NAFDAC’s official product database lists Retrax 40mg tablets, a levamisole based medicine used against parasitic worm infections, as inactive, while European regulators have warned of a rare but serious neurological complication linked to levamisole.
The NAFDAC Greenbook identifies Retrax Tablets as containing 40mg of levamisole hydrochloride and lists the product as inactive. The record shows that its approval, granted in August 2021, expired on August 25, 2026.
The Brandspur Brand News Desk reports that the development comes amid renewed attention to the safety of levamisole medicines after the European Medicines Agency recommended the withdrawal of levamisole containing medicines from the European Union market.
The EMA’s review found that levamisole can cause leukoencephalopathy, a serious condition involving damage to the brain’s white matter. The agency said the complication can be debilitating and potentially life threatening, with symptoms reported after even a single dose.
Symptoms can appear from one day to several months after treatment, according to the European regulator. Reported neurological effects include muscle weakness, problems with speech, impaired cognitive function, difficulty coordinating movements and paralysis.
The European review concluded that the benefits of levamisole medicines no longer outweighed their risks for treating parasitic worm infections, particularly because the onset of leukoencephalopathy is unpredictable and no effective measures were identified to prevent the complication.
Levamisole is an anthelmintic, meaning it is used to treat infections caused by parasitic worms. The EMA said its review considered safety reports, scientific literature and input from independent infectious disease and neurology experts, as well as the World Health Organisation.
The regulator formally endorsed the withdrawal recommendation on March 26, 2026, following an EU wide safety review. A subsequent communication to healthcare professionals stated that levamisole medicines would no longer be available on the EU market because of the risk of leukoencephalopathy.
For Nigerians who may have Retrax or another levamisole containing medicine at home, the available information does not establish that every levamisole product in Nigeria has been withdrawn. Consumers should therefore check the specific product’s regulatory status and seek advice from a pharmacist or doctor rather than relying solely on social media claims.
The NAFDAC database record for Retrax 40mg tablets provides a specific regulatory status for that product, while the EMA decision concerns levamisole medicines authorised in the European Union. The two regulatory positions should not be treated as identical.
