Postpartum depression — extreme sadness, anxiety or despair following childbirth — plagues up to 1 in 5 women. Some women become suicidal.
But after considerable delay, the Food and Drug Administration finally approved zuranolone — the first-ever pill to treat postpartum depression.
NBC reports that the FDA “approved the drug in August, but it took months for supply to become available. Several psychiatrists said they’re just starting to write their first prescriptions…They hope it will be a game changer because it’s fast-acting and can be taken at home.”
It has taken the FDA years to approve zuranalone. And this is actually fast for the FDA:
The FDA fast-tracked zuranolone in 2017 — a step taken for drugs that could treat serious conditions and fill an unmet medical need. In a pair of clinical trials, it was shown to improve symptoms of severe postpartum depression — such as anxiety, difficulty sleeping, loss of pleasure, low energy, guilt or social withdrawal — as early as three days in. The pills are taken daily for two weeks, in the evening with a fatty meal.
The medication isn’t ideal for mild postpartum depression, or the “baby blues,” doctors said. Instead, they’re considering it for patients who [are so severely depressed that they] have a hard time caring for themselves or their babies — in other words, those for whom medical intervention could be lifesaving.”…..
Doctors say not to take zuranolone if you need to drive soon afterwards:
Zuranolone can cause drowsiness, dizziness, diarrhea, fatigue and urinary tract infections. So far, doctors said they’ve heard of patients experiencing drowsiness or dizziness, but not to an extreme degree.
Because of this effect, however, the medication comes with a warning not to drive or operate heavy machinery for at least 12 hours after taking it.
In other news, the FDA is cracking down on useful, reliable home medical tests that have revealed cancers and serious illnesses.
The FDA is often quite slow in approving drugs and medical devices. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff of Fortune noted, the FDA’s delay in approving the home HIV test was a “scandal.” It likely caused the deaths of thousands of people, given the mortality rate from AIDS in years past.
Many people die waiting for the FDA to approve life-saving drugs. For example, at least a hundred thousand people died waiting years for the FDA to approve beta blockers. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to frustrate and inconvenience other people, such as his habit of deliberately driving slowly in the fast lane on highways in order to inconvenience other motorists.
In light of the countless people killed by the FDA’s deadly delays in approving life-saving drugs and medical devices, drugs and devices should not have to be approved by the FDA before they can be sold. Instead, the FDA should only be able to remove drugs and devices from the market once it has evidence that they should be banned based on their ineffectiveness or dangerousness. The FDA should also be allowed to place warning labels on drugs and devices based on their risks, even when the quantum of evidence is not sufficient to prove the need for a ban. Originally, the FDA did not have premarket approval powers, even when it had enforcement authority to take action against quackery and unsafe drugs and devices.
