Safety Alerts – Pradaxa dabigatran – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

Safety Alerts for Human Medical Products > Pradaxa dabigatran: Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin.

ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.


Safety Alerts – Eszopiclone Containing Sleep Aids Can Cause Next-Day Impairment

Safety Alerts for Human Medical Products > Eszopiclone Containing Sleep Aids: Drug Safety Communication – Can Cause Next-Day Impairment.

A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired.  The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. 

Organic Cat Litter Chief Suspect In Nuclear Waste Accident – NPR

Organic Cat Litter Chief Suspect In Nuclear Waste Accident : The Two-Way : NPR.

“It was the wrong kitty litter,” says James Conca, a geochemist in Richland, Wash., who has spent decades in the nuclear waste business.

It turns out there’s more to cat litter than you think. It can soak up urine, but it’s just as good at absorbing radioactive material.

Diabetes and the Heart: Risk Greater in Women

Diabetes and the Heart: Risk Greater in Women.

Data from 64 studies with both male and female participants yielded a 44% greater multiple-adjusted relative risk ratio (RRR) for incident coronary heart disease (CHD) in women compared with men (RRR 1.44, 95% CI 1.27-1.63), Rachel Huxley, DPhil, of the University of Queensland in Sydney, Australia, and colleagues found.

Pooled data from 52 studies indicated that women also had a 44% greater chance than men of dying from fatal CHD associated with diabetes, Huxley and colleagues reported online in the journal Diabetologia.

Johns Hopkins Health Alert – The Compelling Case Against Sugar

Re-posted from the Johns Hopkins Health Alert email The Compelling Case Against Sugar

For years, nutrition experts have warned that consuming too much sugar contributes to excess weight gain. Now, a mounting body of scientific evidence suggests that sugar is even more detrimental to the body than was previously believed. As a result, a growing chorus of scientists and public health advocates is urging the U.S. Food and Drug Administration to set safe limits for sugar consumption.

Recently, researchers at the University of California, San Francisco, took matters even further, suggesting that sugar should be regulated by the government to protect public health — just like alcohol and tobacco. Sugar, they argue, is a toxic substance with a tremendous potential for abuse because it affects the brain in a way that encourages people to consume larger amounts, even when they should be satisfied with what they’ve already had.

What’s more, they contend, sugar changes a person’s metabolism, altering the signaling of hormones (including leptin, ghrelin, and dopamine, which regulate satiety, hunger, and pleasure, respectively) in a detrimental way. In other words, the researchers say, sugar is addictive.

That point of view is quite controversial, however, so it’s not likely that sugar is going to be banned or regulated by the government — at least not anytime soon. Nevertheless, the latest research makes a compelling case for determining just how much sugar is safe for human consumption — and for cutting back on the amount of sugar you consume.

The dangers of added sugar. First, it’s important to distinguish natural sugars from added sugars. Natural sugars are an essential part of our diet because the human body converts them to glucose to meet its energy needs. Natural sugars are found in varying amounts in fruits and vegetables, which contain fructose, and in dairy products, which contain lactose.

Added sugars, on the other hand, are not essential. Added sugars are sugars and syrups that are added to foods or beverages when they are processed or prepared, as well as the sugar you add to your coffee, tea, cereal or other foods. Whether it’s added in the form of white sugar, raw sugar, brown sugar, high fructose corn syrup, honey or molasses, it’s all sugar.

Added sugar has been implicated in a variety of ills, from raising blood pressure and increasing the risk of gout to causing liver damage and accelerating the aging process. Some of the strongest evidence to date shows associations between excess sugar consumption and diabetes, heart disease and obesity.

How much added sugar is too much? Surprisingly, the answer to this question varies. Currently, the USDA recommends that people consume no more than 10 teaspoons of added sugar in a 2,000-calorie per day diet. At 16 calories per teaspoon, that’s 160 calories each day. These days people typically consume twice that amount.