Carcinogen in Zantac Leads to Another Shipment Halt, Recall
Italians order recall of some Zantac, ban use of others.
(Bloomberg) -- A global effort to remove gastrointestinal medication tainted with a potential carcinogen from the market gained momentum, as one of India’s largest generic drugmakers halted shipments to customers worldwide and Italy ordered a recall of some medicine that originated in India.
Dr. Reddy’s Laboratories Ltd. said it is suspending all distribution of its ranitidine, the generic version of the Sanofi stomach drug Zantac, as a precautionary measure. The company expects “to provide an update in the coming days,” said spokeswoman Lori McCreary in an email.
Separately, the Italian Drug Agency said in a statement it was ordering a recall of all versions of Zantac with active ingredient made by the India-based firm Saraca Laboratories Ltd. Italian regulators also banned the use of some types of Zantac produced by other pharmaceutical companies pending analysis of the drugs.
U.S. and European Union regulators said last week they were investigating the discovery of the carcinogen NDMA, or N-Nitrosodimethylamine, in branded and generic Zantac. The regulators said they hadn’t ascertained how the drugs came to be contaminated. In the U.S., the Food and Drug Administration has so far left the drugs on the market.
NDMA was also detected in a commonly prescribed class of blood-pressure drugs, leading to the recall of millions of pills in 30 countries beginning in July of last year.
In addition to the Italian drug agency, Germany’s drug regulator indicated earlier this week there were wider recalls of ranitidine made with active ingredient from Saraca in Europe. Saraca supplies larger drugmakers that make the pills sold to patients.
Health officials in Canada have asked all makers of ranitidine to stop distribution of the heartburn treatment in that country.
Novartis AG’s generic-drug unit, Sandoz, halted global distribution on Wednesday of its generic Zantac, known as ranitidine. Brand-name Zantac maker Sanofi hasn’t halted distribution of the drug or any of its other ranitidine products outside of Canada. About two dozen generic drugmakers are FDA-approved to sell their own versions of prescription and over-the-counter Zantac in the U.S., including Sandoz and Dr. Reddy’s
Bloomberg News has reported on how poor quality controls and efforts to conceal manufacturing problems from the FDA have complicated oversight of overseas drug producers.
As regulators deal with the Zantac investigation, the worldwide recall of tainted blood-pressure pills known as angiotensin II receptor blockers, or ARBs, is still widening. On Thursday, India-based Torrent Pharmaceuticals Ltd., expanded a recall of the ARB called losartan, which has been found to be contaminated with a different potential carcinogen called NMBA.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett
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