A Landmark Shift: New ASH Guidelines Redefine How We Diagnose Iron Deficiency

11/12/2025

Iron deficiency affects more people worldwide than any other health condition, yet it remains dramatically under-diagnosed and undertreated. For years, clinicians have relied on outdated ferritin thresholds—cutoffs that miss millions of patients who suffer from fatigue, brain fog, hair loss, restless legs, and reduced quality of life.

Now, the American Society of Hematology (ASH) has released its Draft Recommendations for the Diagnosis of Iron Deficiency for public comment, and they represent a watershed moment in how we identify iron deficiency across the lifespan. These draft guidelines—developed through systematic review and expert consensus—move ferritin thresholds higher, finally aligning diagnostic criteria with what frontline clinicians already see in real practice.
(Source: ASH Draft Recommendations for Diagnosis of Iron Deficiency – Public Comment)

As someone deeply engaged in clinical care and patient advocacy, I believe these recommendations will transform how we diagnose and treat iron deficiency in Canada.

Why This Matters: Ferritin Thresholds Are Finally Catching Up to Biology

For decades, many laboratories and clinicians used ferritin <15 ng/mL as the cutoff for iron deficiency—an extremely low threshold that fails to identify patients long before anemia develops.

Ferritin is an acute-phase reactant, meaning it rises with inflammation. Many patients experience daily, low-grade inflammation related to chronic stress, metabolic disease, obesity, autoimmune conditions, or infections. Using outdated ferritin cutoffs has led to millions of missed diagnoses.

The new ASH draft guidelines formally acknowledge the modern clinical reality.

Key Draft Recommendations from ASH (2025)

1. Children (9 months–4 years)

Use ferritin ≤20 ng/mL rather than ≤12 ng/mL to diagnose iron deficiency.
Higher thresholds may be needed when inflammation is present.

2. Adults (non-menstruating, non-pregnant)

Use ferritin ≤30 ng/mL rather than ≤15 ng/mL.
For adults with symptoms, risk factors, or chronic conditions, ≤50 ng/mL is appropriate for diagnosis and treatment guidance.

3. Menstruating Individuals

Use ferritin ≤30 ng/mL as the standard threshold.
For those with heavy menstrual bleeding, planned pregnancy, symptoms of iron deficiency, or upcoming surgery, ≤50 ng/mL is recommended.

Good Practice Statement: A thorough menstrual history is essential to diagnosing heavy menstrual bleeding.

4. Pregnant Individuals

Use ferritin ≤30 ng/mL, and avoid relying on the outdated <15 ng/mL threshold.
For pregnant individuals with symptoms, anemia, or risk factors, a ferritin <50 ng/mL supports diagnosis and management.

5. Adults with Inflammation

When inflammation is present—such as in chronic kidney disease, autoimmune disorders, heart failure, cancer, or infection—ferritin alone is not reliable.

ASH recommends using:

TSAT <20%, or
Ferritin <100 ng/mL

TSAT must be drawn fasting, as recent food intake can distort results.

The Most Important Clinical Message from ASH

A complete blood count is NOT enough. Ferritin measurement is essential.

Millions of Canadians with normal hemoglobin levels have untreated iron deficiency because ferritin was not checked.

Why These Guideline Changes Matter for Patients

1. They validate patient symptoms long dismissed as “normal.”

Patients with ferritin 15–40 ng/mL often feel profoundly unwell. The new ASH thresholds finally reflect this reality.

2. They support earlier diagnosis.

Catching iron deficiency before anemia develops leads to better outcomes and reduced healthcare costs.

3. They reduce unnecessary IV iron use.

When deficiency is identified early, highly absorbable oral formulations—such as Sucrosomial® iron—can be used instead of intravenous iron.

How This Aligns with SiderAL® Sucrosomial Iron

At Sigma Life Sciences, our mission is to improve patient care through evidence-based, well-tolerated solutions for iron deficiency. Sucrosomial® Iron offers:

High absorption even in states of inflammation
Minimal gastrointestinal side effects
Comparable effectiveness to IV iron in several studies
Suitability for pregnancy, heavy menstrual bleeding, chronic disease, and individuals who cannot tolerate standard oral iron

As ASH raises the diagnostic thresholds, more patients will finally be recognized—and treated—before symptoms worsen or IV iron becomes necessary.

A New Era for Iron Deficiency Diagnosis

These draft ASH guidelines represent a major evolution in medical practice. They:

Modernize ferritin thresholds
Emphasize early detection
Validate symptom-driven diagnosis
Encourage clinicians to treat proactively

For patients, this means getting answers sooner.
For healthcare systems, it means fewer IV infusions and improved outcomes.
For clinicians, it offers long-awaited clarity.

The public comment period extends until October 29, 2025, after which the final ASH guidelines will be released.

At Sigma Life Sciences, we are proud to support this shift toward earlier, more effective treatment of iron deficiency.