Hard to swallow: FDA says some Bayer products are unapproved.

RODALE NEWSROOM, EMMAUS, PA—The U.S. Food and Drug Administration sent two warning letters to drug manufacturer Bayer on Tuesday, warning the company that it is illegally marketing two aspirin products containing dietary supplements that have not been approved for sale.

THE DETAILS: Basic over-the-counter painkillers like aspirin don’t need FDA approval before going on store shelves. But the Bayer products violated laws because the company paired the aspirin with dietary supplements, which requires FDA approval. Bayer Aspirin with Heart Advantage prominently labels phytosterols, plant compounds, as an ingredient. Bayer Women’s Low Dose Aspirin Plus Calcium contains aspirin plus a dietary supplement (calcium) within a single pill. The products’ labels both claim that the pills can reduce the risk of heart disease, and the calcium-enriched aspirin claims to “fight” osteoporosis. Those are unsubstantiated claims that have not been approved by the FDA.

WHAT IT MEANS: There aren’t any cases showing these products are making people sick, but they haven’t been proven safe, either, and they may not do what they claim. Also, FDA officials worry that people who haven’t been diagnosed with heart disease or osteoporosis by a doctor will self-diagnose and start taking the drugs. “The marketing of these unapproved drugs is troubling,” says Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding.”

There are better, cheaper ways to get calcium and reduce the risk of heart disease without taking over-the-counter painkiller pills-supplement combos. You can get an ample dose of calcium and keep your ticker healthy just by eating and drinking the right things.

Here are some heart-healthy, calcium-rich combos that work:

• Oatmeal with a glass of low-fat, vitamin D–fortified milk (Vitamin D helps your body absorb calcium.)
• Low-fat yogurt with fresh strawberries
• Salmon and white bean salad
• Brussels sprouts with marjoram, carrots, and spinach

Visit the Rodale Recipe Finder for more calcium-rich recipes. And while some doctors do recommend aspirin on a daily basis, it’s not for everyone. Talk to your physician to see if a daily aspirin dose makes sense for you.