Obesity drug withdrawn following trial showing heart attack, stroke risk
SILVER SPRING, Md. Clinical trial data indicating an increased risk of heart attack and stroke has led to the removal from the market of an obesity drug made by Abbott, the Food and Drug Administration said Friday.
The FDA said the drug maker voluntarily withdrew the drug Meridia (sibutramine) following a required post-marketing trial showing that the drug increased by 16% the risk of nonfatal heart attacks and strokes, the need for resuscitation after the heart stopped and death.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achive on this drug to their risk of heart attack or stroke,” FDA office of new drugs director John Jenkins said. “Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight-loss maintenance programs.”
The FDA approved Meridia in 1997 for weight loss and maintenance of weight loss in obese people and some overweight people with other risks for heart disease, based on clinical trial data showing that people taking the drug lost at least 5% of their body weight compared with those taking placebo who relied on diet and exercise alone.
Joy and Eve Behar join heart disease awareness campaign
NEW YORK Bayer Consumer Care and WomenHeart: The National Coalition for Women with Heart Disease on Wednesday partnered with Joy Behar, co-host of the morning program “The View,” and her daughter Eve Behar around an awareness campaign to alert women that being prepared for a possible heart attack can help save their lives.
Preparedness includes recognizing the sometimes-subtle warning signs and keeping aspirin on hand to help reduce damage to the heart. To that end, the Behars, the Bayer aspirin brand and WomenHeart will be offering a special-edition pill tote with a convenient key ring that makes it easy to always have aspirin on hand.
“I’ve experienced firsthand the devastating impact that heart disease can have on a family when left unchecked, and I’ve learned that, when a heart attack strikes, your first line of defense is having an aspirin on hand to help reduce damage to the heart,” Joy Behar said. “This is especially important for women, who are less likely than men to survive [a heart attack] and are more likely to have a second attack. Being prepared can offer women and their families that second chance to embrace a heart-healthy lifestyle.”
Individuals can obtain a pill tote by visiting IAmProHeart.com and making a $5 donation to WomenHeart. For each donation, Bayer will make a matching donation of $5 to WomenHeart, up to a maximum of $100,000. These donations will help fund educational programming and outreach that enable women with heart disease to share their experiences, lessons learned and personal stories of courage and survival with other women who have or are at risk for developing heart disease.
“It’s so important for women to know their risk for heart disease, and to talk to their doctor about ways to be better prepared and better their odds of surviving should a heart attack strike without warning,” stated Karol Watson, chair of the WomenHeart scientific advisory council and co-director of the program in preventative cardiology at UCLA.
Hyperglycemia could cause Type 2 diabetes in acutely ill patients, study finds
NEW YORK Heightened blood sugar during critical illnesses could be a sign of risk for Type 2 diabetes, according to a recent study by researchers in Croatia.
The study, conducted by researchers at University Hospital Centre Rebro and published in the journal Critical Care, followed 591 patients for five years after their discharge, dividing them into a group of 398 who had normal blood sugar levels during their hospital stays, and a group of 193 who developed hyperglycemia during their stays. Of the patients with normal blood sugar, 14 developed Type 2 diabetes, while among those who had hyperglycemia, 33 developed the disease.
“Despite the fact that endocrine and metabolic changes probably occur in all acutely ill patients, evident hyperglycemia is not always present,” lead researcher Ivan Gornik said. “We hypothesized that hospital-acquired hyperglycemia can therefore reveal a patient’s predisposition to impaired glucose control, which could in [the] future lead to diabetes.”