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Patients have reported recurring issues with the Mounjaro KwikPen, particularly regarding its functionality during the third or fourth dose. Over 100 reports have been received about potential technical defects associated with this medication, which contains tirzepatide and is produced by Lilly.
According to Professor Dr. Martin Schulz, Chairman of the German Pharmacists' Medicines Commission (AMK), from May to September of the previous year alone, there were 149 reported cases of mechanical defects in the Mounjaro KwikPen. Each pen is designed to deliver four doses, which patients administer subcutaneously once a week.
Concerns have been raised in pharmacies about the pen becoming blocked during the latter doses, with reports indicating that the dosing wheel can also become unresponsive. Schulz noted that patients are returning to their local pharmacies with these issues, particularly struggling with the necessary venting process before injection. If the pen is vented excessively, it may lock prematurely, preventing the extraction of the medication.
The manufacturer has attributed these problems to user errors rather than a manufacturing defect. However, the Central Laboratory of German Pharmacists (ZL) did not find any production-related quality issues upon reviewing complaints and samples. The tested pens were able to deliver doses without significant remaining volume, which was attributed to overfilling.
Despite the findings, the AMK suspects that there are manufacturer-related factors that could lead to user errors, given the frequency of similar complaints from pharmacies. Consequently, the AMK has urged the pharmaceutical company to enhance the product to better meet patient needs. Key recommendations include:
Schulz emphasized the importance of pharmacy teams in educating patients to ensure safe medication practices. The AMK is currently in discussions with the Federal Institute for Drugs and Medical Devices (BfArM) to initiate risk-reduction measures in collaboration with the manufacturer. Meanwhile, the AMK advises pharmacies to inform patients about proper handling and to report any additional concerns through their official channels.
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Section: Health
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Section: News
Section: News
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