Drugs

FDA Takes Actions to Curb Autism

FDA late 9/22 took two actions against autism, first ordering a label change for acetaminophen (Tylenol) to reflect evidence suggesting that its use by pregnant women may be associated with an increased risk of neurological conditions such as autism and attention deficit in children, and second approving leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate transport into the brain. “Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination,” the agency says.

“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” FDA commissioner Marty Makary is quoted in a release as saying. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”

The agency says data over the years have suggested a correlation between acetaminophen use during pregnancy and subsequent diagnosis of conditions like autism and attention deficit hyperactivity disorder. “Multiple large-scale cohort studies, including the Nurses’ Health Study II and the Boston Birth Cohort, find this association,” it says. “Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy.” The agency also issued a related letter alerting physicians nationwide.

Additionally, FDA says it is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a “process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD. As the New Drug Application (NDA) holder for this medicine, GSK has preliminarily agreed to work with the FDA on this relabeling effort.”

FDA says it has performed a “systematic analysis” of literature published since 2009 and has determined that the information supports a finding that leucovorin calcium can help individuals suffering from CFD.

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