The U.S. FDA recalled the diet pills Redux (sold in the Philippines as Adifax) and Pondimin because of increasing evidence that they can cause damage to the heart and lungs.
I had heard warnings (they turned out to be prophetic) from researchers during a weight management forum I attended in the U.S. in 1996. The researchers were questioning why the FDA had approved the use of Redux for up to a year when, in their opinion, there wasn’t enough evidence yet of safe long-term use. One of the scientists went as far as calling the FDA “crazy”.
They predicted an increase in the number of cases of primary pulmonary hypertension or PPH (high blood pressure of the lungs) and heart valve problems. It didn’t take long for their predictions to come true.
In July 1997, CNN reported that the Mayo Clinic had found evidence of heart disease in 24 women taking either Redux or “fen/phen” (Pondimin in combination with Ionamin). Subsequently, the FDA received reports of 58 more cases.
Old drugs, new combination.
The diet drugs, fenfluramine (Pondimin) and phentermine (Ionamin), have both been around for twenty years but were never very popular because the weight loss effects only lasted for so long as the individual continued to take the pills.
There were also unpleasant side effects. Fenfluramine can cause dry mouth, drowsiness, and diarrhea. Phentermine, meanwhile, can cause dry mouth, nervousness, constipation, and insomnia.
In 1992, Michael Weintraub, a medical doctor doing research at the University of Rochester, discovered that by combining the two drugs, the side effects were lessened and weight loss results were increased. Fenfluramine makes you feel full and reduces cravings for carbohydrates while phentermine suppresses your appetite.
After Weintraub’s findings were published, sales for both fenfluramine and phentermine increased dramatically. In fact, the company that manufactures fenfluramine admitted in an interview with Idea Today, a magazine for fitness professionals, that they could not keep up with the demand in spite of operating their production lines 24 hours a day!
The “fen/phen” craze was off and running. Fen/phen weight loss clinics sprouted almost overnight in major American cities. I once counted nine ads for clinics offering the fen/phen treatment in a single issue of the Los Angeles Times.
Redux was the brainchild of Richard Wurtman, a neurologist at M.I.T. who likened it to a “super Prozac”. It is the first diet pill in 23 years to be approved by the FDA. Redux or Adifax are brand names for dexfenfluramine, a variation of fenfluramine.
It is ironic that the FDA, which is usually very conservative about approving new drugs, would approve Redux when many scientists tried to block approval citing evidence that it could increase pulmonary risk. A major European study that was published in The New England Journal of Medicine found that the risk of primary pulmonary hypertension increased by 30 times in people who took the drug for as little as three months.
Dexfenfluramine had been available in Europe since 1985. After the controversial European study was published, sales in Europe plummeted by 80%. A little too late for the many people who now had an often fatal disease.
PPH is characterized by a tightening of the blood vessels of the lungs. The constricted blood vessels force the heart to work so hard at pumping blood that eventually it fails. The statistics are dismal -nearly half of all PPH patients die from heart failure within four years.
The National Task Force on the Prevention and Treatment of Obesity, an organization that includes 14 of the most prestigious researchers in the management of obesity, also cautioned against the routine use of these diet pills. They discovered that there were only 200 people who had taken the drugs for more than two years. Under the circumstances, the task force felt it was inappropriate to declare the drugs safe for long term use.
Primary pulmonary hypertension is not the only health risk associated with the use of both Redux and fen/phen. Dexfenfluramine and fenfluramine cause changes in brain cells to occur. There is some controversy as to whether these changes can be defined as brain cell damage. Definite cases of brain damage have been found in laboratory animals given the drugs but not in humans. Dr. George Ricaurte, a neurologist at the John Hopkins School of Medicine says that while scientists don’t know whether dexfenfluramine produces the same brain damage in humans, they are concerned that it may.
Lewis Seiden, a neuropharmacologist at the University of Chicago cautions that damaged brain nerve cells may not be apparent for many years. So there is a possibility that the people who are currently taking Redux, Adifax or fen/phen may not notice changes in their behavior or functioning till many years from now.
Use and abuse.
Both Redux and the fen/phen treatments were originally designed to be used only as a last resort with obese people whose lives were being threatened by their excess weight.
Unfortunately, because of the public’s obsession with being thin and unscrupulous medical personnel, these drugs have become available even to people who only need to lose ten or twenty pounds.
Last year, I found myself sitting beside a woman at a luncheon party who showed off her Adifax pill as the latest thing in weight control. This woman was by no means obese. When I told her about the warnings I had heard about dexfenfluramine, she retorted that since it was doctor prescribed it couldn’t possibly be harmful. I wonder what she thinks about it now.
Teagan Clive, a writer for Muscle and Fitness Magazine was able to get a prescription for fen/phen from a weight loss clinic in the U.S. after she claimed she wanted to lose 15 pounds. She had just modeled for a fitness photo layout.
Diet pills not worth the risk.
The sad truth about Redux and fen/phen is that they are only effective while treatment is going on. Once the drugs are stopped, 95 % of the people regain all the lost weight within five years. This is one case where the risks definitely outweigh the benefits!