Over the years, as often happens, a difference between clinical trials and the real world started to emerge.
Imagine a prescription medication that relieves pain just as well as narcotics like Oxycontin, but isn’t addictive. Too good to be true?
Turns out, yes.
For years, that was the case with Tramadol, a synthetic opioid drug that was released in 1995 under the brand name Ultram to great expectations. This new drug seemed to offer all the benefits of more powerful, more addictive drugs, but with fewer of the downsides of dependency — at least in clinical trials. This was apparently in part because trials examined tramadol use by injection, but it is manufactured — and far more potent — in pill form.
And if the drug was unlikely to make people dependent, it was not likely to be abused, unlike other opioid alternatives like Vicodin (also known as Norco), Percocet — let alone be as dangerous as high potency opioid medications like morphine, Dilaudid, or Fentanyl.
So for many years, Tramadol was widely prescribed by doctors as a “safer” alternative to narcotics for pain. The difference between narcotics and opioids is subtle, but opioids are natural or synthetically made drugs that function metabolically in the body like opium derivatives derived from poppy plant, while narcotics is more often used as a legal term, classifying drugs that blur the senses and produce euphoria, including cocaine and other non-opiates.
Indeed, unlike other opioid drugs, the Drug Enforcement Agency didn’t classify Tramadol as a controlled substance, because the FDA believed it had a low potential for abuse.
Though there were concerns about tramadol abuse in the years after release, the FDA repeatedly determined that the drug was not being widely abused, and so left it as an unscheduled drug.
This made Tramadol a particularly dangerous drug — because it was, in fact, highly addictive and prone to abuse. But because it was easier to obtain and had less concerns from physicians, it was more widely prescribed. Over the years, as often happens, a difference between clinical trials and the real world started to emerge. Emergency rooms began to report a growing number of overdoses related to Tramadol ……..
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