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And like many with his condition, the year-old gospel singer and former construction worker used a combination of medications to alleviate his pain. But as he took more drugs, including narcotic painkillers, Fort was often groggy when awake. When he slept, he gurgled and snored so loudly that his fiancee recorded it so she could convince him he was using too much medication.
According to the Milwaukee County Medical Examiner Office he died of an accidental overdose of opioids. Included in the mix were drugs well-known for their abuse and overdose potential -- hydrocodone and methadone -- and one that the medical world long had thought posed little threat: tramadol. But doctors -- and the FDA, the agency charged with regulating drug safety -- may have gotten it wrong. Recent research shows that tramadol has greater potential to be abused and to cause overdoses than was believed when it first appeared on the U. Instead, the agency recommended not putting tramadol under the Controlled Substance Act.
Restrictions on prescribing it are no more stringent than for Lipitor or Viagra. The Controlled Substance Act places drugs into five progressively restrictive based on their abuse potential. At the top of the list are drugs such as heroin. At the other, are some cough medicines with limited amounts of codeine. In approving tramadol, the FDA decision was based largely on research in which the drug was injected.
The FDA also weighed evidence from Europe, where tramadol had been on the market for years. But the FDA also had research showing that when given to opioid abusers orally in high doses, rather than being injected, it produced opiate-like effects that were similar to oxycodone, the narcotic in OxyContin, one of the most abused drugs in America. The FDA did ask Ortho-McNeil, the company that marketed the tramadol, to fund a committee of paid consultants who were to watch for abuse problems that might require making it a controlled substance.
Now, after 18 years of less restrictive treatment, the U. While that has not been done on the federal level, 10 states already have done so on their own. An analysis by the Journal Sentinel and Med Today revealed that tramadol use has increased dramatically since , rising from 25 million prescriptions that year to nearly 40 million in , according to data from IMS Health, a market research firm.
In Florida alone, there were overdose deaths involving tramadol in , up from in In Milwaukee County, 20 people died of a drug overdose involving tramadol from through October , according to records from the Medical Examiner's Office.
In most of those cases, tramadol was one of several opioids that had been taken. Fort had been taking narcotic painkillers after injuring his back at a construction site several years earlier, Wells Odom said. A beam fell on his back, leading to surgery and the placement of 10 screws and a rod in his spine.
Data from Germany had suggested it was only about one-tenth as potent as morphine when injected. Other data showed that after years of use in Germany and other countries there was very little abuse of the drug. However, in the early s, researchers at Johns Hopkins University did a study in which high doses of the drug were given orally to opioid abusers.
Taken that way, tramadol acted much differently than when injected. Taken by mouth, the drug is transformed in the liver to a metabolite known as M1, which is able to attach to and activate opioid receptors in the brain. It is that substance that is believed to produce the desirable, opiate-like effect.
In , Ortho-McNeil, part of the R. The Johns Hopkins study never was published but the company said it was provided to the FDA when it was reviewing the approval for tramadol. Sharon Walsh, PhD, an opioid researcher at the University of Kentucky College of Medicine, said the research provided important evidence that tramadol had the potential to be abused. Given the findings of the Hopkins study, it is unlikely the FDA would approve tramadol today as a nonscheduled drug, said Walsh, director of the university's Center for Drug and Alcohol Research.
But in the early s, when the FDA approved the drug, abuse of opioids such as heroin and morphine often was done by addicts who injected the drugs. In the years that followed, dramatic increases in abuse of pill-form opioids such as OxyContin and Vicodin would plague the country. Yet, rigorous studies never have shown that the drugs are safe and effective when used that way.
Morgan Liscinsky, a spokeswoman for the FDA, said she could not comment on the agency's decision-making process that led to the drug's approval as a noncontrolled substance. As tramadol's public health and abuse risks became more fully recognized, the FDA now has recommended making it a controlled substance, she said.
Liscinsky noted that, at the time, the FDA's advisory committee unanimously said the drug should not be put under the Controlled Substances Act. Yet there was concern that abuse of the drug might occur in the U. Ortho-McNeil paid for the committee's work and also paid consulting fees to its members. Sidney Schnoll, MD, PhD, a former member of the committee, said he could not remember how much the committee members were paid. From early on, Ortho-McNeil's marketing plan for tramadol meant keeping it off the controlled substances list where it would have difficulty competing against other narcotic painkillers such as Tylenol 3 and Tylenol 4, Schnoll said in a interview.
Both Tylenol products contain codeine and are schedule 3 drugs. They wanted to see if it would be possible to get the drug onto the market as a noncontrolled substance. After a decade, the eight-member Ortho-McNeil committee dissolved itself in December , without ever having recommended that tramadol be put under the Controlled Substances Act. Van Houten did, however, add that there were occasional circumstances when company officials were invited to committee meetings. Walsh, the University of Kentucky researcher, and others have done their own studies on oral tramadol showing that experienced opioid abusers like it as much or more than oxycodone.
In a study, they gave up to mg of tramadol, about four times the normal single dose, and oxycodone to nine opioid abusers. On the next day, the test subjects sat at a computer. They were told they would be given the drugs again in increments if they clicked a mouse to earn it. The mouse clicking progressively increased for each additional increment of the drug. To get all the drug, they would have to click the mouse 7, times. Five of the nine test subjects clicked the mouse at least 5, times to get the high-dose tramadol, compared with only one who did so to get the high-dose oxycodone.
The likability of oral tramadol can be seen in the large s of people who have used it recreationally. In , 2. The DEA said the drug is most commonly abused by addicts, chronic pain patients, and health professionals. Over the years, there had been indications that the drug was being abused, but Ortho-McNeil has fought efforts to make tramadol a controlled substance. In , the company argued that by making it a controlled substance, doctors would be less likely to prescribe it for chronic pain. It cited concerns about the stigma attached to opioids and what it called "opiophobia.
Van Houten, the company spokesperson, said the company is reviewing the DEA's proposal to put tramadol under the Controlled Substances Act. In February, the country's Advisory Council on the Misuse of Drugs noted that deaths in which tramadol was mentioned on the death certificate nearly doubled between and Prescriptions for tramadol in England also increased from 5.
The council recommended that tramadol become a scheduled drug, which would make it a crime to use it or deal it without a prescription. It also said doctors should be given training regarding the drug's possible misuse by patients and the serious complications it can cause. More than two-thirds of tramadol prescriptions from through October, were written by those health professionals. Walsh, the University of Kentucky opioid researcher, said she believes that many doctors who prescribe tramadol take their direction from whether a drug is a scheduled narcotic.
Two years after Anthony Fort's death, his former fiancee still has the recording of his loud snoring and gurgling that she made on the day he died. She was going to play it back to him later in hopes that it would make him realize that the medications he was taking were affecting his sleeping.Can you get a high from tramadol
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