Updated: FDA asks for data on Lilly's Foundayo to assess heart, liver risks
The FDA has requested post-marketing safety data from Lilly on Foundayo (orforglipron), citing unexpected MACE cases and potential drug-induced liver injury seen during clinical trials. Lilly says the ACHIEVE-4 trial data shows no liver safety signal and a 16% lower risk of major cardiovascular events compared to insulin.
What This Means for You
The FDA has requested post-marketing safety data from Lilly on Foundayo (orforglipron), citing unexpected MACE cases and potential drug-induced liver injury seen during clinical trials. Lilly says the ACHIEVE-4 trial data shows no liver safety signal and a 16% lower risk of major cardiovascular events compared to insulin.
Two weeks after approving Foundayo, the FDA has asked Eli Lilly to submit additional safety data on cardiovascular and liver risks. The request, which targets data from the ACHIEVE-4 trial, is due by July 2026. If you just started taking Foundayo or are considering it, this probably triggered some alarm bells. Here’s what you need to know.
The FDA flagged two concerns from clinical trials: a higher-than-expected number of major adverse cardiovascular events (MACE) and cases of drug-induced liver injury. They also want 15 years of thyroid cancer monitoring data, plus pediatric and pregnancy safety studies. On paper, that sounds serious. In practice, this type of post-marketing data request is standard for newly approved medications, especially in the GLP-1 class. The FDA approved Foundayo because the overall benefit-risk profile was favorable. These follow-up requests are about filling in gaps, not about reconsidering the approval.
Lilly’s response has been direct. They say the ACHIEVE-4 trial, their longest Phase 3 study, showed no liver safety signal and a 16% lower risk of major cardiovascular events compared to insulin glargine. The MACE finding in earlier trials involved a small number of events in a relatively small study population, which makes it hard to draw conclusions. Larger, longer studies like ACHIEVE-4 are better equipped to detect real signals, and so far the signal is reassuring, not concerning.
Should you stop taking Foundayo because of this? No. The FDA approved the drug with full knowledge of the clinical trial data, including the MACE and liver cases. Their request for additional data is a monitoring step, not a safety withdrawal. Your prescriber should be aware of this request and can discuss it with you, but there’s no recommendation from either the FDA or Lilly to discontinue treatment. If you’re getting your Foundayo through Ro, Hims, or another telehealth provider, they’ll likely send communications about this as part of their standard patient updates. If you experience chest pain, unusual fatigue, yellowing of the skin or eyes, or dark urine, contact your doctor immediately, as you would with any medication. But these symptoms are rare and not specific to Foundayo.
Source: Endpoints News
Frequently asked questions
Is the FDA considering pulling Foundayo from the market?
No. Post-marketing safety data requests are routine for newly approved drugs. The FDA approved Foundayo after reviewing the complete clinical trial package and determined the benefits outweigh the risks. This follow-up request is about ongoing monitoring, not a signal that the agency is reconsidering its decision. If the FDA had serious safety concerns warranting market withdrawal, they would issue a safety communication or boxed warning first.
What were the heart and liver concerns found in trials?
During clinical trials, researchers observed a small number of major adverse cardiovascular events (heart attack, stroke, cardiovascular death) and cases of drug-induced liver injury that were higher than expected. However, the numbers were small and occurred in shorter trials with limited participants. The longer ACHIEVE-4 trial, which ran for over two years, actually showed Foundayo users had 16% fewer cardiovascular events than the control group on insulin. The FDA wants this larger dataset submitted formally to confirm the safety profile.
Should I tell my doctor I’m worried about these findings?
Yes, bring it up at your next appointment or during your telehealth check-in. Your prescriber can walk you through the specific data and put the risk in context relative to your personal health history. If you have existing heart disease or liver conditions, your doctor may want to monitor lab work more closely while the FDA reviews the additional data. Providers like PlushCare and Calibrate that offer ongoing clinical support can help you stay on top of any updates.
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Frequently Asked Questions
Is the FDA considering pulling Foundayo from the market?
What were the heart and liver concerns found in trials?
Should I tell my doctor I'm worried about these findings?
Original source
Read the full article at Endpoints News