A multicentric pharmacovigilance study: collection and analysis of adverse drug reactions in relapsing-remitting multiple sclerosis patients

Abstract

PurposeWe performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions.Patients and methodsWe collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months.ResultsWe received a total of 411 adverse reactions, of which 84.18% were expected and only 15.82% were unexpected. We found no correlation between the number of reported adverse reactions and the route of administration (injectable/intravenous drugs N=224, oral drugs N=187). However, oral agents have caused a greater number of unexpected moderate-to-severe adverse reactions while, in injectable and infusion therapies, they have been evaluated as mild–moderate adverse reactions.ConclusionOur results underscore the importance of monitoring the safety profile of multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.

Salivary Biomarkers: Future Approaches for Early Diagnosis of Neurodegenerative Diseases

“…This cascade of events triggers the activation of an inflammatory reaction responsible for the demyelination process [73]. The symptoms associated with MS are pain, fatigue, visual problems, bowel and bladder dysfunction, depression, motor deficits, and sexual dysfunction [73,74]. MS shows several clinical variants, the most frequent being the relapsing-remitting MS (RR-MS), characterized by acute periods of neurological dysfunctions (relapsing) followed by periods of recovery (remitting) [75].…”

Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project

“…A further study highlighted increased rates of cutaneous malignancies [ 60 , 61 , 62 ]. Furthermore, the results of a recent Italian pharmacovigilance study showed that fingolimod was associated with the occurrence of infections, including one case of candidiasis, one case of influenza, and one case of urinary tract infection, and hematological toxicity, including one case of leukopenia [ 8 ]. Although MS drugs may increase the susceptibility to infections, given their immune-suppressive/modulating mechanism of action, it should be underline that MS patients are exposed themselves to an increased risk of infection from communicable diseases, which may lead to severe disease relapses [ 63 ].…”

“…Even though relapsing-remitting MS (RR-MS) is the most common MS form, most patients gradually develop into a chronic progressive phase, progressive MS (PMS). In order to prevent and reduce the number of relapses and delay the progression of the disease, disease-modifying therapies (DMTs) are prescribed [ 8 ]. In this context, the pipeline of MS therapeutic options has significantly improved thanks to the introduction of many innovative drugs.…”

Sergančiųjų išsėtine skleroze imunomoduliuojančio gydymo vartojimo drausmingumas

“…Mû sø at lik ta me ty ri me pa cien tai, kaip daþ niau sias nepa gei dau ja mas re ak ci jas, nu ro dë vie ti nes re ak ci jas in jekci jø vie to se, gri po simp to mus ir rau me nø bei (ar) sà na riø skaus mus. Pa na ðûs re zul ta tai gau ti ir ki tuo se ty ri muo se [25,28]. Vie nas to kiø ty ri mø, ver ti naes vi sus LEM vais tø ða lu ti nius poveikius, bu vo at lik tas Ita li jo je.…”

“…Daþ niau sios jø bu vo dvi -vie ti nës re ak ci jos in jek ci jø vie to se (skaus mas, pa rau di mas, nie þulys, re tais at ve jais: abs ce sas, ne kro zë, he ma to ma) ir gri po simp to mai. Tiks lin ga pa mi në ti, kad ðios ne pa gei dau ja mos re ak ci jos dau giau sia bû din gos IFN-be ta vais tø gru pei [28].…”