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Home » FDA Approves Zurzuvae, First Pill For Postpartum Depression, What You Need To Know
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FDA Approves Zurzuvae, First Pill For Postpartum Depression, What You Need To Know

adminBy adminAugust 6, 20230 ViewsNo Comments5 Mins Read
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Here’s some potentially uplifting news for those suffering from postpartum depression (PPD). On August 4, the U.S. Food and Drug Administration (FDA) announced that they have approved Zurzuvae, as the first ever oral medication for the treatment of postpartum depression.

Postpartum is pronounced like “post part, umm” with “post” meaning “after” and “partum” meaning “childbirth” in Latin. But postpartum depression shouldn’t be an “umm what” condition. It’s a major depressive episode that affects an estimated one in seven women either in their later stages of pregnancy or after they have given birth. Yet, postpartum depression often goes undiagnosed and untreated.

Zurzuvae is the two-Z brand name for zuranolone that will be the more easy alternative to Zulresso, which is the brand name for brexanolone. Sage Therapeutics, Inc. has been marketing Zulresso whereas Biogen Inc. and Sage Therapeutics, Inc. have developed and will market Zurzuvae. Zulresso ain’t exactly the most convenient of medications to get as Zulresso is typically administered as an intravenous infusion over a 60-hour period. That’s not the type of thing that you can get at a local coffee shop and instead usually requires admission to some type of healthcare facility like a hospital. Oh, and getting Zulresso could end up costing something like $34,000, according to a piece in the University of Michigan’s Michigan Medicine. That’s around the cost of a Tesla, a year of college tuition, or around 2300 apple trees sapplings, not that all of these things are necessarily interchangeable.

Having such a new and presumably less expensive alternative can be welcome news to many mothers who feel like they have no alternative. A reason why you may suffer postpartum depression in silence is that you could feel some shame. You may be worried that revealing symptoms of depression may somehow reflect badly on your parenting. It could go against the unrealistic narrative that “You just had a baby and are supposed to be happy with lollipops and bunnies wearing sweater vests appearing everywhere so why not just taste the rainbow.” Reality, of course, can be very different. The FDA announcement quoted Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research as saying, “Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.” Clearly, PPD is not a fun thing to have.

It’s not completely clear, though, what may cause PPD. It may result from changes in the levels of hormones such as estradiol and progesterone, inflammation of various nerve cells, and changes in neurotransmitter levels. Zurzuvae is a steroid that acts on GABAA receptors in your brain. GABAA receptors are sort of like the little Meryl Streeps of your brain. They play may different roles including helping in the regulation of your mood and behavior.

The FDA granted approval to Zurzuvae not because of the number of “Z” in its name but because of its demonstrated efficacy in two randomized, double-blind, placebo-controlled, multicenter studies. Both compared the use of Zurzuvae (50 mg a day for one study and 40 mg a day for another) versus placebo over the course of 14 days and monitoring what happened for at least four weeks afterwards. Both studies showed that patients getting Zurzuvae experienced significantly greater improvements in scores on the 17-item Hamilton depression rating scale (HAMD-17) compared to placebo at day 15. Not only that, the improvements persisted for four weeks after the last dose of Zurzuvae.

Speaking of “Z’s,” drowsiness is a potential side effect of Zurzuvae. In fact, you may not even realize how drowsy you are, which as you can imagine may affect your judgement. That’s why the FDA warns that you “should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.” So if you are thinking of entering that tractor pull or chain saw juggling competition, don’t. Other possible side effects include dizziness, diarrhea, fatigue, inflammation of the upper respiratory passages, and urinary tract infections. Zurzuvae could potentially cause suicidal thoughts and behavior as well. So, it isn’t a medication that you should necessarily take lightly.

The other warning from the FDA is that Zurzuvae could potentially cause harm to your fetus. Therefore, if you are taking Zurzuvae and thinking of baking the potato, checking the oil, bringing an al dente noodle to the spaghetti house, tossing a hot dog down the hallway, or whatever you call having sex, use effective contraception throughout and for at least one week after taking Zurzuvae. You don’t want to risk getting pregnant again then. Also, hold off on breastfeeding during that period as well.

The recommended dose for Zurzuvae is 50 mg once every evening for a total of 14 days. The FDA recommends that you take this medication with a fatty meal not because cheese on cheese can be oh-so-delish. It’s because fat can help the medication be absorbed.

Read the full article here

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