Remove 2020 Remove Adverse Reactions Remove FDA
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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. Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. “The question is, how safe do you want to be?”

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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).

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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.

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First chikungunya vaccine approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. The vaccine was granted PRIority MEdicine (PRIME) designation by the EMA in 2020. Valneva declared it plans to begin commercialisation of IXCHIQ in the US in early 2024.

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FDA slaps hold on trials of Gilead’s CD47 drug magrolimab

pharmaphorum

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 billion acquisition of Forty Seven in 2020. The post FDA slaps hold on trials of Gilead’s CD47 drug magrolimab appeared first on.

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Drug Discard Date Creates Discord

The People's Pharmacy

If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. We fear that the FDA is not monitoring every link in the chain. Fortunately, a review from The Medical Letter on Drugs and Therapeutics (July 27, 2020) lays that fear to rest. The FDA does virtually no testing.

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Nextstellis®: A new drug update 

Birth Control Pharmacist

new combined oral contraceptive was approved by the FDA (Nextstellis®) in April 2021. Adverse Reactions. The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms. Published April 7, 2020.