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Mandatory adverse event reporting: 503B facilities are required to report adverse events to the FDA, creating a safety surveillance system that parallels (though doesn't replicate) the pharmacovigilance systems used for FDA-approved drugs

However, this was predominantly driven by one trial, DECLARE TIMI 58, which included healthier cohorts than other cardiovascular outcome trials (CVOT) involving SGLT-2 inhibitors [103], and this benefit of asthma risk reduction was neutralized when DECLARE TIMI 58 was excluded from the analysis [105]

People who experience increased thirst on tirzepatide sometimes worry this indicates a urinary problem, when it is typically a normal physiological response to the medication

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There have been no large-scale, long-term studies to truly evaluate safety especially not for cancer risk

It's a catastrophic, yet entirely avoidable, scenario