Three decades ago, a morning sickness drug was pulled from pharmacy shelves after hundreds of women sued its distributor over birth defect claims.
Now the FDA has re-approved Diclegis, a combination of doxylamine and pyridoxine (vitamin B6), for the treatment of morning sickness during pregnancy, and is now being heavily promoted as a cure all for pregnant women everywhere, despite the severity of the previous concerns.
ABC news reported:
“Gilbert Godin, chief executive officer of Duchesnay USA, the drug’s maker, said the safety fears were unfounded and in the intervening decades, Diclegis (doxylamine succinate and pyridoxine hydrochloride) became one of the most-tested pregnancy drugs in history. ‘Contraindications to the mother are also modest. The main side effect is drowsiness,’ he said.”
The fine print on Duchesnay USA‘s website raises a few more concerns, however:
“Diclegis may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis until cleared to do so by their healthcare provider.”
In fact, doxylamine is considered the most powerful sedative available over-the-counter in the U.S.; it has been found in studies to not only be more potent than many prescription hypnotic medications available, and one such study even found it was “superior to even the barbiturate phenobarbital for use as a sedative.” The fact that it can cause Somnolence means patients may gravitate towards “a state of near-sleep, a strong desire for sleep, or sleeping for unusually long periods (e.g. — hypersomnia).”
In addition, the side effects of doxylamine, one of the main ingredients in NyQuil and over-the-counter sleep aids, are numerous. According to Dr. Brandon Peters, the substance doesn’t just cause drowsiness, but can also cause headaches, stomach pains, hyperactivity, sweating, loss of coordination, dizziness, constipation, low blood pressure, blurred vision, rapid or irregular heart rate, difficulty urinating, and sensitivity to light.
[pullquote]Do pregnant women really need doxylamine, with all of its potential risks, for a completely normal and typically short-lived side effect of pregnancy?[/pullquote]And those are just the “common” side effects. Some of the more serious side effects include anaphylaxis, seizures, toxic psychosis, and low blood cell counts. Doxylamine has also shown up on drug tests as a false positive for methadone. Oh, and too much can kill you.
While many women experience some form of morning sickness during pregnancy, it’s a normal side effect that typically goes away after the initial hormonal changes slow down somewhere between 12-14 weeks. Although an unlucky few will experience hyperemesis gravidarum, an extreme version of morning sickness that can lead to dehydration, the Diclegis website openly admits the drug has not been studied in pregnant women who have that condition.
The entire promotion of Diclegis re-entering the market after its reported dangers during its past run may be a serious misdirection from a simple fact — one of its two key ingredients is vitamin B6, which taken alone as a daily supplement (50mg minimum) could be enough to alleviate the worst cases of morning sickness (and prevent hyperemesis gravidarum).
However, vitamin B6, like other nutrients cannot be patented, rendering the profit margin for Big Pharma close to nothing. Instead, the FDA is aiding, through its approval, the marketing of a drug which essentially complicates a readily available vitamin at the expense of the previously reported dangers.
So do pregnant women really need doxylamine, with all of its potential risks, for a completely normal and typically short-lived side effect of pregnancy?
Not so long ago, women were advised not to take any drugs during their pregnancies. Now everything from flu vaccines to up to three tetanus shots are being recommended for pregnant women when they never were before.