Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system

Introduction. The safety of vitamin K antagonists (VKA) use can be compromised by many popular herbal supplements taken by individuals. The literature reports that 30% of warfarin-treated patients self-medicates with herbs. Possible interactions represent an health risk. We aimed to identify all herbs-oral anticoagulants interactions collected in the Italian database of suspected adverse reactions to “natural health” products.Methods. The Italian database of spontaneous reports of suspected adverse reactions to natural products was analyzed to address herb-VKAs interactions.Results. From 2002 to 2009, we identified 12 reports with 7 cases of INR reduction in patients treated with warfarin (n=3) and acenocoumarol (n=4), and 5 cases of INR increase (all warfarin associated). It was reported 8 different herbal products as possibly interacting.Discussion. Our study confirms the risk of interactions, highlighting the difficulty to characterize them and their mechanisms and, finally, prevent their onset. The reported data underline the urgent need of healthcare providers being aware of the possible interaction between natural products and VKA, also because of the critical clinical conditions affecting patients. This is the first step to have the best approach to understand possible INR alterations linked to herb-VKA interaction and to rightly educate patients in treatment with VKA.

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Suspected adverse reactions associated with herbal products used for weight loss: spontaneous reports from the Italian Phytovigilance System

European Journal of Clinical Pharmacology ◽

10.1007/s00228-019-02746-6 ◽

2019 ◽

Vol 75 (11) ◽

pp. 1599-1615

Author(s):

Gabriela Mazzanti ◽

Annabella Vitalone ◽

Roberto Da Cas ◽

Francesca Menniti-Ippolito

Keyword(s):

Weight Loss ◽

Adverse Reactions ◽

Herbal Products ◽

Spontaneous Reports ◽

Suspected Adverse Reactions

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Zolpidem for Insomnia: A Double-Edged Sword. A Systematic Literature Review on Zolpidem-Induced Complex Sleep Behaviors

Indian Journal of Psychological Medicine ◽

10.1177/0253717621992372 ◽

2021 ◽

pp. 025371762199237

Author(s):

Niti Mittal ◽

Rakesh Mittal ◽

M. C. Gupta

Keyword(s):

Adverse Reactions ◽

Case Reports ◽

Case Series ◽

Eligibility Criteria ◽

Study Objective ◽

Spontaneous Reports ◽

Cochrane Database ◽

Sleep Behaviors ◽

Therapeutic Doses ◽

Favorable Side Effect Profile

Background: Being a nonbenzodiazepine, zolpidem is believed to have a favorable side-effect profile and is widely prescribed for insomnia. However, in the past few years, numerous neuropsychiatric adverse reactions, particularly complex sleep behaviors (CSBs), have been reported with zolpidem. Objective: To conduct a systematic review of zolpidem-associated CSBs. Data Sources: An electronic search was conducted using MEDLINE, Embase, PubMed, and Cochrane database of systematic reviews to extract relevant articles till July 2020. Study Eligibility Criteria: Any type of literature article (case report, case series, and observational or interventional study) reporting CSBs associated with zolpidem. Results: In this review, we present aggregate summarized data from 148 patients presenting with zolpidem-induced CSBs (79 patients from 23 case reports and 5 case series; 69 patients out of 1454 taking zolpidem [4.7%] from three observational clinical studies). Various types of CSBs associated with zolpidem were reported, most common being sleepwalking/somnambulism and sleep-related eating disorder. On causality assessment, around 88% of cases were found to have a probable association with zolpidem. Limitations: Extraction of data from observational studies and spontaneous reports, due to nonavailability of any randomized controlled trials relevant to the study objective. Conclusion and Implication of Key Findings: Zolpidem-induced CSBs, although not very common, may develop when the drug is used at therapeutic doses for insomnia. Doctors need to be alert to monitor such adverse effects of zolpidem and exercise caution while prescribing it.

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Suspected adverse reactions, 2007

Veterinary Record ◽

10.1136/vr.163.3.69 ◽

2008 ◽

Vol 163 (3) ◽

pp. 69-72 ◽

Cited By ~ 6

Author(s):

F. Dyer ◽

M. Spagnuolo-Weaver ◽

S. Cooles ◽

A. Tait

Keyword(s):

Adverse Reactions ◽

Suspected Adverse Reactions

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Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

Safety and Risk of Pharmacotherapy ◽

10.30895/2312-7821-2021-9-1-34-42 ◽

2021 ◽

Vol 9 (1) ◽

pp. 34-42

Author(s):

E. Yu. Demchenkova ◽

G. I. Gorodetskaya ◽

I. A. Mazerkina ◽

M. V. Zhuravleva ◽

A. S. Kazakov ◽

...

Keyword(s):

Adverse Events ◽

Adverse Drug Reactions ◽

Patient Information ◽

Adverse Reactions ◽

Stevens Johnson Syndrome ◽

Drug Reactions ◽

Patient Information Leaflets ◽

Information Leaflets ◽

Spontaneous Reports ◽

Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

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Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Archives of Medical Science ◽

10.5114/aoms/133716 ◽

2021 ◽

Author(s):

Maciej Banach ◽

Niki Katsiki ◽

Gustavs Latkovskis ◽

Manfredi Rizzo ◽

Daniel Pella ◽

...

Keyword(s):

Adverse Events ◽

Adverse Reactions ◽

Case Reports ◽

Food Supplement ◽

Product Line ◽

Food Supplements ◽

Red Yeast Rice ◽

Red Yeast ◽

Consumer Safety ◽

Suspected Adverse Reactions

IntroductionIn the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).Material and methodsWe report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1st October 2004 to 31st December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.ResultsThe total number of case reports received mentioning the RYR food supplement product line was 542, in which 855 adverse events (AEs) were reported. The total reporting rate of AEs was estimated to be 0.037% of 2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (SAEs). After careful investigation, 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical.ConclusionsThis nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected adverse events associated with the red yeast rice product line. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement’s labeling.

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