Sweden health authority warns on falsified exenatide pens

The health authority in Sweden has issued a warning on falsified exenatide injection pens found in the legitimate supply chain. The Journal has reviewed the notice and the accompanying photographs; the distinguishing features are a batch-number font difference and a needle-shield colour, neither of which a patient could reasonably be expected to detect.

Comparison of 15 certificates supplied by the reseller against the laboratory’s public archive matched 7 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.

Comparison of 15 certificates supplied by the reseller against the laboratory’s public archive matched 7 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.

The document is the weakest link in this trade. A certificate is a PDF; a laboratory letterhead is an image; a lot number is a string. Nothing in the ordinary transaction allows a buyer to confirm that a given report was issued for a given vial, and the four independent services differ in whether they offer any lookup at all.

Havel Novotný, independent laboratory quality manager, said the underfill finding was the more consequential one. "Nobody is being poisoned by a low content figure. Everybody using that vial is out by a fifth in every calculation they make."

Our series on identity confirmation covers the analytical detection of substitution in detail, including the mass differences that correspond to the commonest related compounds.