U.S. FDA Recalls Chronic Kidney Disease Medications by Dr. Reddy’s Laboratories Due to Carcinogenic Contaminants
Nikhil Prasad Fact checked by:Thailand Medical News Team Nov 18, 2024 1 month, 8 hours, 19 minutes ago
Medical News: FDA Takes Action Over Impurities in Chronic Kidney Disease Drug
The U.S. Food and Drug Administration (FDA) has announced a recall of a medication widely used to manage chronic kidney disease (CKD) and related conditions. The drug, Cinacalcet, is produced in India by Dr Reddy’s Laboratories and distributed by Dr. Reddy’s Laboratories American subsidiary, based in New Jersey.
U.S. FDA Recalls Chronic Kidney Disease Medications by Dr. Reddy’s Laboratories Due to
Carcinogenic Contaminants
The recall stems from the detection of N-nitroso Cinacalcet, a potentially carcinogenic impurity, in levels exceeding the FDA’s recommended interim limit. The affected products include 30 mg Cinacalcet Tablets packaged in 30-count bottles, identified under code NDC 43598-367-30. This
Medical News focuses on the extensive details of the recall and its implications for patient safety.
Which Products Are Impacted?
The recall affects multiple lots of Cinacalcet Tablets with expiration dates ranging from November 2024 to November 2026. Notable lot numbers include:
-Lot numbers T2200120 to T2400474, covering expiration dates from 11/2024 to 11/2026.
In total, 285,126 bottles have been recalled. The FDA categorized this recall as Class II, indicating that while adverse health consequences are unlikely, temporary or medically reversible effects could occur.
https://www.accessdata.fda.gov/scripts/ires/?Product=210444
Why the Concern?
The impurity N-nitroso Cinacalcet falls under the class of nitrosamines, chemical compounds linked to cancer risk. Prolonged exposure to high levels of these impurities may lead to severe health concerns, although short-term risks remain minimal. Nitrosamines are commonly found in processed foods, water, and some drugs, but their presence must be strictly controlled in medications.
Cinacalcet, a calcimimetic agent, plays a critical role in managing secondary hyperparathyroidism in CKD patients. It works by reducing parathyroid hormone levels, which helps regulate calcium and phosphorus in the body. This can provide significant benefits for bone and cardiovascular health. However, the presence of nitrosamines jeopardizes the safety of this essential treatment.
Manufacturer Response and Regulatory Oversight
Dr. Reddy’s Laboratories voluntarily initiated the recall upon discovering the impurity. The FDA continues to monitor the situation closely, emphasizing compliance with Current Good Manufacturing Practices (CGMP). This regulatory framework ensures that pharmaceutical products meet rigorous safety and quality standards before reaching consumers.
Patients using the affected medication are advised to consult their healthcare providers immediately. While no serious health incidents have been reported so far, vigilance rema
ins crucial.
Implications for Public Health
The recall highlights growing concerns about the manufacturing and quality control of global pharmaceutical supplies. Regulators and manufacturers alike face mounting pressure to address nitrosamine contamination in drugs, a challenge that has led to recalls of other medications, including those for heartburn and diabetes.
Conclusion
This incident underscores the critical importance of stringent manufacturing practices and rigorous oversight to ensure drug safety. For CKD patients who rely on Cinacalcet, the recall serves as a reminder to prioritize transparent communication between healthcare providers and pharmaceutical companies.
Although the immediate risk to health is minimal, proactive measures are necessary to protect long-term patient well-being.
For the latest Drug Recalls, keep on logging to Thailand
Medical News.
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