Proton-pump inhibitor use is associated with a broad spectrum of neurological adverse events including impaired hearing, vision, and memory

Abstract

Proton-pump inhibitors, PPIs, are considered effective therapy for stomach acid suppression due to their irreversible inhibition of the hydrogen/potassium pump in the gastric parietal cells. They are widely prescribed and are considered safe for over-the-counter use. Recent studies have shown an association between PPI use and Alzheimer dementia, while others have disputed that connection. We analyzed over ten million United States Food and Drug Administration Adverse Event Reporting System reports, including over forty thousand reports containing PPIs, and provided evidence of increased propensity for memory impairment among PPI reports when compared to histamine-2 receptor antagonist control group. Furthermore, we found significant associations of PPI use with a wide range of neurological adverse reactions including, migraine, several peripheral neuropathies, and visual and auditory neurosensory abnormalities.

Postmarketing safety surveillance data reveals antidepressant effects of botulinum toxin across various indications and injection sites

“…The statistical analysis of the FAERS and other safety surveillance data is well established, it includes frequencies, reporting odds ratios and 95% confidence intervals, and is fully described in many publications 39 – 41 . Here is a summary of the formulae.…”

“…The resulting cohorts were the following: (1) Cosmetic use-facial muscles (wrinkles, skin wrinkling, face lift, skin cosmetic procedure, dermal filler injection); (2) Migraine-facial and head muscles (migraine, migraine prophylaxis, migraine without aura, migraine with aura); (3) Spasms and Spasticity-upper and lower limbs (spasticity, muscle spasms, dystonia, tremor, cerebral palsy, muscle relaxant therapy, muscle tightness, muscle rigidness, muscle tone disorder, muscle contractions involuntary, dyskinesia, joint hyperextension, musculoskeletal stiffness), disorders related to facial muscles such as facial spasms, temporomandibular joint disorder and jaw disorder were excluded; (4) Torticollis and neck pain-neck muscles; (5) Blepharospasmeyelid muscles; (6) Hyperhidrosis-axilla and palm; (7) Sialorrhea-parotid and submandibular glands (drooling, www.nature.com/scientificreports/ Statistical analysis. The statistical analysis of the FAERS and other safety surveillance data is well established, it includes frequencies, reporting odds ratios and 95% confidence intervals, and is fully described in many publications [39][40][41] . Here is a summary of the formulae.…”

Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database

“…), and common case identifiers. FAERS data format changes periodically, requiring each quarterly set to be individually downloaded and standardized [15][16][17][18][19] . The final full data set from the FDA contained 13,773,614 reports.…”

Cardiac adverse events associated with chloroquine and hydroxychloroquine exposure in 20 years of drug safety surveillance reports

“…), and common case identifiers. FAERS data format has had changes historically, requiring each quarterly set to be individually downloaded and modified into consistent data tables [32][33][34] . Since the FAERS/AERS set has reports from all over the world with their respective drug brand names, 27 unique terms were recognized and translated into single generic CQ and HCQ names.…”