Drugs/Medications

The U.S. Food and Drug Administration has approved a brand of emergency contraception - Plan B One-Step - for ages 15 and up without a prescription, in defiance of a judge's order to make the so-called "morning after pill" available to all ages.

The FDA's decision to allow Plan B One-Step to be sold over the counter to some teens without a prescription from a doctor falls short of the orders of a judge last month. In a statement late Tuesday, the FDA said:

"The product will now be labeled 'not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified."

Researchers from the University of Guelph have developed a first-ever vaccine for gut bacterial common in autistic children, which may also help control some autism symptoms.

The study by Brittany Pequegnat and Guelph chemistry professor Mario Monteiro was published in this month's edition of the journal Vaccine.

Pequegnat and Monteiro developed a carbohydrate-based vaccine to combat the gut bacteria Clostridium bolteae, which is known to play a role in gastrointestinal disorders and often appears in higher numbers in the GI tracts of autistic children than in those of healthy children.

More than 90 percent of children with autism spectrum disorders suffer from chronic, severe gastrointestinal symptoms. Of them, about 75 percent suffer from diarrhea.

Monteiro said that little is currently known about the factors that predispose autistic children to C. bolteae, and while most infections are handled by some antibiotics, a vaccine would improve current treatment, noting:

"This is the first vaccine designed to control constipation and diarrhea caused by C. bolteae and perhaps control autism-related symptoms associated with this microbe."

According to new research, marijuana in pill form may work even better as a pain reliever than the drug in its smoked form, and with fewer harmful side effects.

The research, which was carried out by Columbia University in New York, involved a trial of 30 men and women. Some of the participants smoked the drug, while others took the active chemical in a pill called dronabinol, and the remainder took a placebo.

Dronabinol contains the active ingredient tetrahydrocannabino, which is more commonly known as THC. THC helps to block signals from nerve endings from reaching the brain, which in turn inhibits pain.

Study participants were asked to place their hands in ice cold water and then were timed to see how long it took to feel pain and how long they could keep their hands submerged. Both the smokers and thos taking the pill were able to withstand pain for a longer period of time.

The researchers also found that smoking marijuana decreased pain sensitivity for two and a half hours, but the pill provided pain-reducing effects for over four hours.

Even without the alcohol, scientists say that the taste of beer alone may be enough to trigger the release of the pleasure inducing chemical dopamine in the brain.

In order to examine the effects of beer on the brain, researchers gave a group of men small tastes of beer. While the men sipped the beer, the researchers scanned their brains. Following a taste of beer, the men's brains showed a notable release of dopamine. Dopamine is a chemical in the brain that is associated with pleasurable experiences like consuming alcohol and other drugs. Among men who had a family history of alcoholism, the effect was even greater.

Scientists say that the finds are not surprising, but note that having a way to assess predisposition to alcohol abuse would be useful.

The study's lead author, David Kareken, a neuroscientist at the Indiana University School of Medicine, said in a statement:

A drug that was pulled off the market 30 years ago has finally won approval by the Food and Drug Administration as the only drug that's specifically designated to treat morning sickness.

The safety scare from decades ago was proven to be nothing but a false alarm. The FDA's decision on Monday means that a new version one the pill that was once known as Bendectin will offigially return to American pharmacies. The drug, although exactly the same, will now be known as Diclegis.

Ever since lawsuits forced Bendectin off of the market in 1983, doctors have had no officially approved treatment for morning sickness.

Diclegis' main ingredients are B6 and an over-the-counter antihistamine. Over the years, obstetricians often advised patients on how to mix up the proper dose themselves.

On Tuesday, the U.S. Food and Drug Administration warned that the antibiotic azithromycin, which is sold under the brand name Zithromax, can cause a potentially fatal irregular heart rhythm in some patients.

A study published in the New England Journal of Medicine in May 2012 compared the risk of cardiovascular death from different antibacterial drugs and discovered that azithromycin had a higher rate of death.

Zithromax is made by Pfizer Inc. and is also sold by generic manufacturers.

The FDA stated in its warning that the drug can cause abnormal changes in the electrical activity of the heart, which could lead to a potentially fatal heart rhythm known as prolonged QT interval. In prolonged QT interval the timing of the heart's contractions becomes irregular. The FDA recommends that doctors use caution when giving azithromycin to patients know to have this condition, or who have certain risk factors.

A new study suggests that older women who take aspirin regularly may be lowering their risk of developing the deadly skin cancer melanoma. Furthermore, the longest that postmenopausal women take aspirin, the more their melanoma risk appears to diminish.

This effect is only seen with aspirin, and not with other pain relievers like acetaminophen (Tylenol).

The research team collected data on nearly 60,000 white women who were a part of the Women's Health Initiative, a long-term national study. All were between the ages of 50 and 79, and were asked about what medications they took and other lifestyle preferences. The women were followed-up over the course of 12 years.

Researchers found that women who took aspirin had a 21 percent lower risk of developing melanoma compared to those who did not take aspirin.

Lead author Dr. Jean Tang, an assistant professor of dermatology at Stanford University School of Medicine in Palo Alto, Calif., said:

"Aspirin could be potentially used to prevent melanoma, but a clinical trial is needed."

However, Tang cautions that it is too soon to make any solid conclusions as additional research is needed, and thinks that it is too soon for women to start taking aspirin only to try to prevent melanoma.

Bacterial infections are a relatively common occurrence in American hospitals, but federal officials are now warning that they are on the rise and are becoming more resilient. The U.S. Centers for Disease Control and Prevention released its new Vital Signs report on Tuesday, in which it reported that carbapenem-resistant Enterobacteriaceae (CRE) "superbugs" are increasingly resistant to the strongest antibiotics and are the cause of death in half of all patients who develop bloodstream infections from them.

Cases of the superbug are still unusual, but have been on the rise for the past decade.

In a news conference, Thomas Frieden, M.D., MPH, and director of the CDC, said that CRE is potentially a "nightmare bacteria" because the organisms that have been found to be antibiotic resistant can be quite deadly when they invade the blood stream.

Frieden stressed, however, that CRE infections are preventable with proper infection-control measures put in place, such as sanitization and thorough handwashing. He is calling on everyone in the healthcare industry to band together to stop the spread of CRE and other infections.

While CRE has yet to spread to the wider community, the bacteria's dangerous nature makes it a "triple threat", says Frieden.

There's good news for pregnant women suffering with morning sickness bad enough to need to take a prescription medication for it. A very large study from Denmark finds no evidence that using the popular anti-nausea drug Zofran during pregnancy will harm the babies.

One in 10 pregnant women will suffer nausea and vomiting that is bad enough to need medication, but many skip it out of fear of possible side effects. Currently there are no drugs approved for morning sickness in the U.S., but doctors are free to prescribe what they feel is best.

GlaxoSmithKline's Zofran and its generic equivalent has so far been doctor's top choice for treating the worst cases of morning sickness. It is primarily used for treating nausea from cancer treatment and other causes.

Women have been leery of using Zofran due to a small study that previously suggested that it could raise the risk of a particular birth defect - cleft palate.

This new study looked at more than 600,000 pregnancies in Denmark, and did not find evidence of major birth-related problems. The researchers looked at nationwide health registries to compare the rates of miscarriage, stillbirth, birth defects, preterm delivery and low birth weight babies among women who used Zofran during pregnancy and those who did not. The researchers also looked separately at use during the first trimester, which is when risks to the developing fetus are at their highest.

On Monday, the American Academy of Pediatrics issued new guidelines for identifying and treating ear infections in children.

In the guidelines, the AAP more clearly defines the signs and symptoms that indicate an infection that might need treatment. They also encourage observation with close follow-up instead of antibiotic treatment for most children, including some under age 2. For parents of children with recurrent ear infections, the guidelines also advise physicians and parents about when its time to see a specialist.

The last set of guidelines was issued in 2004.

The biggest change in the new guidelines is the definition of the diagnosis itself. The definition is more clear-cut and more precise.

Because the diagnosis is not always easy to make, the AAP provides detailed treatment suggestions, encouraging observation with close follow-up, but still leaves it up to the discretion of the doctor whether or not to prescribe antibiotics. The guidelines recommend that if children who are being observed do not improve within 48 to 72 hours from when symptoms first began, then antibiotic therapy should begin. The guidelines suggest that amoxicillin should be the antibiotic of choice unless the child is allergic to penicillin, or if the child has been treated with amoxicillin within the past month.

Previous guidelines instructed to give antibiotics for ear infections in children age 2 and under. The new guidelines say that children between 6 months and 23 months can be observed with close follow-up as well.