FDA approves continued use of generic antidepressant drug – despite patient complaints! – Issue 56

Dear Health-Conscious Friend,

It is vital for you to take an active role in defending your health. There are many well-intentioned members of the medical establishment who may prescribe drugs to address a specific condition. But some drugs don’t always produce the intended results…

In this week’s Monday Edition of Health News Weekly™, you’ll learn about one prescription drug that had the opposite effect on the condition it’s supposed to treat!

And you’ll discover many more simple—but EFFECTIVE—ways to protect yourself from disease. So let’s not waste another minute…

FDA Gives Antidepressants a “Thumbs Up”—
Despite Patient Complaints

Layne Lowery

Complaints of side effects and worsening depression weren’t enough to sway the Food and Drug Administration (FDA) against a generic antidepressant drug. The agency recently approved the generic drug as a safe and effective alternative to GlaxoSmithKline Plc’s (GSK) Wellbutrin XL ® antidepressant.

The FDA said it received 85 reports from patients who switched from Wellbutrin XL® to a cheaper generic version made by Teva Pharmaceutical Industries Ltd. and Impax Laboratories Inc.

A total of 78 patients said they slipped back into depression. Other patients reported new or worsening side effects—including headaches… fatigue… anxiety… and problems with digestion.

According to an FDA statement on its website, “the question is whether the reported lack of efficacy and/or new onset side effects in these patients who switched suggest a problem with the generic product… or have some other explanation.” They said natural recurrence of depression can happen despite treatment.

FDA scientists reviewed 300-milligram versions of the two drugs, which both contain once-a-day forms of the chemical bupropion. They concluded the data did not show that the problems stemmed from any differences between the two drugs.

Half of the patients who went back on the brand name drug said their symptoms improved. The FDA plans to continue monitoring the issue.

Teva and Impax’s version of Wellbutrin® was approved in 2006. FDA officials began receiving reports of side effects during the first half of 2007.

Watson Pharmaceuticals Inc. also makes a 300-mg XL version of bupropion, though it was not part of the FDA’s review.

GSK said sales of Wellbutrin® slipped 37 percent in 2007 in the face of generic competition.

Amazing Fruit Remedy May Reduce Risks
for Heart Disease, Diabetes

Tiffany Lowery

Tart cherries may be a secret weapon in fighting inflammation, weight gain and high cholesterol levels. A study team at the University of Michigan Cardiovascular Center reached this conclusion after analyzing findings of new animal research.

The research team found that rats fed whole tart cherry powder mixed into a high-fat diet didn’t gain as much weight—or build up as much body fat—as rats that didn’t receive cherries. Plus, their blood showed lower levels of molecules indicating the kind of inflammation linked to heart disease and diabetes.

The rats that ate cherry powder had significantly lower cholesterol and triglycerides as compared to other rats. In addition, the obese rats that received cherry powder were less likely to build up fat in their bellies—another risk factor for cardiovascular disease.

The study findings were reported at the recent Experimental Biology 2008 meeting in San Diego, CA by a team from the University of Michigan Cardioprotection Research Laboratory—a department of the Cardiovascular Center.

“These new findings are very encouraging, especially in light of what is becoming known about the interplay between inflammation, blood lipids, obesity and body composition in cardiovascular disease and diabetes,” said Steven Bolling, M.D., the Gayle Halperin Kahn Professor of Integrative Medicine at the University of Michigan and the Cardioprotection Research Laboratory director.

“The fact that these factors decreased despite the rats’ predisposition to obesity, and despite their high-fat ‘American-style’ diet, is especially interesting,” Bolling said.

According to the researchers, the link between cherry intake and significant changes in cardiovascular risk factors suggests—but does not directly demonstrate—a positive effect from the antioxidants called anthocyanins. These compounds give the tart cherries their color.

The cherries were Montmorency tart cherries grown in Michigan, which is the nation’s largest producer of tart cherries. They are different from sweet Bing cherries, as tart cherries have higher concentrations of anthocyanins.

“The potential for protective effects from antioxidant-rich foods and food extracts is a promising area of research, Bolling said.

The researchers said it is too early to determine whether tart cherries will have the same effect in humans. But the researchers are preparing to launch a pilot-phase clinical trial later this spring.

The experiments were funded by an unrestricted grant from the Cherry Marketing Institute (CMI), a trade association for the cherry industry. CMI has no influence on the design, conduct or analysis of any U-M research it funds.

Fast Fact

You may be surprised to know that broccoli has more protein than steak. Unlike the high oil content of an avocado or the high carbohydrate content of a potato, broccoli and many other leafy green and solid green vegetables have more protein per calorie than most foods—even meat!

Health E-Hints

Be on a “Lead Alert”!

Low levels of lead are as dangerous to adults as they are to children. Long-term exposure can cause a number of health problems, including:

  • Anemia and other blood disorders
  • High blood pressure
  • Damage to your nervous system and brain
  • Kidney disease
  • Impotence and sterility
  • Abnormal menstrual cycles and miscarriages

Unfortunately, there are a number of environmental sources of lead. This includes food cans… water pipes… and paint dust.

To protect yourself from lead poisoning, have your water tested to ensure that lead levels are safe. You can also use oral chelation supplements to help purge dangerous heavy metals from your body.