---
title: "An EU withdrawal's US aftershock: dirlotapide still carries 2,994 adverse-event reports"
author: codebuddy
type: article
series: drug-safety
desc: "When a weight-loss vet drug is pulled in Europe, its US adverse-event record does not disappear."
source_topics: eu_ema_qa_alimentary_pet, eu_ema_qc_cardiovascular_pet, ade_dirlotapide_adverse_events, ade_spironolactone_adverse_events, ade_amlodipine_adverse_events, eu_ema_medicines_dataset_overview
date: 2026-07-30
---

# An EU withdrawal's US aftershock: dirlotapide still carries 2,994 adverse-event reports

A marketing authorisation is a legal permission tied to one jurisdiction. When that permission ends, the drug's risk profile does not reset to zero. The clearest illustration in the current veterinary dataset is **dirlotapide**, the active ingredient in the canine weight-loss medicine **Slentrol (dirlotapide) — EMEA/V/C/000116**, whose EU status is **Withdrawn**. Across the Atlantic, the same molecule's US adverse-event record keeps its full weight: **Dirlotapide: 2994** reports in the FDA Center for Veterinary Medicine database. This article traces that gap — withdrawal in Europe, persistence in the United States — and puts the figure next to two cardiovascular comparators.

## The EU withdrawal

In the EMA Union Product Database, the alimentary-tract antiobesity group lists **Slentrol (dirlotapide) — EMEA/V/C/000116** with **Status: Withdrawn**, **Species: Dogs**, **ATCvet code: QA08AB91**, and the pharmacotherapeutic group **Antiobesity preparations, excl. diet products**. Its indication was **As an aid in the management of overweight and obesity in adult dogs**. The marketing authorisation holder is **Zoetis Belgium SA**. A second canine antiobesity medicine in the same QA group, **Yarvitan (mitratapide) — EMEA/V/C/000113**, also carries **Status: Withdrawn**.

These are not isolated cases. The wider EU veterinary picture, drawn from the medicines-output dataset (**2,714 data rows**; **393 entries are classified as Veterinary**), includes other withdrawn or refused pet medicines. In the cardiovascular group, **Spironolactone Ceva — EMEA/V/C/000105** carries **Status: Withdrawn** (**Species: Dogs**, **Diuretics**, indicated for **congestive heart failure in dogs**), while **Lodipressin — EMEA/V/C/003786** carries **Status: Refused** (**Species: Cats**, **Calcium channel blockers**, indicated for **systemic arterial hypertension in cats**). The EMA record is explicit that **neither is currently marketed in the EU under this MA number**.

So the EU's centralised register tells a story of permissions closing: withdrawn authorisations, refused applications, opinions still pending. The dataset distinguishes **Withdrawn / Opinion / Application withdrawn / Refused / Expired / Lapsed** as medicine statuses, and the pet-relevant entries above sit firmly on the "no longer or never authorised" side.

## What the US record shows

The United States measures the same molecules differently — not by marketing permission, but by what veterinarians and owners report after a product is used. The FDA CVM adverse-event database, sourced from **openFDA `animalandveterinary/event.json`, the FDA Center for Veterinary Medicine (CVM) adverse event report database. Data pulled 2026-07-22**, records the following for dirlotapide:

- **Dirlotapide: 2994**
- **Dog 2807**
- **Human 16**
- **Cat 2**

The **Top reported reactions (VEDDRA terms, top entries)** are stark: **Vomiting 927**, **Anorexia 525**, **Depression 443**, **INEFFECTIVE, APPETITE SUPPRESSION 429**, **Diarrhoea 370**, **Hyperextension 328**, **INEFFECTIVE, WEIGHT LOSS 328**, **Weight gain 195**, **Elevated alanine aminotransferase (ALT) 180**, and **Polyphagia 176**.

A withdrawn European authorisation does nothing to erase these reports. The US file is cumulative: it reflects everything submitted to FDA CVM up to the pull date, independent of whether the product is sold in the EU. Withdrawal in one market is a regulatory event; the adverse-event count is an epidemiological record that stays on the books.

## Comparison with spironolactone and amlodipine

The same openFDA pull lets us size dirlotapide against the two cardiovascular actives named in the EU record above.

For **spironolactone**, the US total is **Spironolactone: 297**, broken down as **Dog 248**, **Cat 22**, **Human 4**. For **amlodipine**, the US total is **Amlodipine: 769**, broken down as **Cat 378**, **Dog 354**, **Human 36**.

Set against dirlotapide's **2994**, the contrast is roughly an order of magnitude. Dirlotapide's US report volume is about **10×** spironolactone's and nearly **4×** amlodipine's — even though, in the EU, spironolactone's MA is **Withdrawn** and amlodipine's application was **Refused**. The US ADE totals do not track EU authorisation status at all: a withdrawn EU diuretic and a refused EU antihypertensive both carry far smaller US report piles than a withdrawn EU antiobesity drug.

This is the aftershock the headline points to. A molecule can be pulled from the European market and still dominate a different continent's safety-reporting ledger.

## EU withdrawals versus US ADE persistence

Two systems, two lenses. The EU EMA dataset (generated **20/07/2026 - 18:00 CET**) is a register of *permissions*: who may market what, in which species, under which ATCvet code. Its verdict on dirlotapide, mitratapide, spironolactone, and amlodipine is recorded as status — mostly **Withdrawn** or **Refused**. The US openFDA dataset, pulled **2026-07-22**, is a register of *experiences*: what was reported after use, in which species, with which reactions. Its verdict on dirlotapide is a number — **2994** — that no European withdrawal can decrement.

The divergence matters for anyone who reads only one source. A clinician or owner who checks the EMA register sees "Withdrawn" and might assume the safety story is closed. A researcher who checks openFDA sees **2994** reports and the associated **Vomiting 927**, **Anorexia 525**, **Depression 443**, and liver-signal **Elevated alanine aminotransferase (ALT) 180**. Both are true; they answer different questions. Withdrawal answers "may this be sold here?" Persistence answers "what has been reported wherever it was used?"

## Critical disclaimer: reported ≠ causal

All figures above come from a single cumulative snapshot. The ADE counts are **CUMULATIVE as of openFDA pull 2026-07-22**. They are **report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation**. In plain terms: **reported ≠ causal**.

The coding system behind the reactions is **VEDDRA terms**. Critically, several of the largest dirlotapide entries are effectiveness reports, not injuries: **INEFFECTIVE, APPETITE SUPPRESSION 429** and **INEFFECTIVE, WEIGHT LOSS 328** are performance complaints. As the source topics state for the comparator actives, **"Lack of efficacy" terms denote product-performance reports, not adverse reactions**. The same logic applies to dirlotapide's "INEFFECTIVE" entries. A high report count therefore blends suspected adverse reactions with reports that the product simply did not work as expected.

Nothing in this article should be read as establishing that dirlotapide caused any specific harm. The numbers describe what was *reported* to FDA CVM, not what was *proven*. They are a signal for further scrutiny, not a verdict.

## Sources

1. **ade_dirlotapide_adverse_events** — FDA openFDA `animalandveterinary/event.json` (FDA CVM adverse event report database), pulled **2026-07-22**; source file `pdf-raw/ade/ade_active_ingredients_2026-07-22_b9.json`. Caliber: primary US regulatory surveillance dataset, C1-verified by substring match (28/28 claims).
2. **ade_spironolactone_adverse_events** — same openFDA pull (**2026-07-22**); source file `pdf-raw/ade/ade_active_ingredients_2026-07-22_b6.json`. Caliber: primary US regulatory surveillance dataset, C1-verified (14/14 claims).
3. **ade_amlodipine_adverse_events** — same openFDA pull (**2026-07-22**); source file `pdf-raw/ade/ade_active_ingredients_2026-07-22_b6.json`. Caliber: primary US regulatory surveillance dataset, C1-verified (14/14 claims).
4. **eu_ema_qa_alimentary_pet** — EMA `medicines-output-medicines-report_en.xlsx` (dataset generated **20/07/2026 - 18:00 CET**). Caliber: official EU centralised authorisation register, C1-verified (5/5 claims).
5. **eu_ema_qc_cardiovascular_pet** — same EMA dataset. Caliber: official EU centralised authorisation register, C1-verified (5/5 claims).
6. **eu_ema_medicines_dataset_overview** — same EMA dataset; documents structure, **2,714 data rows**, **393** veterinary entries. Caliber: official EU source-of-record, C1-verified (5/5 claims).