Drugs

Add Warning to OTC Acetaminophen Product Labels: Petition

Americans for Scientific Integrity is petitioning FDA to amend the labeling requirements for over-the-counter acetaminophen-containing drug products to include warnings about their potential effects on fertility and reproductive development. The petition says the advocacy group “does not assert a causal relationship has been definitively established between acetaminophen use and adverse reproductive outcomes.” Rather, it says, the group submits that the totality of available human, animal, and mechanistic evidence demonstrates sufficient potential risk to warrant precautionary labeling to support informed decision-making.

The petition specifically asks that FDA:

initiate proceedings to amend the conditions of use for acetaminophen-containing drug products so that the labeling contains a reproductive-risk warning and related directions for use;
require that the warning address three distinct specified exposure windows that have different biological concerns — women attempting to conceive and very early pregnancy, pregnancy, and adult male fertility;
at minimum, require labeling language that is functionally equivalent to a supplied recommendation;
require FDA-regulated OTC acetaminophen products to place any new reproductive warning in the Drug Facts “Warnings” section in a manner reasonably calculated to promote consumer comprehension and informed self-selection;
if FDA determines that different wording, headings, or placement are more appropriate, adopt substantially equivalent language communicating the same caution and use limitations; and
not remove acetaminophen products from the OTC market.

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

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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