Assuntos
Fármacos Antiobesidade/uso terapêutico , Benzazepinas/uso terapêutico , Aprovação de Drogas , Frutose/análogos & derivados , Obesidade/tratamento farmacológico , Fentermina/uso terapêutico , Anormalidades Induzidas por Medicamentos , Fármacos Antiobesidade/efeitos adversos , Preparações de Ação Retardada , Combinação de Medicamentos , Feminino , Frutose/efeitos adversos , Frutose/uso terapêutico , Humanos , Gravidez , Agonistas do Receptor de Serotonina/uso terapêutico , Topiramato , Estados Unidos , United States Food and Drug Administration , Redução de Peso/efeitos dos fármacosAssuntos
Fármacos Antiobesidade/história , Obesidade/tratamento farmacológico , United States Food and Drug Administration/história , Adolescente , Adulto , Comitês Consultivos/história , Idoso , Fármacos Antiobesidade/efeitos adversos , Fármacos Antiobesidade/uso terapêutico , Medicina Bariátrica/história , Índice de Massa Corporal , Criança , Congressos como Assunto/história , Ciclobutanos/uso terapêutico , Diabetes Mellitus Tipo 2/epidemiologia , Aprovação de Drogas , Descoberta de Drogas , Feminino , História do Século XX , História do Século XXI , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Obesidade/epidemiologia , Obesidade/história , Avaliação de Resultados em Cuidados de Saúde , Piperidinas/efeitos adversos , Piperidinas/uso terapêutico , Guias de Prática Clínica como Assunto , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Padrões de Referência , Rimonabanto , Retirada de Medicamento Baseada em Segurança , Estados Unidos/epidemiologiaAssuntos
Anticolesterolemiantes/administração & dosagem , Dislipidemias/tratamento farmacológico , Doenças Musculares/induzido quimicamente , Sinvastatina/administração & dosagem , Anticolesterolemiantes/efeitos adversos , Creatina Quinase/sangue , Aprovação de Drogas , Interações Medicamentosas , Rotulagem de Medicamentos , Humanos , Risco , Sinvastatina/efeitos adversos , Estados Unidos , United States Food and Drug AdministrationRESUMO
BACKGROUND: We detected disproportionate reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) in the Food and Drug Administration's (FDA) spontaneous adverse event (AE) reporting system (AERS). PURPOSE: To describe the original ALS signal and to provide additional context for interpreting the signal by conducting retrospective analyses of data from long-term, placebo-controlled clinical trials of statins. METHODS: The ALS signal was detected using the multi-item gamma Poisson shrinker (MGPS) algorithm. All AERS cases of ALS reported in association with use of a statin were individually reviewed by two FDA neurologists. Manufacturers of lovastatin, pravastatin, simvastatin, fluvastatin, atorvastatin, cerivastatin, and rosuvastatin were requested to provide the number of cases of ALS diagnosed during all of their placebo-controlled statin trials that were at least 6 months in duration. RESULTS: There were 91 US and foreign reports of ALS with statins in AERS. The data mining signal scores for ALS and statins ranged from 8.5 to 1.6. Data were obtained from 41 statin clinical trials ranging in duration from 6 months to 5 years and representing approximately 200,000 patient-years of exposure to statin and approximately 200,000 patient-years of exposure to placebo. Nine cases of ALS were reported in statin-treated patients and 10 cases in placebo-treated patients. CONCLUSIONS: Although we observed a data mining signal for ALS with statins in FDA's AERS, retrospective analyses of 41 statin clinical trials did not reveal an increased incidence of ALS in subjects treated with a statin compared with placebo.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Esclerose Lateral Amiotrófica/induzido quimicamente , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , United States Food and Drug Administration , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Esclerose Lateral Amiotrófica/epidemiologia , Ensaios Clínicos Controlados como Assunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Estudos Retrospectivos , Estados Unidos/epidemiologia , United States Food and Drug Administration/estatística & dados numéricosRESUMO
In the early 1930s, the industrial chemical dinitrophenol found widespread favor as a weight-loss drug, due principally to the work of Maurice Tainter, a clinical pharmacologist from Stanford University. Unfortunately the compound's therapeutic index was razor thin and it was not until thousands of people suffered irreversible harm that mainstream physicians realized that dinitrophenol's risks outweighed its benefits and abandoned its use. Yet, it took passage of the Food, Drug, and Cosmetic Act in 1938 before federal regulators had the ability to stop patent medicine men from selling dinitrophenol to Americans lured by the promise of a drug that would safely melt one's fat away.
Assuntos
Fármacos Antiobesidade/efeitos adversos , Dinitrofenóis/efeitos adversos , Legislação de Medicamentos/história , Obesidade/tratamento farmacológico , Fármacos Antiobesidade/história , Fármacos Antiobesidade/farmacologia , Fármacos Antiobesidade/uso terapêutico , Dinitrofenóis/história , Dinitrofenóis/farmacologia , Dinitrofenóis/uso terapêutico , Conhecimentos, Atitudes e Prática em Saúde , História do Século XX , Humanos , Médicos , Charlatanismo/história , Estados Unidos , United States Food and Drug Administration/história , United States Food and Drug Administration/legislação & jurisprudênciaRESUMO
Beginning with the passage of the Federal Food, Drug, and Cosmetic Act in 1938 and escalating with the 1962 Kefauver-Harris amendments, increasing pressure has been placed on pharmaceutical manufacturers to demonstrate that a drug's benefits outweigh its risks. Nowhere has the question of risk versus benefit come under greater scrutiny than with anorectics. After the approval in the 1940s and 1950s of a number of amphetamine and amphetamine-like compounds for the treatment of obesity, the U.S. Food and Drug Administration struggled to define the efficacy and safety of these agents. Labeling restrictions on duration of use and warnings about abuse and addiction ultimately contributed to the reduced use of anorectics. That trend continued until the mid-1990s, when the off-label use of fenfluramine plus phentermine (fen-phen) and the approval of dexfenfluramine gave rise to widespread, long-term use of anorectics to treat obesity. The adverse effects that came to be associated with fenfluramine and dexfenfluramine, leading to their eventual withdrawal from the market, gave pause to regulators, physicians, patients, and drug companies alike. Sibutramine, the latest anorectic to enter the market, is now the focus of a landmark trial that is examining, for the first time, whether drug-induced weight loss reduces the risk for fatal and nonfatal cardiovascular disease.
Assuntos
Depressores do Apetite/história , História do Século XX , Humanos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudênciaRESUMO
Fielding Hudson Garrison once remarked that because his birthday fell on 5 November, Guy Fawkes Day, he was "fated to suffer from in-ward hell-fire and brimstone all [his] life". Though said in jest, Garrison was a vulnerable, melancholic and self-confessed lonely man who found solace in the papers, periodicals and books of the Army Medical Library-today's National Library of Medicine. Over the course of approximately 25 years, and often while working in his spare time, Garrison went from a clerk in the world's largest medical library to America's pioneering and, arguably, most prolific medical historian, past or present.
Assuntos
História da Medicina , Bibliotecários/história , National Library of Medicine (U.S.)/história , História do Século XIX , História do Século XX , Humanos , Medicina Militar/história , Estados UnidosRESUMO
In December 1979, the Food and Drug Administration's (FDA) Division of Metabolic and Endocrine Drug Products issued its Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis. The Guidance Document recommended study designs, patient populations for study, and techniques for evaluating skeletal mass and fracture frequency that were considered central to showing the efficacy and safety of drugs used to treat and prevent postmenopausal osteoporosis (PMO). In this paper, I discuss the evolution of the Osteoporosis Guidance as it relates to the pharmaceutical industry's efforts to develop effective and safe anti-osteoporosis drugs. Current regulatory policy on osteoporosis drugs and thoughts on the future direction of the Osteoporosis Guidance are also provided.