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FDA advises diet drug makers to assess heart risks

Pharmaceutical companies who develop weight loss drugs need to study their medications to determine heart risks before seeking approval from health regulators, the Food and Drug Administration (FDA) said in a report released this week. Three drug companies are vying to get approval for what would be the first diet pills to hit the market in 13 years. Vivus’s drug Qnexa will be reviewed by an FDA panel in April, and Arena’s medication lorcasserin will be reviewed in May. Drug company Orexigen agreed in September to conduct safety studies on its diet pill, Contrave. Contrave hit a snag with FDA ... Read More

Trials on experimental type 2 diabetes drug dropped after dismal results

Pharmaceutical company Targacept, Inc. is giving up on its experimental type 2 diabetes drug known as TC-6987, after it showed less than desirable results in phase II clinical trials. The drug was designed to measure changes in fasting glucose, a metabolic measurement used to identify problems with insulin function. Despite its disappointing performance as a diabetes treatment, the same drug did show promise in phase II clinical trials in treating persistent mild to moderate asthma in patients with inhaled corticosteroids. Diabetes is a chronic disease characterized by high blood sugar. An estimated 198 million people worldwide have type 2 diabetes, ... Read More

Adrenaline for cardiac arrest linked to brain damage, death in long term

Giving patients a shot of adrenaline to jolt their hearts back to beating after cardiac arrest can help save lives, but it could cause damage to the brain in the long term, according to a new study published in the Journal of the American Medical Association (JAMA). Patients experience cardiac arrest when their hearts stop pumping blood. They require immediate cardiopulmonary resuscitation (CPR) or they will most likely die. For patients who experience cardiac arrest outside a hospital setting, adrenaline, also known as epinephrine, is often administered. The new study was conducted by researchers with the Department of Health Services ... Read More

New algorithm detects adverse reactions caused by drug combinations

A new algorithm developed by researchers to search through the U.S. Food and Drug Administration’s (FDA) enormous and complex record of drug interaction data reveals what can happen when patients take prescription drugs in combination. The FDA’s Adverse Event Reporting System (AERS) data, an ever-growing database of hundreds of thousands of drug reactions reported directly to the agency from health care professionals and consumers, provides valuable information about prescription drugs and their possible side effects. The new algorithm, however, unlocks more of the database’s potential by finding previously unknown relationships between different drugs and their consequences for patients. Russ Altman, ... Read More

Public overwhelmingly supports stronger medical device oversight

A Consumer Reports poll shows the public overwhelmingly supports more government oversight of medical devices. The poll was released just as House and Senate Committees released draft legislation to change the way medical devices are approved by the Food and Drug Administration (FDA). Currently, the vast majority of medical devices are approved by the FDA through an accelerated program that allows devices to be approved with clinical trials to evaluate safety and efficacy if there are similar devices already on the market. This process was established several years ago to help move a backlog of devices through the system and ... Read More

Health Canada issues stronger warnings for blood thinner Pradaxa

Health regulators in Canada have issued a warning on the new blood thinner Pradaxa, sold in Canada as Pradax. The new safety label will warn that the risk of internal bleeding events may be increased among patients with kidney problems, Health Canada announced earlier this month. Pradax labels now recommend that all patients should have their renal function assessed before starting the drug, and that doctors should assess any changes in renal function for patients while on the medication, especially for patients who are 75 years of age and older. Health Canada also Pradax was not recommended for patients with ... Read More

Some fruits may help protect against diabetes

A diet rich in certain fruits may help ward off type 2 diabetes, according to a new study published in the American Journal of Clinical Nutrition. The study involved more than 200,000 people and was originally created to see if a diet high in plant secondary metabolites known as flavonoids had any effect on the incidence of diabetes. The study focused on flavonoids subclasses such as flavonols, flavones, flavanones, flavan-3-ols, and anthocyanins, which includes fruits such as blueberries, apples and pears. For the study, participants filled out questionnaires about their eating habits. While no significant findings about flavonoids were confirmed, ... Read More

Researchers wonder why bariatric surgery works better than drugs

A new study presented at the annual meeting of the American College of Cardiology shows that bariatric surgery for obese patients can quickly lower blood sugar levels and reduce or eliminate patients’ need for insulin or diabetes medications. Now researchers are trying find out exactly why the stomach-reducing surgery works far better than drugs. Two separate reports published in the New England Journal of Medicine concluded that bariatric surgery surpasses medical therapy as a treatment for type 2 diabetes, “and are fascinating not only because of the immediate clinical implications … but also because there’s some really cool underlying science ... Read More

Weight loss surgery can reduce, eliminate need for diabetes drugs

Obese people who undergo bariatric surgery to lose weight can reverse the signs of diabetes by quickly lowering blood sugar levels, and as a result reduce or eliminate their need for insulin or other medications, according to a new study presented at the annual meeting of the American College of Cardiology. The study involved 150 people with type 2 diabetes who agreed to have bariatric surgery to lose weight. Researchers found that 42 percent had blood sugar levels that returned to normal after surgery. Some improved so quickly that they went off their diabetes medications before leaving the hospital. Keeping ... Read More

Did Takeda try to cover up serious side effects of diabetes drug Actos?

Takeda Pharmaceutical Co. failed to classify “non-hospitalized or non-fatal” congestive heart failure cases associated with its type 2 diabetes drug Actos as “serious” and purposefully did not alert the Food and Drug Administration (FDA) about these cases as all drug makers are required to do, a former Takeda medical reviewer claimed in a lawsuit recently unsealed. Helen Ge’s lawsuit claims Takeda covered up reports of the adverse events it received because it didn’t want news of serious health concerns to hurt the drug’s growing profits. She also alleges that Takeda tried to show that Actos was safer than GlaxoSmithKline’s type ... Read More