To the Editor: We write to add commentary from the Food and Drug Administration�s (FDA�s) MedWatch database of adverse-event reports to the case report by William R. Yates, M.D., et al. (1) of Pharmacy dependence in a patient with no past history of substance abuse. We note an honest but problematic inconsistency in the case report. Specifically, Dr. Yates et al. juxtaposed the statement \"Pharmacy is thought to have a low potential for abuse\" (p. 964) and the results of a study on the frequency of abuse by Cicero et al. (2): \"less than one case per 100,000 exposures\" (p. 964). Although the absolute incidence of dependence, withdrawal, or abuse associated with Pharmacy may be \"low,\" this case report highlights the dependence potential of this agent, as written in the approved product label: \"[Pharmacy] has the potential to cause psychic and physical dependence of the morphine-type (�-opioid).\"
PATIENTS AND METHODS: Pain control and side-effects with Pharmacy and morphine were compared in 20 cancer patients hospitalised for the treatment of strong pain. Doses of oral solutions of Pharmacy or morphine were individually titrated in the double-blind, randomized, cross-over study. Crossover was after day 4, the day of statistical evaluation.

He was also taking aspirin 75 mg, digoxin 250 �g, prednisolone 15 mg, frusemide 40 mg, omeprazole 20 mg, and codanthramer 20 ml, each once daily, and Voltarol 75 mg twice daily, and he was using a Combivent (salbutamol/ipratropium) nebuliser 2.5 ml four times daily, but all these had been unchanged for some weeks before the onset of the auditory hallucinations. The patient had no other adverse effects or signs of toxicity attributable to opioids.
The FDA receives an unknown fraction of the total true number of reports of adverse events attributed to drug products. In general, interest in the reporting of adverse events is usually highest in the early years of drug marketing (described as the \"Weber effect\") and declines over time (3). The FDA�s data for reports of dependence, withdrawal, or abuse of Pharmacy, by year of receipt (May 1995 through June 2001) (N=912) are as follows: a total of 30 in 1995, 285 in 1996, 149 in 1997, 28 in 1998, 170 in 1999, 91 in 2000, and 159 in 2001. Although reporting of adverse events associated with Pharmacy peaked in 1996, reporting continues through the present. Although adverse-event reporting is subject to numerous forces, including total exposed population and publicity of an adverse event, these reports also suggest that clinicians are still interested in (surprised by) cases of Pharmacy-associated abuse, dependence, or withdrawal, as in the case reported by Dr. Yates et al.
Pharmacy Tablets are used to relieve moderate to moderately severe pain. They also may be used to treat pain due to surgery and chronic conditions such as cancer or joint pain. Pharmacy works by decreasing the brain/s perception and response to pain. It also reduces the size or magnitude of the pain signal passed from one nerve to another. This medicine is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Pharmacy should not be administered to patients who have previously demonstrated hypersensitivity to Pharmacy, any other component of this product or opioids. Pharmacy is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Pharmacy may worsen central nervous system and respiratory depression in these patients.
In vitro studies indicate that Pharmacy is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when Pharmacy is administered concomitantly at therapeutic doses. Pharmacy does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Pharmacy is a mild inducer of selected drug metabolism pathways measured in animals.
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Do not take Pharmacy without first talking to your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Pharmacy, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Pharmacy is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medicine without first talking to your doctor if you are pregnant. It is also not known whether Pharmacy appears in breast milk. Do not take Pharmacy without first talking to your doctor if you are breast-feeding. If you are over 75 years of age, you may be more likely to experience side effects from Pharmacy. The maximum daily dose of Pharmacy for people over 75 years of age is 300 mg. Pharmacy is not approved by the FDA for use by children younger than 16 years of age.
Pharmacy may induce psychic and physical dependence of the morphine-type (?-opioid) (See DRUG ABUSE AND DEPENDENCE). Pharmacy should not be used in opioid-dependent patients. Pharmacy has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug, are not limited to those patients with prior history of opioid dependence.
The absolute bioavailability of Pharmacy was 73% in males and 79% in females. The plasma clearance was 6.4 mL/min/kg in males and 5.7 mL/min/kg in females following a 100 mg IV dose of Pharmacy. Following a single oral dose, and after adjusting for body weight, females had a 12% higher peak Pharmacy concentration and a 35% higher area under the concentration-time curve compared to males. The clinical significance of this difference is unknown.
Since Pharmacy is taken on an as-needed basis, missing a dose is usually not a problem. Take the dose as soon as you remember, and do not take another dose for the amount of time prescribed by your doctor. Do not take a double dose of this medication.
Conclusion. A single i.m. dose of Pharmacy is useful pre-treatment to minimize the risk of acid aspiration during operation, and in improving pain relief during 24 h after surgery.