The FDA Just Approved the First Medication Specifically for Postpartum Depression
The FDA has just announced that it has approved the first medication on the market specifically for postpartum depression. In an official press release, the FDA included more specifics about the drug, which is called Zulresso (brexanolone) and is administered via an IV injection.
And while the move is a positive one that signifies that medical professionals are finally giving more time, attention, and much-needed research to the issue of postpartum depression (a condition which has not only claimed lives of mothers, but ruined entire families and caused long-term damage when the bond between a mother and the rest of her family is so severely broken) it has also been met with some criticism.
The criticism towards the drug is primarily directed towards 1) the high price and 2) the restrictions surrounding its use. This means that unfortunately, women who may be at most risk for postpartum depression will also be the least likely to be able to access it.
According to the FDA, the medication Zulresso will only be available only through a “restricted program” called the Zulresso REMS Program. The program means that the drug can only be administered by a health care provider in a certified health care facility. If you quality for the medication, you have to check into the health care facility to receive the drug as a continuous IV infusion over a total of 60 hours, over 2.5 days. The most common adverse reactions reported by patients treated with Zulresso in clinical trials, included sleepiness, dry mouth, loss of consciousness, and flushing.
The FDA explains that the drug carries a “risk of serious harm” and women are at risk of losing consciousness, so they have to be monitored the entire time to ensure that they are receiving enough oxygen. In addition to the restrictions to actually receive the drug, women have to be “accompanied” during all interactions with their children while they are getting the infusion. I don't know about you, but that rings a bit of “bad mom” to me, but hopefully that's not the intent the FDA was trying to send. Women aren't criminals for needing help with a medical condition, you know?
After the treatment, women can't drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away, so they will need someone to get them home from the treatment.
Although there have been criticisms about the medication, it does seem promising. Instead of a daily antidepressant or therapy that is often difficult for women to get to with young children, the 2-day dose can help alleviate symptoms more quickly and conveniently. The FDA noted that the drug was released after two clinical studies showed improvement after 30 days and 4 weeks following the administration of the medication in women who had both severe and moderate PPD. But, some have cautioned that the trials still weren't total proof that the medication works, because some experts pointed out that even without a drug, getting 3 days away from your family could help a woman struggling with PPD.
And then there's the small matter of the fact that we haven't discussed the price tag of Zulresso yet. You will probably have to brace yourself for this one. Ready? The medication reportedly comes at a $34,000 price tag for one treatment. Yes, seriously. That's $34,000, the cost of more than my college degree, more than my husband's Master's degree, more than my husband's salary for an entire year as a public school teacher. I mean, wow.
Because the drug is so new, it's not entirely clear how many insurance companies will elect to cover it, or to what extent, but it is an option. And when you consider the cost of therapy and/or additional long-term medications to treat PPD, the cost may not seem as overwhelming. But despite the issues, many other experts are reminding both families and medical professionals alike that although the drug may seem too far out of reach for a lot of women struggling with PPD, it is a necessary start and step in the right direction. Today's exclusive $34,000 2-day facility treatment might just be tomorrow's mainstream, everyday solution for moms who are diagnosed with postpartum depression.
What do you think of the new PPD drug? Step in the right direction or further proof that women are on their own with PPD?