After sartans, EMA raises concerns over impurities in diabetes drug made by Hetero

By PharmaCompass

2019-05-02

Impressions: 75 Article

The European Medicines Agency (EMA) is strengthening the monitoring of drug manufacturing. As a precaution, the EMA called on companies using certain reagents to manufacture pioglitazone, a diabetes drug, to test their products and check their processes in order to rule out the presence of nitrosamine impurities, in particular nitrosodimethylamine (NDMA).

This step follows the detection of low levels of NDMA in a few batches of pioglitazone manufactured by Hetero Labs in India.

In March, Hetero had announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium tablets contain the impurity NMBA (N-Nitroso-N-methyl-4-aminobutyric acid), which is a known animal and potential human carcinogen, FDA said. In April, Torrent and Teva had recalled losartan in the US due to the presence of NMBA manufactured by Hetero.

Earlier, EMA had conducted an EU-wide safety review, which had set legally-binding limits for nitrosamine impurities in sartan blood pressure medicines. EMA said it is working with national authorities and international partners to ensure manufacturers avoid or keep the presence of nitrosamine below the acceptable limits.

Meanwhile, the EMA’s human medicines committee (CHMP) have recommended 13 medicines for approval at its April 2019 meeting. The committee recommended granting a marketing authorization for Sixmo (buprenorphine) as a substitute treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months.

Moreover, two orphan medicines received a positive opinion from the CHMP. These were Esperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency), and Ultomiris (ravulizumab), for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria. The CHMP also adopted a positive opinion for Dovato (dolutegravir / lamivudine), for the treatment of HIV infection.

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