A study by Johns Hopkins researchers shows that a fifth of US neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications

The findings suggest that the US Food and Drug Administration (FDA) needs a better way to communicate information to specialists about newly discovered safety risks, the researchers say, since the warnings are in many cases not getting through to doctors making important prescribing decisions.

The researchers add that while their new study, reported in the journal Epilepsy and Behavior, was focused on neurologists and anti-epilepsy drugs, they believe their findings are applicable to a wide spectrum of medical specialists and medications.

“There is poor communication from the FDA to specialists, and there’s some risk to patients because of this,” says study leader Dr Gregory L Krauss, a professor of neurology at the Johns Hopkins University School of Medicine. “Unless it’s a major change requiring the FDA to issue a black box warning on a product, important information appears to be slipping through the cracks. We need a more systematic and comprehensive method so that doctors receive updated safety warnings in a format that guarantees they will see and digest what they need to protect patients.”

Dr Krauss and his colleagues surveyed 505 neurologists from across the nation in different types of medical practices between March and July of 2012. They asked about several new safety risks for antiseizure drugs recently identified by the FDA: increased suicidal thoughts or behavior with newer agents; high risks for birth defects and cognitive impairment in offspring of mothers taking divalproex (sold by the brand name Depakote); and risks for serious hypersensitivity reactions in some patients of Asian descent starting treatment with carbamazepine (Tegretol). One in five of the neurologists surveyed said they knew of none of the risks. Those neurologists who treat two hundred epilepsy patients a year or more were most likely to know all of the risks.

Dr Krauss says he was most struck by the lack of understanding of the risk to certain Asian patients who take carbamazepine to control their seizures. The FDA in 2007 recommended that before initiating the drug in patients of Asian heritage, neurologists should screen to see if those patients have a specific haplotype, a specific section of DNA found in a few per cent of Asian people, before prescribing the drug.

The researchers found that 70 per cent of the neurologists who responded knew of the recommendation. While 147 neurologists (29.1 per cent) reported initiating carbamazepine treatment in Asian patients, only 33 of them (22.5 per cent) said they performed haplotype screening. Eighteen neurologists reported that their Asian patients developed carbamazepine-related hypersensitivity reactions — severe skin rashes that can lead to scarring, blisters in the mouth and shredding of the skin — during this time period.

“If their doctors were more educated about the risks,” Dr Krauss says, “these patients may have avoided these severe hypersensitivity reactions.”

Dr Krauss says doctors may not do the screening because it is difficult to find laboratories able to perform the haplotyping, and he notes that it may make more sense to prescribe an alternate drug to Asian patients.

The researchers found that 80 per cent of respondents knew that the FDA had newly warned that the risk of suicide with newer drugs is 4.3 per 1,000, double what had previously been believed. Seventy per cent said they counselled patients about the risk.

As for pregnancy risks related to divalproex, fewer than half of the respondents knew that a warning had been issued noting high risks of birth defects and of developmental risks in offspring (an 8 to 9 point drop in IQ). While 93 per cent of respondents reported counselling women planning pregnancies about the birth defect risks of divalproex, Dr Krauss says safer drugs should be used if possible during pregnancy.

Dr Krauss says part of the problem is the absence of a single place for neurologists to find updated risk information. Neurologists get safety information from scattered sources; only a few get emails from the FDA, while others get the information from neurology societies, from continuing medical education (CME) courses or from newly published journal articles.

“The FDA needs to do better getting the warnings to prescribing doctors,” he says. “There has to be a direct way to communicate risks without overwhelming physicians with messages.”

Source: http://www.indiamedicaltimes.com/2013/08/31/many-neurologists-unaware-of-safety-risks-related-to-anti-epilepsy-drugs/

More than 530,000 children under the age of 15 have their tonsils removed each year. About 80 percent have obstructive sleep problems – snoring, irregular breathing – and the rest are because of infection, according to The American Academy of Otolaryngology-Head and Neck Surgery.

If your child needs his or her tonsils removed, you might be worried about the procedure, the pain, and the recovery. Here, learn about the new way tonsillectomies are done, if it’s right for your child, and the important questions you need to be asking.

The new way tonsillectomies are done

There are several ways doctors remove tonsils, with one of the most common being the electrocautery method. Using a handheld metal probe heated by an electric current, the tonsil tissue is destroyed and bleeding is well controlled. Yet, because heat is used, the soft tissue of the throat is burned, which causes more pain and a longer recovery.

However, within the last 10 years, doctors have been using a less painful method known as PITA—Partial Intracapsular Tonsillectomy and Adenoidectomy. Using a microdebrider, the surgeon “shaves” the tonsils with a rotating blade and uses suction to stop the bleeding.

“The surgeon is removing the tonsils from what we call inside out – from the center of the throat to the side wall,” said Dr. Julie L. Wei, a pediatric otolaryngologist who practices at Nemours Children’s Hospital in Orlando, Fla.

So instead of removing all of the tonsils, about 90 percent are removed, leaving the capsule or outermost layer behind.

“There are lots of benefits to doing a partial,” said Dr. Didier L. Peron, an attending physician at Morristown Medical Center who is board-certified in otolaryngology-head and neck surgery.

For starters, the nerve endings are not exposed and there’s no damage to the arches of the throat. As a result, children experience less pain, a shorter recovery, and the chance of bleeding is reduced.

According to a study in the journal Otolaryngology-Head and Neck Surgery, kids who had tonsillectomies using the microdebrider method stopped taking pain medicine and returned to their normal activities sooner than those who had the electrocautery method.

Another study also found that kids were at less risk for bleeding and dehydration after surgery. Pain can cause children to refuse to eat or drink, and many are re-admitted to the hospital with severe dehydration, according to Peron.

Can tonsils grow back?

Not all children are good candidates for a partial tonsillectomy, particularly for those who have repeated infections like strep throat. If the tissue is left behind, “there’s a concern they can still get strep more, even though they’ve had their tonsils out,” Wei said.

And with any kind of surgery, there are risks, which include removing normal tissue like the uvula.

But perhaps one of the most significant drawbacks is regrowth. “There’s no doubt that occasionally the tonsils keep growing,” said Peron, who explained that the chances are more likely in young kids. He estimated a 10 percent chance that tonsils will grow back for 2- and 3-year-olds.

There’s one caveat to the question of re-growth, however. Often times, a pediatrician will look in a child’s mouth and see the tonsils but not the scar they’re used to seeing with the electrocautery method. They tell the family the tonsils are there, but “they never realized it was 10 times as big three years ago,” according to Wei. The family is lead to believe the tonsils grew back when actually, “it has to do with how it looks. Maybe there’s not that much regrowth at all,” she said.

The best thing to do is to return to the doctor who did the surgery for a proper evaluation. And even if they did grow back, if it’s not causing the child any problems, leave it alone.

Source: http://www.foxnews.com/health/2013/09/01/what-every-mom-needs-to-know-about-tonsil-surgery/

 

Statins are among the most commonly prescribed medications for cataracts, which is the leading cause of visual impairment worldwide affecting more than 20 million people, according to research.

In the USA they are prescribed to 1 in 3 people over 45 years of age at a cost of 35 billion dollars annually.

“There is persistent concern among physicians and other health care providers about the possible cataractogenicity of statins.1 We therefore investigated the relationship of statins and cataracts in a meta-analysis of 14 studies selected after detailed review of the medical literature. To our knowledge this is the first meta-analysis on the topic,” Professor Kostis said.

The meta-analysis included 2,399,200 persons and 25,618 cataracts. The average duration of treatment was 54 months and average age was 61.

Using random effects meta-analysis, a statistically significant decrease in cataracts with statins was observed.

“This corresponds to an approximately 20 percent lower rate of cataracts with statin use compared to no statin use,” professor Kostis said.

Meta-regression showed that younger people were more likely to benefit.