Update on the safety profile of Tofacitinib in Rheumatoid Arthritis from clinical trials to real-world studies: A narrative review 

By Alvaro-Gracia et al

The anti-rheumatic, Tofacitinib, is approved for usi in adults with moderate to severe rheumatoid arthritis, following  unsuccessful treatment with other standard of care therapies. This paper reviews Tofacitinib’s real-world safety data following 9.5 years of trial data.

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Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease 

By FDA

Patients taking the common seizure and mental health medication Lamictal, who also have heart disease are at greater risk of arrhythmias. Current investigations are underway to uncover whether other drugs of this class have similar effects.

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Efficacy and safety of COVID-19 vaccines in older people

By Soiza et al

The elderly population were among the first group to be vaccinated yet they are often excluded from clinical trials. Though special efforts have been taken to include the older generation in many phase III COVID-19 vaccine trials, very few co-morbidities have been included and actively monitored. This paper focuses on current vaccine trials, particularly in older individuals.

 

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Toxicity of chloroquine and hydroxychloroquine following therapeutic use or overdose 

By Doyno et al 

Hydroxychloroquine has recently been tested as a potential therapeutic in the treatment of COVID-19. Its use looked promising until the occurrence of numerous serious adverse events. This paper aims to review the toxicity associated with hydroxychloroquine and chloroquine use both short-term and long-term and in overdose.

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Sage touts first win in $3B Bio­gen pact, but safe­ty pro­file, doubts over da­ta cloud road ahead

By Jason Mast

Sage and Biogen announced that SAGE-324 had cleared phase II trial for essential tremor. Patients in the 67 person study who received the drug had a 36% reduction in upper limb tremor compared to 21% reduction on placebo.

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Series of JAK inhibitor delays may signal an upcoming FDA adcomm

By Zachary Brennan

Recent progression of a number of JAK inhibitors, including AbbVie’s Rinvoq, Pfizer’s Xeljanz and abrocitinib, and Eli Lilly’s Olumiant is hindered by 3-monthly safety reviews. This could be a sign that the FDA are preparing to hold an outside review of risk/benefit profiles of JAK inhibitors

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Beyond adverse outcome pathways: making toxicity predictions from event networks, SAR models, data and knowledge 

By Ball et al

Adverse outcome pathways identified in 2000’s have become a useful tool in understanding how toxicities came about. This paper constructs networks to predict the likelihood of an adverse outcomes with examples including reprotoxicity and non-genotoxic carcinogenicity.

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