OMAHA, Neb. (WOWT) – The FDA is cracking down on off brand weight loss products similar to Ozempic. <\/p>\n
GLP-1 drugs for weight loss like Wegovy or Zepbound were previously in a shortage. <\/p>\n
\u201cThe combination of demand, most of these medications generally come in injector pens,\u201d said Dr. Brianna Johnson-Rabbett, Endocrinologist at UNMC. \u201cSo I know there has been a lot of issues with just manufacturing the pens.\u201d <\/p>\n
When a medication like Wegovy are under patent, copies are not allowed. <\/p>\n
\u201cBut there is a loophole where medications under a shortage, generally, there is an allowance for production of essential copies of those medications,\u201d explained Dr. Johnson-Rabbett.<\/p>\n
During that time, compounding pharmacies were allowed to sell replica products to make up for the low supply. <\/p>\n
However, recently, the FDA declared the shortage of semaglutide and tirzepatide over, meaning the loophole is closed and enforcement is underway.<\/p>\n
\u201cThe FDA did give that significant lead time in advance of the date that they would start enforcing those violations of those regulations but that final date of not enforcing those was yesterday,\u201d said Dr. Johnson-Rabbett.<\/p>\n
She says that FDA regulation is important when determining a medication as safe and effective. <\/p>\n
\u201cOf course there are many different layers but those are kind of the pillars, the safety, making sure they actually work and the quality,\u201d said Dr. Johnson-Rabbett. <\/p>\n
\u201cMaking sure that batch to batch they are the same. That you know that a dose is labeled as a dose it is that does especially with the GLP 1 type medications, people can be doing really well on one does but could get very ill if they got a different dose a significantly higher dose.\u201d <\/p>\n
Experts say thousands or maybe millions relied on compounded GLP-1 meds due to their cheaper cost. Dr. Johnson-Rabbett has concerns when it comes to seeking this kind of treatment. <\/p>\n
\u201cWith compounded medications some of the concerns are quality problems like contamination with other substances or too much or too little active ingredient. And as such, significant concern about patient safety.\u201d<\/p>\n
She worries folks could seek medication alternatives online. <\/p>\n
\u201cThere are known concerns about even outside of specifically compounding even things that are meant to be used in laboratory settings and things like that being made available,\u201d said Dr. Johnson-Rabbett. <\/p>\n
\u201cAs well as even counterfeit medications that look like a pen of a labeled medication but are not unfortunately.\u201d<\/p>\n
She is optimistic another shortage won\u2019t happen, but \u201cthere is nothing to say that it could not happen that there would be another shortage and then that loophole will open again for allowing compounded versions of patented medications to be available again.\u201d<\/p>\n
Dr. Johnson-Rabbett recommends consulting your doctor before trying any of these medications. There could be alternative ways to support your health goals. <\/p>\n
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