Says affected hand sanitizers contain life-threatening substance
Nigeria’s food and drug regulator, the National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned against the use of Brexil injectable solution, a chemotherapy medication manufactured in Italy.
The body, in a series of alerts published on its website has also warned against the use of toxic methanol-containing hand sanitizers from Mexico and United States.
In an alert dated June 4, 2021, NAFDAC stated that it was informed that Chilean National Drug Agency (ANAMED) has recalled the 20mg/0.5ml versions of the chemotherapy medication, Brexil injectable solution, manufactured by an Italian Pharmaceutical Company, Actavis Italy Spa due to the impaired functionality of the active ingredient, Methotrexate.
As a result, NAFDAC has called on importers, distributors, healthcare professionals and patients to avoid the importation, distribution, sale and use of the affected lot of the medication. The affected lot with the Number, 9GC5023 has an April, 2021 expiry date.
Methotrexate is used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis. It may also be used to control juvenile rheumatoid arthritis.
“Members of the public in possession of the implicated product are implored to discontinue sale or use and submit stock to the nearest NAFDAC office. Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of this drug to the nearest NAFDAC office,” the drug regulator stated in the alert.
In other alerts published on June 28 and 29th, NAFDAC disclosed that it has also received information from US Food and Drug Agency, FDA, on the decision by Mexican pharmaceutical company, Nutricional S,de R,L De C.V (Dibar) to recall all Dibar Labs Hand sanitizers, ProtectoRX Hand sanitizers and Advance Hand sanitizers due to the presence of methanol.
Working on similar hints from US FDA that Las Vegas, Nevada, USA based company, Global Sanitizers. is voluntarily recalling fifty-thousand units of its Medically Minded hand sanitizer due to presence of undeclared methanol.
According to NAFDAC, Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. In the alert, the drug regulator also added that substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.
“Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidentally ingest these products and adolescents and adults who drink these products as alcohol (ethanol) substitute, are most at risk,” NAFDAC stated, adding that Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxicity.
The agency has, therefore called on consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms to seek immediate treatment for potential reversal of toxic effects of methanol poisoning.
NAFDAC stated that the recall of the affected products was initiated after the FDA analysis found the product to contain methanol in laboratory testing.
“NAFDAC encourages members of the public to wash their hands often with soap and water for at least 20 seconds. If soap and water are not readily available, it is recommended to use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol or 70% isopropanol),” it stated.