article thumbnail

STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. Experts say that the Singulair incident highlights a flawed system, both in the U.S.

article thumbnail

Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

He highlighted research by the Association of the British Pharmaceutical Industry (ABPI) from 2022, which found that between 2018 and 2020, “the median time between application for regulatory approval and delivery of a first dose to a participant in a trial increased by almost a month.”

article thumbnail

What are the side effects of black seed oil?

The Checkup by Singlecare

Allergic reactions Hypoglycemia (low blood sugar levels) Elevated liver enzymes Kidney function decline Bleeding Overdose toxicity How soon do black seed oil side effects start? The onset time of adverse reactions to black cumin seed oil has not been elucidated to date.

article thumbnail

Unlocking the potential in rare disease research with decentralised trials

pharmaphorum

The report found that people’s willingness to take part in clinical trials in 2020 fell dramatically compared to previous years – however that survey was conducted with the wider public while the Raremark survey focused specifically on people with rare diseases. Research and development will always be important to rare disease patients.

article thumbnail

First chikungunya vaccine approved

European Pharmaceutical Review

The vaccine was granted PRIority MEdicine (PRIME) designation by the EMA in 2020. As part of the US FDA approval, the FDA stated that the company is required to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of IXCHIQ.

article thumbnail

What are the side effects of Zyrtec in older adults?

The Checkup by Singlecare

But second-generation antihistamines, like Zyrtec, are less likely to cause these side effects for older adults, notes the AAAAI.