Drug manufacturer Abbott India has withdrawn all batches of the popular antacid syrup, Digene gel, which were manufactured at its Goa facility, after customers reported that the liquid in the bottle had turned white, tasted bitter and had a pungent smell when they bought it early August. The syrup is usually pink with a sweetish taste.
The public notice issued by the apex drug controller, Central Drugs Standard Control Organisation, on its website, said: “The impugned product may be unsafe and its use may result in adverse reaction.” It urges people to discontinue the use of Digene gel manufactured at the Goa facility. Doctors say there is no need to panic but add that anyone consuming this over-the-counter medicine for long durations should check in with their physicians. However, consuming Digene in tablet form is safe.
What is Digene used for?
The pink liquid — or its pill form — is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas. It can be prescribed for gastritis (inflammation of the stomach lining) and acid reflux (a condition where stomach acid flows back to the food pipe). It uses basic compounds like magnesium hydroxide to neutralise the stomach acid.
What is the doctors’ view on the recall?
Doctors suggest not consuming the product for which an alert has been raised at present and switching to similar products for now. Always consult a doctor on which brand to buy.
Can the medicine be safely consumed by all?
The antacid i is generally safe and available for use over the counter. However, its long-term use should be avoided as it leads to other complications. “While people continue to take the medicine considering it to be generally safe, long-term use can lead to issues of the kidney and bones. This is the reason people should take such medicines only under the guidance of a doctor if they need it for long-term use rather than an occasional use,” says Dr Suranjit Chatterjee, senior consultant of internal medicine at Indraprastha Apollo hospital.
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Agreeing Dr Rommel Tickoo, director of internal medicine at Max Hospital-Saket, says, “Long term use of the medicine can lead to elevated calcium levels. It can cause a condition known as milk-alkali syndrome marked by this increase in calcium levels, an elevated pH of the body, and kidney damage.” Antacids cause your body to produce more acid, which worsens symptoms, impacts your nervous system, even leads to iron deficiency.
What does the notice say?
The public notice said the company initially withdrew one batch of its product available in mint flavour and four batches in orange flavour after receiving a complaint about a product that was white, had a bitter taste and pungent smell. Within a week the company recalled all batches of its Digene gel sold in mint, orange, and mixed fruit flavours manufactured at its Goa facility.
CDSCO has asked all zonal and state drug controllers to keep a vigil on the movement, sale, distribution, and stock of the said Digene gel. “Draw samples if the said product is lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics acts and rules…” the notice said. It asked all wholesalers and distributors to remove all the impacted products still on-shelf from distribution. The doctors and healthcare professionals have also been asked to educate their patients to discontinue the use of the impacted medicine. It also urges them to immediately avoid any adverse reactions associated with its consumption.
