Drugs

FDA Denies Petition for PPI Pneumonia Warning

FDA has denied a 6/2020 Alliance for Natural Health citizen petition that urged the agency to require all makers of proton pump inhibitors (PPIs) to expand the existing label Warnings to include information about an increased risk of pneumonia. The group’s petition said “the causes of PPI-associated pneumonia are believed to be multifactorial, but stem from compromising the stomach’s ‘acid mantle,’ which protects against pathogenic bacteria.”

In denying the petition, FDA said that while several observational studies showed statistically significant association between PPIs and pneumonia, “we did not find reasonable evidence of a causal association to warrant the labeling changes requested in the petition.”

FDA further said that while available literature does show that PPIs may contribute to moderate inhibition of lysosomal enzyme activities, there still is “insufficient evidence of systematic immunosuppression by PPIs to support the argument set forth in the petition. Our review found no convincing evidence that moderate inhibition of lysosomal enzyme activities or other changes to the gastric environment such as changes to the gastrointestinal microbiota have a role in causing pneumonia.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome