CONSUMER ALERTS

The National Agency for Food and Drug Administration and Control (NAFDAC) wishes to draw the attention of the general public to the regulatory action taken by the Agency on the following drugs, some of which have been banned /restricted internationally.

• CODEINE CONTAINING COUGH SYRUPS

• PUBLIC ALERT NOTICE ON AVASTIN

• PUBLIC ALERT NOTICE ON CHLORZOXAZONE

• PUBLIC ALERT NOTICE ON CONTAMINATED ISOTAB® 20MG (ISOSORBIDE MONONITRATE).

• PUBLIC ALERT NOTICE ON ROSIGLITAZONE (AVANDIA, AVANDAMET)

• PUBLIC ALERT NOTICE ON VALPROATE SODIUM 

 

PUBLIC ALERT NOTICE ON VALPROATE SODIUM

VALPROATE SODIUM  This is an anti-epileptic drug which is normally prescribed as a prophylactic medication.  It has been found to cause neural tube defects in children born to women who took this drug during pregnancy. The affected children suffer from what is known as "foetal anticonvulsant syndrome", or FACS, which causes a range of neural, behavioral and physical disorders. These disorders include; cleft palate and spinal bifida, learning difficulties, behavioral problems and abnormalities in movement, speech, vision and hearing.  In Nigeria, Epilim and Epivan, brands of sodium valproate are registered for use as anti-epileptic drugs. NAFDAC strongly advise that women within the reproductive (child bearing) age SHOULD NOT use this drug.  However, antiepileptic drugs, including valproate, could be administered to women of childbearing potential only if they are clearly shown to be essential in the management of their medical condition.

PUBLIC ALERT NOTICE ON CHLORZOXAZONE

  1. CHLORZOXAZONE is a centrally acting muscle relaxant which has been linked with hepatotoxicity, a rare but serious adverse drug reaction. Other adverse reactions that may be associated with the use of Chlorzoxazone include; gastrointestinal bleeding, drowsiness, dizziness, light headedness and malaise. Studies have also shown that there is no evidence of the superiority of the effectiveness of one muscle relaxant from another; however its combination with analgesics tends to produce superior pain killing effects than the single formulated muscle relaxant.

Currently, two brands of Chlorzoxazone are licensed for distribution in Nigeria by NAFDAC. One of the registered brands is a combination product, while the other brand is a mono-component product of Chlorzoxazone.

In view of the safety concerns on the use of Chlorzoxazone, healthcare providers are advised to prescribe and dispense this drug rationally. NAFDAC also wishes to advise healthcare providers to actively monitor the use of Chlorzoxazone in their patients with regards to its potential to precipitate hepatotoxicity.

PUBLIC ALERT NOTICE ON AVASTIN

  1. AVASTIN is a drug that was approved for the treatment of breast cancer. Investigations by the US FDA have shown that patients on Avastin experienced high blood pressure and fatigue. A follow up investigation by the manufacturer, Roche also revealed that the drug does not significantly prolong the lives of patients when compared to chemotherapy. The US FDA has proposed a ban of the drug due to the observed serious side effects and its failure to slow tumor growth or help breast cancer patients. In view of the current findings on Avastin, NAFDAC is closely monitoring the safety/efficacy of this drug with a view to determining appropriate regulatory action. NAFDAC also wishes to advise all healthcare practitioners to closely monitor the use of Avastin and report any observed adverse effects to the National Pharmacovigilance Centre, NAFDAC Abuja.

PUBLIC ALERT NOTICE ON ROSIGLITAZONE (AVANDIA, AVANDAMET)

ROSIGLITAZONE (AVANDIA, AVANDAMET) belongs to a class of antidiabetic drugs used to treat Type II diabetes.  Worrying concerns on this drug were raised when it’s use in exposed patients was associated with increased cardiovascular adverse effects. The European Medicines Agency (EMA) had recommended the

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