Possible carcinogens found in Merck's Sitagliptin drugs Januvia, Janumet: USFDA
Advertisement
New Delhi: The U.S. Food and Drug Administration said on Tuesday certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and Janumet, were contaminated with a possible carcinogen.
The agency said it would temporarily allow Merck to distribute drugs with sitagliptin containing a higher than normally acceptable amount of the impurity Nitroso-STG-19, also known as NTTP, in order to avoid a shortage.
Merck said it notified authorities it had detected that some batches of the drugs contained the impurities and implemented additional quality controls to make sure its drugs will meet the interim acceptable limits.
"We remain confident in the safety, efficacy and quality of our sitagliptin-containing medicines," Merck said, noting that no significant impact on supply is expected.
Shares of Merck, which was not immediately available for comment, fell sharply before recovering to close up over 1% at $89.53.
Sales of Januvia and a related combination medicine called Janumet totaled $1.23 billion in the second quarter.
NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens, based on laboratory tests, the agency said.
Agency scientists evaluated the risk of exposure to NTTP at interim acceptable intake levels up to 246.7 nanogram per day and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to NTTP at the 37 nanogram per day level.
In recent years, some drugmakers have had to recall some batches of drugs like Pfizer's anti-smoking treatment, Chantix, and stopped selling others like the heartburn treatment ranitidine, often sold under the brand name Zantac, due to the presence of nitrosamines.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Exposure to the impurities above acceptable levels over long periods of time could increase the risk of cancer.
Read also: Merck Specialities ropes in Pratima Reddy as new MD in India
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.