information on how to safely prescribe and use a drug. Manufacturers may also have to establish additional safety measures to manage unique risks of a medicine. For this formulation of morphine, the manufacturer had to develop a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose.
In My Opinion...
I'm glad to see this first step in getting the “banned” drugs back on the market and available to patients. And I certainly have no problem with ensuring that any medication we take is safe. However, with all the talk of the FDA developing new “Risk Evaluation and Mitigation Strategies” (REMS) for opioids, I can't help but worry that these “safety programs” which are now required may eventually make it even more difficult than it already is for pain patients to get needed medications. I hope that's not the case, but only time will tell.
FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain. January 26, 2010. U.S. Food and Drug Administration.
Published On: January 30, 2010