GSK re­calls heart­burn drug Zan­tac af­ter can­cer scare

The Korea Times - - HEALTH -

Glax­oSmithK­line on Tues­day said it is re­call­ing the pop­u­lar heart­burn medicine Zan­tac in all mar­kets as a “pre­cau­tion,” days af­ter the U.S. Food and Drug Ad­min­is­tra­tion found “un­ac­cept­able” lev­els of prob­a­ble can­cer-caus­ing im­pu­rity in the drug.

Zan­tac, also sold gener­i­cally as ran­i­ti­dine, is the lat­est drug in which can­cer-caus­ing im­pu­ri­ties have been found. Reg­u­la­tors have been re­call­ing some blood pres­sure and heart fail­ure medicines since last year.

Bri­tain’s medicines watch­dog said Glax­oSmithK­line (GSK) was re­call­ing four pre­scrip­tion-only Zan­tac medicines: a syrup, an in­jec­tion and tablets of 150 and 300 mil­ligram (mg) dosages.

Over-the-counter 75 mg dosage Zan­tac prod­ucts are pro­duced by a dif­fer­ent com­pany and are not af­fected by the re­call, it added.

“GSK in­formed the MHRA of our de­ci­sion to sus­pend the re­lease, dis­tri­bu­tion and sup­ply of all dose forms of Zan­tac prod­ucts,” a com­pany spokesman con­firmed to Reuters.

“GSK is con­tin­u­ing with in­ves­ti­ga­tions into the po­ten­tial source of the NDMA,” he said, adding that the in­ves­ti­ga­tions in­clude con­tin­ued en­gage­ment with its sup­pli­ers and with ex­ter­nal lab­o­ra­to­ries to con­duct tests on fin­ished prod­uct batches of Zan­tac.

The Medicines and Health­care prod­ucts Reg­u­la­tory Agency (MHRA) said health­care pro­fes­sion­als were told on Mon­day to “stop sup­ply­ing the prod­ucts im­me­di­ately, quar­an­tine all re­main­ing stock and re­turn it to their sup­plier.”

“We are ad­vis­ing that pa­tients should not to stop tak­ing their med­i­ca­tion, and do not need to see their doc­tor un­til their next rou­tine ap­point­ment but should seek their doc­tor’s ad­vice if they have any con­cerns,” the MHRA said.

Global stop­page

U.S. and Euro­pean health reg­u­la­tors said last month they were re­view­ing the safety of ran­i­ti­dine, af­ter on­line phar­macy Val­isure flagged the im­pu­ri­ties.

The FDA said Val­isure’s higher-tem­per­a­ture test­ing method gen­er­ated very high lev­els of NDMA from the ran­i­ti­dine drugs.

NDMA had pre­vi­ously been found in some blood pres­sure medicines from a class of drugs known as an­giotensin II re­cep­tor block­ers, or ARBs.

Af­ter check­ing the over-the­counter drugs us­ing a low-heat method of test­ing, the FDA said it found much lower lev­els of NDMA than was dis­cov­ered with a higher tem­per­a­ture test em­ployed by Val­isure.

The U.S. reg­u­la­tor has asked ran­i­ti­dine mak­ers to con­duct their own test­ing to as­sess lev­els of the im­pu­rity and to send sam­ples of their prod­ucts for test­ing by the agency.

Swiss drug­maker No­var­tis halted global dis­tri­bu­tion of its ran­i­ti­dine drugs last month.

Last week, Wal­mart joined phar­macy chains CVS Health, Wal­greens Boots Al­liance and Rite Aid in sus­pend­ing the sale of over-the­counter heart­burn drugs con­tain­ing ran­i­ti­dine.

Reuters-Yon­hap

Zan­tac heart­burn pills are seen in this pic­ture taken Oct.1.

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