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The Non-Prescription Products – Market-Profits and Public Health in Conflict
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
For many years, the FDA acted against unproven products on a case-by-case basis. With inadequate funding and manpower, it was not possible to be everywhere at once. A good example of FDA using its power wisely came in the wake of a deadly tragedy (555). In 1989, FDA warned consumers not to take l-tryptophan sold as a sleep aid, although evidence of safety and efficacy were lacking. Unfortunately, it was found to be the proximate cause of at least 1,500 cases of eosinophilia-myalgia syndrome, with 31 or more deaths (555). FDA imposed a detention on the imported supplement and recalled it to prevent further deaths.
The Epidemiological Approach
Published in Hanna Pickard, Serge H. Ahmed, The Routledge Handbook of Philosophy and Science of Addiction, 2019
An instructive example can be seen in Figure 21.1, which depicts a United States (US) epidemic curve, 1988–1990, for a sometimes fatal eosinophilia-myalgia syndrome (EMS), observed as progressively worsening muscle pain, generally with fatigue, plus elevated pro-inflammatory white blood cells indicative of immune response and inflammation, often seen with allied clinical features. Initial clinician case reports about EMS launched government-initiated nationwide surveillance, plus several small scale ‘controlled retrospection’ case-control studies typified in the next section. Suspected exposures to L-tryptophan-containing products (e.g., LTCP dietary supplements) were identified as potential EMS causes before November 1989. That month, the US Food and Drug Administration (FDA) asked vendors to disrupt LTCP sales and encouraged users to abstain. The epidemic ended soon afterward. The FDA investigation of LTCP batches disclosed likely contamination via a manufacturing process change. Swygert et al. (1990) provided details about EMS-LTPC; Goodman and colleagues (2012) summarized and added details on other epidemiology victories in public health.
Generic prescribing
Published in Conrad Harris, Jane Richards, Prescribing in General Practice, 2018
In some cases, lack of therapeutic equivalence may be due to an excipient or impurity causing an ‘allergic’ response. Erythema multiforme developing after a patient was switched from Tegretol® to a generic preparation has been reported. One patient had a skin complaint attributed (correctly) to an excipient in Epilim®. The widely publicized problem of eosinophilia myalgia syndrome following tryptophan ingestion has been attributed to an impurity. Similarly, during the illicit production of a ‘designer’ opiate in California, a contaminant, known as MPTP, led to Parkinsonism.
Pharmacotherapeutic management of sleep disorders in children with neurodevelopmental disorders
Published in Expert Opinion on Pharmacotherapy, 2019
Oliviero Bruni, Marco Angriman, Maria Grazia Melegari, Raffaele Ferri
In 1989, LT (not L-5-HTP) caused an epidemic of eosinophilia-myalgia syndrome [140–142]. Because of its chemical and biochemical relationship to LT, 5-HTP has been under vigilance for its safety. However, no definite cases of toxicity have emerged despite the worldwide usage of 5-HTP for several years [143]. On the other hand, there are several recent reports on the use of L-5-HTP in children without the occurrence of side-effects [144–146]. The substances contaminating previous pharmaceutical preparations of L-5-HTP are no longer present in measurable amounts in the preparations now available on the market because of the improved purification and analysis methods.
Associated factors of early-onset pulmonary hypertension and clinical difference between early- and late-onset pulmonary hypertension in Thai systemic sclerosis
Published in Modern Rheumatology, 2021
Thanachit Krikeerati, Burabha Pussadhamma, Ajanee Mahakkanukrauh, Siraphop Suwannaroj, Ratanavadee Nanagara, Chingching Foocharoen
A cohort study was conducted among SSc patients over 18 years of age who attended the Scleroderma Clinic at Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand, between January 2014 and December 2016. We excluded patients diagnosed with (a) any overlap with other connective tissue diseases, (b) coexisting localized scleroderma, (c) eosinophilic fasciitis, (d) eosinophilia myalgia syndrome, and/or (e) PH or pulmonary arterial hypertension (PAH) without right heart catheterization (RHC) confirmation.
Clinical guide to eosinophilic fasciitis: straddling dermatology and rheumatology
Published in Expert Review of Clinical Immunology, 2022
EF is distinguished from systemic sclerosis by the absence in EF of three typical findings in systemic sclerosis – sclerodactyly, Raynaud’s phenomenon, and nailfold capillary changes, as well presence of anticentromere, anti- topoisomerase I, and anti-RNA polymerase III antibodies. In distinction, the face, hands, and feet are spared in EF [1,3]. Morphea profunda holds clinical and histological similarities with plaque-like EF [3,5]. While isomorphic morphea occurs in areas of skin friction (not so EF), the symmetrical morphea variant is distributed on the trunk and extremities alike EF and may be confused with EF. Moreover, EF and morphea may overlap. The toxic oil syndrome, caused by ingestion of adulterated rapeseed oil 1981 in Spain, was characterized by morphea-like skin lesions affecting the face, trunk, and extremities, along with myopathy, peripheral neuropathy, and arthralgia [8]. The eosinophilia–myalgia syndrome, which had epidemic proportions in 1989 was caused by ingestion of the dietary supplement L-5-hydroxytryptophan, unfortunately contaminated. Patients complained of severe myalgias. Morphea-like lesions were conspicuous. Visceral involvement was occasionally present. Blood eosinophilia was a frequent attribute [9]. Nephrogenic systemic fibrosis is a progressive multiorgan fibrosing condition developing 2 to 75 days after exposure to gadolinium-based contrast agents used for magnetic resonance imaging. Patients with advanced renal insufficiency are at higher risk. Prominent findings on physical examination are indurated papules and plaques, on the extremities, buttocks, and trunk, sparing the face [10]. Other fibrosing disorders, easily distinguished on physical examination from EF, are myxedema, scleredema, and palmar fasciitis. Pretibial myxedema is a cutaneous manifestation of Graves’ disease presenting as yellowish-brown papules, nodules and plaques on both shins; it may be refractory to control of underlying thyroid disease. Scleredema of Buschke is characterized by stiffness and hardening of the subcutaneous tissues on the upper back and posterior surface of the neck. Palmar fasciitis is a paraneoplastic syndrome manifesting as a painful swelling of the hands, caused by inflammation and sclerosis of the palmar fascia, tendon sheaths, small joints of the fingers, and flexion contractures.