 |
Glucagon like peptide (GLP) |
I was content to let the FDA release and the news media handle this problem until I watched a TV news person say the following: “Counterfeit Ozempic or off label Ozempic is potentially dangerous…..” Off label Ozempic is NOT counterfeit Ozempic. Off label medications are FDA approved medications that are prescribed for indication other than what is listed in the package insert. Based on a recent table that I made from package insert information practically all GLP-1 agonists like Ozempic are prescribed off label because the FDA indication is Type 2 diabetes mellitus rather than weight management. The FDA news release is all about Ozempic look alikes being sold as the real product. In some cases they do not contain any active ingredient and in the majority of cases what they actually contain is currently unknown.
The FDA warning (1) about counterfeit Ozempic surfaced on
12/21/2023. Ozempic and many drugs in
this class come in an injection device, since most of the dosing is by
subcutaneous (SC) injection. The FDA also warned that the needles in these
devices were counterfeit and their safety and sterility could not be
guaranteed. In the warning in reference
1 they describe 5 incidents of adverse effects – none life threatening. The confiscated pens are being analyzed to
determine what is being used rather than Ozempic. Counterfeit pens were found in at least 9
countries and in some – insulin was found (2). The FDA provides lot and serial
numbers of the counterfeit medication and advises pharmacies not to use it.
The same day as this release, the FDA also warned about
compounded GLP-1 agonists (3). Compounded
products are prepared by compounding pharmacies. If medications are in short supply –
compounding pharmacies can produce them. Ozempic and Wegovey are both on that
list. Both are semaglutides and adverse
events have occurred with the compounded versions. Some of the counterfeit versions contain the
salt form of semaglutide compared with the FDA approved medication that is the
base form. This warning also describes
counterfeit semaglutide being marketed online, concerns about counterfeit
Ozempic in the US, and it encourage patients to protect themselves by only
purchasing semaglutides through state licensed pharmacies.
Although it is not emphasized in the warnings, I also have
concern about the injection pen device that the semaglutide is contained
in. The injectors are calibrated to
deliver 0.25. 0.5, and 1 mg doses according to the prescription for each
patient. The device is supposed to click
when it is at the corrected dose. This
medication and unique injector is reminiscent of other medications where the patented
delivery system was so critical to the medication that it essentially extended
the patent. Unless the counterfeiters
are using a very similar device the recommended doses of medication might not
be delivered correctly. Exactly how
problematic that will be depends on the medication or substance that has been
substituted for the semaglutide. Even if
the counterfeiters can produce a semaglutide like name brand Ozempic or Wegovey
– there is no guarantee that the pen device they are using can guarantee
accurate delivery of the dose.
At this time, I have not heard that there has been an attempt
to synthesize the actual medication. With today’s technology I would not be
surprised if that attempt was made at some point.
That led me to think about the issue of legal and illicit
drugs. At some point – knowledge obtained in the past century seems to have
been replaced by the rhetoric of drug legalization. These arguments are always
about drugs that reinforce their own use or what are commonly referred to as
addictive drugs. The legalization myth generally skips over the harms of these
drugs directly to what is often referred to as harm reduction. That generally means that it is more harmful
to insist that people stop using these drugs than providing them with safe
forms to continue using or in the more extreme case to leave drug dealing and all
the illicit forms intact. In the latter case, methods to test the drugs and provide
safer methods of delivery offer the users an opportunity to protect themselves
from suppliers who may add adulterants to the drugs or substitute a more
dangerous drugs without informing them.
GLP-1 agonists are clearly not addictive drugs as far as
anyone knows at this point. But the issue I attempted to cover in this post is drug safety – specifically the safety of the drug supply to patients with a prescription.
Despite the provocative way the pharmaceutical industry is covered and often villainized
in the press – there is no doubt that they can and have provided a safe supply
of medication to the public. There are lapses and inadequate inspections and
recalls. The current system is far from
perfect. But it is clearly superior to any system being run by a criminal
enterprise supplying illicit drugs. It is hard to imagine a system where you
would have to personally run a chemical test on your prescription medications
to make sure they were safe. It is
equally hard to imagine producing counterfeit drugs and selling them to the
public like the real thing.
That is what the FDA is trying to prevent with this warning.
George Dawson, MD, DFAPA
References:
1: FDA. FDA warns consumers not to use counterfeit
Ozempic (semaglutide) found in U.S. drug supply chain. December 21, 2023 https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain
2: National
Association of Boards of Pharmacy.
Counterfeit Ozempic Found in US Retail Pharmacy. August 7, 2023 https://nabp.pharmacy/news/blog/regulatory_news/counterfeit-ozempic-found-in-us-retail-pharmacy/
3: FDA. Medications Containing Semaglutide Marketed
for Type 2 Diabetes or Weight Loss.
December 21, 2023 https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
Peptide Structure:
Drawn with PepDraw: https://pepdraw.com/
.jpg)
