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Twenty-five years ago, the great Athenian doctor Hippocrates believed that balance is health and that imbalance is the cause of all illness and pain. For more than three hundred years, this concept has been in disfavour. Now, clinical experiences with Phen/Fen suggest that Hippocrates was right. While both phentermine and fenfluramine have been available since the mid-seventies, patients were generally reluctant to use them because of the always present fear of addiction.
During many instances when people did try either one of these new drugs, they could not tolerate the side effects. The pills in fact do work, because they trick the brain into thinking that the stomach is full. But they also seem to affect the brain in other, less desirable ways. The thought process behind creating a 'super drug's uch as Phen/Fen, was that by combining the two medications, one could take advantage of their different pharmacologic actions getting, in essence, better effectiveness while hopefully minimizing the "mild" side effects (Michael D. Myers. 1997). Despite the side effects that are still present, drug companies are making lots of money off of Phen/Fen.
It is the second fastest growing drug in the country. In 1996, it earned about $ 191 million for its maker, With-Myers (CNN. 1997). Obesity, poor nutrition, and inactivity are estimated to contribute to about 300, 000 deaths a year (National Institution of Health. 1996), thus there is an increased demand for such pills as Phen/Fen. In this paper, I will discuss the two drugs that make up Phen/Fen, Fenfluramine and Phentermine, and discuss the side effects for each of the pills. I will introduce Serotonin and Dopamine, two of the brain's neurotransmitters and the effect of Phen/Fen on them.
I will also discuss who should and who shouldn't use this potentially dangerous diet. Finally, I will look at a case study from Michael D. Myers which makes some very important conclusions about the diet. Fenfluramine Fenfluramine was discovered at approximately the same time as it's cousin, Phentermine.
Fenfluramine has always been strongly associated with many side effects. The most prominent of it's side effects is Primary Pulmonary Hypertension which is a life threatening complication (Michael D. Myers. 1997). An estimated 1 in 17, 000 patients that are treated for longer than 3 months will develop this condition (New England Journal of Medicine. 1996).
The symptoms may be vague chest discomfort of development of an insidious feeling of shortness of breath (Abenhaim, L. 1996). If a person develops pulmonary hypertension, stopping the medication may or may not stop the disease process; a lung or even a heart-lung transplant may be required. Fenfluramine may also cause significant damage to the brain's serotonin levels. Low levels of serotonin are associated with sleep and mood disorders, especially depression. Fenfluramine is also associated with other, less serious side effects s!
uch as dry mouth, drowsiness, diarrhea, dizziness, sedation and heart palpitations. None of the latter side effects are life threatening but are very annoying and many people tend to avoid Fenfluramine just to avoid the displeasing side effects. On a common bottle or prescription of Fenfluramine, the label may read; Tradename: Pondimin Manufacturer: Robins Treatment Class: Psychopharmacologic and Neurologic (CNS) Indication: Obesity Phentermine Phentermine (resin) is a cationic exchange resin complex. Phentermine is alpha, alpha- dimethyl phenethylamine (phenyl-tertiary-butyl amine).
Phentermine (resin) is a sympathomimetic amine with pharmacologic activity similar to the prototype drug of this class used in obesity, amphetamine (d- and dl- amphetamine). Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics. " It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression.
Other central nervous system actions, or metabolic effects may be involved. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. The magnitude of increased weight loss of drug-treated patients over placebo- treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks.
The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' or months' duration; thus, the total impact of drug-induced weight loss over that of diet alone! must be considered clinically limited. The bioavailability of Phentermine (resin) has been studied in humans in which blood levels of phentermine were measured by a gas chromatography method.
Blood levels obtained with the 15 mg and 30 mg resin complex formulations indicated slower absorption with a reduced but prolonged peak concentration and without a significant difference in prolongation of blood levels when compared with the same doses of phentermine hydrochloride. The clinical significance of these differences is not known. In clinical trials establishing the efficacy of Phentermine (resin), a single daily dose produced an effect comparable to that produced by other regimens of "anorectic" drug therapy. Phentermine (resin) is indicated in the management of exogenous obesity as a short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class should be measured against possible risk factors inherent in their use such as those described below. The following are some of the more serious side effects of Phentermine; Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma.
WARNINGS: If tolerance to the "anorectic" effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. Phentermine (resin) may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly. When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol. DRUG DEPENDENCE: Phentermine (resin) is related chemically and pharmacologic ally to amphetamine (d- and dl-amphetamine) and other stimulant drugs that have been extensively abused. The possibility of abuse of Phentermine (resin) should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamine (d-and dl-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction.
There are reports of patients who have increased the dosage of some of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatomes, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.
The fact whether phentermine is safe to use during pregnancy has not yet been established. Use of Phentermine (resin) by women who are or may become pregnant requires that the potential benefit be weighed against the possible hazard to mother and infant. Phentermine (resin) is not recommended for use in pediatric patients under 12 years of age. The following are some precautions that should be taken before using phentermine (resin).
Caution is to be exercised in prescribing Phentermine (resin) (phentermine resin) for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of Phentermine (resin) and the concomitant dietary regimen. Phentermine's effect on the cardiovascular system: Palpitation, tachycardia, elevation of blood pressure. Phentermine's effect on the central nervous system: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses with some drugs in this class. Manifestations of acute over dosage may include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultive ness, hallucinations, panic states. Fatigue and depression usually follow the central stimulation.
Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Over dosage of pharmacology...
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