Drugs

FDA Nixes Certain Boxed Warnings from Hormone Therapy

In what it describes as one of the most sweeping policy shifts in women’s health in decades, FDA says it will begin removing broad boxed warnings from menopause-related hormone replacement therapy (HRT) products. HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary unveiled the changes at a press conference in Washington where they framed the action as a long-overdue correction to what they called flawed interpretations of early 2000s data that triggered widespread fear about HRT’s safety.

“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” an HHS notice says. “We are returning to evidence-based medicine and giving women control over their health again.”

The boxed warnings resulted from the Women’s Health Initiative, a 2002 study involving women with an average age of 63 and using formulations rarely prescribed today, FDA says. Critics have long argued that the study’s age profile and product differences distorted real-world risk for women in their 40s and 50s experiencing menopause.

FDA is now moving to remove boxed language referencing cardiovascular disease, breast cancer, and probable dementia, following a literature review, an expert panel meeting in July, and a public comment period. The agency will retain the boxed warning on endometrial cancer for estrogen-alone products.

Randomized studies cited by HHS show that women who begin systemic HRT within 10 years of menopause onset — or before age 60 — may see reduced all-cause mortality and fracture risk, and significant reductions in cardiovascular and Alzheimer’s disease risk. FDA’s updated labeling will reflect these timing considerations, though individual prescribing decisions remain between clinicians and patients, FDA notes.

Alongside the policy shift, FDA approved two new menopause-related drugs: the first generic version of Premarin in over 30 years, expected to expand access by lowering costs, and a new non-hormonal therapy for moderate to severe vasomotor symptoms such as hot flashes.

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

Read more

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