FDA: Long Drug Warnings Hide Risks
FDA: Long Drug Warnings Hide Risks
Agency proposes simple, serious, warnings in drug ads

Pharmaceutical marketing has had a profound effect on America’s growing prescription drug appetite. Now regulators worry that advertising may cause consumers to miss the biggest risks.

The U.S. Food and Drug Administration (FDA) is reconsidering what regulators call the “major statement”—an obligatory list of side effects and health hazards that accompany each pharmaceutical ad. The major statement serves to balance the slick sales pitch with the risks associated for a particular drug, and hopefully leads the consumer toward an informed decision.

According to an FDA announcement, “The major statement is often too long, which may result in reduced consumer comprehension.” The concern is that ads, which drone on about dry mouth, nausea, and skin irritation, may distract consumers from the most serious risks, such as suicidal thoughts, heart attack, or stroke.

Regulators will investigate consumer comprehension by having test subjects watch a series of drug ads that restrict their major statement to “serious and actionable.” If the studies demonstrate that shorter warnings are better understood, future ads will point to a resource for a comprehensive risk list that consumers can research for themselves.

Shrinking the Risk List

While regulators want consumers to be more mindful of the most serious dangers, many believe that drug ads are already too brief on side effects, and the advertising is far too prevalent.

The United States and New Zealand are the only nations to permit drug ads that directly target consumers. Until the mid-1980s, drugs were only promoted to doctors who determined whether new pharmaceuticals were appropriate for a particular patient.

When consumer drug ads first emerged, the FDA required promotions to include every possible risk associated with a drug. Drug companies were slow to embrace the new medium, because most of their ad space was sacrificed to precautions. But soon after the FDA allowed for an abbreviated risk list in 1997 and direct to consumer promotions nearly quadrupled. In 2012 drug companies spent $3.1 billion on direct to consumer marketing, according to Pew Research Center.

Proponents of direct to consumer drug ads said marketing new drugs helps people to be better informed about new treatments. However, most doctors believe they’re a hindrance.

Doctors Disapprove

According to an April 2013 physician survey by CMI/Compas, about 70 percent of doctors want to eliminate or reduce drug ads, 63 percent accused ads of misinforming patients, and 74 percent criticized ads for devoting too much time to drug benefits and not enough to warnings.

Research suggests the problem may be more than consumer comprehension. According to a September 2013 study by the Journal of General Internal Medicine, 6 out of 10 drug ads contain “potentially misleading claims.”

The FDA will accept public comment the study until April 21, 2014.

  • JasmineStarlight

    I never got those ads, smile and be happy again with product XXXXX, with a happy bouncing icon dancing along the screen or butterflies fluttering about……oh by the way side effects may include– suicidal thoughts, heart attack, stroke, liver disease, kidney disease–etc. Oh yes I need that in my system—happy doesn’t come in a pill form. Some parents give meds to kids who don’t sit still—crazy!!
    Many doctors overly prescribing drugs for every ailment imaginable—have a bad day, here’s a pill. These drugs to not fix the root problem either, only producing more addicts. The pharmaceutical company gets richer, while their victims get sicker, lost in a fog.

    • HessenBalkan

      Yes the influence of the pharmaceutical companies is getting more and more.
      When I lived in the US my kids got their wisdom teeth removed, each one got a prescription for 30 vicodin! Each time I asked for a smaller amount, 1 or 2 tablets would have been enough. No, they told me, 30 was the smallest number they could do.
      I think my daughter took one my son didn’t even touch them. So here I was with 59 vicodin left. My son said: hey I can sell them at high school for 3 bucks a piece! Of course I didn’t let him. But who is making these laws? Is this necessary?

      • JasmineStarlight

        Hessen so many horror stories out there regarding these ‘prescriptions’.
        Parents should be vigilant in researching prescriptions given their kids. SOME doctors and definitely the pharmaceutical companies is money driven, bottom line. Hell pharmaceutical companies give away vacations–money–gifts, and beautiful reps. showing up at the doctors door—-nothing more then kick-backs!
        It’s easy for kids to get hook too, hence kids wanting to sell the stuff…they’re usually looking to escape, get high, party….the kids are pretty adept in knowing which drugs produces the high. It’s sad they don’t comprehend the lasting effect it can have them. I remember one ‘stoner’ from HS—he would just sit and stair at the bleachers at lunch….. I went over to talk with him once, I knew him from before and I was shocked, a completely different person. He was so GREAT before starting all the meds and doing drugs—-funny, alert, and involved in art. I guess his parents wanted more of a doctor mindset or something—-destroyed a great
        person. I hope they do away with the ads, seducing people watching these ads….that this drug will change your life, no more problems.
        BTW, one more thing, sometimes a little depression is trying to tell you something….perhaps you’re not living your life right, something it’s a stirring within to change, and we all hate change….or do not understand it at the time, so many cry out for a pill, to make it go away. Sorry I get ranting on this issue— I lost someone very close to me because of these drug plays.

        • HessenBalkan

          Thanks for the long reply, it’s a tough subject and I wish we could make laws to stop that advertising and punishing Dr.s harder that misuse/prescribe too much of that stuff. And the pharma company should be somehow ruled in.
          What I always explain to my kids is exactly that…sometimes you feel a bit down…it’s normal..it’s not right away a depression. We can’t feel happy all day every day long, it’s just not possible. So we have ups and downs and get over it (of course if a real depression it’s different).
          My son spent last year 6 month living and working with his father (and new family) in the US before continuing his studies. His father and the new wife are big into meds, not necessary abusing, but using a lot. If you can’t sleep…sleeping pill….you are feeling blue…some stuff that cheers you up….if you are over excited ….something that will calm you. So very much the opposite to me. They really dragged him to a Dr. because he couldn’t sleep for a couple of days! (he told me that) Thank god that Dr. was smart enough to just recommend some herbal tea for him. My son told me he wouldn’t have taken tablets even if he prescribed some, I guess he is a bit brainwashed by me to be careful and he has seen bad cases of med abuse from friends and their moms.
          I have the feeling it’s in the US worse then in other countries, I’m not sure why. Sometimes I think people want always instant gratification, instant results.
          I’m glad my kids staying away from these medication mixes. Unfortunately I see my nephew getting into some real stupid stuff and all talking doesn’t help….(taking a deep breath)…what can you do….I don’t know.

  • Canukistani

    It seems that the drug companies aren’t satisfied with the amount of drugs that doctors are prescribing and are telling the public, who in many cases, doesn’t know any better to go to their doctor and demand these drugs. I’m sure it helps their sales, but I’m far less sure that it helps either doctors or their patients.

    When it comes to matters of public health like this, I think this kind of advertising needs to at least be regulated and maybe even banned entirely.

    • EmpressL

      AND then there are those ads 3 AM asking to contact a tort lawyer if you had side effects from drugs they are forming a class action suit against! If it weren’t for the Tort Lawyers we would be slowly poisoned to death.

  • EmpressL

    Isn’t one of the Monsanto EXECUTIVES now running the FDA? What else would you expect.

    I don’t think Prescription drugs should be advertised. All of the mass shootings have been committed by someone on or coming off of Prescription drugs. AND NONE of them had a violent history. That’s what needs to be investigated.

  • EmpressL

    Here’s how effective those drugs are:
    Columbine Eric Harris – Luvox
    Thurston High, Ore Killed 2 + parents (1989) Kip Kinkel – Prozac & Ritalin
    Winnetka (1988) Laurie Dann (killing 1 wonding 6) – Anafranil & Lithim
    Paducah, Ky (1997) 14-year-old Michael Carneal killing 3 – Ritalin
    Red Lake Indian Reservation (2005) Jeff Weise killed 9 – Prozac
    Standard Gravure Ky Joseph T. Wesbecker shot 20 workers – Prozac
    Kurt Danysh, shot his own father – Prozac
    John Hinckley shot President Reagan took four Valium 2 hours before
    Andrea Yates killed her 3 kids – Effexor
    Virginia Tech – Cho – Paxil
    Christopher Pittman – shot grandparents – Paxil and Zoloft
    GlaxoSmithKline paid $6.4 million Donald Schnell murdered wife, daughter and granddaughter – Paxil
    Columbine – 1999 Harris – Prozac, Paxil, Zoloft, Effexor & Klebold – Luvox
    Arora, Colorado Theater Shooting James Holmes – Sertraline, a generic version of Zoloft & Clonazepam, a benzodiazepine
    Sandyhook – Newtown – Adam Lanza – “Fanapt” -strong antipsychotic

    • JasmineStarlight

      It cooks your brain!!

    • Robin S Summertown

      I do not support the advertising of drugs. There is no place for them in our lives. We have doctors to look at us and our problem and make the determination what is right for us. That’s what they spent so much time and money in school for.

      That said, it is also the responsibility of the doctor to educate the patient and/or parents what to look for. They seldom do that. Parents and or the patient need to report changes in behavior. Especially when those changes are in the negative. Yes, all of those drugs have side effects. And its our responsibility to be aware of those side effects and be watchful.

      I was on Effexor for a really rough patch in my life. It pulled me out of the hole I was in but then . . . My doctor did not do follow ups. Left me on it and the drug then caused a massive depression. Had it not been for a friend who is a physician hearing me say I was selling my house, my horses, taking my dogs and vanishing, I would not have known the drug was doing it. But I knew my strong desire to divest myself of my life was also not right thinking, that’s why I told him.

      Too few have the self awareness or the availability of a doc to recognize when things are going wrong. We have to be able to depend on our family physicians to keep watch over us when taking any drug that involves brain chemistry.

      • EmpressL

        You are spot on! I hope you wound up keeping everything. I also know about deep depression where you’d rather not feel any thing than that big black hole.

        • Robin S Summertown

          That issue was a one of in my life. Several devastating deaths with no opportunity to grieve the loss of one before another hit.

          What bothers me are blankets. Pointing fingers at one thing when it is far more complicated than the drug. These drugs have done a lot to better a sufferer’s life. But they are only as good as the medical backup being given. Yes, they have side effects. We know they have side effects and the medical professional needs to be open and up front about the possible complications and warn the patient or parents about these side effects. Most do not.

  • abxnomore

    Drug companies should not be allowed to advertise.

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