Drugs

Public Citizen Sues FDA to Force Benzocaine Ruling

Public Citizen has filed suit against FDA in DC federal court over the agency’s failure to rule on the advocacy group’s three-year-old petition asking that it address life-threatening health risks associated with benzocaine, an ingredient common in certain infant teething and other medicines. The suit asks the court to compel FDA to answer the petition, which asks FDA to limit the legal uses of and revise labeling requirements for over-the-counter (OTC) oral healthcare products that contain benzocaine.

Public Citizen says that benzocaine is linked to methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen. It wants the agency to no longer permit the products to be labeled for use in infant teething and to put Warnings on other OTC benzocaine products.

The suit says that FDA violated the Administrative Procedure Act by unlawfully withholding or unreasonably delaying action. It asks the court to order FDA to act on the petition because the agency’s failure to respond “is unreasonable in light of the nature and extent of the public health interests at stake.”

In a statement, Public Citizen Health Research Group director Michael Carome says that FDA concluded several years ago that OTC benzocaine products should generally not be used to treat teething pain in infants. “They are ineffective for this use and can cause a rare, but potentially deadly, adverse reaction,” he says. “It is unconscionable that the agency has failed to take the regulatory actions necessary to address the health risks.”

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