United States Pharmacopeia Safety Evaluation of Spirulina

Abstract

The Dietary Supplements Information Expert Committee (DSI-EC) of the United States Pharmacopeial Convention (USP) reviews the safety of dietary supplements and dietary supplement ingredients for the purpose of determining whether they should be admitted as quality monographs into the United States Pharmacopeia and National Formulary (USP-NF). The United States Food and Drug Administration (FDA) has enforcement authority to pursue a misbranding action in those instances where a dietary supplement product indicates that it conforms to USP standards but fails to so conform. Recently DSI-EC undertook a safety evaluation of spirulina, a widely used dietary ingredient. DSI-EC reviewed information from human clinical trials, animal studies, and regulatory and pharmacopeial sources and analyzed 31 adverse event reports regarding spirulina to assess potential health concerns. At the conclusion of this review, DSI-EC assigned a Class A safety rating for Spirulina maxima and S. platensis, thereby permitting the admission of quality monographs for these dietary supplement ingredients in USP-NF. DSI-EC continually monitors reports concerning the safety of dietary supplements and dietary supplement ingredients for which USP dietary supplement monographs are developed. The DSI-EC may revisit the safety classification of spirulina as new information on this dietary ingredient becomes available.

Study of the Toxicity of ?Spirulina Plus? in HIV1 Infected Patients in Ouagadougou, Burkina Faso

“…The enrichment of spirulina with zinc and selenium as well as the posology used, could possibly explain these differences. Similarly, the same undesirable effects noted with simple spirulina types such as the following: hypoglycaemia, reduction of triglycerides and total cholesterol [23][24][25][26][27][28][29][30][31][32][33][34], hepato toxicity through increase in transaminases [11,12], increase in hemoglobin [3,7,31], were not observed in patients taking "Spiruline plus" only. This presumably would confirm the important role of oligo elements (zinc and selenium) when added to spirulina.…”

“…Indeed persons with HIV on antiretroviral treatment, sometimes have problems with toxicity, especially those vital functions (liver, pancreas, heart) and metabolic (hematological disorders, glucose, lipid). Also some of these side effects have been reported in clinical cases [9,10] and pharmacovigilance reports [12] with spirulina. Hepatic toxicities encountered with antiretroviral drugs non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors for HIV (IP) have been reported in these reports.…”

“…As a matter of fact, a realization of electrophoresis of proteins should have confirmed that. Hepatic, dermatological and rhabdomyalyse toxicities noticed in clinical studies [9][10][11] as well as hepatic, dermatological, hematological, nephrological toxicities and electrolytic problems referred to in pharmacovigilance reports [12] with simple spirulina were observed neither in patients taking "Spiruline plus" nor only in those taking ARTs and "Spiruline plus". The enrichment of spirulina with zinc and selenium as well as the posology used, could possibly explain these differences.…”

“…However, adverse effects reported in previous studies [9][10][11][12], raise questions about the possible consequences of its association with antiretroviral [2]. Indeed persons with HIV on antiretroviral treatment, sometimes have problems with toxicity, especially those vital functions (liver, pancreas, heart) and metabolic (hematological disorders, glucose, lipid).…”

Análise Da Desidratação De Spirulina Platensis Por Infravermelho

“…O termo Spirulina se refere a um grande número de espécies de microalgas, cujas espécies mais comumente utilizadas na dieta são S. maxima, S. platensis e S. fusiformis (Marles et al, 2010). Também conhecida como alga verde-azulada, a Spirulina é uma fonte segura e natural de uma elevada variedade de nutrientes essenciais, tais como pró-vitaminas, minerais, proteínas e ácidos graxos poli-insaturados (Miranda et al, 1998).…”