Safety risks found in one-third of drugs approved by the FDA

❝ Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval…

The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market.

❝ To win FDA approval, medications must be shown to be safe and effective. But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.

❝ The researchers reviewed 222 products approved between 2001 and 2010 and followed them through February of this year. With 32 percent of the medications, they found, the FDA took some kind of action to deal with safety issues that emerged after approval.

Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency’s most serious safety alert, included in the drug’s packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.

The median time for an FDA action was 4.2 years after approval…

You, too, can be a beta tester for the FDA. Betting your life on it.

3 thoughts on “Safety risks found in one-third of drugs approved by the FDA

  1. Doc says:

    The White House on Tuesday, after weeks of delay, approved tough new standards for coronavirus vaccines — but only after the Food and Drug Administration unilaterally published the guidelines on its website as part of briefing materials for outside vaccine advisers. https://www.washingtonpost.com/health/2020/10/06/coronavirus-vaccine-fda-standards/
    And then: “Trump claimed, without justification, that new tighter FDA vaccine guidelines were a ‘political hit job,’ hours after the White House approved them” https://www.businessinsider.com/trump-tighter-fda-covid-19-vaccine-rules-political-hit-job-2020-10
    Meanwhile: “A top Food and Drug Administration official warned vaccine makers that the agency could call upon rarely-used powers to disclose significant safety issues, after being asked about month-old investigation into an experimental Covid-19 shot from by AstraZeneca Plc. https://www.bloomberg.com/news/articles/2020-10-06/fda-vaccine-head-warns-drugmakers-on-disclosing-safety-issues

  2. Nurse Nancy says:

    Back in August, the Food and Drug Administration ousted Emily Miller from her role as the agency’s top spokesperson. Miller, a right-wing activist and former One America News reporter, was installed in the FDA by the White House and given the role of assistant commissioner for media affairs, a role typically held by nonpartisan civil servants. She held the post for a mere 11 days and was fired amid intense controversy after several high-profile agency missteps. https://arstechnica.com/science/2020/08/white-house-installed-oan-reporter-as-fda-spokesperson-she-lasted-11-days/
    Miller is now the senior advisor to the chief of staff at the FDA. As an FDA employee, she has publicly promoted an unapproved drug as being “like a cure” for COVID-19 on Twitter. Her tweets support unproven and potentially dangerous statements from President Trump and may violate FDA regulations. The drug she promoted is currently being reviewed by the FDA for emergency use, raising concerns about the agency’s impartiality.
    The drug Trump and Miller were referring to as “like a cure” for COVID-19 is a cocktail of monoclonal antibodies made by Regeneron Pharmaceuticals. https://arstechnica.com/science/2020/10/trump-appointee-fired-from-fda-is-still-at-fda-promoting-unapproved-drugs/
    Regeneron CEO: Trump ‘is a case of one’ and ‘weakest evidence’ for Covid-19 treatment https://www.politico.com/news/2020/10/11/regeneron-trump-covid-coronavirus-428691
    Trump has ties to drugmaker Regeneron — and now its stock is surging https://www.cnn.com/2020/10/05/investing/trump-regeneron/index.html

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