Health Alert: NAFDAC cautions consumers, affirms hypertension drug Cardura XL fails impurity specifications

*Nigeria’s National Agency for Food and Drugs Administration and Control explains it is recalling Cardura XL (doxazosin mesylate) Extended-Release Tablets, an alpha-adrenergic blocker used to treat hypertension (high blood pressure) or to improve urination in men with benign prostatic hyperplasia (enlarged prostate), because the affected lots failed to meet impurity and degradation specifications

Isola Moses | ConsumerConnect

In line with its consumer-focused education, the National Agency for Food and Drugs Administration and Control (NAFDAC) has said it is recalling two lots of hypertension drug, Cardura XL (Doxazosin) extended-release tablets (8mg & 4mg) because the lots have failed to meet impurity and degradation specifications.

ConsumerConnect reports the health sector regulatory agency, in a recent public alert issued a recall of the two affected lots of the medication, manufactured by American global pharmaceutical and healthcare company, Viatris Incorporated, with lot numbers 81470418163765 and 81470408163764.

NAFDAC stated Cardura XL (doxazosin mesylate) Extended-Release Tablets is an alpha-adrenergic blocker used to treat hypertension (high blood pressure) or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Risks of poor-quality drugs for consumers

The health regulatory agency also noted the consequences of poor-quality drugs could include ineffective treatment, increased risk of adverse events, allergic reactions, anxiety, and general harm to patient and even death.

Viatris Incorporated is the new company name following a merger of Pfizer’s Upjohn and Mylan.

The health regulator, therefore, implored importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the affected lots of the product.

The health alert further stated: “All medical products must be obtained from authorised/licensed suppliers.

“The products’ authenticity and physical condition should be carefully checked.”

The agency said: Anyone in possession of the affected lots is advised to immediately discontinue sale or use and submit stock to the nearest NAFDAC office.

“If you have used this product, or someone you know, have used it, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.”

It equally urged healthcare professionals and consumers to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng,” NAFDAC said.