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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. ” said Ameet Sarpatwari, the assistant director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital.

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Opinion: Health care coaches are the next big thing. They’re also completely unregulated

STAT

It turns out that one of the supplements recommended by the health coach has adverse reactions with a medication prescribed by his doctor. He goes to the emergency room, where they immediately ask him about medications and supplements he’s taking. The health coach never asked John about his medications. Read the rest…

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

The most common adverse reactions seen in a trial cohort of 38,000 patients were at injection sites (84.1%) followed by fatigue (62.9%) and headache (55.1%), and serious adverse reactions occurred in 0% to 4.6% of participants.

Vaccines 111
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Regional variations uncovered in the impact of dexamethasone treatment for severe COVID-19: Study

Express Pharma

Serious adverse reactions: Regarding serious adverse reactions (SARs), an interesting finding was made. On day 28, the higher-dose group’s risk of death was 8.3 per cent lower for patients in Europe, whereas there was essentially no difference (0.1 per cent) in India. While a larger percentage (-1.0 per cent).

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How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

1 But while data on adverse reactions is rightly used to help with these decisions, there is currently no additional modelling on the positive impact regulatory action could have on public health. Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Study focus.

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NICE says yes to BeiGene’s Brukinsa after Scottish nay

pharmaphorum

.” The document notes however that there is a high unmet need for an effective and well tolerated treatment for WM “where current chemoimmunotherapy options can cause severe adverse reactions and the need for frequent hospital visits.”

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EC approves Libtayo® for metastatic cervical cancer

European Pharmaceutical Review

Immune-mediated adverse reactions (ARs) occurred in 21 percent of patients treated with Libtayo ® and led to permanent discontinuation in 4.6 Safety was assessed in 1,281 patients with advanced solid malignancies who received Libtayo ® monotherapy in five clinical studies. percent of patients. percent), immune-mediated hepatitis (2.4