FDA: usual starting dose of METHADONE for the management of pain
FDA "ADVISORY" AND MANUFACTURERS "PATIENT INFORMATION" STATEMENT ON METHADONE FOR PAIN - FAR TOO LITTLE, FAR TOO LATE
On Nov. 27, 2006, FDA issued an "advisory" on methadone for the management of pain. It and the associated new "patient information" issued by Roxane Labs actually divert attention from the only major change that has recently been introduced: a marked reduction in "usual" starting methadone dose from a maximum of 80mg to a maximum of 30 mg per day.
Neither the FDA Advisory nor the manufacturer's information sheet makes any reference to any specific dosages - let alone is there mention of the dramatic reduction in what is considered to be an appropriate "usual" starting dose. It's hard to imagine why, since this flurry of activity is clearly in response to the recognition that 80 mg on day one is potentially lethal. One would imagine banner headlines on both documents proclaiming 30 MG methadone IN FIRST 24 HOURS TOP OF THE RANGE FOR INITIATING TREATMENT FOR PAIN; HIGHER DOSES CAN HAVE FATAL OUTCOME. Sure, one would want to leave flexibility to the individual practitioner - but the generalization of high, potentially fatal, risk should have been highlighted and extreme caution urged before exceeding the "usual" range. Instead, as noted, dosages were not even mentioned! What did receive great attention, as reflected in the very title of the FDA advisory, are references to allegedly life-threatening "heart beat" irregularities, though we have been unable to identify a single report in the professional literature of any death attributed to methadone-induced cardiac effects.
So where does one find the dramatic new methadone dosage references? Only on page 15 of a 17-page, very fine print, comprehensive, description of methadone (Dolophine, to be exact). There, under the heading "initiation of therapy in opioid non-tolerant patients, is written: "...the usual oral methadone starting dose is 2.5 mg to 10 mg every 8-12 hours slowly titrated to effect." Until now, the same section read : 2.5-10 mg every THREE TO FOUR HOURS. Thus, the top of the range for initial management has been reduced from 80 mg to 30 mg but no hint of this very substantial reduction is alluded to by either FDA or Roxane.
Clearly, the "advisory" and "patient information" notices are far too little in not spelling out up front precisely what new message must be heeded to protect patients. The notices are also far too late - certainly, too late for some of those patients who may have been prescribed the previously noted "usual" methadone doses, and/or who relied on the FDA-approved "package inserts" that spelled out the same total day one range of 15-80 mg, and who may have suffered an overdose as a result. Note that a 2003 study (Ballesteros et al, JAMA, July 2, 2003) of deaths "due to methadone" in North Carolina, reported by CDC, found that of almost 100 patients for whom information was available "75% had been prescribed methadone by a physician." One can only speculate whether at least some of these deaths might have been avoided had the "usual" methadone dosages specified by FDA and the manufacturer been consistent with what has been known for decades. Indeed, FDA itself puts a 30mg day one limit on starting doses of methadone for opioid-dependent (and thus opioid tolerant!) individuals beginning maintenance treatment (see, for example, the US Department of Health and Human Services Treatment Improvement Protocol TIP 43," 2005, p. 67; and also the 1999 Federal Register, July 12, 1999, vol. 64, number 140, p 398401). The evidence regarding initial methadone dosages that are least likely to cause serious adverse effects is massive, consistent and worldwide; it was embodied years ago in the clear and concise Province of Ontario methadone maintenance guidelines: "START LOW, GO SLOW".
Marijuana Health Effects and Workplace Issues
Marijuana Health Effects:
Emphysema-like conditions
One joint of marijuana contains cancer-causing substances equal to 1/2 pack of cigarettes.
One joint causes the heart to race and overwork. People with heart conditions are at risk.
Marijuana is commonly contaminated with the fungus aspergillus, which can cause serious respiratory tract and sinus infections.
Marijuana lowers the body's immune system response making users more susceptible to infection.
Chronic Marijuana smoking causes changes in brain cells and brain waves. The brain does not work as efficiently or effectively. Long-term brain damage may occur.
Tetrahydrocannabinol (THC) and 60 other chemicals in marijuana concentrate in the ovaries and testes.
Chronic smoking of marijuana in males causes a decrease in testosterone and an increase in estrogen, the female hormone. Therefore, the sperm count is reduced, leading to temporary sterility.
Chronic smoking of marijuana in females causes a decrease in fertility.
A higher than normal incidence of stillborn births, early termination of pregnancy, and higher infant mortality rate during the first few days of life are common in pregnant marijuana smokers.
THC causes birth defects including brain damage, spinal cord, forelimbs, liver, and water on the brain and spine in test animals.
Prenatal exposure may cause underweight newborns.
Fetal exposure may decrease visual functioning.
User's mental function can display the following effects:
- delayed decision making
- diminished concentration
- impaired short-term memory
- impaired signal detection
- impaired tracking
- erratic cognitive function
- distortion of time estimation
Marijuana Workplace Issues
THC is stored in body fat and slowly released.
Marijuana smoking has long-term effects on performance.
Increased THC potency in modern marijuana increases the impairment.
Combining alcohol or other depressant drugs with marijuana increases impairment.
Cocaine Health Effects and Workplace Issues
Cocaine is used medically as a local anesthetic. When abused, Cocaine becomes a powerful physical and mental stimulant. The entire nervous system is energized. Muscles tense, the heart beats faster and stronger, and the body burns more energy. The brain experiences an exhilaration caused by a large release of neurohormones associated with mood elevation.
Cocaine Health Effects
Regular Cocaine use may upset the chemical balance of the brain. As a result, it may speed up the aging process by causing damage to critical nerve cells.
Parkinson's Disease could also occur.
Cocaine causes the heart to beat faster, harder, and rapidly increases blood pressure. Cocaine also causes spasms of blood vessels in the brain and heart. Both lead to ruptured vessels causing strokes and heart attacks.
Strong dependency can occur with one "hit" of Cocaine. Usually mental dependency occurs within days for "crack" or within several months for snorting coke. Cocaine causes the strongest mental dependency of all the drugs.
Cocaine treatment success rates are lower than other chemical dependencies.
Extremely dangerous when taken with other depressant drugs. Death due to overdose is rapid.
Fatal effects are usually not reversible by medical intervention.
Cocaine Workplace Issues
Extreme mood and energy swings create instability. Sudden noise causes a violent reaction.
Lapses in attention and ignoring warning signals increases probability of accidents.
High Cocaine cost frequently leads to theft and/or dealing.
Paranoia and withdrawal may create unpredictable or violent behavior.
Performance is characterized by forgetfulness, absenteeism, tardiness and missing assignments.
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