Pregnant women warned as ‘rogue’ drug is recalled
Bottles of folic acid tablets found to contain a potentially dangerous anti-inflammatory
THE discovery of potentially dangerous “rogue” pills mixed in with harmless over-thecounter vitamins has led to the recall of more than 18 000 containers of folic acid tablets from around South Africa.
A complaint to Ranbaxy Pharmaceuticals (SA) (Pty) Ltd last week that its Be-Tabs Folic Acid product included a Schedule 3 prescription capsule called Betacin led to the company issuing a recall notice on Wednesday.
Folic acid, or vitamin B9, is routinely prescribed for women who are planning to fall pregnant, or who are in their first trimester. Folic acid has been found to prevent birth defects such as spina bifida and hemolytic disease.
The supplement is also used to prevent and treat anaemia, colon or cervical cancer, heart disease and strokes.
But Betacin is an anti-inflammatory drug with the active ingredient indomethacin. It has a range of side effects in pregnant women, including delayed labour. And indomethacin may be passed on to babies through breast milk.
A pharmacist at a leading pharmacy chain, who did not want to be identified, warned that Betacin was potentially dangerous for pregnant women.
“The Be-Tab Folic Acid that has been recalled is a very popular brand. It is a big concern to us that rogue Betacin is contained RED ALERT: The little yellow pills that contain folic acid. Betacin capsules have been mixed in by mistake in the same bottle,” the pharmacist said.
“Betacin is a yellow capsule, while folic acid is a small yellow tablet.
“An ordinary person taking it can see the difference between a capsule and a tablet, but if a pregnant woman takes it, there could be serious repercussions; there could be birth defects and it could cause an abortion.”
The pharmacist said a pregnant woman would have to take a week’s supply of Betacin for it to cause “substantial damage”.
“It causes gastrointestinal bleeding, and if people taking it don’t suffer with any inflammation problems, an ulcer will result almost immediately.”
The pharmacist said that by declaring Betacin a Schedule 3 drug, the authorities were warning that it had serious side effects, and could therefore only be prescribed by a doctor and not sold over the counter.
Keiso Mofokeng, a quality control manager at Ranbaxy, said the
Betacin . . . has a range of side effects in pregnant women, including delayed labour
company had issued the recall because of Betacin’s side effects.
The affected Be-Tabs product was made at the company’s Roodepoort, Johannesburg, plant in 2014 and was sent to two national suppliers.
Mofokeng said: “At this stage we don’t know how widespread this is, and we are in the process of doing an investigation.”
He was unable to comment on possible legal implications.
“Only once we have done an internal investigation can we make a statement on possible implications.
“When we hit a quality control issue we recall, and then evaluate. Upfront, we can’t speculate on who may or may not have taken the pills,” Mofokeng said.
“We know over 18 000 units of that particular batch have been released,” he said. “We don’t know how many contain the incorrect medication, and we don’t know how many are in the supply chain.”
He said the company was appealing to those who had inadvertently taken pills from batch 2651410 to do three things: “Firstly, cease taking the pills; secondly, return the used container to the pharmacy, clinic or wherever it was obtained; and, thirdly, contact the company.”
Ranbaxy South Africa — owned by Sun Pharma, the world’s fifth-largest generic pharmaceutical company — makes generic and original medicines and sells them in South Africa and neighbouring countries.