Fluorouracil FDA Alerts
The FDA Alerts below may be specifically about fluorouracil or relate to a group or class of drugs which include fluorouracil.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for fluorouracil
Safety Announcement: FDA Highlights Importance of DPD Deficiency Discussions with Patients Prior to Capecitabine or 5FU Treatment
January 24, 2025 -- The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients.
Fluoropyrimidines are a class of anti-cancer drugs that include fluorouracil (5-FU) and capecitabine, a prodrug of 5-FU. The DPYD gene encodes the enzyme DPD, which breaks down >80% of fluorouracil. Patients with certain homozygous or compound heterozygous variants in the DPYD gene, known to result in complete or near complete absence of DPD activity (complete DPD deficiency), are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity). Patients with partial DPD activity (partial DPD deficiency) may also have increased risk of serious, including fatal, adverse reactions.
Project Renewal
The FDA Oncology Center of Excellence, under Project Renewal, updated the product labeling of Xeloda (capecitabine tablets) to include additional information on DPD deficiency and the importance of discussing DPD deficiency with patients; a safety labeling change updated the 5-FU labeling to include the same DPD deficiency information as in Xeloda. The product labeling of both drugs state:
- Capecitabine or fluorouracil are not recommended for use in patients known to have certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. No dose has been proven safe for patients with complete DPD deficiency.
- There is insufficient data to recommend a specific dose in patients with partial DPD deficiency.
- All healthcare providers should inform patients of the potential for serious and life-threatening adverse reactions due to DPD deficiency. Providers should discuss with their patient whether the patient should be tested for genetic variants that are associated with an increased risk of serious adverse reactions from the use of capecitabine or 5-FU.
- Providers should consider testing prior to initiating capecitabine or fluorouracil to reduce the risk of serious adverse reactions.
- Providers should be aware of the signs and symptoms associated with adverse reactions due to DPD deficiency and advise patients to immediately contact their provider if these occur, including severe mucositis, diarrhea, neutropenia, and neurotoxicity.
- Providers should withhold or permanently discontinue capecitabine or 5-FU based on clinical assessment of the onset, duration, and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe reactions, which may indicate complete DPD deficiency.
- Four DPYD variants have been associated with impaired DPD activity in White populations, and one variant has been associated with impaired activity in individuals of African ancestry.
See the full prescribing information for Xeloda and 5-FU for additional information on DPD deficiency, located in Sections 5, 12.5, and 17.
The FDA will continue to monitor this safety issue and evaluate the evolving landscape and impact of DPD deficiency on the safety of capecitabine and fluorouracil; additional regulatory actions will be considered. The FDA urges patients and healthcare providers to report side effects involving capecitabine or 5-FU products to the FDA MedWatch program.
Source: FDA
Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate
July 2, 2019 -- Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level due to the potential for glass particulate. The affected lots, distributed between December 6, 2018 and February 20, 2019, are listed below:
| Product Name/Size | NDC Number | Product Code | Lot Number | Expiration Date | First Ship Date | Last Ship Date |
|---|---|---|---|---|---|---|
| Fluorouracil Injection, USP, 5g/100mL (50mg/mL), 100mL fill in a 100mL vial |
63323-117-69 | NP101761 | 6120341 | 04-2020 | 12/06/2018 | 12/18/2018 |
| 63323-117-61 | 101761 | 6120420 | 04-2020 | 12/07/2018 | 02/20/2019 |
Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences. Reports in the literature suggest that sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis may occur.
To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.
The company is issuing this notification after finding glass particulate in five vials in retained sample inventory of lot 6120341 during an inspection for a quality investigation. The second lot (6120420) is included in the recall as a precautionary measure as it was produced in the same filling campaign.
Fluorouracil is a chemotherapy drug that is administered intravenously and indicated for the treatment of a variety of cancers.
Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates.
Consumers with questions regarding this recall may contact Fresenius Kabi at 1-800-551-7176 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@freseniuskabi.com Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.
Source: FDA
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter
[Posted 07/27/2015]
ISSUE: Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. To date, Teva has not received any reports of adverse events related to this recall. See the press release for product lot numbers affected by this recall.
BACKGROUND: Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages.
RECOMMENDATION: Teva is arranging for impacted product to be returned to Inmar. Anyone with an existing inventory of the recalled lots should stop use and distribution, and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the user level.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[07/24/2015 - Press Release - Teva Parenteral Medicines]