FDA Policy/General

Researchers Challenge FDA Lamictal Safety Warning

Rutgers Health researchers say they have determined that GlaxoSmithKline’s antiseizure drug Lamictal (lamotrigine) is safe in older adults with epilepsy, contrary to an FDA safety warning. An online university post says that in 2020 FDA put a safety warning on the lamotrigine label based on reports the drug could increase the risk of heart conditions. Thus, it says, patients with epilepsy who might be good candidates for the treatment but had a history of heart issues could be precluded from being prescribed the drug.

Because the FDA warning came with a caveat that it was based on limited evidence, the Rutgers researchers wanted to further analyze the drug’s risks in epilepsy patients.

“It’s important for the public to know that our research found that lamotrigine is safe in older adults with epilepsy, including those with underlying heart disease,” the researchers say. The study was published 6/11 online in Neurology, the American Academy of Neurology journal.

The researchers say they looked at data from more than 158,000 adults with epilepsy and found no increased risk for heart rhythm problems or sudden cardiac arrest among older adults taking lamotrigine compared to those using levetiracetam (UCB’s Keppra and others), the other commonly prescribed anti-seizure drug. Study findings were consistent across a range of subgroups including age, gender, race, and those with histories of heart conditions, the researchers say.

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