Posted by: Chris Maloney | April 14, 2011

Stinky drugs: Now Topamax is withdrawn.

EuroPallet

Image via Wikipedia

For the second time in two years we have a major recall of drugs because of odor issues.  This time it’s Johnson and Johnson and the drug is Topamax.  Sounds like a minor issue until you start searching for why the odor is occurring.  “Odor” turns out to be a nice way of saying “contamination by highly volatile organic compounds with no known human safety data.” 

According to last year’s inquiry by the FDA, the drug manufacturers are heedlessly storing our drugs next to wood pallets that have been sprayed with a fungicide2,4,6-Tribromoanisole.  Although this fungicide is not allowed in the U.S., other countries are still allowing its use.  Yep, you can still buy it in bulk, but use a respirator when spraying. 

So, those pesky wood pallets’ odor migrates over to the drugs, where it -PENETRATES THE PLASTIC- that’s right, and settles on your drugs.  Wow, that’s some chemical, right?  And we know this is true because the FDA believes the manufacturers, who told them this was the case.  Phew, good thing too, because there aren’t any human studies on the effects of this chemical. 

We do have studies on the effects of this chemical on zebra fish.  They weren’t terribly happy and didn’t reproduce terribly well.  But we don’t have anything on human exposures.  Except that people got nauseous from taking the drugs that smelled bad.  So, of course, there’s the question of a class action lawsuit.  Just an idea, because after all it was just a bad smell. 

The trouble is that wine manufacturers have been dealing with this particular odor for many years.  It involves contamination of the wine, often from the cork.  But we don’t have an absorbent cap on drugs, so we should assume contamination from other sources.  The wood pallet idea doesn’t make as much sense as spraying of the fungicide on and around the empty bottles.  The most likely culprit is fungal contamination of the drugs by the fungus Paecilomyces variotii which can convert the nonsmelly fungicide into its odiferous version.  That way the drugs, all sprayed with a fungicide, wouldn’t show up with a bad smell until the conversion took place on pharmacy shelves.  Most of the time the odor problems wouldn’t happen because you need both fungicide contamination and contamination from the resistant fungus.   

Since the recall is voluntary, the FDA will not be testing for anything.  It’s just an odor.  But it makes me wonder how many contaminants get into the drug supply that just don’t smell bad enough for consumers to notice them?

When I looked, are the zebra fish studies and a study on contamination of our ocean fish with the chemical.  There is nothing on medline about human exposures.

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