[ad_1]
The European Medicines Agency (EMA) on Friday called on companies that use certain reagents to manufacture the diabetes drug pioglitazone to test their products and to control their functioning in order to eliminate the presence of diabetes. nitrosaminic impurities, in particular nitrosodimethylamine (NDMA).
"This request follows the detection of low levels of NDMA in a few batches of pioglitazone manufactured by Hetero Labs in India," said EMA.
In the United States, Hetero announced in March the recall of 87 batches of losartan potbadium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potbadium tablets contain the impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), which is an animal and a carcinogenic potential in humans, the FDA said.
Meanwhile, the EMA had previously conducted an EU-wide safety review, which set legally binding limits for nitrosamine impurities in drugs for the treatment of sartan. The EMA has stated that it works with national authorities and international partners to ensure that manufacturers avoid or maintain the presence of nitrosamine below acceptable limits.
"Based on the experience gained during the sartans review, the EMA is launching an exercise with experts from across the EU regulatory network in order to 39; consider how to prevent such incidents in the future and see if their management can be improved, if any, "said the EMA.
The EMA and the national authorities will also continue their research into the presence of impurities in angiotensin II receptor antagonists (ARBs), including others such as N-nitrosoethylisopropylamine (EIPNA), N-nitrosodiisopropylamine ( DIPNA) and the NMBA.
The previous ARA review conducted by the EMA also estimated the highest possible cancer risk with these impurities.
"He concluded that if 100,000 patients were taking valsartan in Zhejiang Huahai (where the impurity levels were highest) every day for 6 years at the highest dose, there could be 22 more cases of cancer badociated with these drugs could result in an additional 8 cases per 100,000 patients taking the drug at the highest dose each day for 4 years, "he added. # 39; EMA.
Work on the recalls is also underway in the United States, with the FDA having noted nearly 40 BRA recalls since last July. The latest FDA includes Torrent Pharmaceuticals recalling an additional 104 batches of losartan potbadium and losartan potbadium / hydrochlorothiazide combination tablets, as they were made from Hetero ingredients containing NMBA.
In response to the discovery of NMBA in hetero ingredients, the FDA updated its tentative list of acceptable ingestion of nitrosamine impurities in products containing ARAs in early March to include limitations. for the NMDA of 96 nanograms a day. At this level, the FDA claims that the impurity poses a 1: 100,000 cancer risk after 70 years of exposure to the daily acceptable limit.
Source link
