July 23, 2014
Recently, the DEA made the decision to reclassify Tramadol as a schedule IV controlled substance and the decision will officially go into effect on August 18th. Tramadol is an opioid analgesic and aside from its generic form it can also be found in brand names such as Ultram, ConZip and Ryzolt.
This is considerably important news for a number of reasons. First, Tramadol is one of the last commonly prescribed opioids to not be scheduled by the DEA. It has long been used by physicians as a “substitute” for other opioids perceived to be more dangerous. The prevailing thought has been that tramadol has a better safety profile and is not associated with dependence or other negative side effects as much as its headline grabbing brethren such as Oxycontin. In work comp and really in health care in general, it has been this type of thinking that has led to the frequent prescribing of Tramadol as a first line treatment even prior to recommending an NSAID.
The DEA however, has now realized that the data shows something different entirely. And because Tramadol was not scheduled upon FDA approval, it had been closely monitored since it hit the market in 1995 … that is until the steering committee tasked with monitoring dissipated in 2005 due to lack of response to their findings. And what they found was that Tramadol had a high incidence report as related to emergency room visits, a high potential for abuse and astonishingly atypical withdrawal symptoms both when the drug was titrated and stopped abruptly. There were 16,000 emergency room visits related to Tramadol in 2010 yet still 40 million prescriptions made it out of doctors’ offices in 2012.
It is unfortunate that it has taken the DEA this long to do what 10 states have already found necessary (states have the right to schedule differently than the feds), but at the very least this action has brought increased awareness to the dangers of all opioids – not just the typical headline grabbers. And to their credit, throughout their process the DEA was faced with pushback from a number of interest groups citing the potential for a new black-market to emerge, fear of criminal action by prescribing physicians and even the complaint that there is a never ending practice of drug-scheduling (give me a break); but through it all they held firm and got this done.