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Is The New Morning Sickness Drug Safe?
If Kate Middleton’s pregnancy has taught us anything, it’s that, for some women, morning sickness is way more than just a pregnancy-related annoyance. In fact, about one percent of pregnant women suffer from symptoms that are so severe, they actually require medical treatment. Luckily for these women, the FDA just approved a drug to treat morning sickness—the first in more than 30 years.
The drug, Diclegis, should be available by the end of May. While you may not have heard of it before, it’s actually far from new: Diclegis was sold in the U.S. more than 50 years ago under a different brand name, Bendectin. Bendectin was approved by the FDA in 1956 for the treatment of vomiting and nausea due to pregnancy. However, many women who took Bendectin ultimately filed lawsuits against the manufacturer, claiming that it caused birth defects. The FDA continued to maintain that Bendectin was completely safe, but the lawsuits persisted. Swamped by legal costs and bad press, the manufacturer stopped making the drug in 1983.
As scary as this all may sound, there is no clinical evidence to suggest that Diclegis can harm a fetus. In fact, Diclegis has been tested extensively in the intervening 30 years. Two meta-analyses of existing research have concluded that it’s safe for a growing baby. In 1999, the FDA announced publicly that the drug was not discontinued for safety reasons. Now, a Canadian manufacturer has stepped in, tested the drug under a new name, and received FDA approval.
Many doctors have welcomed the development with open arms. “It’s a very well-studied medicine,” says Jeffrey Ecker, MD, an obstetrician at Massachusetts General Hospital and a member of the American College of Obstetricians and Gynecologists. “The available information does not suggest a risk.” In fact, the ACOG has recommended the two main ingredients in Diclegis—pyridoxine hydrochloride and doxylamine succinate—as a treatment for morning sickness for the past nine years.
Bottom line: All signs indicate that Diclegis is safe. Still not sure if this pill is right for you? This info will help you decide.
What is it?
Diclegis contains pyridoxine hydrochloride and doxylamine succinate. Pyridoxine is a form of vitamin B6, and doxylamine is an antihistamine (also found in certain allergy medicines). The tablets are delayed-release, so taking two at bedtime should help prevent the onset of morning sickness. If your symptoms are severe enough, you can take two more tablets throughout the day to keep your nausea in check. It’s not known why these ingredients work to reduce morning sickness, but in a recent study, it was found to be more effective than a placebo at reducing nausea and vomiting symptoms.
What are the possible side effects?
Drowsiness is the main one. Like all antihistamines, doxylamine is known to make you sleepy. It’s best to avoid driving or operating heavy machinery while on the medicine.
How do you know if you should take it?
If dietary and lifestyle changes aren’t working to ease your morning sickness, you may want to try taking vitamin B6 (one of the two ingredients in the drug) on its own. Ecker commonly prescribes 25 to 50 mg of B6, to be taken two to three times a day, to women with morning sickness. But if the B6 doesn’t help you, Diclegis may be your best bet.
“As with all medicines, folks that have had reactions to the ingredients shouldn’t take them,” says Ecker. If you know you have a B6 allergy or have reacted badly to anti-histamines in the past, skip this drug. For most people, though, these ingredients shouldn’t cause any problems—just easier mornings for moms-to-be.
photo: iStockphoto/Thinkstock
More From Women’s Health:
How to Deal With Severe Morning Sickness
Prenatal Yoga: Happy, Healthy Baby
What You Should Know About Pregnancy
The Anti-Flu Drug That May Not Work
Still haven’t gotten your flu shot? Here’s another reason to hit up a drug store for the vaccine, STAT: The editors of a major medical journal have cast doubt on the effectiveness of Tamiflu, the only drug FDA-approved for preventing and treating the flu. Roche, the manufacturer of Tamiflu, claims that the drug can reduce your risk of flu after exposure by 92 percent, and speed recovery by 30 percent (about 1.3 days) when taken with 48 hours of first flu symptoms. Researchers and BMJ editors have asked for Roche to release conclusive data to support these claims, but Roche hasn’t complied. In response, a leading researcher has called for a boycott of Roche’s products and for European governments to sue.
While Tamiflu (clinical name “oseltamivir phosphate”) was approved for use by the FDA in 1999, is currently recommended by the Centers for Disease Control and Prevention (CDC), and joins aspirin on the World Health Organization’s List of Essential Medicines, evidence of its effectiveness comes from Roche-funded research that has only been published in part. In a series of open letters to the manufacturer, The British Medical Journal (BMJ) and a team of reviewers who were commissioned by Britain to evaluate flu drugs in a Nordic Cochrane Center review have requested complete access to Roche’s 123 clinical trial studies, each four to five chapters in length. So far, only the first chapters have been released, leaving an estimated 60 percent of the data undisclosed. “It’s not enough to assess the drug’s effectiveness,” says Peter Doshi, Ph.D., postdoctoral fellow in comparative effectiveness research at Johns Hopkins University Medical School and part of the Cochrane review team.
In a BMJ paper published in January, Doshi’s team found that Tamiflu does reduce recovery time, but only by about 21 hours—that’s 10 hours less than Roche claims. The review additionally confirmed known side effects of nausea and vomiting and found evidence to support suspected neuropsychiatric harm as well as other dangerous side effects.
“We have concerns on a number of fronts: the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects,” writes Fiona Godlee, BMJ editor-in-chief in an open letter to Roche board member John Bell, a professor of medicine at Oxford University.
According to FDA spokesperson Sandy Walsh, the FDA routinely monitors adverse reactions and updates drug labeling information accordingly. Still, the prospect of un- or under-reported side effects is frightening, considering Tamiflu is the most widely used influenza drug in this country. Its alleged ineffectiveness is equally alarming, as governments all over the world have stocked up on it in response to widespread flu scares at the expense of billions of dollars of taxpayers’ money.
The bottom line: Tamiflu’s ability to prevent the flu is questionable, and it may have some fishy side effects.
With that in mind, here are 7 tips for how to avoid the flu and stay healthy this winter—so you won’t even need Tamiflu.
Wash your hands compulsively
“The number one thing you can do to protect yourself from a cold or flu is to wash your hands thoroughly and frequently,” says microbiologist Andrew Pekosz, Ph.D., of Johns Hopkins University. Build up a lather with running water and soap and scrub away for twenty seconds, focusing on your palms, between your fingers, and the backs of your hands.
Carry around hand sanitizer
When you can’t get to a sink with soap, hand sanitizer that’s at least 60 percent alcohol can be a good failsafe, according to the Centers for Disease Control and Prevention.
Get the latest flu vaccine
This year’s vaccine contains the two new strains of flu virus, which weren’t used in previous vaccines. The CDC recommends everyone over the age of 6 months receive an annual vaccination. If you’re not convinced, check out five common excuses not to get the vaccine—and why they’re all bogus.
Moisturize… the air
Very humid air might be toxic to flu viruses. It’s unclear why, but one reason might be because droplets that contain the virus shrink quickly in arid environments, which lets them float around for longer. In moist air, though, they get heavy quickly and fall to the ground, away from your nostrils and mouth, says Ted Myatt, Sc.D., an environmental scientist in Boston. Buy a humidifier that keeps the humidity level between 40 and 60 percent.
Ease up on the alcohol
Alcohol can impair your white blood cells’ ability to combat viruses for up to 24 hours after you overindulge, according to a study in BMC Immunology. The next time you hit up happy hour with colleagues, pay in cash (no open tab), so you’re more likely to drink just one.
Catch more ZZZs
If you regularly get less than 7 hours of sleep at night, you triple your risk of developing a cold compared to people who sleep for 8 or more hours, according to the Archives of Internal Medicine. So set a schedule and stick to it – be in bed at a reasonable hour as often as you can.
Eat colorful fruits and veggies
Immune-boosting antioxidants in brightly colored fruits and veggies battle the free radicals that dampen your natural defenses, says Josh Miller, D.O., an internist at the Cleveland Clinic. Think red beans, berries, and green tea.
Additional reporting from Women’s Health editors.
photos: iStockphoto/Thinkstock
More from WH:
The Best OTC Medications
Alternative Cold and Flu Remedies
How to Germ-Proof Your Office
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