SATURDAY, Sept. 29 (HealthDay News) -- U.S. health experts on Friday urged the federal Food and Drug Administration to consider banning the sale of over-the-counter cough and cold medicines for young children.

The recommendation, from FDA safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents released Friday, the Associated Press reported.

The products include approximately 800 popular medicines that are sold in the United States under names like Toddler's Dimetapp, Triaminic Infant and Little Colds, The New York Times reported.

FDA advisers will consider the recommendation during a meeting on Oct. 18 and 19, and will then offer their opinion to the full agency.

In the safety review released Friday, the FDA experts recommended that all infant cough and cold products be removed from the market. They also recommended that the sizes of the droppers, cups and syringes packaged with products be standardized to reduce the possibility of confusion and overdose, the Times said.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine, the AP said.

Most of the deaths were children younger than 2.

The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, backs the recommendation that the cold and cough treatments not be used in children younger than 2. As for antihistamines, the group recommends adding a warning that the drugs not be used to sedate young children, the AP said.

Also Friday, FDA officials announced a crackdown on drug companies that make unapproved prescription drugs containing the narcotic hydrocodone, which is used as a cough suppressant and pain killer.

Hydrocodone is one of the strongest drugs used to treat pain or to suppress cough. It's also widely abused and, if improperly used, can lead to illness and death. Overdoses of hydrocodone can cause breathing problems or cardiac arrest and can impair motor skills and judgment, U.S. Food and Drug Administration officials said.

"The FDA is announcing an action to stop the illegal marketing of any unapproved drug product containing hydrocodone," Deborah M. Autor, director of the agency's Office of Compliance, Center for Drug Evaluation and Research, said during a Friday teleconference.

Some pain-relief products containing hydrocodone, such as Vicodin, are FDA-approved. But, most of the drugs with hydrocodone now marketed to suppress coughs have not been approved, officials said.

Autor said the unapproved products are made by some 100 manufacturers.

The FDA said it was particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants -- also known as antitussives. None of the drugs that contain hydrocodone has been approved for children younger than 2 years old. "There are hydrocodone-containing products on the market that claim they are suitable for children as young as 2," Autor said.

Also, many of the products don't carry the proper warning label and often have similar names to other medications, creating a high risk of medication error, Autor said. "Product names are so similar that the wrong doses or wrong medication may be dispensed," she said.

Hydrocodone is a narcotic regulated by the U.S. Drug Enforcement Administration, Autor said.

Friday's announcement comes one day after President George W. Bush signed a five-year renewal of a law that helps fund the FDA's ability to oversee prescription drug safety.

The new law allows the FDA to collect higher fees from drug and medical device makers, which helps defray the agency's costs of reviewing products submitted for approval. The law also gives the agency more powers to take action when there are problems with drugs already on the market. For example, the FDA can order drug companies to do further studies on the safety of medicine and to put new label warnings on products. The agency now has the authority to fine companies that fail to comply with such orders.

Under the new Food and Drug Administration Amendments Act of 2007, drug and medical device companies must also publicly release results of all clinical trials that show how well approved drugs performed, according to published reports.

But the FDA's ability to oversee clinical trials was called into question Friday with the release of a highly critical report by the inspector general of the U.S. Department of Health and Human Services.

In the report, Daniel R. Levinson said he found that FDA officials didn't know how many clinical trials were being conducted and audited fewer than 1 percent of clinical testing sites. In the few instances where FDA inspectors did check a site, they generally showed up long after the tests had been completed, Levinson noted, The New York Times reported.

The FDA has 200 inspectors to monitor about 350,000 testing sites. Even when inspectors identified serious problems in human clinical trials, top FDA officials downgraded the inspectors' findings 68 percent of the time, Levinson found. In the rest of the cases, it was rare for the FDA to follow up with inspections to assess whether corrective actions ordered by the agency had been done, the Times reported.

The Levinson report echoes other recent criticisms of the FDA's oversight of imported food, foreign drug manufacturers, animal food and medication safety.

In announcing Friday's decision on hydrocodone, the FDA said it was prompted to take the action, because it had received reports of "medication errors associated with unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products."

Autor said that about 2 percent of all prescriptions written in the United States are for unapproved drugs. With some 200 unapproved drugs containing hydrocodone on the market, it's highly likely that most of the prescriptions for cough medicines that contain hydrocodone are for unapproved brands, she said.

Currently, the approved cough medications containing hydrocodone are: TussiCaps; Tussionex Pennkinetic; Hydrocodone Compound; Mycodone Homatropine Methylbromide; Hycodan; Tussigon; and Vicodin, she said.

According to the FDA, companies marketing unapproved hydrocodone products that are labeled for use in children younger than 6 years of age must stop manufacturing and distributing the products by Oct. 31.

Companies making other unapproved hydrocodone drug products must stop manufacturing such products on or before Dec. 31, 2007, and must "cease further shipment in interstate commerce on or before March 31, 2008."

The FDA said there are alternatives to unapproved hydrocodone-containing products. These include one of the seven approved cough medicines that contain hydrocodone as well as other cough suppressants that don't use hydrocodone.

More information

For more on drugs containing hydrocodone, visit the U.S. Food and Drug Administration.

FRIDAY, Sept. 14 (HealthDay News) -- Many of those who helped clean up an oil spill off the northwestern coast of Spain in November 2002 ended up with long-term respiratory trouble, a study finds.

It's the first research to examine the long-term effects of this kind of exposure on respiratory health.

The oil tanker Prestige sank and spilled about 67,000 tons of oil that contaminated more than 1,000 kilometers of coastline.

During the first few weeks after the disaster, much of the clean-up work was done by men and women from local fishing villages who lacked proper protective equipment.

About two years after the spill, researchers at the Hospital Universitario 12 de Octubre, Madrid, surveyed about 7,000 local people about their respiratory health. Of the respondents, about two-thirds of the men and more than half the women had directly participated in the oil spill clean-up.

"Prevalence rates of lower and upper respiratory tract symptoms were significantly higher in (those) who had participated in clean-up activities," the study authors wrote.

Overall, clean-up workers were 1.7 times more likely than others to report lower respiratory tract symptoms. Men who took part in the clean-up were twice as likely as those not involved in the clean-up to report chronic cough or phlegm or asthma within the previous year. Among women, those who took part in the clean-up were 1.7 times more likely to report chronic phlegm and 1.6 times more likely to report nasal symptoms than those not involved in the clean-up.

These symptoms of lower- and upper-respiratory tract symptoms persisted for more than a year after the last time the people helped in the clean-up. However, there was an eventual decline in symptoms, which suggests that the damage may be partly reversible, the researchers said.

The findings are published in the September issue of the American Journal of Respiratory and Critical Care Medicine.

More information

The U.S. National Oceanic and Atmospheric Administration has more about oil and chemical spills.

FRIDAY, Sept. 28 (HealthDay News) -- Poor family support and bad neighborhoods can aggravate asthma symptoms in kids, Canadian research suggests.

Edith Chen and colleagues at the University of British Columbia in Vancouver examined the degree of support that 78 children with asthma received from family and peers. They also looked at social problems, such as crime and violence, in the children's neighborhoods.

They then assessed the children's lung function, asthma symptoms, and certain behaviors that can affect asthma.

The results indicated a correlation between social environment and asthma symptoms and lung function. Children who reported less family support and lived in worse neighborhoods experienced greater asthma symptoms, the team said. Those who reported less family support had poorer lung function.

Further analysis revealed that low levels of family support were associated with greater lung inflammation which, in turn, was associated with poorer asthma outcomes. Family support did not appear to influence behaviors that can affect asthma.

The researchers also concluded that living in worse neighborhoods was associated with higher rates of child smoking and exposure to smoke, which is associated with poorer asthma outcomes.

"Poor family relations may foster psychological experiences with direct physiologic consequences, whereas problematic neighborhoods may operate by providing the role models for maladaptive behaviors," the study authors wrote.

Peer group support had no significant effect on asthma symptoms or lung function. The study was published in the first issue for October of the American Journal of Respiratory and Critical Care Medicine.

More information

The American Lung Association has more about childhood asthma  .