Carcinogen worry causes generic Zantac recall at U.S. pharmacies
Some generic Zantac is being pulled from major chain pharmacies in the U.S. shortly after French officials recalled all versions of the popular stomach drug amid a global investigation into a carcinogen found in the pills.
Canadian drugmaker Apotex Inc. is recalling its over-the-counter generic Zantac tablets made for Walgreens Boots Alliance Inc., Walmart Inc. and Rite Aid Corp., the U.S. Food and Drug Administration said in a statement Thursday. France’s drug safety regulator, the Agence Nationale de Scurit du Mdicament, said in a statement dated Wednesday that it ordered a recall of all brand-name and generic Zantac available in pharmacies.
European and U.S. health officials said earlier this month they are looking into how the drugs came to be contaminated. Zantac and its generic equivalents are used by millions of people, including pregnant women and infants, to treat gastrointestinal disorders and discomfort. Recalls or distribution halts have also been announced by multiple manufacturers.
The U.S. Food and Drug Administration is investigating the carcinogen levels and hasn’t required any recalls or distribution halts. Canadian health officials required drugmakers last week to halt distribution of all versions of Zantac.
California Representative Anna Eshoo, the Democratic chairwoman of the House Energy and Commerce Committee’s health panel, wrote the FDA last week with concerns about its efforts on Zantac, known in its generic form as ranitidine.
“The United States has moved slowly to address this cancer risk,” Eshoo wrote Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in the letter reviewed by Bloomberg.
At Eshoo’s urging, she and Woodcock are set to talk Monday about the FDA’s response, according to the congresswoman’s office.
“FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking ranitidine,” the agency said in the statement Thursday.
Novartis AG’s Sandoz unit recalled its generic prescription Zantac in the U.S. earlier this week after detecting elevated levels of the carcinogen NDMA. The carcinogen is the same one that last year sparked a recall in about 30 countries of millions of blood-pressure pills called angiotensin II receptor blockers. Sandoz has also halted worldwide distribution of its generic Zantac.
The FDA asked all makers of brand-name and generic Zantac to test their own products for NDMA.
GlaxoSmithKline Plc, the original branded maker of Zantac, halted global distribution of the drug Wednesday and recalled its pills in India and Hong Kong. The recalled medicine is made with an active ingredient from two India-based suppliers, Dr. Reddy’s Laboratories Ltd. and Saraca Laboratories Ltd., Kristen Neese, a spokeswoman for Glaxo, said in an email Wednesday. Some European regulators have initiated recalls of ranitidine made with active ingredient from Saraca as well.
Dr. Reddy’s, one of India’s largest generic drugmakers, is cleared to sell its own finished versions of prescription and over-the-counter generic Zantac in the U.S. It hasn’t recalled any product, but last week it suspended all its shipments of the drug.
A recall means drugs must come off of pharmacy shelves, while a distribution halt means the company is no longer supplying the drugs, though typically those already on shelves can be sold.
Glaxo doesn’t supply or manufacture ranitidine products in the U.S. or Canada, said Kathleen Quinn, a spokeswoman for the company. The company does supply ranitidine products in multiple markets in Europe that are made at sites in Italy and Spain, and via third-party manufacturers in Germany, according to Quinn.