An experimental stimulant drug from the Second World War era is appearing in weight loss and sports supplements sold today, according to a new study.
The stimulant, known as fenprometamine, was last sold as a nasal inhaler called Vonedrina in the 1940s and 1950s, but has since been withdrawn from the market and has never been approved for oral use, according to the study, published Tuesday. fair (March 23)) in the newspaper Clinical Toxicology. It is also prohibited from competitive sports by World Anti-Doping Agency. The new study appears to be the first to confirm the presence of fenpromethamine in supplements, the authors said.
In addition to phenpromethamine, the study identified eight other stimulants banned in sports and weight loss supplements, which were often found mixed together in various combinations to create “cocktails” of stimulant drugs that have never been studied in people, the authors said.
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“This is really surprising,” said the study’s lead author, Dr. Pieter Cohen, a general practitioner at Cambridge Health Alliance and an associate professor of medicine at Harvard Medical School, to Live Science. “Finding nine different banned experimental stimulants at the same time was really quite shocking.” The authors found up to four different stimulants in a single supplement.
The risks of consuming these combinations of stimulants are unknown and these stimulants are not always listed on product labels, the authors noted.
“The FDA should alert consumers to the presence of experimental stimulant cocktails in weight loss and sports supplements and take immediate effective measures to remove these stimulants from the market,” wrote the authors in the study.
Prohibited stimulants
The researchers began their study looking not for phenpromethamine, but for a different stimulant called deterenol. Studies in Europe have found that supplements containing deterenol along with other stimulants have been associated with harmful effects in people, including nausea, vomiting, chest pain, cardiac arrest and even sudden death. (Deterenol was never approved for use in the United States, and in 2004, the FDA determined that the stimulant was not allowed in dietary supplements.)
For the study, they looked at 17 brands of supplements sold in the United States that were labeled as containing deterenol or a synonym for the drug. These products were generally marketed as weight loss supplements or sports supplements. (A complete list of these supplement brands can be found in the study.)
The researchers found deterenol in 13 of the 17 supplements. The next most commonly detected stimulant was fenpromethamine, present in four of the 17 brands.
There are very few data on the safety of fenpromethamine. When it was used in the 1940s and 1950s, it was only available as a nasal spray, Cohen said. The effects of taking the drug orally, which is how people would consume it today, are unknown. “If you concentrate it and take it in pill form, it can have totally different effects,” said Cohen.
Phenpromethamine is not the first stimulant of World War II to appear in dietary supplements. In 2004, after the FDA banned the stimulant ephedra from dietary supplements, manufacturers started adding other experimental stimulants, including 1,3-DMAA, which was previously marketed in 1948 as a nasal inhaler, said the authors. Since then, the FDA has banned 1,3-DMAA from supplements and has issued warnings that it may increase the risk of heart problems.
“As soon as the FDA warns of a stimulant, new, variants close to them tend to appear,” said Cohen.
So far, the FDA has not issued warnings to consumers about phenpromethamine, according to the study. In addition, FDA scientists recently detected deterenol in supplements, publishing their findings in the journal Drug testing and analysis in September 2020. But even after this discovery, the agency did not issue a warning, although the supplement was banned by the agency, Cohen said.
“There is no doubt that the FDA should have acted as soon as it determined [deterenol] was present, “said Cohen.” They should immediately alert consumers to deterenol; they must communicate to manufacturers that any supplement containing the stimulant needs to be removed. “
Although the FDA may not have warned about deterenol, the agency has warned about weight loss supplements in general. In your location on the Internet network, the FDA claims to have “identified an emerging trend” of dietary supplements that contain hidden and potentially harmful active ingredients. “Consumers may unknowingly take products mixed with varying amounts of approved prescription drug ingredients, controlled substances and untested and untested pharmaceutically active ingredients,” says the agency.
Of the nine stimulants found in the new study, seven – including 1,3-DMAA – have already been the subject of FDA warnings due to their presence in supplements. This finding agrees with that of a 2018 study by Cohen and colleagues that found that some dietary supplements still contain experimental stimulants years after these stimulants were banned by the FDA, Live Science previously reported.
Knowing whether a dietary supplement contains a prohibited stimulant can be difficult because manufacturers may not list the drug on the label or may use a synonym for the drug, Cohen said.
But in general, Cohen advises consumers to avoid two categories of dietary supplements – those labeled to say they will help you lose weight and those labeled as pre-workout or muscle-building supplements. (The latter category excludes protein powders, which usually contain amino acids and are not a cause for concern, Cohen said.) These categories of supplements cannot be considered safe until two things happen: “We reform the law so that the FDA has more authority enforcement agencies, and the FDA is beginning to enforce the law effectively, “said Cohen.
In a statement provided to Live Science, the FDA said it is reviewing the new study. “The FDA is dedicated to promoting our strategic priorities for dietary supplements: safety, product integrity and informed decision making. We appreciate studies like this to raise awareness and draw the necessary attention to these issues,” said the statement.
Originally published on Live Science.