Breaking: SOME Morning After Pills Will Be OTC

The battle over where Plan B belongs in the drugstore continues: First, an April judicial ruling required the FDA to make emergency contraceptives available over the counter without any point-of-sale or age restrictions. Then, the Department of Justice later appealed the decision, asking for a temporary suspension of the case. The latest update: Earlier today, The U.S. Second Circuit Court of Appeals ruled that the FDA must provide unrestricted over-the-counter access to some forms of emergency contraception, but not others, according to a recent press release from the Reproductive Health Technologies Project.

The new ruling says that the FDA does not need to provide OTC access to one-pill versions of emergency contraception (like Plan B One-Step); however, they do need to make two-pill versions available OTC immediately, without any age or point-of-sale restrictions. Essentially, it enforces the original order to put the morning after pill on store shelves, but only as it applies to the two-pill methods. According to the Center for Reproductive Rights, the FDA will now have 14 days to appeal this ruling, or they could comply and start working on getting two-pill doses (like the generic Levonorgestral tablets, 0.75mg) moved out from behind the pharmacy counter.

So why are they allowing the two-pill dose to hit shelves instead of the much more widely available one-pill version? It isn’t entirely clear. “I think it’s based on legal and procedural issues, not with what has been shown to be a safe and effective product—both in one pill and two pill versions,” says Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project.

While it might seem confusing that some forms of emergency contraception will be on store shelves while others will be behind the counter (and still others will require a prescription!), it’s important to note that all options are safe and effective forms of backup birth control, says Baruch. And this new ruling will mean that you can get the morning after pill whenever you need it—albeit in a slightly less convenient two-pill formula.

“This is a good day,” says Baruch.” We’re happy with the decision and eager to see what happens next. The path to full access to emergency contraception is open and we’re headed down that path.”

photo: WaveBreak Media/Thinkstock

More From Women’s Health:
The Morning After Pill May Soon Be OTC
The FDA Approves Plan B One Step
DOJ Appeals Emergency Contraception Ruling

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Male Birth Control Pills Finally On the Horizon

Every couple of years, a new birth control method for women pops up on pharmacy shelves or in your gyno’s office that is safe, easy, and super-effective—for example, the extended cycle pill, OTC emergency contraception, and the shorter-term Skyla IUD all made their debuts in the last decade.

But for guys? Their options are stuck in a time warp. If a man wants to take pregnancy prevention into his own hands, his choice basically comes down to condoms, a vasectomy, withdrawal, or abstinence. That’s why it’s so amazing that scientists are finally developing some real advancements when it comes to male contraception.

Researchers writing in the April issue of the Open Access Journal Contraception published a rundown of the top emerging options. A few hold real promise, particularly a daily or weekly pill that would deliver a dose of artificial hormones to a guy’s bloodstream, which would then act on reproductive hormones to stop sperm from being produced. Like the female hormonal pill, the male hormonal pill would be reversible. But also like the female hormonal pill, there appear to be side effects—among them acne, weight gain, and even trickier to work around, changes in testosterone levels that trigger a plunge in libido, says review coauthor Deborah A. Garside, a member of the department of medicine at Imperial College in London, UK.

Non-hormonal techniques are also being developed, particularly a vaccine that immunizes men with antibodies to halt to sperm production. This so-called male birth-control shot is encouraging, says Garside, because it targets sperm directly (rather than targeting other hormones in the body) and doesn’t have the testosterone-lowering side effects of a hormonal pill. Each injection would last for long intervals (experts aren’t yet sure how long), but the pregnancy-preventing effects would be reversible if and when a guy decides he’s ready to be a dad.

So when can you expect to see men rushing out to the pharmacy counter to pick up their new birth control Rx? “I think we may see a novel male contraceptive within 10 years,” says Garside. That may seem far off, but hey—at least it’s finally within sight.

An international poll cited in the article showed that only two percent of women in monogamous relationships would not trust their partner to take a male contraception method. How about you—would you rely on your guy to take a birth control pill or shot as directed?

  • Yep, definitely.
  • No way!
  • I’d trust him to at least tell me if he messed up and we needed a backup method.
  • I’m single.

photo: iStockphoto/Thinkstock

More From Women’s Health:
How Much Do Men Know About Birth Control?
Birth Control FAQs
All About Birth Control

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Are the New Weight-Loss Pills the Solution?

 
qnexa: qsymiaAfter a 13-year dry spell, the Federal Food and Drug Administration (FDA) has approved two new weight-loss pills in less than a month. Are either of these new pills a magic bullet for dieters—or even a helpful weapon to add to their fat-fighting arsenal?

The latest FDA-approved pill is called Qsymia, a mix of the appetite-suppressing phentermine (not to be confused with Fenfluramine, a now-illegal ingredient in the infamous weight-loss drug known as fen-phen) and topiramate, an anticonvulsant. While Qsymia was officially approved on Tuesday, this drug combination has been prescribed off-label for years, says Stephen Gullo, Ph.D., president of the Institute for Health and Weight Sciences in New York City. Still, Qsymia, which was formerly known as Qnexa, is meant for a very specific type of patient and could have serious side effects. (Read our take on the first drug, Belviq, here.)

How does Qsymia work?
Phentermine is a well-known appetite suppressant that’s used for short-term weight loss. Topiramate (an anti-seizure medication) makes people feel fuller after eating. Doses are determined by a person’s Body Mass Index (BMI) and change over the course of treatment.

In two year-long studies with approximately 3,700 total obese and overweight participants, patients had an average weight loss of 6.7 to 8.9 percent over placebo groups. In addition, approximately 62 to 69 percent of patients lost at least five percent of their body weight, compared with about 20 percent of patients treated with placebo.

Qsymia, like its recent predecessor Belviq, requires a lifelong commitment. “People in this weight category have a chronic problem and therefore, they need a chronic solution,” says Dr. Gullo. In other words, the pills may help people lose weight but there are no promises the weight loss will stick once someone goes off the drugs.

Who should take Qsymia?
Qysmia is meant for obese people (BMI of 30 or greater), or overweight people (BMI of 27 or greater) with at least one weight-related health problem, like high blood pressure, type 2 diabetes, or high cholesterol. Calculate your BMI here. (Learn more about how your BMI can affect your health.)

People with hyperthyroidism or heart problems are advised against taking Qsymia because it can cause an increase in heart rate. Pregnant women are also steered away from the drug because of the risk of birth defects, including cleft palate. Women who choose to take the medication must first take a pregnancy test. They’re also expected to use contraception and to take monthly pregnancy tests just to be safe.

When will Qsymia be available?
Vivus, the makers of Qsymia, say the drug will be available before the end of 2012. However, it will only be available by mail through specially certified pharmacies.

Even once it’s on the market, more studies of Qsymia will be conducted to determine its long-term risks, particularly its potential effects on heart health. “I would wait a year or two to see if there were any reported significant effects,” says Dr. Gullo.

Which diet pill is the best, Qsymia or Belviq?
Experts are split on this one. Dr. Gullo is partial to Qsymia (over Belviq) because its ingredients have been used together (off-label) for weight loss for many years. Other experts are concerned about Qsymia’s possible risks, especially heart problems and birth defects. But Belviq has risks too, including a potential for dependence.

Dr. Gullo recommends that people who take either pill see their doctor often. He also emphasizes that taking these pills is not an excuse to eat poorly. People prescribed these medications should follow a weight-loss focused diet (about 1200 calories a day) and exercise regularly (about 30 minutes, 3 to 4 times a week).

Unfortunately, for those who hoped the Fat-Melting Fairy had arrived in the form of these new weight-loss pills, Dr. Gullo brings us back to reality. “I don’t think the cure for obesity will be magically found in either of these drugs,” he says.

The Time-Tested Alternative
If you’re looking for a safe and healthy way to lose a significant amount of weight, we can help. Combine a sensible eating plan with our side-effect free Total-Body Transformation, a 12-month workout program designed by trainer Chris Powell of ABC’s show Extreme Makeover: Weight-Loss Edition.

photo: Vivus, Inc.

 
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The Hunger Paradox
Are Your Friends Making You Fat?
One-Week Meal Plan
 
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