Lawsuits sniff out zinc hazard in nasal cold remedy.

Eight users of Cold-eeze nasal spray, an over-the-counter cold remedy containing zinc as its active ingredient, are suing its manufacturer, claiming that it caused them to lose their sense of smell. (Angelfire v. Quigley Corp., No. 0407364 (Pa., Bucks County Ct. Com. P1. filed Nov. 4, 2004).)

The lawsuit is one of 10 filed against Quigley Corp. alleging harm from its nasal spray. Hundreds of other people have filed similar lawsuits against Matrixx Initiatives, the maker of Zicam nasal gel, another zinc-containing intranasal cold remedy and Cold-eeze's major competitor.

The Pennsylvania Cold-eeze complaint, like at least one Zicam lawsuit, makes claims for fraud, negligence, strict products liability, breach of warranty, and breach of the state's consumer protection statute. The plaintiffs allege that after using the product as instructed on the package, they suffered from substantial or total loss of smell, a condition called anosmia. They claim the condition--which they believe is permanent--affects not only their sense of taste, but also their safety, because they cannot smell smoke, gas, or other fumes.

According to the complaint, zinc's toxicity in nasal passages has been studied since 1937, when 5,000 Toronto children were given an intranasal zinc=containing compound that doctors believed would protect them from polio. The compound failed to prevent the disease, and mare' children who received it suffered anosmia. Subsequent animal studies showed a similar effect.

More recently, researchers at the University of Colorado studied patients who used intranasal zinc-containing compounds and developed anosmia. The 2004 study determined that "the mechanism of olfactory loss is thought to be the direct action of the divalent zinc ion on the olfactory receptor cell."

The cold remedies" manufacturers dispute the alleged connection. In a press release distributed a day after the Pennsylvania lawsuit was filed, Quigley cited a double-blind, placebo-controlled study it conducted before marketing Cold-eeze. The 80 people who used the spray for three days "did not demonstrate a diminished sense of smell," the company said. Zicam's maker noted in an October filing with the Securities and Exchange Commission that a 2004 epidemiologic study of 3.7 million users of the intranasal gel showed "statistically significant associations between anosmia and numerous medical conditions and multiple classes of drugs."

Citing poor sales, Quigley removed Cold-eeze from the market in September about a year after it was first available to consumers. Zicam is still sold.

The FDA is investigating both products in response to consumer complaints. A spokeswoman would not give derails about the investigation or say how many complaints had been filed.

Barry Reed, an attorney in Scottsdale, Arizona, and of counsel for the plaintiffs in the Cold-eeze lawsuit, said his firm is handling nearly 300 cases related to intranasal cold remedies that contain zinc. He said a class action max be hard to certify because manufacturers are likely to argue that anosmia is caused by a variety of factors.