Phentermine is an appetite suppressant that is used in conjunction with an overall diet plan to reduce weight. It is available as a generic medicine and as a brand medicine.
Phentermine is the most commonly prescribed prescription appetite suppressant, accounting for 50% of the prescriptions. Part of this reason is because it’s significantly cheaper than the other major FDA-approved diet drugs, Meridia and Xenical.
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Phentermine first received approval from the Food and Drug Administration (FDA) in 1959 as an appetite suppressant for the short-term treatment of obesity. Phentermine resin became available in the United States in 1959 and Phentermine Hydrochloride in the early 1970s.
In the US, Phentermine is currently sold under the brand names Ionamin® (Medeva Pharmaceuticals) and Adipex-P® (Gate Pharmaceuticals). It is also available as a generic medication, known as ‘phentermine’.
Previously, it was sold under the name Fastin® (formerly produced by King Pharmaceuticals for SmithKline Beecham). In December 1998, SK-Beecham withdrew Fastin from the market.
As Phentermine is an older drug, no new efficacy trials have been conducted. The one notable exception, are several trials on the combination of Phentermine and Fenfluramine in the early and mid 1990s.
Fen-Phen refers to the combination, or cocktail, of Fenfluramine or Pondimin (the “Fen”) and Phentermine (the “Phen”). Fenfluramine received FDA approval in 1973 for the short-term treatment of obesity. Together, Phentermine and Fenfluramine produced a powerful diet drug cocktail.
The FDA never approved the Fen-Phen combination, but once the agency has approved a drug, doctors may prescribe it at will. Their use, together, was considered “off-label”.
In 1992, Dr. Michael Weintraub of the University of Rochester and several colleagues published a study citing Fen-Phen as a more effective method than dieting or exercise in reducing the weight of the chronically obese. Even better – Fen-Phen, unlike an earlier generation of speed-laden diet drugs, seemed to be without immediate side effects.
The Fen-Phen cocktail became an overnight sensation. 1996 saw 6.6 million prescriptions of Fen-Phen in the U.S.
Dexfen-Phen refers to the combination, or cocktail, of Dexfenfluramine or Redux (the “Dexfen”) and Phentermine (the “Phen”). Dexfenfluramine received FDA approved in 1996 for use as an appetite suppressant in the management of obesity.
Like Fen-Phen, Dexfen-Phen, too, became an overnight sensation.
Neither combination, however, was ever tested for safety ….
By the summer of 1997, the Mayo Clinic reported 24 cases of heart valve disease. All 24 people had taken the Fen-Phen cocktail. The cluster of unusual cases of heart valve disease in Fen-Phen users suggested a co-relation between Fen-Phen use and heart valve disease.
On July 8, 1997 the FDA issued a Public Health Advisory to report the Mayo findings (which were later published in the August 28 issue of the New England Journal of Medicine). Please click here to read the FDA Health Advisory.
The FDA continued to received additional reports of heart disease, including reports from patients who had taken only Fenfluramine or Dexfenfluramine.
Further evaluations of patients taking Fenfluramine or Dexfenfluramine, showed that approximately 30% had abnormal valve findings. This figure is much higher than expected for abnormal test results and suggest Fenfluramine and Dexfenfluramine as the likely causes of Primary Pulmonary Hypertension (PPH) and valvular heart disease.
The FDA responded promptly to the alarming findings, and in September 1997, requested drug manufacturers to voluntarily withdraw Fenfluramine and Dexfenfluramine. At the same time, the FDA recommended that patients using either Fenfluramine or Dexfenfluramine stop taking them. To view the FDA September 1997 statement regarding the withdrawals, please click here.
The FDA did not, however, request the withdrawal of the third drug involved in the cocktails, Phentermine.
The newest cocktail involving Phentermine is “Phen-Pro” – the “Pro” standing for Prozac. Any one of the following antidepressants: Zoloft, Celexa, Luvox, Trazadone or Effexor may be used in lieu of Prozac.
The use of the antidepressant in the Phen-Pro cocktail is unrelated to depression. The cocktail is necessary because the effects of Phentermine, when used alone, lessen over time. The Phen-Pro cocktail enables Phentermine to work better and for a longer period of time. The cocktail does not appear to cause the problems that resulted from the usage of Fen-Phen.
The combination of Phentermine and Prozac is considered an “off-label” use, meaning that the FDA, who often voice concerns regarding the mixing/combining of medications, does not approve it. However, once the agency has approved a drug, doctors may prescribe it at will.
For further information on Phen-Pro, we suggest the following article from the American Medical Association (AMA).
How to Take Phentermine Properly
This medicine is an appetite suppressant used along with diet, exercise, and behavior therapy for the short-term management of obesity.
Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking. Do not use this medicine if you are also taking guanadrel, guanethidine, furazolidone, fenfluramine, dexfenfluramine, or monoamine oxidase inhibitors (MAOIs). Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. Use of this medicine is not recommended if you have a history of heart conditions, brain or spinal cord disorders, atherosclerosis, high blood pressure, glaucoma, or hyperthyroidism. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
Follow the directions for using this medicine provided by your doctor. Swallow whole. Do not break, crush, or chew before swallowing. Take your dose in the morning before breakfast or 2 hours after breakfast as directed by your doctor. Be sure you take your dose at least 10 to 14 hours before bedtime. Store this medicine at room temperature in a tightly-closed container, away from heat and light. If you miss a dose of this medicine, take it as soon as possible. If it is after noon, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Do not exceed the recommended dose or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may cause serious side effects. Keep all doctor and laboratory appointments while you are using this medicine. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Before you have any medical or dental treatments, emergency care, or sugery, tell the doctor or dentist that you are using this medicine. For women: if you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. It is unknown if this medicine is excreted in breast milk. Do not breast-feed while taking this medicine.
possible side effect
Side effects that may occur while taking this medicine include restlessness, nervousness, difficulty sleeping, or dry mouth. If they continue or are bothersome, check with your doctor. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.
if you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, tremor, rapid breathing, confusion, nausea, vomiting, diarrhea, and stomach cramps.
Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.