Health
NAFDAC warns of potentially unsafe blood pressure drug in circulation
Written By: Editor
31 Jan 2026 07:24 PM
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding the circulation of revalidated and unregistered batches of Natrilix SR, a medication used to treat high blood pressure, raising concerns over its quality, safety, and effectiveness.
Natrilix SR, which contains 1.5 mg of indapamide in sustained-release tablets, is a diuretic commonly prescribed alone or in combination with other drugs to manage hypertension.
The agency highlighted that the product's potency and stability rely heavily on strict regulatory compliance, and any unauthorized changes, such as extending shelf life, could endanger public health.
According to the alert, investigations uncovered two problematic batches: Batch 32417 (manufactured March 2023, expiring March 2026), which has been revalidated—meaning its shelf life was altered without NAFDAC approval.
Batch 34934 (manufactured January 2025, expiring January 2027), identified as a case of parallel importation, making it unregistered and unauthorized for sale in Nigeria.
These issues stem from non-compliance in the supply chain, potentially compromising the drug's integrity.
NAFDAC emphasized the dangers associated with using these affected products, including reduced therapeutic effectiveness due to degraded potency, higher risk of treatment failure for patients with high blood pressure, and possible development of resistance to similar medications.
Also, adverse reactions or unpredictable side effects and instability from improper storage or handling.
The agency noted that such alterations could lead to severe health complications, particularly for individuals relying on the drug for long-term management of hypertension.
In response, NAFDAC has directed all zonal directors and state coordinators to conduct surveillance and remove the implicated batches from circulation.
The alert will also be shared with the World Health Organization's Global Surveillance and Monitoring System (GSMS) to broaden awareness.
Healthcare providers, distributors, retailers, and consumers are urged to exercise vigilance in the supply chain and source products only from licensed suppliers, and verify the authenticity and condition of Natrilix SR packages.
Patients currently using Natrilix SR are advised to check batch numbers and consult their doctors if their medication matches the affected lots.
This alert comes amid ongoing efforts by NAFDAC to combat substandard and falsified medical products in Nigeria's markets, which remain vulnerable to illegal imports and counterfeits.
The agency reaffirmed its commitment to public health surveillance to ensure only safe and effective medicines are available.
No immediate reports of adverse events linked to these batches have been confirmed, but NAFDAC encourages proactive reporting to prevent potential harm.
Natrilix SR, which contains 1.5 mg of indapamide in sustained-release tablets, is a diuretic commonly prescribed alone or in combination with other drugs to manage hypertension.
The agency highlighted that the product's potency and stability rely heavily on strict regulatory compliance, and any unauthorized changes, such as extending shelf life, could endanger public health.
According to the alert, investigations uncovered two problematic batches: Batch 32417 (manufactured March 2023, expiring March 2026), which has been revalidated—meaning its shelf life was altered without NAFDAC approval.
Batch 34934 (manufactured January 2025, expiring January 2027), identified as a case of parallel importation, making it unregistered and unauthorized for sale in Nigeria.
These issues stem from non-compliance in the supply chain, potentially compromising the drug's integrity.
NAFDAC emphasized the dangers associated with using these affected products, including reduced therapeutic effectiveness due to degraded potency, higher risk of treatment failure for patients with high blood pressure, and possible development of resistance to similar medications.
Also, adverse reactions or unpredictable side effects and instability from improper storage or handling.
The agency noted that such alterations could lead to severe health complications, particularly for individuals relying on the drug for long-term management of hypertension.
In response, NAFDAC has directed all zonal directors and state coordinators to conduct surveillance and remove the implicated batches from circulation.
The alert will also be shared with the World Health Organization's Global Surveillance and Monitoring System (GSMS) to broaden awareness.
Healthcare providers, distributors, retailers, and consumers are urged to exercise vigilance in the supply chain and source products only from licensed suppliers, and verify the authenticity and condition of Natrilix SR packages.
Patients currently using Natrilix SR are advised to check batch numbers and consult their doctors if their medication matches the affected lots.
This alert comes amid ongoing efforts by NAFDAC to combat substandard and falsified medical products in Nigeria's markets, which remain vulnerable to illegal imports and counterfeits.
The agency reaffirmed its commitment to public health surveillance to ensure only safe and effective medicines are available.
No immediate reports of adverse events linked to these batches have been confirmed, but NAFDAC encourages proactive reporting to prevent potential harm.
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