Drug Recall: Sapropterin Dihydrochloride Recalled Over Potency Concerns

April 24, 2024

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Last Updated on October 9, 2024 by The Health Master

Drug recall

Dr. Reddy’s Laboratories Ltd. has issued a voluntary nationwide drug recall of six specific lots of their medication Sapropterin Dihydrochloride (Kuvan), a prescription drug used to manage Phenylketonuria (PKU) in adults and children.

This drug recall is due to potential decreased potency of the medication in some packets, identified through stability testing and customer complaints.

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What is Phenylketonuria (PKU)?

Phenylketonuria (PKU) is a rare inherited metabolic disorder that affects the body’s ability to process the amino acid phenylalanine (Phe).

Untreated PKU can lead to a buildup of Phe in the blood, causing intellectual disability, behavioral problems, and seizures.

How Does Sapropterin Dihydrochloride Work?

Sapropterin Dihydrochloride works by increasing the body’s natural production of a molecule called BH4, which is necessary for processing Phe. This helps to lower blood Phe levels in patients with PKU.

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Why Was the Drug Recall Issued?

Dr. Reddy’s initiated the drug recall after discovering discolored powder in some packets of Sapropterin Dihydrochloride.

This discoloration may indicate a decrease in the medication’s potency, meaning it might not be as effective in lowering blood Phe levels.

Potential Risks of Reduced Potency Sapropterin Dihydrochloride

Elevated Blood Phenylalanine Levels: If Sapropterin Dihydrochloride is not working effectively, blood Phe levels may rise in patients. Chronically high Phe levels in infants and children can lead to permanent intellectual disabilities.
Pregnancy Complications: In pregnant women with PKU, high Phe levels during pregnancy are linked to microcephaly (small head size) and congenital heart disease in the developing baby.

What Should You Do If You Have Recalled Sapropterin Dihydrochloride?

Check the Lot Number: Locate the lot number on your bottle of Sapropterin Dihydrochloride. A list of the specific recalled lot numbers can be found on the FDA website: https://www.fda.gov/.
Stop Taking the Medication: If your Sapropterin Dihydrochloride belongs to a recalled lot, discontinue use immediately.
Contact Your Doctor: Consult your healthcare provider to discuss alternative treatment options and how to return the recalled medication.
Report Adverse Events: If you have experienced any side effects potentially related to the recalled Sapropterin Dihydrochloride, report them to the FDA at 1-800-FDA-1088: tel:1-800-FDA-1088.

Dr. Reddy’s Actions

Dr. Reddy’s Laboratories Inc., the U.S. arm of the company, is actively notifying distributors and customers about the recall through letters and arranging for the return of all affected medications.

Key Takeaways

Dr. Reddy’s has recalled specific lots of Sapropterin Dihydrochloride due to potential reduced effectiveness.
This recall is due to discolored powder in some packets, which may indicate decreased potency.
Reduced potency Sapropterin Dihydrochloride could lead to elevated blood Phe levels in PKU patients, posing a risk of intellectual disability and pregnancy complications.
Patients taking Sapropterin Dihydrochloride should check the lot number and contact their doctor if they have a recalled medication.

Please note: This article is for informational purposes only and should not be construed as medical advice. Always consult with your healthcare provider for any questions or concerns you may have regarding your PKU treatment.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.