NCHR Testimony on Tramadol and Celecoxib for Acute Pain Relief

Nina Zeldes, PhD, National Center for Health Research, January 15, 2020

Thank you for the opportunity to speak here today. My name is Dr. Nina Zeldes and I am here speaking on behalf of the National Center for Health Research, where I am a Senior Fellow. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

We have two major concerns about this drug and the study provided.

In this factorial study, the combination drug is compared to a low dose of celecoxib (200 mg), a non-addictive pain medication. But doctors usually prescribe 400 mg for the management of acute pain, followed by an additional 200 mg if needed. In other words, there is absolutely no evidence that this combination drug with an opioid is as effective or more effective than a standard dose of just the NSAID. Since this combination drug contains an opioid, it should only be considered for approval if it is more effective than a non-opioid painkiller.

Combination drugs should only be approved when they have clear benefits that outweigh the risks of either of the drugs alone. We know that some surgeons, for example, prescribe both opioids and NSAIDs after surgery. Now that we know how quickly patients can become addicted to opioids, all opioids should be stopped within a few days (if prescribed at all), whereas, if necessary, NSAIDs could be continued for a longer period of time since they are not addictive. However, if patients are prescribed this combo drug, instead of 2 separate drugs, not only have they been introduced to an opioid, but they can’t easily just stop the opioid while still getting the benefits of a non-opioid painkiller. They would have to obtain a non-opioid option instead of just having to stop taking one of their prescribed drugs.

In addition to the above problems, the generic celecoxib and tramadol are likely to be much less expensive than a newly approved combo drug, and only the new drug is likely to be heavily promoted. The cost of medication is not FDA’s concern, but FDA has expressed an interest in facilitating savings by approving generic drugs more quickly, and this type of unproven combo drug with potential risks of addiction, which would replace the same generic drugs taken separately, is exactly why medical costs are so high.

The Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee were split on the issue of whether a combination of tramadol hydrochloride (HCl) 44 mg and celecoxib 56 mg for pain, should be approved. 13 members of the committee voted for approval and 13 voted against approval.