Drugs

FDA Orders Addyi Safety Labeling Changes

Following its review of postmarketing studies, FDA is ordering Sprout Pharmaceuticals to make safety labeling changes for its Addyi (flibanserin) that is indicated to treat acquired, generalized hypoactive sexual desire disorder in postmenopausal women. An agency media statement says that at the time Addyi was approved 8/2015, FDA reviewed data including several cases of severe hypotension and syncope when Addyi and alcohol were taken together. As a result, the drug’s labeling contains a Boxed Warning stating that alcohol must be avoided in women treated with Addyi.

The agency now says that based on the results of the postmarketing studies, it believes changes must be made to the labeling to clarify that there still is a concern about consuming alcohol close in time to taking Addyi, but it does not have to be avoided completely.

The Boxed Warning, Contraindication, Warnings and Precautions, and Adverse Reactions sections of the labeling are being updated to reflect that women should stop drinking alcohol at least two hours before taking Addyi at bedtime or skip the dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime, FDA says.

The agency ordered Sprout to make the changes because it was unable to reach an agreement with the company, which was requesting removal of the Boxed Warning and Contraindication about alcohol completely from the labeling.

“FDA determined, based on a careful review of available data, that removing this important safety information was not acceptable for the protection of public health,” the media statement says.

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