Drugs

BMJ Study Raises Doubt on 2011 Citalopram Safety Alert

A new study in the British Medical Journal (BMJ) raises some doubt about a 2011 FDA drug safety alert on selective serotonin reuptake inhibitor citalopram and its association with QT prolongation at higher doses (see earlier story). The agency subsequently restricted the maximum dose to 20 mg for subgroups of patients. This label change, affecting the most widely prescribed antidepressant in the U.S. at the time, with 37.8 million prescriptions in 2011, left clinicians unclear about appropriate next-step strategies because of the lack of data comparing citalopram with other antidepressants.

The main findings of this 240,000 patient observational study were that selective serotonin reuptake inhibitors “were not associated with an increased risk of arrhythmia, myocardial infarction, or stroke or transient ischaemic attack in a general population cohort of people with depression aged 20 to 64 and that risk of arrhythmia was not significantly increased in patients treated with citalopram even at high doses (40 mg/day and over), although numbers in this category were relatively small,” the authors said. “We found some evidence that selective serotonin reuptake inhibitors were associated with a reduced risk of arrhythmia and myocardial infarction. Fluoxetine was associated with the lowest risks of these two outcomes, but overall no significant differences were seen between the selective serotonin reuptake inhibitors. The risk of arrhythmia was significantly increased in the first four weeks of starting tricyclic and related antidepressants, and the tricyclic drug lofepramine was associated with a significantly increased risk of myocardial infarction in the first year of follow-up.”

The latest study will likely be weighed by FDA in addition to other research data that have been amassed since the 2011 safety alert. In 2013, a separate BMJ study gave credence to the agency’s action. Study authors conducted a pharmacovigilance study using electronic health records from 38,397 patients treated with antidepressants from which they identified “statistically significant evidence of modest QT prolongation for some pharmacotherapies, namely methadone and the tricyclic antidepressant amitriptyline, as well as for citalopram and escitalopram. However, the sizes of these effects were small, and the proportions of individuals with abnormal QTc intervals were broadly similar across individual antidepressant treatments. Results from a complementary, within-subject means of analysis for citalopram supported a dose-response association.”

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