Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Probiotics study

This article was originally published in The Tan Sheet

Executive Summary

Administration of probiotics in patients with predicted severe acute pancreatitis must be regarded as unsafe, according to research published in The Lancet online Feb. 14. Conducted by Hein Gooszen, University Medical Center, Utrecth, Netherlands, et al., the double-blind, placebo controlled trial involved 296 patients with predicted severe acute pancreatitis - 152 were in the probiotics group and 144 in the placebo group. The probiotic preparation or placebo was administered directly to subjects' digestive tract twice daily for two weeks. Researchers found infectious complications in about 30 percent of patients in both groups. While 16 percent of the probiotics group patients died, 6 percent in the placebo group died. "Our findings show that probiotics should not be administered routinely in patients with predicted severe acute pancreatitis, and that the particular composition used here should be banned for the present indication," Gooszen et al. note. "Most importantly, probiotics can no longer be considered to be harmless adjuncts to enteral nutrition, especially in critically ill patients or patients at risk for non-occlusive mesenteric ischaemia"...

You may also be interested in...

FDA Wants To Put Hep C Tests On 510(k) Pathway

The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.

Facing Shortage, FDA Further Relaxes Face Mask, Face Shield And Respirator Guidance

As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers

Why US FDA Requested Ranitidine Withdrawal, And How Other Drugs Could Follow

FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts