Dante Carrillo
Fen-Phen, a combination of fenfluramine and phentermine, was a popular weight-loss drug in the 1990s. However, it was soon linked to severe cardiac issues, leading to its decline. Dexfenfluramine, or Redux®, was introduced as a substitute for fenfluramine, but it also caused similar heart problems when combined with phentermine. While some sources suggest lorcaserin as a potential alternative, lacking the harmful side effects of Fen-Phen, others mention dexfenfluramine as a replacement, reporting no issues with addiction or abuse.
| Characteristics | Values |
|---|---|
| Name | Dexfenfluramine, also known as Redux |
| Combination with other drugs | Dexfenfluramine combined with phentermine is known as Dexfen-Phen |
| FDA approval | Yes, approved in 1996 |
| Side effects | Heart disease, cardiac valvular disease, primary pulmonary hypertension (PPH), and cardiac fibrosis |
| Safety testing | Not appropriately safety tested |
| Addiction | No addictions reported |
| Abuse | No abuse reported |
Explore related products
What You'll Learn
- Dexfenfluramine is a new drug that has been used in other countries with no reported addictions or abuse problems
- In 1997, the FDA ordered the removal of fenfluramine and dexfenfluramine from the market due to heart valve damage
- Users of fen-phen have described it as a miracle that turned into a nightmare, with some requiring heart valve replacement surgery
- Lawsuits were filed against the manufacturers of fen-phen, resulting in settlements for those affected by the drug's side effects
- Lorcaserin is a new weight-loss drug that may offer similar effects to fen-phen without the same heart-related side effects
Dexfenfluramine is a new drug that has been used in other countries with no reported addictions or abuse problems
Dexfenfluramine is a drug that has been used in other countries for about 15 years with no reported addictions or abuse problems. It is the d-enantiomer of fenfluramine and is structurally similar to amphetamine but lacks any psychologically stimulating effects. Dexfenfluramine was introduced as an alternative to fenfluramine, which was found to be associated with an increased risk of primary pulmonary hypertension and valvulopathy. Dexfenfluramine was also considered to be more potent and to have reduced risks of toxicity.
Dexfenfluramine is an appetite suppressant that was used to promote weight loss. It was approved by the United States Food and Drug Administration (FDA) for weight loss purposes for some years in the mid-1990s. However, in 1997, the FDA withdrew its approval due to concerns about its cardiovascular side effects. The drug was then pulled out of other global markets as well.
The amphetamine-like abuse potential of dexfenfluramine was evaluated in studies using drug discrimination and self-administration procedures. These studies suggested that dexfenfluramine would not have amphetamine-like abuse potential in humans. The results showed that dexfenfluramine maintained rates of self-administration within a range similar to saline and considerably below that of cocaine and d-amphetamine.
Dexfenfluramine was also found to have better long-term benefits than fenfluramine and phentermine, a stimulant that was sometimes combined with fenfluramine for weight loss. The combination of fenfluramine and phentermine, known as "phen-fen" or "Fen/Phen," was banned in Tennessee in 1991 because it was found to be addictive and often abused, in addition to causing health problems.
Transitioning Your Dog's Diet: From Chicken and Rice
You may want to see also
Explore related products
In 1997, the FDA ordered the removal of fenfluramine and dexfenfluramine from the market due to heart valve damage
The Food and Drug Administration (FDA) ordered the removal of fenfluramine and dexfenfluramine from the market in 1997 due to heart valve damage. Fenfluramine, marketed as Pondimin, was shown to cause potentially fatal pulmonary hypertension and heart valve problems. Dexfenfluramine, on the other hand, is the "active" enantiomer of fenfluramine, which means it has the same chemical formula but a different three-dimensional structure, making it more "active" in the body.
The decision to withdraw these drugs from the market was based on findings from doctors who evaluated people taking these drugs using echocardiograms, a procedure that can test the functioning of heart valves. The findings indicated that approximately 30% of people who had taken the combination for up to 24 months had abnormal echocardiograms, even though they showed no symptoms. This percentage of abnormal test results was much higher than would be expected from a sample of the population who had not taken either drug.
Follow-up studies showed that for people who took the combination for 3 months or less, the rate of heart valve complications was less than 3%. However, the FDA continued to receive reports of valvular heart disease in people who had taken these drugs, even after the withdrawal request. This disease typically involves the aortic and mitral valves.
The withdrawal of fenfluramine and dexfenfluramine from the market was unusual because they were widely used for the treatment of obesity and had sales well in excess of $100 million in the last 12 months before their removal. The manufacturer of fenfluramine, Wyeth-Ayerst Laboratories, and the licensor of dexfenfluramine, Interneuron Pharmaceuticals, voluntarily complied with the FDA's request.
Protein for Horses: What's the Deal?
You may want to see also
Explore related products
Users of fen-phen have described it as a miracle that turned into a nightmare, with some requiring heart valve replacement surgery
In the 1990s, a new "miracle medicine" for weight loss emerged in the form of a combination drug called fen-phen, which is a combination of fenfluramine and phentermine. The drug was initially popular as it allowed users to shed pounds effortlessly. However, what started as a miracle soon turned into a nightmare for many users.
In 1997, the FDA ordered the removal of fenfluramine (Pondimin) and a related drug, dexfenfluramine (Redux) from the market after studies showed that they caused damage to heart valves. This effectively put an end to the fen-phen craze. Users of fen-phen have described it as a miracle that turned into a nightmare, with some requiring heart valve replacement surgery.
Phyllis Hardy, a former fen-phen user, recalled her experience with the drug. In her late 30s and weighing over 300 pounds, Hardy was eager to try the new diet pill that her coworkers at the hospital were using with apparent success. Her doctor prescribed fen-phen, and within a few months, she had lost more than 25 pounds. However, she soon started experiencing health issues. Hardy, now 57, believes that fen-phen caused her to develop a leaky heart valve, a serious condition that may require surgery to repair or replace the damaged valve.
The link between fen-phen and heart valve damage was first suggested in a 1997 study by the Mayo Clinic, which found an association between the drug and a heart valve disorder in a group of women with no previously known heart disease. This disorder can cause symptoms such as chest pain and shortness of breath. While the study did not prove causation, the findings were concerning enough for the FDA to issue a warning to doctors. Subsequent reports have emerged of fen-phen users suffering from heart valve damage, including an additional nine women in the United States.
While fen-phen was banned due to its harmful effects, there are new drugs on the horizon that may provide safer alternatives for weight loss. One such drug is dexfenfluramine, which has been used in other countries for about 15 years without reports of addiction or abuse. It remains to be seen whether these new drugs can provide the benefits of weight loss without the dangerous side effects that turned fen-phen into a nightmare for many users.
Smart Eating: Managing Acute Pancreatitis
You may want to see also
Explore related products
Lawsuits were filed against the manufacturers of fen-phen, resulting in settlements for those affected by the drug's side effects
Fen-phen was a combination of two drugs, fenfluramine and phentermine, that acted as an anti-obesity medication. Fenfluramine was marketed by American Home Products (later known as Wyeth) as Pondimin, while dexfenfluramine was sold under the brand name Redux. Fen-phen was shown to cause potentially fatal pulmonary hypertension and heart valve problems, which eventually led to its withdrawal from the market in 1997.
Following the drug's withdrawal, numerous lawsuits were filed against the manufacturers of fen-phen, alleging that the drug caused serious side effects, including heart valve disease and pulmonary hypertension. In total, more than 50,000 product liability lawsuits were filed by alleged fen-phen victims, resulting in settlements totalling billions of dollars.
American Home Products Corp agreed to pay $3.75 billion to thousands of people who claimed they were injured by taking fen-phen. The settlement, one of the largest in product liability cases, offered refunds of $30 to $60 for those who used the drug for 60 days or less, while those with heart valve injuries could receive up to $1.5 million. The settlement also included a sum of up to $429 million for lawyers' fees.
Wyeth, the manufacturer of Pondimin, was still negotiating with injured parties in February 2005, offering settlements ranging from $5,000 to $200,000. The company had set aside $21.1 billion to cover the cost of the lawsuits. The total liability for fen-phen lawsuits was estimated to be as high as $14 billion.
The fen-phen settlement was not without its critics. Some lawyers and plaintiffs felt that the payments were not sufficient to cover the medical expenses incurred by those who suffered adverse effects from the drug. Additionally, the settlement did not cover all fen-phen liabilities, and there were concerns that if too many people dropped out of the settlement, the company could scrap the agreement.
Sourdough: Friend or Foe in an Anti-Inflammatory Diet?
You may want to see also
Explore related products
Lorcaserin is a new weight-loss drug that may offer similar effects to fen-phen without the same heart-related side effects
Fen-phen, a combination of fenfluramine and phentermine, was a popular weight-loss drug in the 1990s. However, it was pulled from the market in 1997 due to its association with heart valve problems and cardiac valvular pathologies. This prompted the development of new weight-loss drugs that could provide similar effects without the same heart-related side effects.
Lorcaserin, a novel weight-loss drug, has emerged as a potential alternative to fen-phen. It targets the same appetite pathway as fen-phen but in a more selective and safer manner. Lorcaserin is a selective agonist of the 5-HT2C receptor, which plays a critical role in regulating food intake. By targeting this receptor, lorcaserin helps reduce energy intake without increasing energy expenditure.
Studies have shown that lorcaserin is well tolerated and not associated with cardiac valvulopathy or pulmonary hypertension, addressing the heart-related concerns associated with fen-phen. In a study involving over 3,100 obese or overweight individuals, nearly 48% of those taking lorcaserin lost at least 5% of their body weight over one year, with an average weight loss of about 13 pounds. Importantly, the study also suggested that side effects were not a significant issue, as more people on lorcaserin stayed in the study compared to those on placebo pills.
Additionally, lorcaserin has been found to be safe and effective in multiple clinical trials. In one phase lb trial, individuals receiving lorcaserin daily for 14 days reported no serious adverse events. The drug's once-daily dosing suitability and lack of central nervous system side effects at lower doses further highlight its potential advantages over fen-phen.
Overall, lorcaserin offers a promising approach to weight loss, providing similar or even better outcomes than fen-phen without the same heart-related risks. With further research and approval, it could become a valuable tool in the fight against obesity, especially for individuals with heart problems who cannot use current weight-loss medications.
Diets: Why Most Plans Fail in the Long Run
You may want to see also
Frequently asked questions
Dexfenfluramine, also known as Redux, was introduced as a substitute for fenfluramine, one of the two drugs that made up fenphen. However, dexfenfluramine was also banned by the FDA in 1997 after it was found to cause similar heart problems when used with phentermine, the other drug in fenphen.
Fenphen was banned due to severe cardiac problems in users, including heart valve damage. Approximately one in three people exposed to fenphen showed signs of abnormal heart issues.
Lorcaserin is a drug that is believed to work in a similar way to fenphen without the side effects. It attaches to the 2C receptor at a much higher rate than the 2B receptor, which is believed to be the cause of fenphen's heart problems.
