This practice is perfectly legal. In fact, one out of five common drugs for adults is prescribed off label, according to a well-regarded analysis in the Archives of Internal Medicine.
The theory is that as long as a drug has been approved and is on the market, physicians may use it as they see fit. However, while this leeway has created some happy surprises such as the discovery that migraines can be treated with Botox , it also exposes patients to a medical gray zone where, without FDA-vetted research, they are completely dependent on the wisdom of their doctors. One result: Most of the drug combos being used by dieters have not been tested in clinical trials conducted by drug companies or in rigorous studies led by academic researchers.
There are also safety issues. For instance, when a drug manufacturer tried to market a single pill called Qnexa that combined the two medications Sibley took although in different doses , the FDA rejected it over concerns about birth defects and cardiovascular risks.
Yet both doctors and patients can point to success stories in which these medication regimens have led to weight loss without evident health damage. Here, More takes a closer look. Birth of a Notion The idea of combo-pilling diet drugs was born on a wintry Midwestern day in the s, when a pharmacologist from the University of Rochester was snowed in at the Kansas City airport.
In a study published in , Weintraub conducted a now-famous trial on subjects and found that the combination of phentermine, a stimulant, and fenfluramine, a medication that increases the release of serotonin in the body, worked like two fingers crossing for good luck. After eight months, people on the double regimen—later known as fen-phen—lost an average of 32 pounds, and the combo was an enormous hit. You may remember the ending to the fen-phen story. On September 15, , one half of the duo, fen-fluramine, was withdrawn from the market because it was associated with heart-valve disease.
But the double-drug concept had established itself in the minds of the dieting public. Skversky also reports that two of his patients, including one relative, developed pulmonary problems he believes were related to the drug combo.
An Antidepressant Cocktail The phen side of fen-phen is still available, but to be a real diet aid, it needs a dance partner.
But they can be expensive. If you and your doctor have decided that you need a weight-loss medicine, make sure you know how much you will have to pay. Take time to find out about how your insurance covers the cost of these medicines. Your insurance company may not pay for the medicines. Ask the customer service representative these questions:.
Weight-loss medicines can harm unborn babies. Women who are pregnant should not take these drugs. Women who do take them should use birth control to avoid getting pregnant. If you decide to stop taking these medicines, talk to your doctor. Some weight-loss medicines should not be stopped suddenly. Current as of: September 23, Author: Healthwise Staff. This information does not replace the advice of a doctor. Healthwise, Incorporated, disclaims any warranty or liability for your use of this information.
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Among the drugs used for obesity, orlistat has been approved for long-term use, and phentermine, the most commonly used drug, has been approved for short-term use. However, phentermine can increase blood pressure and pulse rate. Meanwhile, several studies have shown that orlistat, a pancreatic lipase inhibitor, lowers blood pressure and pulse rate and diminish LDL-cholesterol. Lowering LDL-C could lead to improved vascular endothelial function.
Randomly assigned to each group at 1: 1, and allocation codes are generated using SAS Ver. The investigators provide orlistat and phentermine or placebo and phentermine. The investigators check physical measurement, blood test, questionnaire, blood pressure and pulse, body composition, FMD, heart rate variability test, in the first visit.
The investigators check for changes in body weight, compliance, and side effects after 4 weeks and 8 weeks, respectively. After 12 weeks, the investigators re-check physical measurement, blood test, questionnaire, blood pressure and pulse, body composition, FMD, heart rate variability test. Continue reading your article with a WSJ membership. Resume Subscription We are delighted that you'd like to resume your subscription.
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