FDA cracks down on unproven prescription cold medicines

Federal health officials Wednesday announced a crackdown on the sale of prescription cold, cough and allergy products that had never been proven to be safe and effective.

About 500 products that had never been formally evaluated by federal regulators will be removed from the market, the Food and Drug Administration said. The move is the latest in a series of actions by the agency to stop the sale of products that were being sold without government authorization.

Although the agency had received some reports of complications from the products, such as irritability and over-sedation, officials said they did not know how widely the products might cause problems or even how commonly the products are used. Many of the products -- such as Lodrane, Cardec, Organidin and Pediahist -- are not household names.

"Like a lot of things that are related to unapproved products, the problem is what we do not know," said Deborah Autor, an FDA director. "We do not know if they are safe. We do not know if they are effective. ... We do not even necessarily know who they are."

Because many of the products went on the market years ago, before stringent requirements were put into place, many doctors prescribing them might be unaware that they had not been carefully evaluated, she said.

Among the concerns are that some of the products, which contain 27 different ingredients, are labeled for use by infants and young children, Autor said. In 2008, the agency issued an advisory warning against the use of over-the-counter cough and cold products for children younger than 2 because of serious, potentially life-threatening side effects.

Officials are also concerned because some of the products are supposed to be time-released to prevent delivering too high or too low a dose. Some products that are supposed to release sedating antihistamines, for example, over eight to 12 hours delivered their full dose within 30 minutes, Autor said.

A 50-year-old with Type 2 diabetes will lose an average six years of life as a result of the disease, only one year less than that lost by a smoker of the same age, researchers reported Wednesday.

He or she is more than twice as likely to die of cardiovascular disease as someone without diabetes and 25 percent more likely to die of cancer, said the international study of more than 820,000 people published in the New England Journal of Medicine.

People with Type 2 diabetes are also more likely to die from kidney disease, liver disease, pneumonia, infectious diseases and even intentional self-harm, said the study conducted by the Emerging Risk Factors Collaboration, based at the University of Cambridge in England.

The data are especially concerning in light of the rapidly expanding incidence of diabetes in the United States, fueled by the growing spread of obesity. An estimated 25.8 million Americans now have diabetes, 10 million more than only two decades ago.

Researchers knew that diabetes could shorten lifespan, "but this really says how many years of life may be lost and to what causes," said Dr. David Kendall, chief scientific and medical officer of the American Diabetes Association, who was not involved.

Parkinson's disease may be less likely to develop in people who take ibuprofen, a nonprescription painkiller, according to Harvard University research.

In one study, men and women who used three or more tablets of ibuprofen each week were about 38 percent less likely to develop Parkinson's, a brain disorder that can cause trembling and stiffness, than patients who didn't take the drug, researchers said in the journal Neurology. The medicine was associated with 27 percent less risk of getting the disease when earlier studies were also accounted for, the scientists said. As many as 1 million Americans have Parkinson's, said the Parkinson's Disease Foundation, based in New York.

Lead author Xiang Gao is a scientist at Harvard School of Public Health and at the Channing Laboratory, a unit of Brigham & Women's Hospital and Harvard Medical School. Gao said more studies are needed before doctors should recommend taking ibuprofen to ward off the illness.

The study is one of the largest to examine possible benefits of ibuprofen on Parkinson's, according to the St. Paul-based American Academy of Neurology, publisher of the journal. The scientists analyzed data from almost 99,000 women enrolled in the Nurses' Health Study and more than 37,000 men in the Health Professionals Follow-Up Study.