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The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public of a circulation of counterfeit Dostinex (Cabergolin) 0.5mg tablet in Nigeria.
The Agency is issuing this alert following the notification received from Pfizer Specialties Limited (The manufacturer of the original product) disclosing a patient’s complaint about the product.
Though a laboratory analysis has not been conducted on the counterfeit Dostinex as sample of the product was not submitted by the complainant, the pictures of the product shared by the complainant were scrutinized by pfizer and the following observations were made;
- The shape of the tablets is not corresponding to the authentic Dostinex tablets.
- The expiry date captured within the Data-Matrix, 24/08/2012, does not match the expiry date printed on the box, 08/2024.
Pfizer has concluded that the product is counterfeit, as the features of Dostinex 0.5mg displayed in the pictures does not meet the Pfizer Dostinex specifications.
Dostinex contains the active ingredient cabergoline. Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas (tumors of the pituitary gland). Dostinex can also be used to prevent the lactation in women after birth.
Risk Statement
The illegal distribution of substandard medicines or counterfeits poses a risk to health, as the safety, quality and efficacy cannot be guaranteed.
Product details
The details of the product are as follows;
Product Name: Dostinex 0.5mg tablet
Stated Product Manufacturer: Pfizer.
Expiry date: 08/2024
Images to identify the illegally marketed product:
Please note that the product is not in NAFDAC database. However, importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the substandard (contaminated) syrups. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Anyone in possession of the above-mentioned product is advised to discontinue sale or use and submit stock to the nearest NAFDAC office. If you, or someone you know, have used this product, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of sale and use 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………safeguarding the health of the Nation!!!
Director General
