USFDA approves first drug for postpartum depression

Robie de Guzman   •   March 21, 2019   •   4044

Photo by Oleksandr Pidvalnyi from Pexels

The United States Food and Drug Administration (USFDA) has approved the first drug specifically for postpartum depression (PPD) in adult women.

PPD is a debilitating disorder that affects women during pregnancy or within a month of childbirth. It is characterized by feelings of worthlessness or guilt, or thoughts of suicide and is far more severe than the so-called “baby blues.”

“PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation,” the USFDA said in a statement released on March 19.

Tiffany Farchione, acting director of the Psychiatry Products Division at USFDA said that PPD is a serious condition that, when severe, can be life-threatening.

“Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” Farchione added.

The newly approved drug called brexanolone will be marketed under the name Zulresso. It will be manufactured by Sage Therapeutics.

The USFDA said the drug will be administered intravenously for 60 continuous hours or 2.5 days.

The approval of the drug requires that it be administered under strict safety conditions because of concerns about serious risks, including excessive sedation and sudden loss of consciousness.

The drug will be available only to patients who are enrolled in a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility.

“Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient,” Farchione said.

While receiving the infusion, patients’ pulse oximetry (oxygen levels in the blood) must be carefully monitored. They should also be accompanied during interactions with their child(ren).

Patients will also be advised against driving, operating machinery, or doing other dangerous activities until feelings of sleepiness from the treatment have completely gone away.

The most common adverse reactions reported by patients treated in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing.

The necessary steps in administering this drug will be carried in a “boxed warning” which is the strongest warning required by the USFDA.

The agency said the drug’s efficacy was shown in two clinical studies in which participants received either the medication or placebo and were then followed for four weeks.

Around the world, about 10 percent of pregnant women and 13 percent of women who have just given birth experience a mental disorder, primarily depression, according to the World Health Organization (WHO).

In the United States, postpartum depression affects an estimated 900,000 women each year, based on a report by the US Center for Disease Control and Prevention.

In the Philippines, a 2004 data have shown that around 126,826 women suffer from PPD, however, this number had been heavily measured through statistical extrapolation rather than an actual count.

Women diagnosed with PPD are commonly treated with antidepressant and physiotherapy; however, the drugs take several weeks to be fully effective. The new drug, in contrast, takes effect quickly and lasts for 30 days, based on clinical studies.

Farchione said the approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option. – Robie de Guzman

Breastfeeding pain linked to postpartum depression

admin   •   November 3, 2015

WHO recommends exclusive breastfeeding for babies up to 6 months old and says it reduces child mortality and has proven health benefits that extend into adulthood. (REUTERS)

WHO recommends exclusive breastfeeding for babies up to 6 months old and says it reduces child mortality and has proven health benefits that extend into adulthood. (REUTERS)

(Reuters Health) – Women who stop breastfeeding due to pain or difficulty getting babies to nurse may be more likely to develop postpartum depression than mothers who stop nursing for other reasons, a small U.K. study suggests.

Pediatricians recommend that mothers exclusively breastfeed infants until at least six months of age because it can reduce babies’ risk of ear and respiratory infections, sudden infant death syndrome, allergies, childhood obesity and diabetes.

Mothers can benefit too, with longer periods of breastfeeding linked to lower risks of depression, bone deterioration and certain cancers.

Whether women experience depression after breastfeeding may be related to how much they felt they had control over the reasons that motivated them to stop, lead study author Amy Brown of Swansea University in Wales said by email.

“Perhaps if new mums stop breastfeeding because they find it embarrassing or for lifestyle issues then they feel a personal benefit from doing so – maybe they’re ready to stop,” Brown said.

“However, if they feel they have to do it because of pain or physical difficulties then they may not be so ready and really want to continue, but feel the choice has been taken away from them,” Brown added. “They may also worry that they’re doing it `wrong’ or in some way they are to blame.”

Brown and colleagues analyzed questionnaires from 217 women who started breastfeeding when their babies were born but stopped before six months.

Questions touched on how long women breastfed, why they stopped and also measured depression.

Women were 32 years old on average, and most were married or living with a partner. Typically, they had professional or managerial jobs and at least some higher education.

Overall, the earlier women stopped breastfeeding, the higher their postpartum depression score was on the questionnaires, according to the results in the Journal of Advanced Nursing.

But this association could mostly be explained by women’s experiences breastfeeding.

Pain, cracked nipples, breast infections and challenges with milk production or getting babies to latch on and suck properly were all reasons for stopping that were linked to an increased risk of depression than other causes.

It’s also possible, however, that postpartum depression might lead women to perceive breastfeeding as a more painful or physically difficult experience, the authors note.

Shortcomings of the study include its sample of older-than-average new mothers with more education and professional occupations than might be typical in the general population, the authors acknowledge as well. The questionnaire may also be an imperfect measure of depression, the researchers note.

Still, the findings highlight the need for women to get support to help work out any challenges with breastfeeding, whether from doctors or midwives or volunteer organizations, Brown said.

“The better informed the mother is about breastfeeding and its potential benefits, the better for her mental health,” said Cristina Borra, a researcher at the University of Seville in Spain who wasn’t involved in the study.

When women don’t get enough education about the benefits and logistics of breastfeeding during pregnancy and right after delivery, they are more likely to struggle, Borra said by email.

In previous research, Borra found that the benefits of breastfeeding were concentrated among mothers who were not previously depressed, planned to nurse their babies and then were able to do so.

“For the majority of mothers – not at risk of depression during pregnancy – being able to follow their plans was positive for their mental health,” Borra said.

SOURCE: Journal of Advanced Nursing, online October 23, 2015.

FDA warns about another illegal stimulant in supplements

admin   •   April 29, 2015


A view shows the U.S. Food and Drug Administration headquarters in Silver Spring, Maryland, August 14, 2012.

(Reuters) – The U.S. Food and Drug Administration is warning companies to stop selling dietary supplements that include a stimulant known as DMBA, the latest in a series of moves to clamp down on potentially dangerous weight-loss and body-building products.

In an April 24 letter to one manufacturer, 1ViZN LLC, the agency noted that its product Velocity listed AMP as a dietary ingredient. AMP is also known as 1,3-Dimethylbutylamine, DMBA, 2-amino-4-methylpentane and methyl-2-pentanamine.

The FDA said it considered Velocity adulterated because there is not enough information to provide reasonable assurance that DMBA is safe.

Earlier this month the agency warned five companies to stop selling dietary supplements containing a stimulant known as beta-methylphenylethylamine, or BMPEA, which is often hidden in supplements containing Acacia rigidula.

The FDA actions come amid pressure from lawmakers and a Harvard University academic, Dr. Pieter Cohen, who has been studying the presence of synthetic stimulants in supplements.

“This is extremely welcome news,” Cohen said. “Rather than waiting until heart attacks, strokes or deaths are definitely linked to this new designer stimulant, the FDA has now made it extremely clear to manufacturers that there is no justification to sell DMBA in supplements.”

Last year Cohen published a study showing DMBA was present in 12 supplements marketed to improve athletic performance, increase weight loss and enhance brain function. He also pointed out that products containing BMPEA were still on the market a year after FDA researchers discovered the stimulant in Acacia rigidula supplements.

DMBA and BMPEA are similar to 1,3-dimethylamylamine, or DMAA, which has already been banned by the FDA.

The FDA banned a stimulant known as ephedra in 2004. Since then, companies have tried to replace it with other stimulants purported to be natural.

“On closer review these ‘natural’ stimulants have turned out to be nothing other than new, untested drugs,” Cohen said.

(Reporting by Toni Clarke in Washington; Editing by Ted Botha)

FDA Commissioner says measles outbreak ‘alarming’

admin   •   February 11, 2015

A measles vaccine is seen at Venice Family Clinic in Los Angeles, California February 5, 2015.

(Reuters) – Describing the latest measles outbreak as “alarming,” Dr. Margaret Hamburg, outgoing commissioner of the U.S. Food and Drug Administration, said on Tuesday that the measles vaccine “should be used by everyone who has not been vaccinated.”

Her comments, published in a blog post on the FDA’s website, come as the United States battles a resurgence of the disease, driven by fears among some parents of an association between vaccines and autism – fears that experts say have no basis in science.

Hamburg said vaccination is the single best way to prevent the spread of the disease.

“Simply put, these vaccines are safe and effective, and serious side effects are rare,” she said.

This year more than 120 people across 17 states have been infected with measles, according to the Centers for Disease Control and Prevention. Last year, 644 cases were reported, the highest number since the disease was effectively eliminated from the United States in 2000.

Before the measles vaccination program began in 1963, three to four million people were infected with measles each year, of whom 400 to 500 died, another 48,000 were hospitalized and others developed pneumonia, brain damage or deafness.

“Let’s not return to these grim statistics,” Hamburg said.

(Reporting by Toni Clarke in Washington; Editing by Bernard Orr)


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