Rheumination

Lyrica Safer in Canada

I tossed and turned all night after I read the FDA's warning about increased risk of suicidal behaviour with the use of Lyrica. After all, it's been one of the choice drugs for the treatment of fibromyalgia for quite some time.  When I went back to work in January I asked my colleagues what they thought about the warning.  None of them had heard of it.  I asked a colleague who does fibromyalgia research and prescribes Lyrica  by the truck-load.  Hadn't heard a thing.  Then it dawned on me.  Here in Canada we don't get FDA warnings. If you don't read blogs or read American news, you'd never be aware of the warning. So then I had to wonder; what are my legal and ethical obligations regarding this matter?  Legally I imagine I'm off the hook.  If Health Canada is good with a drug,  I can't see a problem.  But ethically, can I ignore the warnings of the FDA.  With it's relatively massive resources, the FDA has studied and concluded that there is a problem. Health Canada may never get around to looking into the matter.  Makes sense that I should  consider the FDA as a reliable source and act accordingly.  But if this is the case, am I, as a Canadian,  obliged to keep up with all the wisdom arising from below the 49th and treat it as my own?  And the Europeans aren't exactly slouches over there.  Must I keep abreast of all things brewing at the European Medicines Agency , or the UK's NICE.  Should I learn how to speak Australian. so I can get info from the Australian TGA.  Maybe so.

FDA's Lousy Christmas Present

My holidays may have been a little more enjoyable if they hadn't been disturbed by a Dec. 16 FDA advisorysuggesting that antiepileptic drugs cause an increase in suicidal thoughts. Lyrica (pregabalin), one of a very tiny few drugs shown to be effective (well, somewhat effective anyway) for the treatment of fibromyalgia, is on that list.  

The study by the FDA was a review of 199 clinical trials, although it isn't clear if the fibromyalgia studies were included.  They did include epilepsy, psychiatric disorders, migraine and neuropathic pain.  There was a near doubling of suicidal thoughts or behaviours, .43% vs .24%, which would represent about one case per five hundred treated patients.  There were four suicides in treated patients and none in the controls.Whether four suicides amongst 28000 treated patients is considered a lot depends on the condition treated.  In the case of fibromyalgia, we're talking about a nonfatal disease.

This is of course, not a definitive study, but it carries considerable weight given that labeling must now include this in the warning section as well as the patient information section.  In other words, we must now warn our frequently depressed, anxious stressed fibromyalgia patients that one of the best treatments for their condition may increase their thoughts of killing themselves.  That ought to help their sleep.

Too much heat at -20 Celsius

Now that was weird.  In Montreal, as in much of Canada, we are going through a rather brutal cold snap. Today it has warmed up to a balmy -18C (-1F)  and with this warming, my computer has finally come back to life.  Even more unusual was the malady my Mac acquired over the holidays, narcolepsy.  The thing would go to sleep in mid-blog or mid-mail.  You could wake it up easily enough but it would then proceed to go right back to sleep.  It was eerily in sync with my teenage daughter.  If you woke it up often enough, it would just shut down completely, but not before some mischief with whatever app was  open at the time. The friendly geniuses at the Apple store were stumped. I was desperately trying to figure out how to administer Ritalin to my computer when one of my friends, a computer science prof, suggested that it might be a heat issue, that my fan wasn't working.  In checking into this I discovered that my air intake port was clogged with dust from recent renovations.  Apparently the problem is now solved .  Who would have thought, a heat problem during a cold snap.

It's All About The Numbers

    There's a curious belief amongst academic specialists that because they are the most tertiary of tertiary centres,  they alone see serious cases.  A few years ago, when we were just two rheumatologists in our hospital, a  possible recruit visited her favorite attending to discuss the possibility of joining our team.  Our hospital is non academic but is the only tertiary hospital for a very large region, and we were the only rheumatologists for a catchment area of 1.3 million people.  The professor told her that she would only see back pain, fibro and OA.  

    Fortunately I was able to convince her that this was far from the truth.  In fact, most patients are frankly unaware of the fact that they have lupus or vasculitis when they get sick. They don't google their symptoms, diagnose themselves and then search the appropriate rheumatologist of fame.  They just feel terrible and go to the nearest hospital emergency.  When you have a population of 1.3 million, that makes for a lot of hospital visits.

  This holiday period, I took the last few days of call.  These are some of the patients our new colleague signed over to me:

Pt  with progressive neurological deficit suggestive of vasculitis, found to have Arnold Chiari malformation requiring emergency surgery.

 

Pt in ICU with acute pulmonary-renal syndrome found to have ANCA negative Wegener's.

Elderly man in ICU with arthritis, rash and sepsis.

Dermatomyositis patient in ICU for respiratory decompensation.

Young woman with polyarthritis and  probable auto-immune hepatitis. Probable lupus.

Probable Henoch Schonlein vasculitis  vs polyarteritis nodosum.

I then saw, amongst a smattering of gout and pseudogout:

Pregnant woman presenting with acute sacro-iliitis and E Nodosum.

Known lupus patient presenting with acute pericarditis and nephritis.

Oddly, none thought to google there way to the academic centre just a few miles away.