Drug/Device Pipeline

Zantac Distribution Halted

Edward V. Loftus, MD
Edward V. Loftus Jr.

Zantac manufacturer Novartis has stopped the distribution of its heartburn medication across all available markets, including the United States and Canada, Reuters reported.

The halt in distribution comes days after the FDA announced that it had found low levels of N-nitrosodimethylamine (NDMA), a possible human carcinogen, in the medication.

Novartis said in an emailed statement to Healio Gastroenterology and Liver Disease that the precautionary distribution stoppage of all ranitidine-containing medications will remain in place until further clarification.

“Our internal investigation is ongoing to determine further details,” the statement reads. “In case of concerns, adequate additional measures will be implemented in alignment with relevant health authorities as required.”

Novartis noted that the FDA announced that the agency will post more information as it becomes available and “will take appropriate measures based on the results of the ongoing investigation.”

This is somewhat similar to what recently occurred when the FDA recalled certain versions of valsartan, losartan, and irbesartan – angiotensin II receptor blockers (ARB) – after chemical impurities were found in some generic versions of the therapies, according to Healio Gastroenterology and Liver Disease Chief Medical Editor, Edward V. Loftus Jr., MD.

“The FDA detected minute amounts of a contaminant in ranitidine. This contaminant is a known carcinogen at high doses,” Loftus told Healio Gastroenterology and Liver Disease. “As far as I know, the FDA has not told patients to stop ranitidine. For patients on over-the-counter ranitidine who would prefer to stop their therapy, they could try another H2-blocker, famotidine.”

Loftus noted that he’s not sure exactly what the next step will be, but that physicians must be upfront with their patients.

“It’s important to let patients know about this, inform them of the possible risks, and offer alternatives if they ask,” he said.

Edward V. Loftus, MD
Edward V. Loftus Jr.

Zantac manufacturer Novartis has stopped the distribution of its heartburn medication across all available markets, including the United States and Canada, Reuters reported.

The halt in distribution comes days after the FDA announced that it had found low levels of N-nitrosodimethylamine (NDMA), a possible human carcinogen, in the medication.

Novartis said in an emailed statement to Healio Gastroenterology and Liver Disease that the precautionary distribution stoppage of all ranitidine-containing medications will remain in place until further clarification.

“Our internal investigation is ongoing to determine further details,” the statement reads. “In case of concerns, adequate additional measures will be implemented in alignment with relevant health authorities as required.”

Novartis noted that the FDA announced that the agency will post more information as it becomes available and “will take appropriate measures based on the results of the ongoing investigation.”

This is somewhat similar to what recently occurred when the FDA recalled certain versions of valsartan, losartan, and irbesartan – angiotensin II receptor blockers (ARB) – after chemical impurities were found in some generic versions of the therapies, according to Healio Gastroenterology and Liver Disease Chief Medical Editor, Edward V. Loftus Jr., MD.

“The FDA detected minute amounts of a contaminant in ranitidine. This contaminant is a known carcinogen at high doses,” Loftus told Healio Gastroenterology and Liver Disease. “As far as I know, the FDA has not told patients to stop ranitidine. For patients on over-the-counter ranitidine who would prefer to stop their therapy, they could try another H2-blocker, famotidine.”

Loftus noted that he’s not sure exactly what the next step will be, but that physicians must be upfront with their patients.

“It’s important to let patients know about this, inform them of the possible risks, and offer alternatives if they ask,” he said.