FDA Alert Capecitabine & The Critical Role of DPD Deficiency Testing Before Treatment

Allen Wilbanks

10 months ago

An infographic titled 'FDA Safety Update: DPD Deficiency and Fluoropyrimidines' shows a doctor in conversation with an older patient in a clinical setting. The infographic is divided into four sections: 1. Key Message - 'FDA emphasizes discussing DPD deficiency risks before capecitabine or 5-FU treatment.' 2. Risks - 'DPD deficiency can cause serious, life-threatening reactions to these drugs.' 3. Action Required - 'Healthcare providers should inform patients and consider genetic testing.' 4. Monitoring - 'Watch for severe mucositis, diarrhea, neutropenia, and neurotoxicity.' The background is dark, with white text for readability.

The U.S. Food and Drug Administration (FDA) has recently underscored the significance of understanding Dihydropyrimidine Dehydrogenase (DPD) deficiency in patients before initiating treatment with capecitabine or fluorouracil (5-FU). This announcement comes with updated safety labeling for these medications, which are common in chemotherapy regimens for various cancers.

Key Points from the FDA Announcement:

DPD Deficiency Awareness: DPD deficiency affects how the body metabolizes these drugs, potentially leading to severe, life-threatening toxicities like mucositis, diarrhea, neutropenia, and neurotoxicity.
Prevalence: It’s noted that about 3-5% of the White population carries a partial DPD deficiency, with around 0.2% having a complete deficiency, which can result in significant adverse reactions.
New Labeling Updates:
- Warnings for Patients: Patients should be informed of the risks associated with DPD deficiency before starting treatment.
- Genetic Testing Recommended: Discussions about genetic testing for DPD variants are encouraged to mitigate risks.
- Dose Adjustments: No safe dose has been established for patients with complete DPD deficiency, and caution is advised for those with partial deficiency.
Action for Healthcare Providers:
- Educate patients on the potential for severe adverse reactions.
- Consider testing for genetic variants associated with DPD deficiency before treatment initiation.
- Monitor for signs of toxicity and adjust treatment as necessary.

What This Means for Patients:

If you or a loved one is considering or currently undergoing treatment with capecitabine or 5-FU, it’s crucial to:

Talk to Your Doctor: Discuss your risk for DPD deficiency and the implications it might have on your treatment plan.
Be Informed: Understand the symptoms of toxicity and when to seek immediate medical attention.
Genetic Screening: Ask if genetic testing for DPD deficiency is recommended for you.

Read More: For the full FDA announcement and detailed guidance, please visit the FDA’s official statement.

Engage & Discuss:

Have you or someone you know faced challenges with these medications?
What are your thoughts on genetic testing before starting cancer treatments?

Hashtags: FDASafetyAlert DPDDeficiency Capecitabine 5FU CancerTreatment GeneticTesting PatientSafety HealthcareEducation

Disclaimer: This post is for informational purposes only. Always consult with healthcare professionals for medical advice tailored to your situation.

https://www.fda.gov/drugs/resources-information-approved-drugs/safety-announcement-fda-highlights-importance-dpd-deficiency-discussions-patients-prior-capecitabine

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