Drugs

Study Finds Birth Defect Risks with ADHD Drugs

A new study suggests that pregnant women who take certain drugs for treating attention deficit hyperactivity disorder have a higher risk that their babies could be born with heart deformities and other birth defects. The study, which was published in the Journal of American Medicine Psychiatry, analyzed data on more than 1.8 million pregnancies in the U.S., including 2,000 women who took methylphenidate (Ritalin, Concerta, Daytrana) and 5,500 who took an amphetamine (Adderall) during their first trimester. The analysis showed that women who took methylphenidate were 11% more likely to have a baby with birth defects and 28% more likely to have infants with heart malformations than those who did not take the attention deficit drugs.

The study found no increased risk of birth defects or heart malformations with amphetamines like Adderall, the researchers said. “Our findings suggest that there might be a small increase in the risk of cardiac malformations associated with intrauterine exposure to methylphenidate,” said lead study author Krista Huybrechts of Harvard Medical School and Brigham and Women’s Hospital in Boston.

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