Tramadol
Safety
Submitted: April 2, 2007
Tramadol
is an acting analgesic chiefly used for treating pain that ranges from
moderate to severe. Tramadol is a synthetic agent—a 4-phenyl-piperindine
analogue of Codeine—which appears to have actions on the GABAergic,
noradrenergic and serotonergic systems. Developed by the German
pharmaceutical company,
Grünenthal GmbH, Tramadol was marketed under the trade name of Tramal.
Grünenthal cross-licensed the drug to several other pharmaceutical
companies which marked it under various names—Tramadol is normally
marketed as Tramadol Hydrochloride (hydrochloride salt). This is
available in oral and intravenous preparations.
Numerous reports of possibility of medicine misuse and side reactions
caused FDA to modify the recommended prescription dosage of Tramadol.
FDA has also sent a letter to medical physicians including information
about the safety of Tramadol. When the medicine was admitted to the
market in 1995, 115 reports of substantial drug abuse, dependence,
withdrawal symptoms and international overdose by individuals who used
Tramadol were on record. Moreover, under post marketing surveillance
there were also reported 83 seizure cases in patients taking
Tramadol
together with other medicines like serotonin uptake inhibitors (Prozac,
fluoxetine) or tricyclic antidepressants (Elavil or amitriptyline).
FDA in cooperation with Tramadol marketers continue to work on
developing new labeling which would make care professionals aware that
Tramadol should not be prescribed to patients with a history of
dependence or morphine-like addiction. The new labeling makes it clear
that Tramadol medicines shouldn’t be used by patients allergic to
codeine—due to some patients showing severe allergic reaction using the
medicine. A comprehensive explanation of the risk of seizures is also
available on labeling.
Tramadol
reduces pain intensity, produces symptom relief and improves
function—although the benefits are quite small. This is the main reason
participants stop taking Tramadol, that could limit the usefulness of
this medication. Research shows that individuals who received Tramadol
had a 37% increase in the likelihood of reporting moderate improvement.
Individuals receiving Tramadol may have more of a chance of side-effects
than those who use the placebo medication. However, the benefits of
Tramadol in patients will usually dominate those of placebo in
patients.
Normally, Tramadol must be swallowed whole as opposed to being crushed,
chewed or split. Seizures have been reported in individuals taking
Tramadol. The risk of seizures is increased with Tramadol doses above
the recommended range. The use of Tramadol increases the seizure risk in
individuals taking antidepressants, other morphine-like drugs and other
drugs which can cause seizures. The risk of convulsions may even
increase in individuals with a history of seizures or epilepsy.
Tramadol
medications should be used with caution in individuals taking
medications like hypnotics, tranquilizers, morphine-like drugs or
alcohol. Tramadol may impair your ability to perform hazardous tasks,
like operating machinery or driving a vehicle. Dizziness, constipation,
sleepiness, nausea and feeling flushed are the most typical side-effects
reported with Tramadol medication. When it comes to chronic pain, any
kind can be quite debilitating (physical and mental). It’s important to
understand what it is you are enduring before you find the best method
to relief. Various Tramadol medications offer proven efficacy and safety
in millions of individuals that suffer from persistent, moderate to
severe chronic pain.
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