FDA wants heartburn meds off the market due to contamination

FDA wants heartburn meds off the market due to contamination

WASHINGTON — U.S. health regulators are telling drugmakers to immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought.

The move from the Food and Drug Administration Wednesday applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. The drugs are widely used to treat stomach acid and ulcers.

Many makers of ranitidine drugs already removed their products from the market in the U.S. and Canada, including Zantac-manufacturer Sanofi. Additionally several drug store chains pulled the drugs from their shelves last year.

Health Canada said last year it was investigating the possible presence of a carcinogen in some ranitidine drugs available by prescription and over-the-counter. The agency issued a precautionary request in September 2019 for companies to stop distributing the medication.

Patients should stop taking any of the medications they currently have and throw them away, the FDA said.

The agency last year said patients could continue taking the medications and did not face health risks from low levels of a “probable” cancer-causing contaminant found in multiple brands.

But officials reversed that decision, saying they’ve now determined that levels of the chemical increase over time, especially if tablets and capsules are stored at higher temperatures. That poses an unacceptable risk to patients, they said.

“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,” said Dr. Janet Woodcock in a statement.

Woodcock said there are multiple alternative medications to treat heartburn, including Prilosec, Nexium and Tagament.

Dozens of recalls have been linked to the same probable carcinogen since last year. The FDA is still investigating the issue and has sanctioned at least one manufacturing plant in India that makes ingredients used in the medications.

The FDA has suspended nearly all U.S. and foreign inspections due to travel restrictions caused by the coronavirus outbreak.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Matthew Perrone, The Associated Press

Health

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Central Alberta crime spree ends with arrest in Erskine

Blackfalds and Stettler RCMP make arrest, assisted by Lacombe and Sylvan Lake

84 new cases of COVID-19 reported Friday

1,036 active cases across Alberta, 10,796 recovered cases

Rimbey anticipating action-packed racing at COVID Cup

The event at Central Alberta Raceways will see three days of racing on the dirt oval, Aug. 21-23

76 new cases of COVID-19 reported Thursday

Active cases at 1,036, 10,713 recovered cases

Alberta RCMP launch online crime reporting

Select property crimes can now be reported online through the province-wide initiative

Premier Jason Kenney in Lacombe to introduce rural Internet

Shaw to provide 1g Internet to all AB residential customers

Widow of slain Red Deer doctor thanks community for support ahead of vigil

Fellow doctors, members of the public will gather for a physically-distanced vigil in central Alberta

‘So sorry:’ Man pleads guilty for gas-and-dash death of Thorsby gas station owner

Mitchell Robert Sydlowski was charged with second-degree murder, but the 29-year old pleaded guilty to the lesser offence

VIDEO: World responds to B.C. girl after pandemic cancels birthday party

Dozens of cards and numerous packages were delivered to six-year-old Charlie Manning

U.S.-Canada pandemic border restrictions extended into September

‘We will continue to keep our communities safe,’ says Public Safety Minister Bill Blair

AB Infrastructure Minister announces $8,522,800 regional water transmission line

Funding is covered jointly by the province, Ottawa and benefiting municipalities

WE Charity registers as lobbyist, lays off staff, looking to sell real estate

WE Charity said its financial position has been greatly affected by the COVID-19 pandemic

Wetaskiwin Regional Public Schools receive grant from Indigo Love of Reading Foundation.

WRPS has received $15,975 from the Indigo Love of Reading Foundation.

Most Read