When Your Diabetes Drug Smells Like Rotting Fish
3 CommentsBy Ed Silverman // February 17th, 2010 // 7:57 am
Open your Glucophage and take a whiff. A group of family physicians in Georgia was surprised to learn many of their diabetes patients had stopped taking metformin because it smelled like “dead fish,” according to a clinical observation published Monday in the Annals of Internal Medicine (look here). And they want to warn other docs to be on the lookout for what are being called stinky drugs.
“A physician may prescribe a drug and as far as seeing the drug, they may never have seen the tablet before and certainly never tried smelling it,” J. Russell May, a co-author of the clinical observation and a professor at the University of Georgia College of Pharmacy in Athens. Ga., tells ABC News.
His colleagues’ patients stopped taking the med because they assumed the fishy smell meant the drugs had “gone bad,” although May described metformin ’s odor as “the inside of the inner tube mixed with fish.” Patients have discussed the problem online, under such postings as “What does your metformin smell like?”
A spokesman for Bristol-Myers Squibb, which sells metformin as Glucophage and Glucophage XR), tells The New York Times the drugmaker “is aware that the inherent characteristics of metformin have been associated with a mild odor upon opening the bottle, but there has been no correlation between an odor and the efficacy of metformin.”
fish pic thx to laszlo-photo at flickr creative commons
Paul G. King, PhD
Personally, I wonder if the odor attributed to the Metformin HCl, the active ingredient in Glucophage is NOT related to impurities in the active ingredient, N,N-Dimethylimidodicarbonimidic diamide hydrochloride, rather than the active ingredient in the drug product pre se.
In my experience with many “odiferous” drug products, the most frequent odor problem has been with the impurities or, in cases where the structure contains nitrogen groups that are to be protonated, incomplete protonation.
Perhaps if the mfg of the API were to recrystallize the product from a suitable solvent system containing a slight excess of Hydrochloric Acid, the odor level might be significantly reduced or eliminated.
Given the reported melting point of the compound (in excess of 200 degrees C) and the fact that it is a HCl salt, would not expect the “pure” compound to have any odor at all.
I can remember being repeatedly told about the “odor” (stench) of semi-synthetic penicillin products, like Amoxicillin Trihydrate USP, only to find out that highly purified Amoxicillin Trihydrate has NO odor whatsoever.
In this regard, all should remember that a “USP/EP/JP/BP” grade of an API is NOT pure but rather simply meets the “USP/EP/JP/BP” standards for quality that, in many cases, may be less than they can be and which, to maximize profit, most API producers simply strive to meet — NOT significantly exceed.
Finally, if a drug maker wants a better quality API from an outside source, the outside source is usually amenable to providing that better quality PROVIDED the drug maker is willing to pay for the extra costs incurred plus a reasonable amount to ensure the API maker has a reasonable return on investment. If the source is inside the company, then management need only either reduce its profit or increase the drug product’s price to recover the increased costs.
Hopefully, someone who is more knowledgeable than I am about Metformin HCl can answer the question as to whether “pure” Metformin HCl has, or does NOT have, an odor.
cliffintokyo
On a more serious note, anyone out there interested in conducting a survey to find the percentage of people who have investigated the odor of the INSIDE of an inner tube……would that be for a bicycle tire?
Smells like an outdoor-type of person to me.
francisco rodriguez
i wonder if metformin is got a recall also for rotten smell. please let me know