New cancer-causing toxin found in recalled blood pressure pills

The FDA also said it is working to develop testing methods to detect other cancer-causing impurities. (Shutterstock)
Updated 02 March 2019
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New cancer-causing toxin found in recalled blood pressure pills

  • The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs

WASHINGTON: US health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India’s Hetero Labs Ltd. a day earlier, adding to a global recall of commonly used drugs to treat hypertension.
The US Food and Drug Administration is also looking into whether these types of impurities could be found in other classes of drugs, a spokeswoman for the regulator said.
The toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero’s losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.
The FDA said Torrent Pharmaceuticals Ltd. is expanding its voluntary recall to include 114 additional lots of losartan-containing medication due to unacceptable amounts of NMBA in the losartan manufactured by Hetero Labs.
Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with two probable carcinogens — N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA).
The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.
The FDA said increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.
The recalls began last year after regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co. to produce valsartan contained cancer-causing impurities.
Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis’ Sandoz have recalled products containing the tainted ingredients.
In January, the FDA warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls.
The FDA also said it is working to develop testing methods to detect other cancer-causing impurities. (


Jazz Pharma’s sleep disorder treatment gets US FDA nod

Updated 21 March 2019
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Jazz Pharma’s sleep disorder treatment gets US FDA nod

  • The drug, solriamfetol, will treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
  • The patent of Jazz's narcolepsy drug, Xyrem, were declared invalid by a US appeals court in July
The US Food and Drug Administration approved Jazz Pharmaceuticals Plc’s treatment for patients with a form of sleep disorder, the company said on Wednesday.
The drug, solriamfetol, will treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).
Solriamfetol is expected to be commercially available in the United States following the final scheduling decision by the Drug Enforcement Administration (DEA), Jazz said in a statement.
The approval comes as Jazz is trying to reduce its reliance on its blockbuster narcolepsy drug, Xyrem, whose patents were declared invalid by a US appeals court in July.
Xyrem is an approved treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy. It brought in sales of $1.4 billion in 2018 and accounted for about 70 percent of company’s revenue.
“Jazz is trying to reduce its reliance on Xyrem, and solriamfetol will be one of the drugs it plans to launch to do that,” Mizuho Securities USA analyst Irina Koffler said ahead of the agency’s decision.
“Solriamfetol is expected to be an important driver of both diversification and growth,” RBC Capital Markets analyst Randall Stanicky said in a note ahead of the approval.
Solriamfetol is expected to bring in revenue of $314 million by 2024, Stanicky said.
Narcolepsy is a chronic sleep disorder with overwhelming daytime drowsiness and sudden attacks of sleep, while obstructive sleep apnea is a potentially serious sleep disorder that can cause breathing to repeatedly stop and start.
“Narcolepsy is very disabling to people as they often get diagnosed young and stop their education and drop out of high school or college,” Koffler said.
“Sleep apnea is a different problem in the sense that a lot of people don’t know they have it, have trouble breathing at night and they even fall asleep during the day.”