Zicam Not Alone in Side Effect Reports

"He might not get hurt most of the time, but his pocketbook is getting hurt all of the time," he says. He says "it doesn't make sense" that the FDA requires homeopathic medicine to bear a label saying what it treats because, in his view, most of it treats nothing.

"Very often, the only active ingredient is alcohol, and patients don't know that, and they get a buzz-on. The therapeutic effect is no greater or less than a martini," says Dr. Jerry Avorn, an expert in pharmaceutical safety at Harvard Medical School.

Richardson says he thought he was taking a government-approved drug when he took a whiff of homeopathic cold gel. He says he felt a burning sensation and hasn't smelled much since. A doctor who tested his sense of smell tentatively linked his condition to Zicam, Richardson's medical records show.

Some independent research also has blamed the active ingredient in Zicam, zinc gluconate, for such problems.

Even before the FDA action, the Federal Trade Commission was investigating whether Zicam was deceptively marketed, and the industry group Council of Better Business Bureaus had recommended that some Zicam advertising claims be toned down.

Zicam seller Matrixx Initiatives, of Scottsdale, Ariz., which grew out of a chewing gum company, paid $12 million in 2006 to settle lawsuits with about 340 Zicam patients. It has won a lawsuit in California, and several other federal cases were dismissed.

But complaints by dozens of patients remain before the courts. The Motley Rice law firm in Mount Pleasant, S.C., represents more than 300 with Zicam claims, says lead lawyer Lynn Seithel. She says the FDA warning this week "validates what our clients have been saying."

The company, which has sold more than 1 billion doses since the products came to market in 1999, says it settled in the past simply to reduce its legal exposure. The remedy has recently been sold with a redesigned spray nozzle, and the company argues that it is safe, citing academic studies that it funded. Matrixx says some people failed to follow package directions and stuck the nozzle too far up their noses.

Faced with the FDA warning, the company's acting president, William J. Hemelt, blamed much of the smelling problems on the colds that patients were treating. However, the company agreed to suspend shipments and reimburse customers who want refunds.

Questions can be raised about the touted safety record of other homeopathic remedies, too.