Eskatrol was the

brand name A brand is a name, term, design, symbol or any other feature that distinguishes one seller's goods or service from those of other sellers. Brands are used in business, marketing, and advertising for recognition and, importantly, to create and ...

of a

combination In mathematics, a combination is a selection of items from a set that has distinct members, such that the order of selection does not matter (unlike permutations). For example, given three fruits, say an apple, an orange and a pear, there are ...

prescription drug A prescription drug (also prescription medication, prescription medicine or prescription-only medication) is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs c ...

manufactured by Smith, Kline & French Laboratories and

marketed Marketing is the act of acquiring, satisfying and retaining customers. It is one of the primary components of business management and commerce. Marketing is usually conducted by the seller, typically a retailer or manufacturer. Products can ...

in the

United States The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 ...

as an

appetite suppressant An anorectic is a drug that reduces appetite, resulting in lower food consumption, leading to weight loss. These substances work by affecting the central nervous system or certain neurotransmitters to create a feeling of fullness or reduce the desi ...

and weight loss agent (" diet pill").. The product's active ingredients comprised the

central nervous system The central nervous system (CNS) is the part of the nervous system consisting primarily of the brain, spinal cord and retina. The CNS is so named because the brain integrates the received information and coordinates and influences the activity o ...

(CNS)

stimulant Stimulants (also known as central nervous system stimulants, or psychostimulants, or colloquially as uppers) are a class of drugs that increase alertness. They are used for various purposes, such as enhancing attention, motivation, cognition, ...

, dextroamphetamine sulfate and the

typical antipsychotic Typical antipsychotics (also known as major tranquilizers, and first generation antipsychotics) are a class of antipsychotic drugs first developed in the 1950s and used to treat psychosis (in particular, schizophrenia). Typical antipsychotics m ...

prochlorperazine Prochlorperazine, formerly sold under the brand name Compazine among others, is a medication used to treat nausea, migraines, schizophrenia, psychosis and anxiety. It is a less preferred medication for anxiety. It may be taken by mouth, rectal ...

–the former of which was also manufactured by Smith, Kline, & French and marketed on its own as ''Dexedrine''. Eskatrol was among the 200 most commonly-prescribed medications in the U.S. in the early 1980s, when in 1981, the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) mandated the product cease production and be withdrawn from the market, on the assertion that SF&K had to failed to prove the medication's therapeutic efficacy ( ''E''_max).

Contextual background

Beginning with the

Kefauver–Harris Amendment The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs ...

in 1962, public policy discourse pertaining to combatting

substance abuse Substance misuse, also known as drug misuse or, in older vernacular, substance abuse, is the use of a drug in amounts or by methods that are harmful to the individual or others. It is a form of substance-related disorder, differing definition ...

by criminalizing drug use and strengthening legal penalties for drug use prohibiting substances like cannabis, LSD, and heroin was increasing, resulting in passage of

Controlled Substances Act The Controlled Substances Act (CSA) is the statute establishing federal government of the United States, federal drug policy of the United States, U.S. drug policy under which the manufacture, importation, possession, use, and distribution of ...

in late 1970, followed by the creation of the

Drug Enforcement Administration The Drug Enforcement Administration (DEA) is a Federal law enforcement in the United States, United States federal law enforcement agency under the U.S. Department of Justice tasked with combating illicit Illegal drug trade, drug trafficking a ...

in 1973.

Withdrawal of Combination Anorectics from the U.S. market

In August 1970 the U.S. FDA and announced a plan to combat stimulant abuse by limiting the number of treatment claims permitted on stimulant drug labels to three specific indications: the treatment of

narcolepsy Narcolepsy is a chronic neurological disorder that impairs the ability to regulate sleep–wake cycles, and specifically impacts REM (rapid eye movement) sleep. The symptoms of narcolepsy include excessive daytime sleepiness (EDS), sleep-r ...

, treatment of

hyperactivity Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by symptoms of inattention, hyperactivity, impulsivity, and emotional dysregulation that are excessive and pervasive, impairing in multiple ...

, and

treatment of obesity Management of obesity can include lifestyle changes, medications, or surgery. Although many studies have sought effective interventions, there is currently no evidence-based, well-defined, and efficient intervention to prevent obesity. Treatment ...

; in the case of treating obesity, in addition to intensifying warnings of potential drug hazards and side effects. Regarding the use of amphetamines as

anorectic An anorectic is a drug that reduces appetite, resulting in lower food consumption, leading to weight loss. These substances work by affecting the central nervous system or certain neurotransmitters to create a feeling of fullness or reduce the desi ...

agents, the FDA further restricted use of such drugs for

weight loss Weight loss, in the context of medicine, health, or physical fitness, refers to a reduction of the total body mass, by a mean loss of fluid, body fat (adipose tissue), or lean mass (namely bone mineral deposits, muscle, tendon, and other conn ...

to short-term use, generally six to twelve weeks. As a result of this context, the combination drugs

Obetrol Obetrol was the brand name of a drug combining several amphetamine salts indicated for the treatment of exogenous obesity. It was originally sold by the American company Obetrol Pharmaceuticals. Obetrol was a popular diet pill in America in the ...

, Desbutal, Acutranand were all withdrawn from the market concurrently in 1973, followed by Eskatrol in 1981, and

Dexamyl Dexamyl (or Drinamyl in the UK) was the brand name of a combination drug composed of amobarbital (previously called amylbarbitone) and dextroamphetamine (Dexedrine) within the same pill. It was widely abused and is no longer manufactured. First ...

in 1982.

Pop culture

Jimmy Buffett James William Buffett (December 25, 1946 – September 1, 2023) was an American singer-songwriter, author, and businessman. He was known for his tropical rock sound and persona, which often portrayed a lifestyle described as "island escapis ...

references the drug in his 1980 song "Fool Button," with the lyric "If you don't believe my words/ Or think my story′s true/ Get a bottle of rum and a Eskatrol/ And watch the same thing happen to you."

References

Withdrawn drugs Substituted amphetamines {{gastrointestinal-drug-stub

Contextual background

Withdrawal of Combination Anorectics from the U.S. market

Pop culture

See also

References