About a third of FDA-approved drugs go on to have major safety issues

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Keep this in mind as the FDA tries to accelerate new drug releases…

About a third of the drugs that the Food and Drug Administration deems safe and effective go on to have major safety issues years after their approval, researchers report in JAMA.

The finding lands amid pressure from lawmakers and the Trump Administration to hasten the already fast-pace of the agency’s drug reviews.

Among 222 novel therapeutics approved by the agency between 2001 and 2010, 71 (or 32 percent) had safety events arise a median of 4.2 years later. Safety events assessed in the study were marked by any of three FDA actions: withdrawing a drug entirely from the market; adding a boxed warning to a drug’s label, which is often added for life-threatening health risks; or issuing a safety communication, which is for serious, but non-life-threatening health risks.

In all, the agency withdrew three drugs*, added boxed warnings to 61, and issued safety communications for 59.

Full story here:

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I learned in my pharmacology class that many of the harmful side effects of drugs are found after fda approval and definitely after clinical trials.

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Well, in the book Surviving Schizophrenia, the author mentioned that newer medications are risky and it’s probably best to stay on the older medications because they work about the same. Do you want to be a guinea pig? I went down that road too many times.

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I’m kind of a guinea pig when it comes to Vraylar.

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Generally yes, but there are situations where newer medications are preferred over older ones.

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I don’t think it’s a good idea to want a lot of drugs in a short amount of time that will kill us.

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