The Medication of Which We Do Not Speak

I’ve just come off a week of mandatory training on epilepsy and anti-epileptic drugs, many of which are also used to treat mental illnesses. Some time around the end of training day 3, as I was slogging through prescribing information (PI) for 4 different products, it occurred to me that we take pharmaceuticals far too lightly here in the US.

I’m speaking as a consumer and sister of someone who takes some serious psych meds and not as an employee of a pharmaceutical manufacturer. This is strictly my own opinion and does not necessarily reflect the perspective of my employer.

There is an odd cultural phenomenon in our country that, based on my international travels, appears peculiar to the US. We expect and, to a great extent, trust the government and big business to keep us safe. If they fail to do so, we file a lawsuit. And we often win with outrageous settlements giving the government and big business further incentive to continue trying to protect us from our own stupid decisions. Our confidence in prescription medicine goes hand-in-hand. We tend to believe a product is “safe” if the FDA (Food and Drug Administration) approved it. Am I right? While it is true that the FDA requires two randomized clinical trials demonstrating safety and efficacy for a medication to be approved, that does NOT mean, by any stretch of the imagination, that the medication is without risk. FDA approval basically means the benefits of the product outweigh the risks for the population in which the medication was tested and for whom it is indicated. In pharmaceutical math, that doesn’t necessarily equal “safe”.

If you read the PI for any given medication, you’ll find a contraindication section which specifically lists conditions in which the use of the medication is decidedly not “safe”. There is also a “Warnings and Precautions” section that outlines specific usages, with concomitant medications or in patients with specific illnesses or conditions, in which healthcare providers should exercise extreme caution when prescribing.

If you aren’t familiar with PIs, I’m not surprised. All medications in the US have one; the FDA requires it. It’s that multipage document in teeniny print to which origami is applied to reduce it to the smallest folded size possible. You are supposed to receive a copy of the PI with every medication you fill, but some pharmacies may or may not provide it based on your medication’s packaging. For example, if your medication comes in the standard orange vial with white screw-top, you likely won’t get a copy of the full PI but you may get some excerpts stapled to the bag.

You can find a copy of the full PI online for many medications. If the medication is relatively new (< 10 years) and is currently being promoted (via commercials, media ads, sales representatives), there is likely a manufacturer website named http://www.[insert drugname].com where you can usually locate a PDF of the PI (sometimes as a link at the very bottom of the homepage in small print or sometimes under a tab for professionals). If there is no brand website, DailyMeds, an NIH (National Institutes on Health) site, has PIs online for over 35,000 drugs.

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If you have a family member taking psych meds, I highly recommend you read the PIs for all their medications. It’s written for healthcare professionals and can be daunting to understand–do it anyway. In recent years, the medication guide (often found at the end of the PI) is an attempt to translate the information in the PI for the average consumer.

Here’s why you need to read it. In addition to the peculiar faith we Americans place in The Establishment, we place a similar faith in the medical profession. We tend to believe all health care professionals are intimately familiar with every medication. Ridiculous, if you think about the sheer number of drugs actually on the market. But also scary. Particularly when dealing with medications that target the brain.Your family member with mental illness could be taking a drug that should never have been prescribed for them given other co-existing medical conditions or other medications they are taking.

Take, for example, the medication-of-which-we-do-not-speak. If you’ve read my older posts, you know I’m referring to ADHD medications, specifically Adderall at the moment, a widely-abused amphetamine. While this medicine may be arguably safe and effective for children with ADHD, no one with Jerri’s history should be prescribed Adderall. Here’s what the PI says:

  • Adderall is contraindicated in patients with glaucoma and a history of drug abuse. (Jerri has both.)
  • Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD.
  • Both hepatic (liver) and renal (kidney) dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. (Jerri has hepatitis C which impacts liver function.)
  • Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. (In other words, Adderall can cause manic episodes in people like Jerri with bipolar disorder.)
  • There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in the absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. (Interpretation: Adderall can increase the likelihood of seizures particularly in people with a past history. Jerri has a prior history of seizures.)
  • Adderall is a schedule II controlled substance. Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to levels many times higher than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines may include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. (Need I say more?)
  • So you can see why I’m so against Jerri taking the drug. For her, the benefits do not outweigh the risks. For her, it is not safe. Her prescribing physician (who is not her psychiatrist) should know better as I’ve made sure he is aware of Jerri’s medical and psychological history. I’ve repeatedly expressed my concerns but he continues to prescribe it. Perhaps he thinks it will do no harm. Ha! He needs to read the PI. It should not come as a surprise to any of us if that medication eventually kills her.

    Jerri is just as adamant about taking Adderall as I am opposed to it. Can you say “psychological dependence”? So it has become the-medication-of-which-we-do-not-speak. It’s very difficult knowing my sister is basically playing Russian Roulette and I’m unable to get her to put down the gun. I feel for those of you in similar circumstances.

    The moral of this story is know your meds. If you have a family member with mental illness, know their meds. Don’t take their medications lightly. Read the PI or medication guide. Talk to a pharmacist if there is any information you don’t understand. Speak up if you have concerns. You have a voice–use it. You may not be able to change either the prescribing behavior of the doctor or the drug-seeking behavior of your loved one but at least you’ll be better informed should a drug-related crisis occur.

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