New Delhi: Mumbai-based drugmaker Lupin Pharmaceuticals is voluntarily recalling a variant of its anti-diabetic medicine metformin hydrochloride in the US market due to the presence of a cancer-causing substance.
The US Food and Drug Administration (FDA) Thursday announced the recall and said its analysis revealed that a lot of the extended-release tablets of 500 mg “exceeded the acceptable daily intake limit for the impurity N-Nitrosodimethylamine (NDMA).”
The extended-release variant of the drug is formulated so that it is released slowly in the body over time. The advantage of this is that a patient will need to take pills less often. It also means there may be fewer side-effects as the levels of the of drug in the body are more consistent.
“To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall,” FDA said in the statement.
NDMA is classified as a probable human carcinogen — a substance that could cause cancer — based on results from laboratory tests. NDMA is a known environmental contaminant and in lesser quantities, it is found in water and foods, including meats, dairy products and vegetables.
A prescription oral medication, metformin hydrochloride is one of the best drugs to improve blood glucose control in adults with type 2 diabetes mellitus. It works by lowering glucose production in the liver, delaying the absorption of sugar (glucose) from the intestines and increasing the body’s sensitivity to insulin.
“Lupin, one of the top manufacturers of the drug in the US, is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot,” FDA said.
Not the first time
On 28 May, the US FDA had announced that the agency laboratory testing had revealed levels of NDMA above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin.
“The agency is in contact with five firms to recommend they voluntarily recall their products… There are additional manufacturers of the metformin ER formulation that supply a significant portion of the US market, and their products are not being recalled,” it said earlier.
“The FDA is continuing to work closely with manufacturers to ensure appropriate testing. Assessments are underway to determine whether metformin ER recalls will result in shortages and the agency will work closely with manufacturers to prevent or reduce any impact of shortages.”
India monitoring updates closely
India, known as the diabetic capital of the world, has around 7.3 crore diabetes patients. Considering the concerns raised, several doctors have stopped prescribing the extended release tablets.
“In view of carcinogenic impurities in long acting (ER) metformin preparation, we have stopped prescribing this drug,” said Dr Anoop Misra, chairman of the Delhi-based Fortis Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology. “On the other hand, we will continue to use plain metformin since it is the best drug for diabetes,” he said.
The Indian drug regulator, Central Drug Standard Control Organisation (CDSCO), is also monitoring the US FDA updates.
“While we haven’t noticed any concerns with the Indian products, we are monitoring the US FDA updates closely,” a senior official said.