scholarly journals Postmarketing safety surveillance data reveals protective effects of botulinum toxin injections against incident anxiety

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
M. Axel Wollmer ◽  
Tigran Makunts ◽  
Tillmann H. C. Krüger ◽  
Ruben Abagyan

AbstractRandomized controlled trials (RCTs) have shown an antidepressant effect of glabellar botulinum toxin (BoNT) injections. In the FDA Adverse Event Reporting System (FAERS) database, BoNT injection is associated with reduced incidence rates of depression across various non-psychiatric indications, which confirms the previous findings independently of specific expectations to an antidepressant effect of BoNT. The rationale of using BoNT to treat depression is to interrupt proprioceptive body feedback that may reinforce negative emotions. Negative emotions also occur in other mental disorders, suggesting a transdiagnostic therapeutic potential of BoNT in psychiatry. Here we report an analysis of the FAERS database, in which we found that, compared to alternative treatments, BoNT injections were associated with lower incidence of anxiety symptoms and related disorders. Among seven indications/injection sites, we found this protective effect of BoNT in cosmetic use/facial muscles, migraine/facial and head muscles, spasms and spasticity/upper and lower limbs, torticollis and neck pain/neck muscles, and sialorrhea/parotid and submandibular glands (reporting odds ratios 0.79–0.27). These findings are encouraging for possible future RCTs on the use of BoNT as a treatment for anxiety and related disorders.

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254898
Author(s):  
Hyo-In Rhyou ◽  
Young-Hee Nam ◽  
Su-Chin Kim ◽  
Go-Eun Doo ◽  
Chae-Yeon Ha ◽  
...  

Cefaclor, a second-generation oral cephalosporin, is the most frequently prescribed cephalosporin in Korea. Studies, however, have yet to analyze the incidence of cefaclor-associated adverse drug reactions (ADRs), including hypersensitivity (HS), according to total national usage rates. This study aimed to investigate the incidence rates and clinical features of cefaclor ADRs reported to the Korean Adverse Event Reporting System (KAERS) and Health Insurance Review and Assessment Service (HIRA) database for the most recent 5 years. Reviewing the HIRA database, which contains information on all insurance claims, including prescribed medications and patient demographics, we identified the total number of individuals who had been prescribed cefaclor and other cephalosporins including 2nd generation without cefaclor and 3rd generation antibiotics from January 2014 to December 2018. Additionally, we retrospectively analyzed all ADRs reported to the KAERS for these drugs over the same study period. Incidence rates for ADRs, HS, and anaphylaxis to cefaclor were 1.92/10,000 persons, 1.17/10,000 persons, and 0.38/10,000 persons, respectively, lower than those to other 2nd and 3rd cephalosporins. Among all ADRs, HS (60.9% vs. 43.6% vs. 44.8%, P <0.001) and anaphylaxis (19.8% vs. 4.6% vs. 4.7%, P <0.001) were more common for cefaclor than for other 2nd and 3rd cephalosporins. Females, individuals under 65 years of age, concomitant use of drugs, and serious ADRs were more strongly associated with HS to cefaclor than with HS to other 2nd and 3rd cephalosporins. In a nationwide database for the Korean population, the incidence of cefaclor-induced ADRs, particularly HS and anaphylaxis, was high. Female sex, age younger than 65 years, and concomitant use of drugs may be associated with HS to cefaclor.


2018 ◽  
Vol 72 ◽  
pp. 278-289
Author(s):  
Małgorzata Zbrojkiewicz ◽  
Agata Lebiedowska ◽  
Barbara Błońska-Fajfrowska Barbara Błońska-Fajfrowska

It has been nearly 200 years since the discovery of the botulinum toxin and the strain responsible for its synthesis Clostridium botulinum. Over this period, the knowledge about botulism and the use of botulinum toxin in medicine has been significantly expanded. Currently, eight serotypes of botulinum toxin (A-H) are known and they differ from each other by molecular weight, antigenic structure, immunogenicity, receptors, localization of coding genes and by the duration of the therapeutic effect. American physician Allan B. Scott was the first to demonstrate the use of botulinum toxin for medical purposes. Nowadays, botulinum toxin type A is widely used in medicine. Botulinum toxin injections are not only one of the most popular non-surgical aesthetic-cosmetic procedures, but are also widely used in neurology, ophthalmology and dermatology. The therapeutic potential of botulinum toxin has not been exhausted yet. Currently, many clinical trials are underway to extend the therapeutic indications of botulinum toxin and to improve its safety. Due to the huge development in medicine, botulinum toxin is today not only associated with aesthetic procedures and improvement in appearance, but also with raising the quality of life for people suffering from diseases with excessive muscle contraction and with other neuromuscular disorders.


2021 ◽  
Author(s):  
Matthew Clark

Abstract While COVID19 vaccines have been administered to over 100 million patients, a small minority (40,000) have reported adverse events, and an even smaller fraction have reported cardiovascular issues (~500). There have been reporting of a few unusual cardiovascular events associated with some varieties of COVID19 vaccines resulting in pauses of use. Here we analyze the reports of adverse events associated with the COVID19 vaccines in the FDA Vaccine Adverse Event Reporting System (VAERS) database to apply standard methods of detecting safety signals. In this work we apply this methodology to reports in the FDA VAERS database and have identified concerning signals for pulmonary embolism and myocardial infarction associated with COVID19 vaccines. These signals are compared with cardiovascular events reported in connection with influenza (FLU3) vaccines that are administered to a similar population. While signals of these events are higher for COVID19 than other vaccines, the incidence rates are comparable to the normally expected rate for non-vaccinated individuals.


2021 ◽  
Author(s):  
Matthew Clark

Abstract While COVID19 vaccines have been administered to over 100 million patients, a small minority (40,000) have reported adverse events, and an even smaller fraction have reported cardiovascular issues (~500). There have been reporting of a few unusual cardiovascular events associated with some varieties of COVID19 vaccines resulting in pauses of use. Here we analyze the reports of adverse events associated with the COVID19 vaccines in the FDA Vaccine Adverse Event Reporting System (VAERS) database to apply standard methods of detecting safety signals. In this work we apply this methodology to reports in the FDA VAERS database and have identified concerning signals for pulmonary embolism and myocardial infarction associated with COVID19 vaccines. These signals are compared with cardiovascular events reported in connection with influenza (FLU3) vaccines that are administered to a similar population. While signals of these events are higher for COVID19 than other vaccines, the incidence rates are comparable to the normally expected rate for non-vaccinated individuals.


2004 ◽  
Vol 171 (4S) ◽  
pp. 452-452 ◽  
Author(s):  
Apostolos Apostolidis ◽  
Roshni Popat ◽  
Yiangos Yiangou ◽  
Preston A. Baecker ◽  
Anthony Ford ◽  
...  

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