Tramadol: Generic Form of Ultram
Submitted: January 17, 2007 3:40pm
Introduction:
Tramadol was approved
for marketing as a non-controlled analgesic in 1995 under the trade name of
Ultram. Although the company initially claimed that this substance
produced only very weak narcotic effects, recent data demonstrates that
opioid activity is the overriding contributor to the drug’s pharmacological
activity. Because of inadequate product labeling and lack of established
abuse potential, many physicians felt this drug was perfectly safe to
prescribe to recovering narcotic addicts and to known narcotic abusers. As a
consequence, a large number of reports of abuse and dependence have been
received.
Licit Uses:
Tramadol is approved for the treatment of moderate to moderately severe pain in
adults. Although FDA has still not recommended the scheduling of this
substance in the Controlled Substances Act (CSA), a requirement necessary
for DEA to place a substance under control, they have required the company
to inform physicians about recent abuse data and to include new information
under the "Drug Abuse and Dependence" section in the approved labeling. The
labeling now contains the following language:
"Ultram has a potential to cause psychic and physical dependence of the
morphine-type (μ-opioid). The drug is associated with craving, drug-seeking
behavior and tolerance development. Cases of abuse and dependence on Ultram have been reported. Ultram should not be used in
opioid-dependent patients. Ultram can reinitiate physical dependence
in patients that have been previously dependent or chronically using other
opioids. In patients with a tendency to drug abuse, a history of drug
dependence, or are chronically using opioids, treatment with Ultram is not recommended."
Chemistry/Pharmacology:
Tramadol is a centrally acting synthetic opioid. Opioid activity is due to both the parent
compound and the more active O-desmethylated metabolite. Apart from
analgesia, tramadol may produce a number of symptoms including dizziness,
somnolence, nausea, and constipation similar to other opioids.
Tramadol
is well absorbed orally. It can be administered in 50 to 100 mg doses as
needed for pain relief every 4 to 6 hours, not to exceed 400 mg/day.
Seizures have been reported in patients receiving recommended doses but are
more likely in high doses associated with abuse of this medication.
Poison Control
data (2002 AAPCC Annual Report) indicates that there were 2,400 exposures of
tramadol reported to poison control centers. Of those, 108 resulted in a
major medical outcome and 8 resulted in death.
Illicit Uses:
Tramadol is abused for its opiate effects. The Drug Abuse Warning Network (DAWN) is a
database which provides data on drug related episodes reported by hospital
emergency rooms. In 2002, there were 1,714 episodes for tramadol and a total
of 7,890 episodes from 1998 through 2002. DAWN medical examiners reported
that tramadol was involved in 95 drug-related deaths in 2002 and a total of
382 deaths from 1998 through 2002.
The National Forensic Laboratory System (NFLIS) and System to Retrieve Drug Evidence
(STRIDE) are both DEA databases that collect scientifically verified data on
analyzed samples in state/local and DEA forensic laboratories, respectively.
In 2003, there were 267 exhibits of tramadol in NFLIS and 2 exhibits in
STRIDE. These relatively small numbers are most probably a reflection of the
uncontrolled status of tramadol in the U.S. User
Population:
The current pattern of tramadol
abuse in the US involves street drug addicts, chronic pain patients, and
health professionals. The lack of control and lack of urine toxicology
screen for this medication have probably contributed significantly to the
availability of this drug. Illicit distribution:
Like other legal
pharmaceuticals with abuse potential, diversion of this medication occurs in
a number of ways including prescription fraud. As an uncontrolled substance,
there are no CSA regulations regarding manufacturing, distribution, or
prescription of this medication. Control status:
Tramadol is not controlled under the CSA but is under review for possible control.
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