Senior Man, arms crossed, looks down at large assortment of prescription pill bottles, wrong medicines

How do you know what side effects your drug can cause? If you ask doctors or pharmacists, they will often consult the official prescribing information sanctioned by the Food and Drug Administration. This is considered the ultimate authority on how to use the medicine and what to expect from it.

Why is the FDA so Slow?

Sadly, this resource is flawed. The trouble is that it can take years, or even decades, for significant drug side effects to emerge. For example, fluoxetine (Prozac) was launched in the U.S. in 1988 as the first of a new type of antidepressant called a selective serotonin reuptake inhibitor (SSRI).

Within a few years it had become a best seller that spawned many similar drugs, from citalopram (Celexa) and paroxetine (Paxil) to sertraline (Zoloft) and venlafaxine (Effexor). Side effects such as weird dreams, drowsiness, fatigue, dizziness, nausea and diarrhea were noticed right away.

Sexual problems took longer to be detected, although well over half of the people taking such medicines report low libido, inability to achieve orgasm or erectile dysfunction when questioned.

A New Drug Side Effect from SSRIs

Just last month a new side effect surfaced. SSRIs are widely prescribed for many conditions other than depression or anxiety. They can be helpful for the hot flashes and night sweats of menopause, and may be prescribed to help control them. One drug, paroxetine (Brisdelle), has been specifically approved for this purpose.

A study covering 137,031 perimenopausal women with no diagnosis of depression found that those taking SSRI medications were significantly more likely to suffer a bone fracture during the 12 years from 1998 to 2010 (Injury Prevention, online June 25, 2015).

The comparison group was 236,294 women matched for age, but taking heartburn pills instead of SSRIs.

A Better Way to Detect Drug Side Effects?

Is there a way to discover such complications sooner, so that doctors and patients alike could be aware of them? This would help doctors decide if a specific drug might be a good choice for a particular patient, and it would certainly help patients decide if they want to chance the risks inherent in taking the drug.

The FDA is testing a way to let patients help. The agency is partnering with a patient network called PatientsLikeMe.com. On this website, more than 350,000 members trade information about symptoms and treatments for the 2,500 or so conditions that they suffer. This is a much larger number of people than the relative handful–a few hundred to a few thousand–who participate in clinical trials of a new drug.

PatientsLikeMe gives its members an easy way to report their experience to the FDA. Since patients have the most “skin in the game,” they are likely to take more time than doctors or pharmacists to give reports of potential drug reactions.

Readers of this newspaper column have been reporting adverse drug reactions for decades. Through them we learned that SSRIs cause a high rate of sexual side effects, and that was before the FDA recognized the problem.

We also heard about blood sugar elevations with statin-type cholesterol-lowering drugs. Our readers have reported rebound hyperacidity and horrible heartburn upon stopping acid-suppressing drugs such as omeprazole.

We too report these signals to the FDA. Anyone wishing to share his experience can do so at www.PeoplesPharmacy.com. Just go to our Drug Information tab at the top of the page and pull down the Drug Side Effects menu. You can search for your medication and post in the comment section at the bottom of the page. Help us keep the FDA informed about adverse drug effects and real-life patient experience.

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  1. Sally
    Texas
    Reply

    What a wonderful way to improve communication and to better connect patients, the FDA and other people with side effects. Right now, there is a big breakdown in providing crucial information to patients of known side effects, and I believe some pharmacies are guilty of producing insufficient and poorly printed important drug package inserts with all prescriptions.

    I am on a mission right now to provide better drug information to patients in my present pharmacy which is one of the largest pharmacies in the U.S. Several years ago, a Texas teenager died from complications/side effects from a drug he was taking for ADHD. In a lawsuit that ensued, the pharmacy admitted they missed three opportunities in giving the mother drug inserts/counseling of potential side effects which also were overlooked by the boy’s doctors. Some drugs have over 100 known side effects and some as many as 525 (Dr. Joe Mercola).

    What better place to start than with two letters I wrote several months ago to the president of the company involved so that they would get into the right hands. I told him my/our health was in jeopardy since I first started with them the first of the year because of insufficient pharmacy information especially because 1) In-store produced printouts were of poor quality and difficult to read, 2) Inserts were given just once and not with every refill, 3) Pill changes upon refill were not noted/explained (mistake of pharmacist or change in manufacturer?), and 4) Important black box warnings overlooked (they did not acknowledge a life-threating black box warning for possible fetal toxicity on my losartan one year after directed by the FDA). I actually sent the FDA a copy of the second letter noting the omission of the black box warning. I knew of the warning from the weekly digest I receive from the FDA.

    All of the above omissions can result in serious consequences. To my surprise, however, I noticed new pharmacy procedures last week as I picked up my refill of losartan. The pill was a new looking one, but not acknowledged as such by the pharmacist as it should have been, but he actually personally consulted with me for the first time. Taped to the bottle of losartan was a big red notice about the fetal toxicity. The printouts also were more clear on the prescriptions I picked up for my husband. Did my letters help? Who knows, but I did notice improvement.

    Being on Medicare, we are forced to receive generic prescriptions. For this reason, we need to be more vigilant than ever on what we receive and deserve to know the identity of the manufacturer printed on each insert. Too many pharmacies in India have produced substandard medicine. Our previous pharmacy would even let us reject medicine from companies being penalized by the FDA in exchange for others.

    Lives can be saved if a better partnership is formed between patients and pharmacies. Doctors cannot know of all the side effects, so the responsibly rests with the patients. Now, a two-way opportunity is available with this new website for more direct communication with the FDA. In 2010, the New England Journal of Medicine reported that an estimated 450,000 preventable medication-related adverse events occur in the U.S. every year. Perhaps fewer lives can now be lost from “death by prescription.”

  2. Joyce G
    USA
    Reply

    Cymbalta a “failed antidepressant”? I have been taking it for 4 years, grateful for both analgesic and antidepressant properties. No side effects…but a generic by Teva didn’t work.

  3. Jean
    Arkansas
    Reply

    I would like to hear more about cymbalta. I have my own story about that ‘drug’!!

  4. Cindy M. Black
    Seattle, WA
    Reply

    I worked in the mental health system for some 35 years, and I know why the side effects of psych meds are so slow to be recognized. Many psych patients are anxious, mistrustful, oppositional, paranoid or downright delusional. Therefore any patient who’s taking any med even remotely psychoactive seems to get lumped in with ALL patients receiving mental health treatment; i.e., any complaints of medication side effects are simply given little or no credibility. I’ve seen patients literally staggering around, drooling, holding their heads and moaning…. and they’re just given more meds to help them “calm down.” I’m describing inpatient facilities, but I’m sure the phenomenon is fairly universal.

  5. Laurie M
    Waseca, MN
    Reply

    I saw the advertisement for Patients like Me on Facebook and that is where I joined. It is a great Site!!

  6. Mary
    Reply

    In spite of all the reports here about the possible extremely serious effects of statin drugs, physicians seem blind to that possibility.

    I suspect it may be the same thing with other side effects.

    Do read about the known side effects if you experience something yourself. It may be there.

  7. JBG
    IL
    Reply

    In at least a few places, I understand, medical organizations are beginning to take advantage of the digitalization of medical records to systematically track relationships between treatments and outcomes. That is, another path to finding out about the effects of drugs is to look to see what happens when they are used in the ordinary course of the practice of medicine. Fancy, expensive trials are all well and good, but proof of the pudding is in the daily eating. The sooner this trend becomes widespread, the better off we will all be, because the kind of intermittent feedback from scattered patients that People’s Pharmacy has found so useful will be matured into consistent feedback from many patients.

  8. Helen M
    Modesto, CA
    Reply

    Sometime in the mid 90s, we bought our first home computer. Around the same time I was given amitriptyline (sp) for diabetic neuropathy. I was also in therapy at the same time. I grew increasingly more depressed, found myself in a very dark place, and my therapist became concerned that I might harm myself. After a visit with her, that night, time for the med, I could not take it. At the next visit she was delighted to find me restored to my “old” self. Then I looked it up online, found a patient website, where people shared experiences similar to mine. I do not remember the site; but I do remember someone writing that it was the worse thing that had ever happened to him. I never took it again.

  9. Sabrina
    San Diego
    Reply

    This is a great idea [and web site] but let’s give credit where credit is due. This sight is NOT the brainchild of the FDA but their collaboration with patientslikeme.com is an amazing step forward for the antiquated good-old-boy mentality that the FDA has become.

    Jamie and Ben Heywood should be getting the credit for co-founding this site. Just like Joe and Terry Graedon should be given credit for their innovative and tireless work towards the same objective.

    Thank you for bringing this site to our attention.

  10. Judith Ronat M. D.
    Kfar Saba, Israel
    Reply

    Sometimes it is difficult to distinguish between a side effect and a placebo effect.

    Also it takes a long time to find that a rare side effect is indeed attributable to a specific medicine.

    • O.G.
      SC
      Reply

      Begging Dr. Ronat’s pardon, but it isn’t difficult at all for a patient with any degree of awareness to figure out that a pharmaceutical has caused a side effect, which is exactly the opposite of a placebo effect. All it takes is 1.) taking the medication 2.) Observing the side effect 3.) Stopping the medication and 4. ) Observing (with gratitude) that the side effect has stopped.

      I think The People’s Pharmacy’s involvement in this exploration, as well as the FDA’s experimental alliance with PatientsLikeMe (which I had never heard of before this) should provide a very positive avenue of patient input about the effects of the drugs prescribed for them.

      As a patient who had an extremely unpleasant (and fortunately very brief!) experience with Cymbalta, the failed anti-depressant now prescribed as an analgesic — and yes, I filed a written complaint with the FDA — I welcome more channels for patient reporting and perhaps more rapid responsiveness on the part of the FDA regarding drug side effects.

      Perhaps more patient reporting will also remind physicians of the old admonition “First, do no harm” before they write a prescription.

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