New Postpartum Depression Drug Carries Hefty Risk

The FDA recently approved a new drug, Zulresso/brexanolone for postpartum depression. It is the first drug approved for postpartum depression by the FDA. While touted as a potential miracle drug, it comes with very hefty price tag of $34,000 per treatment and a Black Box Warning.

Prescription and administration of Zulresso will be restricted. Patients who are accepted for this drug program are required to be hospitalized with close monitoring during the administration of the medication. The drug is given as a continuous IV infusion over 60 hours in a monitored health setting. Black Box Warnings come with Zulresso as it carries risk of serious harm. Potentially dangerous adverse effects include excessive sedation, sudden loss of consciousness, and decreased oxygen levels.

There are at least 167 drugs that negatively interact with Zulresso and increase toxicity causing more sedation or central nervous system depression. Sedation is more than just feeling sleepy. It refers to central nervous system depression or slowing of brain function. Lowered vital signs reflect this type of central nervous system depression and may be seen as slowing of the heart rate, breathing, and reflexes.

National Institute of Mental Health press release describes how Zulresso works but the overall mechanisms are not fully understood. The drug affects GABA-A receptors, which are binding sites for GABA. GABA is a neurotransmitter that inhibits or even prevents function and cellular communications. GABA-A receptors are found in the limbic system of the brain. The limbic system, located deep within the brain, is where feelings and emotional memories are made and stored. When GABA-A receptors are activated, their response is to inhibit stress responses – fight/flight and overwhelming strong emotions. GABA-A receptors and GABA help “cool off” stress responses and in turn helps de-stress the autonomic nervous system.

Rapid Hormone Changes Affect GABA

Pregnancy and delivery hormone levels have wide fluctuations. During pregnancy, levels of one of the hormone metabolites, allopregnanolone, are high. After birth, allopregnanolone levels drop. Scientists believe this drop in allopregnanolone triggers postpartum depression.

Allopregnanolone is a steroid that acts in the brain or is a neurosteroid. This neurosteroid is made from progesterone. It acts as a strong, positive modulator of the GABA-A receptor. When Zulresso enters the brain it is thought to modulate allopregnanolone levels and GABA-A receptors. Progesterone is made in the ovaries, placenta, and the adrenal glands. It is derived from cholesterol.

Postpartum Depression

Postpartum depression may cause several symptoms. These include crying more often than usual, feelings of anger, numbness, guilt, doubt, or make you feel disconnected from your baby and others. You may want to withdraw from loved ones. You may worry that you will hurt the baby. Symptoms may become so debilitating that you become unable to care for yourself, the baby, or your family.

Baby blues that affect up to 80 percent of women is a mild version of depression after birth, whereas postpartum depression is more severe and may affect about 15 percent of women shortly after giving birth and may last for several months. Postpartum depression can be incapacitating and life threatening when the body has reached a point of extreme exhaustion and depletion.

The arrival of a new family member occurs with much anticipation, excitement and numerous questions and concerns. Yet, coupled with this are the changes in hormones, exhausting sleepless nights in caring for a newborn, breastfeeding, other family needs, and even going back to work. This leads to an enormous energy debt that must be counteracted.

Zulresso is a powerful drug that tries to put the brakes on a crisis. In today’s world of medicine, those who can afford an enormously expensive drug now have a “fast food treatment” approach. For some, this may be a lifesaver. Not everyone who needs support will be able to go this route. A healthy pregnancy and delivery requires preparation, nutritional fortification, and adequate support. As you go through postpartum care and recovery, your body needs enormous support. Your needs as a mom don’t stop after creation, development, and delivery of a baby. It is an ongoing need. Fortify yourself at all stages. Your whole being requires this. Getting to know your new baby should be some of the most momentous times of life.