FDA flags diabetes drug with potential to cause cancer
A potential cancer-causing ingredient has been found in a common diabetes drug, but health authorities say halting its use is more life threatening than the drug component is to the patients.
The Food and Drug Administration (FDA) alerted Merck & Co, the manufacturers of the drug whose chemical name is sitagliptin, to consider checking the drug compound level in a day to minimise risk.
The carcinogenic ingredient found in the drug is called nitrosamine, chemically known as Nitroso-STG-19 and abbreviated as NTTP. In Kenya, the drug is marketed as Januvia, Zita or Trevia, depending on the companies that produce it. However, the FDA has highlighted only Januvia.
The drug is commonly used by patients who have diabetes type 2 to bring down high blood sugar levels. The FDA warns that this finding is based on laboratory tests and that there is a probability that the component in the drug could cause cancer.
“Although there is no data available to directly evaluate the carcinogenic potential of NTTP, FDA used information available on closely related nitrosamine compounds to calculate lifetime exposure limits for NTTP,” explained the FDA.
Risk of exposure
The agency, however, advises patients to consult their healthcare providers before taking any step.
“It could be dangerous for patients with this condition to stop taking their sitagliptin without first talking to their healthcare professional.”
“FDA recommends prescribers continue to use sitagliptin when clinically appropriate to prevent a gap in patient treatment,” said the FDA.
An analysis by the FDA showed that the risk of exposure that could lead to cancer occurs when a patient takes more than the interim accepted levels of 246.7 nanograms a day. The acceptable intake in a day is 37 nanograms.
“FDA does not expect nitrosamines to cause harm when ingested at low levels. Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at, or below, the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” they explained.
The diabetes drug was approved in 2006 by the FDA. The compound in the drug is also used in other medications and is found in some antibiotics and some heartburn medicines.
In 2020, the FDA warned that there were other medications, aside from the diabetes one, which have the compound and which should be regulated.
Over-the-counter drugs
“This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products,” they said.
They, however, warned against taking over-the-counter drugs that have that impurity.
“Consumers taking over-the-counter medications with potential nitrosamine impurities may consider using other OTC products approved for their condition,” said the FDA.
