safety concerns

Politicians and pharmaceutical manufacturers often complain that the FDA is too slow in allowing new drugs on the market. As a result of such pressure, the FDA has been striving for more rapid drug approvals. But there could be a downside to such speed-serious safety concerns later on.

How Often Do Scientists Discover Safety Concerns After a Drug Is Approved?

A new analysis published in JAMA reveals that one third of the 222 medications approved between 2001 and 2010 were later found to cause serious safety concerns. These adverse drug reactions were not identified during the review process.

In many cases it took several years for the complications to surface. Drugs that were fast-tracked were more likely to to have unexpected safety problems pop up later.

Problems with Post-Marketing Surveillance:

Even if the FDA asks the drug company to do studies after the drug is approved, pharmaceutical firms don’t always complete such post-marketing surveillance projects in a timely fashion. As a result, physicians and patients may be unaware of the potential risks of recently marketed medicines.

Downing et al, JAMA, May 9, 2017


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  1. Larry
    Raleigh, NC

    Is it a matter of testing longer, or simply testing better? Or maybe getting doctors to read the prescribing information, pharmacists to actually look for conflicts (instead of just claiming to do so), and actually giving the patient information?

    I speak from experience; my late wife was prescribed Tramadol (Ultram) in 1995 when it was first introduced. She had tremors within a few weeks which grew to full, all-out lying on the floor thrashing her arms and legs seizures in a few months. All we could do was hold her head to make sure she didn’t hurt herself, and wait until the once-or-more per day seizures were over. Eight physicians couldn’t figure it out. After a year we searched “tramadol seizures” in the new internet and found many hits, including the black box warning on the patient insert.

    One could argue that the testing was not done with sufficient diversity, and surely this can be done better today. Many common mutations are known and cheaply testable, e.g., MTHFR, TOMM40 BRCA2. Why not make sure these are represented in every test population? How about including young, elderly, native American, African-American, Hispanics, diabetics, males, and females in statistically significant numbers in any test population?

    Beyond the testing, fix the other problems. Here in North Carolina at the time I’m describing, we had a very boastful pharmacist association. They regularly issued statements on the importance of buying locally, not via mail, and on getting all your prescriptions in one place so they could warn of conflicts. Nice story, but it didn’t actually happen. When I ultimately confronted the pharmacist and asked how he could regularly refill prescriptions for Tramadol and anti-seizure medication without warning, he simply responded “Not my job.” And when I asked why no patient insert was included with the prescription, he simply shrugged his shoulders. This problem could be solved with a regular ethics refresher for pharmacists.

    When the prescribing physician initially prescribed Tramadol, he said “The rep just told me about this great new drug. It is supposed to be really good for pain.” When I asked the physician a few months later whether the drug could be causing the seizures, he assured us it was impossible, stating “If that were the case, we’d have an article for the Harvard Medical Journal.” Clearly the rep hadn’t bothered to talk about known side effects. That problem could be fixed by requiring full disclosures at the dinners, seminars,golf vacations and travel weekends that were common at the time, and still occur in different forms.

    Another problem is physician reluctance to report adverse effects. We saw this first-hand. When the more-than-daily seizures stopped and the brain fog lifted 12 hours after stopping Tramadol, we asked the prescribing physician to file an adverse effects report with the FDA. He had a dozen reasons why he couldn’t do it: Didn’t know how, couldn’t find the form, the form I sent was too small on his screen and he didn’t know how to enlarge it, and more. He eventually assured me he had submitted it but I am dubious. We all know that every physician sees adverse events: someone says the migraine medication made her itch and they change the drug; someone else says the blood pressure medication made him cough and they change the drug; someone’s pain drug or anxiety drug damaged her kidneys and they stop the drug. No big deal, right? Well, those are adverse effects. If every physician were measured on the number of adverse effects reports he submitted each month, we would know a lot more about these effects, a lot sooner. This problem could be solved with a real quota, just like traffic police are reputed to have.

  2. Mary M.

    Unfortunately, I have very little faith in the FDA these days.

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