NBME 20 Discontinue the new drug in affected patients and file MedWatch reports on the FDA's Web site (NBME Answers)

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Retired NBME 20 Answers

nbme20/Block 2/Question#46 (reveal difficulty score)
A physician prescribes a newly marketed drug ...
Discontinue the new drug in affected patients and file MedWatch reports on the FDA's Web site 🔍 / 📺 / 🌳 / 📖
tags: pharm

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submitted by ∗strugglebus(189)

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I chose this solely because it was so damn specific

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sympathetikey Same. Learn something new every day: See more: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program +5

karljeon I didn't choose it because it was so damn specific. :( +48

lovebug Could anyone explain for B) for me? because I choose B).:( +2

j44n B.) is wrong because its never been shown to show adverse effects "any offcial data linking the drug" and the fact that it's "newly marketed" +

j44n and because its in 5/45 patients roughly 10% of the population, that might not seem like much but most of the diseases we freak out over are in 1-2% of the population, to put that into perspective if we gave this drug to every person in the US (every big pharma wet dream) with a population of 300 million... 30 million people would have this adverse event... hope that helps +

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submitted by ∗hello_planet(43)

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The question stem describes that the drug is "newly marketed", so it's likely in Phase IV drug trials.

From FA 2019 pg. 256, Phase IV = "Postmarketing surveillance of patients after treatment is approved." Phase IV is for detecting rare side effects that weren't picked up during the smaller clinical trials or long-term effects. Phase IV determines if the drug can stay on the market.

The drug is approved and is appropriate to use in patients without side effects, but the drug is still being monitored by the FDA so any new, previously unreported side effects need to be filed with the FDA.

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-2 upvote downvote
submitted by ∗rockodude(39)

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always do no harm ppl, comes up again and again and again

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