Every time I turn on the TV, I see where another drug has been approved by the FDA.
The commercials always show these exceptionally happy people who obviously haven’t
actually taken the drug, nor read the FDA Label.
This is the first of a series where I will tell you what the commercials won’t.
The FDA’s latest approval: Zurzuvae for postpartum depression.
The first thing to do is access the FDA Label. It’s an easy “search engine of your choice”
lookup, but here it is: Zurzuvae for postpartum depression
Now let’s look at some Selective statements from the FDA Label (With my comments
in parentheses):
1. “The mechanism of action of zuranolone in the treatment of PPD is not fully understood but is thought to be related to its positive allosteric modulation of GABAA receptors.”
(Don’t you just love it when they really don’t have a clue why or how it works? However, the mechanism of action CAN be the most useful part of the label.)
2. “These highlights do not include all the information needed to use ZURZUVAE safely and effectively.”
(Always read the full Prescribing information. It’s not just for doctors. It’s where you find the most important information. Like the mechanism of action.)
3. “[controlled substance schedule pending] Initial U.S. Approval: [pending controlled substance scheduling]”
(Wouldn’t want to determine this BEFORE it’s FDA approved and new mothers are taking it, now, would we?)
4. “WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES”
(No driving for you, Mom! I’m sure you didn’t have anything to do anyway.)
5. “Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after administration.”
(So, about the time you’re ready for bed…)
6. “Patients may not be able to assess their own driving competence, or the degree of impairment caused by ZURZUVAE”.
(Oh….)
7. “ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults.”
(REMEMBER THIS! This is related to the Glutamate / Gaba neuroprocess in the body. Most drugs and diseases associated with Neuro, Gastro, Skin, or Endocrine System have an effect on Glutamate, GABA, or other parts of this process. You’ll see as I review more drugs.)
8. “CONTRAINDICATIONS: None.”
(Really? Everyone can take this drug safely?)
9. “ZURZUVAE can cause CNS depressant effects such as somnolence and confusion….in patients whose PPD worsens, or who experience emergent suicidal thoughts and behaviors.”
(Wait…What…isn’t this drug supposed to PREVENT those things???)
10. “Embryo-fetal Toxicity: May cause fetal harm. Advise a pregnant woman of the potential risk to an infant exposed to ZURZUVAE in utero. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during ZURZUVAE treatment and for one week after the final dose.” (No further comment necessary.)
11. “ADVERSE REACTIONS: Most common adverse reactions….were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.”
(Some of these side effects sound depressing. Just saying.)
12. “CNS Depressants: Concomitant use may increase impairment of psychomotor performance or CNS depressant effects. If use with another CNS depressant is unavoidable, consider dosage reduction.”
(So, you might need TWO anti-depressants?)
13. “Strong CYP3A4 Inhibitors: Concomitant use may increase the risk of ZURZUVAE-associated adverse reactions…may decrease the efficacy of ZURZUVAE. Avoid concomitant use.”
(Better choice: Don’t use it at all.)
As you can see, Drug Labels are basically a list of disclaimers to protect the
manufacturer in a court of law if they are sued. You can’t say you haven’t been warned.
Watch for more drug reviews coming up.
And let me know if there’s a particular drug you would like me to look at.
Please keep on doing these drug reviews! Sometimes doctors will tell patients not to bother reading the drug label as they will be unduly influenced by side effect statements. This is important research, keep at it!
If “the mechanism of action of zuranolone in the treatment of PPD is not fully understood" and the "experts" approve the drug is clear that the drug is potentially perilous and the "experts" are perverted. Q.E.D.