How a nasal decongestant became the biggest appetite suppressant of all time

It’s surprising to think that the elimination of a single medically approved ingredient could cripple two separate pharmaceutical industries. It’s also surprising to think that the pharmaceutical in the most popular appetite suppressants of all time – phenylpropanolamine, more commonly abbreviated as PPA – made its initial breakthrough as a nasal decongestant.

And yet, that is exactly what happened.

PPA hit the market in the mid-1930s with the kind of blood vessel-tightening properties that staved off nasal congestion, only for users to report the side effect of not feeling hungry. The diet industry, of course, quickly picked up on this, and for the next 60 years played chicken with the Food and Drug Administration and other prominent health experts, before it all happened. collapses – taking almost all cold and flu meds. down with that.

APP officially enters the market as an appetite suppressant

The real rise of APP as an appetite suppressant began in the 1950s when its patent protection expired – particularly in terms of newspaper advertising volume. Although sold under brand names like Curb-wate and Trimet, the majority of advertisements were transparent in revealing that the main active ingredient was none other than PPA. In fact, Trimet’s advertisements went to great lengths to explain why an approved nasal decongestant had come to be used in an appetite-suppressing capacity.

“There is a well-known drug called phenylpropanolamine hydrochloride, which has been widely recognized and used in the control of symptomatic hay fever allergy and bronchial asthma,” said one such 1957 advertisement. patients often complained that it seemed to reduce their appetite. This led some doctors to try it as an appetite suppressant in obese patients who had trouble controlling their eating. Found free of unwanted side effects, it was considered as safe for use without medical supervision.

In response, the National Better Business Bureau quickly released a statement disparaging the marketing of PPA as a “no-diet miracle drug” as “false, misleading and a disservice to the public.” But PPA’s legitimate prescriptive usefulness as a nasal decongestant seemed to offer it a level of protection against stricter regulations that other appetite suppressants rarely enjoy.

Ads for two very different PPA products from 1959

With no real competitors on the appetite suppressant front who enjoyed similar protection from regulation, the proliferation of APP continued unabated over the following decades, finding its way into a growing number of products, including a wider range of cold medicines and appetite suppressants. The drug also received unexpected support from the Food and Drug Association.

In December 1972, Director of the FDA’s Office of Drugs, Henry E. Timmons, testified before a Senate subcommittee and resisted encouragement from subcommittee members to reject the FDA’s appetite suppressants. era – almost all of which contained a combination of PPA and benzocaine – as ineffective. “Obesity is a serious disease and there is nothing effective except food, if you can get a patient to stay on a diet,” he argued. “These drugs are very effective for some people. They should be available for those who need something; otherwise, they would have nothing to turn to.

Contac Anti-Cold Container from 1965, with PPA as the active ingredient

Meanwhile, manufacturers of appetite suppressants have filled the vacuum of FDA inaction with unflinching claims about the effectiveness of their products. “We have many women who write to us who have tried our product and say they have lost 5, 10 or 15 pounds and are happy with it,” said Duane Nickless, director of sales for the Gobese company, in an April. 1974 article from Mail-post.

The appetite suppressant effects of PPA are proven

Finally, in February 1979, the results of two tests carried out at the University of Pennsylvania and at Princeton University seemed to confirm that PPA did indeed have appetite suppressant properties. Ironically, Princeton researcher Bartley G. Hoebel’s concern was rooted in identifying whether or not cold and allergy medication clients had their appetites unnecessarily reduced due to uninformed consumption of side-effect medications. hidden.

Another pharmaceutical researcher who declined to be named shared similar concerns with the Mail-post“Too many people take over-the-counter drugs and are unaware of their unlisted side effects. Whether or not it is harmful to them individually, people have a right to know that a cold pill they are taking contains an appetite suppressant.

And yet, again, some voices inside the FDA – this time an internal advisory group – continued to claim that phenylpropanolamine was a “safe and effective way to control appetite for weight loss.” Appetite suppressant producers seized on this statement, quickly adding “FDA approved” labels to their product descriptions, knowing full well that an internal FDA panel did not equate to official approval. by the agency as a whole.

In fact, the larger FDA has declared PPA a drug that is still under official review, and the agency has firmly established 37.5 milligrams as the maximum recommended single dose of PPA, with 75 milligrams as the maximum daily dose. Additionally, the FDA has asked manufacturers offering larger doses to voluntarily remove their products from the market.

Their plea, however, fell on deaf ears, as revenue from APP-containing appetite suppressants doubled from $100 million to $200 million between 1979 and 1980.

PPA in the hot seat

Now that the effectiveness of APP as an appetite suppressant could no longer be disputed, many of its opponents sought to ban it on the grounds that it might prove harmful. By mid-1985, it appeared that the PPA’s days were numbered, as the FDA was holding town hall meetings across the country seeking input from those who would prefer to see it banned from all appetite suppressants. At a time, The medical lettera bi-weekly peer-reviewed publication that provides pharmaceutical drug reviews, has begun reporting serious cases of illness and death in heart patients taking PPA for its uncontroversial use as a remedy for cold symptoms, with some citing even incidents of kidney failure. .

Yet the problem persisted for several years as weight-loss supplement manufacturers developed even more elaborate methods of delivering PPA, such as adhesive patches that delivered PPA through the skin. As reported by New York Daily News in May 1988, “Most patches use herbal potpourri, but one company – the perfect combination based in North Carolina – relies on the drug PPA, which is FDA-approved for use in pills and sold by other companies in pill form like Dexatrim and Accutrim.

But again, PPA had never been officially approved for use as an appetite suppressant by the FDA; the agency had simply refused to make an official decision on the matter. In the meantime, the Washington Post reported in June 1988 that the FDA had already decreed the seizure of diet patches that provided motion sickness medication as an active ingredient.

Eventually, in August 1991, the FDA took action by banning the sale or marketing of 111 ingredients as weight loss aids, including alcohol, caffeine, guar gum, ascorbic acid, sodium and yeast. However, no decision has been rendered against PPA, which has managed to linger in regulatory limbo for nearly another decade.

The last days of the PPA

In October 2000, Yale researchers presented the results of a five-year study to the FDA which indicated that users of cough, cold, and allergy remedies containing PPA were 50% more likely to experience a stroke. hemorrhagic than those who had not used them. also noting that women seemed to be particularly susceptible. In total, the study estimated that between 200 and 500 people suffered strokes each year as a direct result of ingesting PPA for approved medical purposes.

“It’s a heart and brain stimulant,” Raymond Woosley, chairman of pharmacology at Georgetown Medical School, told Gannett News Service. “It’s a weakling, but there are people who are extremely sensitive to it.”

In official response, the FDA quickly issued a public warning about the health threat posed by PPA and asked each drugmaker to voluntarily remove its PPA-fortified products from pharmacy shelves and reformulate these drugs before a return. on the market. Simultaneously, several national drugstore chains, including Walgreens and Rite Aid, preemptively removed PPA products from shelves — a serious undertaking since PPA was an active ingredient in almost every cough, cold, and allergy remedy on the market. the market at the time (from Alka Seltzer Plus to Robitussin).

However, not everyone agreed with the FDA’s decision or its implications. When Health Canada took the FDA’s request one step further and outright banned more than 60 APP-containing drugs until reformulations were complete, Steven Milloy of national post said the whole ordeal was an act of “statistical malpractice” in light of the billions of doses of blacklisted products that were dispensed each year compared to the small number of alleged strokes.

But at least in the United States, this proved to be an unconvincing argument. The FDA applied the “non-monographic” label to APP in 2005, officially declaring it “not generally recognized as safe and effective”, unofficially giving it a death sentence. And that was more or less that. Cold and sinus meds reverted back to being mostly cold and sinus meds (without ASF), and the diet industry was forced to look elsewhere for pharmaceutical solutions they could market as wonder drugs. – the two apparently very different paths having never crossed since.

About Terry Gongora

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