Four pharmaceutical manufacturers have removed their medicines which suppress stomach acid from South African shelves and another two drugmakers have quarantined their imports over safety concerns, according to the country’s medicines regulator. According to a BusinessLIVE report, the development has been triggered by a global scare about ranitidine, the active ingredient in these products, which has been found to contain traces of a potentially carcinogenic substance called N-nitrosodimethylamine (NDMA).
Medicine regulators around the world are investigating ranitidine-containing products, triggering both voluntary and mandatory product recalls. The report says last week South Africa’s biggest drug manufacturer, JSE-listed Aspen Pharmacare, announced that it had been forced to restate its financial results for the year to June and write down the value of its heartburn medicine Zantac by R719m, after a nationwide ranitidine recall ordered by the Australian Therapeutic Goods Administration in October.
The SA Health Products Regulatory Authority (Sahpra) said Cipla Medpro, GlaxoSmithKline, Sandoz and Pharma-Q had recalled their ranitidine products in South Africa, while Biotech Laboratories and Gulf Drug Company had placed batches under quarantine.
[link url="https://www.businesslive.co.za/bd/national/health/2019-11-04-four-drugmakers-withdraw-heartburn-medicine-in-sa-over-safety-concerns/?utm_source=&utm_medium=email&utm_campaign=Shoprite+may+pull+plug+on+some+offshore+stores+%7C%C2%A0Rand+andbondsrally+onMoody%E2%80%99sreprieve+%7C%C2%A0Dealing+in+cannabis+remains+illegal%2C+police+and+medicines+regulator+warn&utm_term=http%3A%2F%2Fwww.businesslive.co.za%2Fbd%2Fnational%2Fhealth%2F2019-11-04-four-drugmakers-withdraw-heartburn-medicine-in-sa-over-safety-concerns%2F"]BusinessLIVE report[/link]
See also….
[link url="https://www.medicalbrief.co.za/archives/aspen-writes-down-value-after-australia-recalls-heartburn-drug-over-cancer-risks/"]Aspen writes down value after Australia recalls heartburn drug over cancer risks[/link]