Beneath Comforting Labels

The news has been awash with word of the link between epilepsy drugs and suicidal tendencies. The FDA has decided to not stick large labels on my pills that say, "Death is really not that great an option and ignore the voices debating the subject cause they are just a side effect of the meds holding your seizures at bay. Srsly."

From a practical point of view, big scary labels don't provide enough specific information about the relative merits flowing from a particular drug. Statically it may be more effective to plaster MAY CONTRIBUTE TO SUICIDE warnings on kitchen knives, top floors of skyscrapers or car doors if your name happens to be Thelma or Louise. That being said, big scary labels help raise public awareness of side effects and adapt accordingly. Something did resonate in our consciousness when Olestra and anal leakage were written in close proximity.

Needless to say, the FDA did not require labeling because the study had a smallish data pool and there was fear that epileptics would stop taking their antiseizure meds out of fear of the side effects. Abandoning drugs and risking seizures has more immediate risks and longterm consequences.

Personally, I don't care how they label the drugs as long as the info is easily accessible somewhere--the internets, in the tiny print of the drug users manual or in my doctor's brain. Afterall, I won't really pay attention unless I'm told directly, get bored/obsessed and have internet access or experience weirdness. Plus I'm anal enough/aware that I'm not a doctor to just take my meds as long as I can afford them.

A consequence of this discussion on scaring the bejeezus out of the public with regulatory policy is an assumption that that a law will cover all permutations of the problem it seeks to address. Law is never a panacea for problems or thinking. Laws (in this case a label) should pique our curiousity and not be an excuse to be mindless drones. As individuals we take a stab at interpreting laws (i.e. why we go under or over the speed limit as the situation warrants even though it is a law that is on its face pretty clear and publicly posted). But from time to time our interpretations get called into question and then we get to have a longer more nuanced conversation vis a vis the judicial system.

Drug labeling is like this too--the majority of users of anti-seizure drugs are probably not doctors or pharmacists. Unlike the general public who are not shelling out hundreds of dollars for these products, we do have some self interest in learning more about how to interpret the "law of the label." Much like a motorcyclist has a bit more self interest in highway pavement quality and may voice those concerns more adamantly to the local DOT, the discourse on "what should be" gets shaped by those who step up and talk about their experience.

So I'll step up. Here's my experience so far with Lamictal.

According to the most cursory of internet research, RxList.com states:

Most Common Adverse Events in All Clinical Studies: Adjunctive Therapy in Adults With Epilepsy

The most commonly observed (≥5%) adverse experiences seen in association with LAMICTAL during adjunctive therapy in adults and not seen at an equivalent frequency among placebo-treated patients were: dizziness, ataxia, somnolence, headache, diplopia, blurred vision, nausea, vomiting, and rash.

Okay...I'm not a Scrabble junkie so I don't have a large useless precise vocabulary, so definitions are inserted as needed.

Dizziness--not so bad. Before the brain surgery, I would get serious head rush. Can say with confidence, "not a symptom I enjoy."

Somnolence: Sleepiness, the state of feeling drowsy, ready to fall asleep. A person experiencing somnolence is somnolent and is acting somnolently. This I've experienced but tend to credit it to having too much on my plate. Perhaps as a reflection of my insecurities, I'm inclined call myself lazy if I'm tired.

Ataxia: Wobbliness. Incoordination and unsteadiness due to the brain's failure to regulate the body's posture and regulate the strength and direction of limb movements. Despite wearing heels daily, this isn't popping up.

Diplopia/Blurred Vision: Hard to know. I'm missing part of the left side of my visual field from the surgery, compounded by needing glasses as I've grown nearsighted (thanks law school!). Too many variables to know for sure.

Nauseua & Vomiting: I barf when really stressed so this has diminished over time.

Rash: Ummm....my hands kind of look like baby swiss. However I think this flows from stress as I've had it long before the meds.

What's the common theme? Its hard to sort out what is a side effect of a medication and the day-to-day consequences of living. Since tossing the meds to narrow the variables is fraught with risks of seizure, the logical option is deal with the anxiety I carry around.

Here's the thing--though it would be easier to blame the meds, the side effects flow from me. That means I have to step up and change myself if I want them to change. There is a dark selfish two-year-old part of me that wants to be able to tap these health problems for pity and attention. I'm not proud of that. Instead, I'm seeking a process or dialog or a source of more information to face the problem before me.

So, like how to label risk factors drugs, the challenge of unpacking multi-layered problems that we face from external and internal factors feels overwhelming because where do you start? And where do you stop (if ever)? It would be really comforting if there was just a big label that told us the crux of every problem. I wish there were a panacea for problems or thinking. It would be less scary and intimidating.

But it would ignore our power.

Interpreting the suggestions to solve problems takes time and energy. It raises anxieties and fears that transcend the problem at hand.
In law that fear is "will be all be treated with equal respect and dignity, even when we approach a rule with different perspectives?"
In healthcare that fear is "will I know what's going on within my body?"
Inside me that fear is "can I face myself flawed and strong?"