treatment would be as valuable to treatment of drug use as are multiple forms of antibiotics for
infections.
Patient safety must remain the prime concern, however, and too-quick acceptance of new medications that supplant what
is seen by some as the gold standard opioid agonist, methadone, may indeed prove harmful.
Currently, newer medications are being hailed by some as being superior to methadone for opioid dependency. In
particular, buprenorphine has been portrayed as being a cutting edge medication.
Further, a combination product containing burprenorphine and naloxone has been cited as being investigated.
Still another drug, LAAM (levo-alpha-acetylmethadol), approved by the United States Food and Drug Administration
(FDA) in 1993, is also seen as a safe and effective option to methadone.
To examine the safety issues raised by previous research, these authors analysed adverse-event reports concerning
methadone, LAAM and buprenorphine submitted to the FDA over a three-year period between November 1997 and November
2000.
A search of the medical literature was done to identify published evidence supporting or opposing the findings.
Study authors defined adverse events (AE) as unanticipated reactions or consequences considered medically harmful
either to patients or to a female patient's unborn baby.
In the three-year period, there were 170 AE reports for methadone, 40 for LAAM and 178 for buprenorphine.
Compared with methadone, for which the AE reports represented 0.03 percent of all methadone-treated patients in the
three years, the number of AEs associated with LAAM and buprenorphine were "unexpectedly high", the researchers report.
Yet, they note, in the United States, people on methadone outnumber LAAM patients by 45 to one.
They also suggest in this wide-ranging review that buprenorphine's potential for intravenous abuse has also been widely
reported.
"Reactions specifically associated with intravenous abuse of buprenorphine involved injection site complications, such as
blood vessel inflammation or clots, abscesses, edema and pain.
FDA-reported cardiac-related events were minimal for methadone and buprenorphine but disproportionately much greater for
LAAM.
There were also high percentages of fetal deaths and neonatal complications linked with buprenorphine.
"This is a particular concern because the medication has been proposed for major use in younger addicts, which would
include women of primary childbearing age."
Review authors did this review on an education grant from one of the manufacturers of methadone.
They note that in its approximately 35-year treatment history, methadone has been the gold standard for treatment and
has proved to be a safe and effective medication.
Although new safe and effective drugs would only benefit patients, vigilance in both the research surrounding new and
proposed new medications, as well as their acceptance, is critical to ensuring the patient safety.
A.T.F. Volume X #2 Spring 2001. "Clinical Concepts - How Safe Are Methadone, LAAM, Buprenorphine?"
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