Drugs

FDA Research Links Montelukast to Mental Issues

FDA researchers have identified potential links between the widely prescribed asthma drug montelukast (Organon’s Singulair) and serious mental health issues, including depression and suicidal behavior, according to Reuters. FDA’s research findings, which are preliminary and have not been released publicly, were presented to a limited audience at the American College of Toxicology meeting in Austin, TX 11/20.

The agency’s data show that the drug binds to brain receptors critical for psychiatric functioning, suggesting possible neuropsychiatric effects. FDA National Center for Toxicological Research deputy director Jessica Oliphant said at the meeting that laboratory tests showed “significant binding” of montelukast to multiple receptors found in the brain, the Reuters report says. More study is needed about how the drug accumulates in the nervous system, Oliphant said. “These data indicate that montelukast is highest in brain regions known to be involved in (psychiatric effects),” she said.

Psychiatric-related adverse events linked to Singuilair have been tracked and evaluated for years. In 2020, FDA approved a new Boxed Warning for the drug and generics to increase awareness of potential mental health side effects (see earlier story).

The agency took the action after reviewing continued reports of neuropsychiatric events, feedback from stakeholders, and a reevaluation of the drug’s benefit/risk profile. Although the prescribing information already included warnings about mental health side effects including suicidal thoughts or actions, many healthcare professionals and parents/caregivers still are not aware of the risk, according to the agency.

“The label changes will provide a stronger warning of potential risks so healthcare professionals and patients/caregivers can make informed decisions about use of the medications and look for warning signs,” FDA said at the time.

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