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FDA calls for heartburn drug Zantac to be pulled from market immediately

The US Food and Drug...

Posted: Apr 1, 2020 4:26 PM
Updated: Apr 1, 2020 5:00 PM

The US Food and Drug Administration is requesting that manufacturers pull all prescription and over-the-counter ranitidine drugs, known by the brand name Zantac, from the market immediately, the agency announced on Wednesday.

The FDA noted that an ongoing investigation has determined that levels of a contaminant in the heartburn medications increase over time and when stored at higher-than-normal temperatures, pose a risk to public health.

The contaminant, N-nitrosodimethylamine or NDMA, is a probable human carcinogen and the FDA has been investigating levels of it in ranitidine since the summer of 2019.

'We didn't observe unacceptable levels of NDMA in many of the samples that we tested,' Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in Wednesday's announcement.

'However, since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,' Woodcock said in part. 'The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.'

According to the FDA's announcement, letters are now being sent to all manufacturers of ranitidine requesting that they withdraw products from the market, and consumers are advised to stop taking any ranitidine tablets or liquid medications they currently have. The FDA said to dispose of them properly and not buy more.

Due to the coronavirus pandemic, the FDA said don't return your medicines to a 'drug take-back location,' but rather follow disposal instructions in the medication guide or insert -- or follow the FDA's recommended safe disposal steps on its website.

Consumers who wish to continue treating their condition should consider using other approved medications, according to the FDA.

To date, the FDA has not found NDMA in some other products, such as famotidine or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.

For patients taking prescription ranitidine, the FDA said to talk to your doctor about other treatment options before stopping the medicine.

'There are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA,' according to the FDA.

In September, CVS Pharmacy, Walgreens and Walmart announced they would no longer sell Zantac and other over-the-counter ranitidine medications due to concerns they might contain NDMA.

Then in October, drugmaker Sanofi voluntarily recalled Zantac OTC sold in the United States and Canada. At the time, the company said it issued the recall 'due to inconsistencies in preliminary test results.'

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 708779

Reported Deaths: 13226
CountyCasesDeaths
Marion966191721
Lake51761946
Allen39224672
Hamilton34549405
St. Joseph34157541
Elkhart27356432
Vanderburgh22081394
Tippecanoe21853212
Porter17935299
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Ohio55811
Unassigned0408

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1054807

Reported Deaths: 18991
CountyCasesDeaths
Franklin1225191356
Cuyahoga1074592069
Hamilton783261168
Montgomery50176996
Summit45557909
Lucas40298765
Butler37768570
Stark31513895
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Clark13660293
Wood12806185
Portage12431196
Allen11352229
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Muskingum8717127
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Marion8390135
Tuscarawas8387240
Erie7600154
Hancock6730123
Ross6707146
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Scioto6295101
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Union558447
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Jefferson5343147
Huron5314114
Darke5273121
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Seneca5139120
Washington5087107
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Auglaize476284
Mercer471984
Shelby456590
Knox4397108
Madison423959
Putnam421799
Ashland413488
Fulton410567
Defiance404296
Crawford3883101
Brown386955
Logan374476
Preble371098
Clinton362160
Ottawa357978
Highland347459
Williams328674
Champaign321557
Jackson308551
Guernsey307549
Perry290549
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Morrow275939
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Henry264366
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Van Wert239262
Pike233831
Gallia233446
Adams229152
Wyandot227553
Hocking209759
Carroll189447
Paulding168838
Meigs141738
Noble132937
Monroe128941
Morgan106823
Harrison105636
Vinton81614
Unassigned02
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