New Delhi: The US Food and Drug Administration (FDA) has approved this week the first ever drug treatment for postpartum depression (PPD) in adult women.
PPD is a type of depression that either develops during pregnancy or after childbirth, which could adversely affect the growth of the offspring, according to the World Health Organisation (WHO).
The FDA has approved the injection of the drug named Brexanolone, which is sold under the brand name Zulresso. It is manufactured by US-based Sage Therapeutics, a biopharmaceutical company.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may have thoughts about harming themselves or their children. Postpartum depression can also interfere with the mother-child bond,” said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a press statement.
“This approval marks the first time that a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” she said.
Also read: This is the world’s biggest mental health problem, & it’s probably not what you think it is
Important drug for India and developing countries
“Scars of PPD can have life-long impact on the development of a child. New approaches, like the new drug, can be a game-changer. If available, in the Indian context, it would be of significant help in the treatment, albeit the costs and adverse effects need to be taken into account,” said Dr. Sanjay Garg, consultant of the Department of Mental Health and Behavioural Sciences at Fortis Hospital in Anandapur.
According to the WHO, depression during pregnancy and after childbirth is known to have adverse effects on the growth and development of the offspring, especially in developing countries.
The reported prevalence of PPD in India, as per a WHO report titled Depression in India. Let’s talk, ranges between 15.3 per cent and 23 per cent. Around 14 per cent of the mothers continue to have symptoms of depression till up to six months after delivery.
“Economic and interpersonal relationship issues, violence by partner, use of alcohol by spouse and gender of the newborn child are among some of the major determinants of the postpartum depression,” the report said.
“It is not known whether the manufacturer of the drug intends to launch it in India. If they plan to do so, it will take at least two years for the drug to clear regulatory procedures and become available for Indian patients,” said Ashok Madan, executive director, Indian Drug Manufacturers Association, an outfit representing over 1,000 pharma companies in India.
Also read: Mental health problems during pregnancy are common but there is very little help available
FDA warns of careful administration of the drug
“Zulresso is administered as a continuous intravenous infusion over a time of 60 hours (2.5 days),” the US health regulator said.
The FDA said that after the drug was administered, the patient must be monitored for excessive sedation and sudden loss of consciousness. There should also be constant monitoring of oxygen levels in the blood.
The health regulator has warned of serious harm such as a sudden loss of consciousness, hence, the medicine must be given under a restricted access programme. It can only be administered by a healthcare provider to patients in a certified healthcare facility.