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It has been eleven years since the FDA approved the first Zicam product, and since then more than 130 people in the United States have developed anosmia (also called loss of the sense of smell) after using specific Zicam brand cold treatments. Back in June 2009, the FDA sent out a public health warning to consumers about the risks of injury from Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size.

On March 3, 2010, four Ohio residents told a Cincinnati judge that they lost their sense of smell after using Zicam Nasal Gel to relieve their cold symptoms, according to a Cincinnati Enquirer news report. The four made the accusation in a lawsuit filed in U.S. District Court that claims the maker of Zicam, Matrixx Initiatives Inc., based in Scottsdale Arizona, knew about the health risks but continued to promote and sell the product.

The suit claims a scientist who developed the technology for the nasal gel warned company officials the product could cause damage and told them more testing should be done before it was put on the market.

“Despite this knowledge, defendants continued to manufacture, market and sell Zicam Nasal Gel,” the lawsuit states.

But soon after they used Zicam, all four claim they experienced discomfort or a burning sensation in their nasal passages. They said doctors later told them they had lost their sense of smell, possibly permanently.

Zicam contains zinc gluconate, a chemical compound that the lawsuit said is known to cause damage to tissue inside the human nasal cavity.

In May 2009, Hydroxycut, a trendy product of dietary supplements, was recalled by the FDA after the products were found to trigger an increased risk of life-threatening liver failure, liver disease, other severe injuries, and death. A new study strengthens evidence that the once widely advertised weight-loss supplement, Hydroxycut caused serious liver damage in some users, according to a recent Reuters news report.

The warning was based on 23 reports to the agency describing liver damage in Hydroxycut users ranging from inflammation to tissue death severe enough to require a liver transplant. The supplement was also linked to one death.

Iovate, the maker of Hydroxycut said in May that it was recalling Hydroxycut because they “became aware that the U.S. Food and Drug Administration’s assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate’s analysis.”

In the new study, reported in the American Journal of Gastroenterology, researchers analyzed 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study.

Looking at factors like patients’ risk factors for liver disease and the timing of their Hydroxycut use, the researchers found that for eight of the liver-damage cases, there was a greater than 95 percent likelihood that the weight-loss aid was to blame.

In five cases, the researchers concluded that Hydroxycut was “highly likely” the cause (a 75 to 95 percent chance), while it was probably to blame in two cases (a 50 to 74 percent chance). The last two cases were considered to be possibly linked to Hydroxycut use.

“I think that consumers need to approach health supplements with caution,” he said. “I would ask them to, before buying, try to look for scientific evidence that they are effective and safe.”

The recalled Hydroxycut products contained a mix of herbs and other ingredients, like caffeine, and investigators have not yet determined which substances might be behind the liver damage.

Popular asthma drugs such Advair, Foradil, Serevent, and Symbicort, also know as long-acting beta agonists (LABAs), have been linked to life-threatening breathing complications, allergic reactions, irregular heartbeats, and death. On February 18, 2010, the FDA called for placing new limits on powerful and long-lasting bronchial drugs that millions of Americans use to treat asthma, according to a recent Los Angeles Times report.

Physicians were urged to switch asthma patients away from medicines containing both long-acting beta agonists, commonly called LABAs, and inhaled corticosteroids. Instead, the FDA said, patients should use products containing only the corticosteroids or other asthma-relieving medication whenever possible. Additionally, patients who cannot control asthma symptoms any other way should use LABAs for the shortest possible time, but the drugs should never be used alone in treating asthma in adults or children, the agency said.

Manufacturers will be required to include new warnings on the drugs’ labels, educate patients and physicians about risks associated with the use of LABAs and study whether using the long-acting compounds in tandem with other drugs makes them safer.

The goal is to manage the risk of LABAs while “keeping them available for patients who really need them,” because alternative options “are not that great,” said Dr. John Jenkins, FDA’s director of new drugs and a pulmonologist.

LABAs are also used to treat chronic obstructive pulmonary disease, commonly called COPD, and bronchial spasms associated with vigorous exercise. The FDA’s new guidance does not apply to those treatments.

The new guidance is based on clinical trial data showing that use of LABAs carries an increased risk of aggravating asthma symptoms leading to hospitalization and, in some cases, death.

LABAs relax muscles in bronchial passages, allowing more air to flow. They provide immediate relief to asthma sufferers but don’t address the underlying inflammation, creating the risk of a life-threatening condition.