Milly Gaines
The 1990s saw the emergence of a new prescription diet pill called Fen-Phen, a combination of fenfluramine and phentermine. Despite never being approved by the FDA, Fen-Phen became popular as a quick fix for weight loss. However, in 1997, two separate studies linked Fen-Phen to severe cardiac issues, including heart disease and cardiac fibrosis, with approximately 1 in 3 users experiencing abnormal heart problems. This revelation brought attention to the dangers of diet pills, which have a long history dating back to the late 1800s. Over the years, various diet pills have been linked to adverse effects, including death, with rainbow diet pills in the 1940s causing dozens of fatalities before being removed from the market in the 1960s. The 1990s also saw the reintroduction of these rainbow pills in Spain and Brazil, highlighting the ongoing demand for weight loss solutions despite the potential risks.
| Characteristics | Values |
|---|---|
| Name of diet pill | Fen-Phen (fenfluramine and phentermine) |
| Other names | Dexfen-Phen, Pondimin®, Redux® |
| Side effects | Heart disease, cardiac valvular disease, primary pulmonary hypertension (PPH), cardiac fibrosis, abnormal heart issues, nausea, anxiety |
| FDA approval | Not approved by the FDA for separate or combined use |
| Year entered the market | 1992 |
| Year withdrawn from the market | 1997 |
| Other dangerous diet pills | Rainbow diet pills, aminorex fumarate, dinitrophenol |
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What You'll Learn
- Fen-Phen: a combination of fenfluramine and phentermine
- Redux: a variation of fenfluramine
- Dexfen-Phen: fenfluramine and dexfenfluramine with phentermine
- Rainbow diet pills: brightly coloured capsules with amphetamines, diuretics, laxatives, and thyroid hormones
- Phenylpropanolamine: an ingredient in popular non-prescription diet pills
Fen-Phen: a combination of fenfluramine and phentermine
In the 1990s, a prescription known as Fen-Phen, a combination of fenfluramine and phentermine, became popular as an easy way to lose weight. Despite never being approved by the FDA for safe use, manufacturers quickly produced the drug to meet rising demand. Fen-Phen was thought to be a very effective and safe weight loss drug, but two medical studies submitted to the New England Journal of Medicine (NEJM) in 1997 showed evidence of severe cardiac problems in people who took the drug. Approximately 1 in 3 people exposed to Fen-Phen showed signs of abnormal heart issues, including heart disease, cardiac valvular disease, primary pulmonary hypertension (PPH), and cardiac fibrosis.
Fenfluramine was initially developed in the early 1970s to treat obesity, but it only achieved minor results, and patients complained of side effects like nausea and anxiety. In 1992, a research team led by Dr. Michael Weintraub of the University of Rochester claimed that combining fenfluramine with phentermine was more effective in treating obesity without causing the annoying side effects of previous diet drugs. However, this combination was never adequately tested for safety. The drug company was much more interested in gaining FDA approval for fenfluramine than ensuring the drug was safe for consumption.
The popularity of Fen-Phen as a weight-loss drug highlights a recurring issue with diet pills: the promise of quick and easy weight loss often overshadows the potential risks and side effects. This was also seen with the so-called ""rainbow diet pills"" in the 1960s, which combined amphetamines, diuretics, laxatives, and thyroid hormones to maximize weight loss, while other drugs were added to suppress the side effects of the weight-loss medications, such as insomnia, palpitations, and anxiety. These pills were heavily marketed and prescribed, but as deaths and injuries linked to their use accumulated, the FDA removed them from the market.
The case of Fen-Phen underscores the importance of thorough testing and regulatory oversight in the weight-loss supplement industry. While the combination of fenfluramine and phentermine was touted as a miracle drug for weight loss, the lack of proper testing and approval led to serious health consequences for many individuals. This incident serves as a reminder that the potential risks of any weight-loss regimen should be carefully considered, and the safety and effectiveness of a drug should be established before it is made available to the public.
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Redux: a variation of fenfluramine
Fenfluramine was first introduced in the 1970s as a drug to treat obesity. However, it was not popular as it only temporarily reduced weight. In the early 1990s, fenfluramine was combined with phentermine and heavily marketed. This combination was called Fen-Phen, a name derived from the names of the individual drugs. Fen-Phen soon gained immense popularity as a wonder drug that could help people lose weight faster than diet and exercise. Despite gaining FDA approval for separate use, the combination was never approved by the FDA.
Not long after Fen-Phen was introduced, another version of fenfluramine called Redux entered the market. Redux is the brand name for dexfenfluramine, a substitute for fenfluramine, and was manufactured by Wyeth, a subsidiary of American Home Products. Dexfenfluramine was thought to carry fewer side effects than fenfluramine. However, when used in combination with phentermine, it was later found to cause the same heart problems as Fen-Phen.
In 1997, two separate studies appeared in the New England Journal of Medicine (NEJM) linking Fen-Phen and Dexfen-Phen to several serious side effects, including heart disease, cardiac valvular disease, primary pulmonary hypertension (PPH), and cardiac fibrosis. These studies declared that an abnormal number of people using Fen-Phen or Dexfen-Phen showed signs of these conditions. Symptoms were seen in approximately 30% of the surveyed patients, which was an extraordinarily high number given the patients' ages. 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%.
Upon the release of the information regarding the cardiac risks, the drugs were withdrawn from the market in September 1997. The action was based on findings from doctors who had evaluated people taking these drugs with echocardiograms, a procedure that can test the functioning of heart valves. The findings indicated that approximately 1 in 3 people exposed to Fen-Phen showed signs of abnormal heart issues.
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Dexfen-Phen: fenfluramine and dexfenfluramine with phentermine
Dexfen-Phen was a combination of dexfenfluramine and phentermine. It was thought to be an effective way to fight obesity. However, like Fen-Phen, this drug combination was not adequately tested for safety. The drug manufacturer was more focused on obtaining FDA approval for dexfenfluramine than ensuring the drug was safe for consumers.
In 1997, two separate studies published in the New England Journal of Medicine (NEJM) linked Dexfen-Phen to several serious side effects, including heart disease, cardiac valvular disease, primary pulmonary hypertension (PPH), and cardiac fibrosis. An abnormally high number of people using Dexfen-Phen showed signs of these conditions, with symptoms appearing in approximately 30% of surveyed patients. This was considered an extraordinarily high number given the patients' ages.
The popularity of Dexfen-Phen can be traced back to the 1990s when a new prescription known as Fen-Phen, a combination of fenfluramine and phentermine, entered the market. Fen-Phen gained popularity as an easy way to lose weight. Despite never receiving approval from the FDA, manufacturers quickly produced and marketed the drug to meet the rising demand from patients across the country.
Following the introduction of Fen-Phen, another version of fenfluramine called Redux® was introduced to the market. Both Fen-Phen and Redux® were initially believed to be safe and effective weight loss drugs. However, in 1997, two medical studies submitted to the New England Journal of Medicine (NEJM) revealed evidence of severe cardiac problems in individuals who had taken these drugs. Approximately one in three people exposed to Fen-Phen exhibited signs of abnormal heart issues.
The history of diet pills is marked by a recurring tension between the desire for easy weight loss and the need for safe, effective solutions. While Dexfen-Phen and similar drugs may have offered a tempting solution to weight loss struggles, the lack of adequate safety testing and the emergence of serious side effects highlight the potential risks associated with such drugs.
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Rainbow diet pills: brightly coloured capsules with amphetamines, diuretics, laxatives, and thyroid hormones
Rainbow diet pills, named for their bright and varied colours, are a combination of amphetamines, barbiturates, thyroid extract, diuretics, and laxatives. These pills first emerged in the 1940s, when the anorectic effects of amphetamine were discovered, generating interest in combination weight loss regimens. Pharmaceutical companies attempted to capitalise on amphetamine's appetite-suppressing effects while suppressing its adverse effects.
The brightly coloured capsules and tablets, commonly referred to as rainbow diet pills, were heavily promoted by pharmaceutical firms to physicians and patients. These pills combined amphetamines, diuretics, laxatives, and thyroid hormones, along with other drugs like digitalis, benzodiazepines, barbiturates, potassium, corticosteroids, and antidepressants. The additional drugs were meant to suppress the common side effects of weight loss medications, such as insomnia, palpitations, anxiety, and gastrointestinal issues.
The use of thyroid hormones in weight loss treatments dates back to the late 19th century when thyroid extract was believed to boost metabolism and promote weight loss. While it was initially recommended only for individuals with hypothyroidism, it was later used routinely for weight loss, leading to serious symptoms such as thyrotoxicosis. Amphetamines, on the other hand, were understood to control appetite, but their long-term use was associated with cardiac stimulation and the potential for addiction.
By the 1960s, the rainbow pills had caused dozens of deaths, leading to their removal from the US market by the FDA. However, they continued to be popular in Spain and Brazil in the 1980s and 1990s, with similar compositions and side effects. In Brazil, for example, rainbow pills combined amphetamine derivatives, thyroid hormones, laxatives, and diuretics with benzodiazepines, fluoxetine, potassium, and herbal ingredients. In Spain, physicians prescribed rainbow pills that included amphetamines, thyroid hormones, diuretics, corticosteroids, benzodiazepines, and other glandular extracts.
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Phenylpropanolamine: an ingredient in popular non-prescription diet pills
In the 1980s and 1990s, "rainbow diet pills" were popular in Spain and Brazil. These pills, a combination of amphetamines, diuretics, laxatives, and thyroid hormones, were initially marketed in the US in the 1940s. By the 1960s, they had caused dozens of deaths and were removed from the US market.
In the 1990s, a prescription known as Fen-Phen (fenfluramine and phentermine) gained popularity as an effective way to lose weight. However, it was not approved by the FDA, and in 1997, two separate studies linked it to severe cardiac problems.
Another diet pill ingredient that caused concern in the 1980s was phenylpropanolamine. Phenylpropanolamine is also found in cold and allergy medications. It was believed to be an effective appetite suppressant, with some studies showing that dieters taking it lost an average of one pound a week. However, a study in 1980 showed that a single dose could cause alarming rises in blood pressure, even in young, healthy people. Several students in the study had headaches, chest pain, heart palpitations, and dizziness, and three required intravenous medicine to lower their blood pressure.
The Food and Drug Administration asked companies to take their best-selling products containing phenylpropanolamine off the market due to the potentially dangerous side effects. Products containing this ingredient that were withdrawn from the market included Diatec Diet Aid Drops, Dietic tablets, Ayds AM/PM, Appetite Suppressant Capsules, Control Drops, Extra Strength Appedrine tablets, Vita-Slim Capsules, Super Odrinex Tablets, Power-Slim Packets, and Bio Slim T Time-Release Capsules.
Despite the dangers, some firms continued to produce high-dose diet pills containing phenylpropanolamine. This was due to an FDA panel conclusion that the ingredient was "safe and effective." However, this conclusion was sharply criticized by other drug and obesity experts, who stated that there was no good evidence that the ingredient helped obese patients achieve long-term weight reduction.
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Frequently asked questions
Fen-Phen, a combination of fenfluramine and phentermine, was a popular diet pill in the 1990s. While it was never approved by the FDA, it was widely used and linked to severe cardiac issues. including heart disease and cardiac fibrosis.
"Rainbow diet pills", which were a combination of amphetamines, diuretics, laxatives, and thyroid hormones, were also popular in the 1990s in Spain and Brazil. These pills had caused dozens of deaths by the 1960s and were removed from the US market. However, they continued to be used in underground markets in Europe and enjoyed a resurgence in the 1980s and 1990s in Spain and Brazil.
Approximately 1 in 3 people exposed to Fen-Phen showed signs of abnormal heart issues. In addition, two separate studies in 1997 linked Fen-Phen to serious side effects, including heart disease, cardiac valvular disease, primary pulmonary hypertension (PPH), and cardiac fibrosis.
