FDA Experts Urge Ban on Cold Medicines for Young Children

(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.

A group of outside experts advising the FDA will consider the recommendation during a meeting on Oct. 18 and 19, and will then offer an 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 added.

"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 came 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 law, the 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 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, she added, the approved cough medications containing hydrocodone are: TussiCaps, Tussionex Pennkinetic, Hydrocodone Compound, Mycodone Homatropine Methylbromide, Hycodan, Tussigon, and Vicodin.

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.

Genes Might Predispose Antidepressant Users to Suicidal Thoughts

(HealthDay News) -- Variations in two genes may help spur suicidal thinking in individuals taking a commonly prescribed antidepressant, research suggests.

Although preliminary, the findings could pave the way for genetic testing to determine which patients with depression are likely to have this unusual but dangerous side effect.

"These findings, if replicated, would provide a way to have a genetic test that would tell us who is at a higher risk of developing suicidal ideation when taking antidepressants," said Dr. Gonzalo Laje, lead author of the study and associate clinical investigator at the U.S. National Institute of Mental Health. "Our long-term goal is to make sure that people with depression can take antidepressants, because treating depression is the best way to avoid suicide," he said.

Other experts stressed the need for more studies before getting too excited about the finding.

"The real key is, does it replicate in another data set? . . . [because] replicating results is rare," said Dr. Michael Slifer, assistant professor of medicine at the University of Miami Institute for Human Genomics. "It's a very important topic," said Slifer, who was not involved in the study.

"Nobody has really looked into what might be different about the background of these folks that have such a difficult time in treatment and get suicidal thoughts. This is a first step, but it's only a first step."

There is some evidence that people starting antidepressant medication can develop suicidal ideation, or suicidal thoughts and ideas, although this notion remains controversial.

In 2004, the U.S. Food and Drug Administration (FDA) recommended that the class of drugs known as selective serotonin reuptake inhibitors (SSRIs) carry a strong "black box" warning on the label outlining the possibility of an increase in suicidal ideation. SSRIs include widely used drugs such as Celexa, Paxil, Prozac and Zoloft.

The black box warning was based on studies that found that 4 percent of the group taking SSRIs had suicidal ideation, compared with 2 percent of the group taking a placebo.

"It is a severe side effect, but it is unusual," Laje stated. "Given the warnings by regulatory agencies, we thought this would be a very important side effect to look at."

The current study was part of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, the largest trial to date to look at depression in real-world settings. Participants in STAR*D were treated with the SSRI citalopram (Celexa) for up to 14 weeks.

For this study, Laje and colleagues analyzed DNA samples from 1,915 participants, looking for associations between reports of suicidal ideation at 768 sites in 68 genes.

Versions of two genes involved with cellular glutamate receptors, which have been implicated in depression, were more prevalent in participants reporting suicidal thinking.

While overall about 6 percent of the patients reported suicidal thoughts when taking Celexa, 36 percent of patients who carried both of the gene variations reported suicidation. Overall, 59 percent of those who reported suicidal ideation had at least one of the suspect gene types.

One percent of the participants had a version of the kainate receptor gene (GRIK2) that increased the risk of suicidal thinking more than eightfold.

Forty-one percent had a version of the AMPA receptor gene (GRIA3) that almost doubled the odds.

Eleven participants, or one-half of one percent, had both versions which resulted in a 15-fold increase in risk.

Since the researchers only looked at Celexa, it's unknown if the findings extend to other antidepressants, even those in the same class of SSRIs.

This study, which is published in the October issue of the American Journal of Psychiatry, is the first to find a significant association between a genetic marker and suicidal ideation.

Researchers elsewhere are working to further clarify the links, if any, between antidepressant use and suicide ideation.

On Thursday, scientists led by Dr. John March, chief of child and adolescent psychiatry at Duke University Medical Center, announced the launch of a large-scale safety registry tracking antidepressant use by children and youth.

In its first study, the Child and Adolescent Psychiatry Trials Network (CAPTN) hopes to follow the outcomes of 2,420 children and adolescents prescribed either an SSRI or another type of drug, a serontonin-norepinephrine reuptake inhibitor (SNRI) to help treat depression, anxiety disorders, and other psychiatric woes. A subset study will examine gene variants associated with an increase in either the benefits or side effects of psychiatric medicines in young users.

The CAPTN effort is funded by the U.S. National Institute of Mental Health.

More information
There is more on suicide prevention at the U.S. National Institute of Mental Health.

Doctors' Office Outreach Boosts Colon Cancer Screening

(HealthDay News) -- Simple, personalized outreach in doctors' offices can improve colorectal cancer screening rates, a new study finds.

Colorectal cancer is the third most common kind of cancer and the third leading cause of cancer death in the United States. Most patients don't experience any symptoms until the disease is in an advanced stage, which means that early screening is critical to saving lives.

However, studies show that only 42 percent of Americans have received fecal testing for blood or endoscopy screening for colorectal cancer in the previous five years.

In this study of 1,546 people at risk for colorectal cancer, researchers from Thomas Jefferson University in Philadelphia examined the effectiveness of standard and tailored educational interventions in primary practice settings.

The participants were randomly assigned to: no intervention/control; standard intervention (SI) with mailing of education and screening supplies; tailored intervention (TI) with mailing of education and screening supplies; or tailored intervention plus one-year phone follow-up (TIP).

Two years later, colorectal cancer screening rates were 48 percent in the TIP group, 46 percent in the SI group, 44 percent in the TI group, and 33 percent in the SI group.

"These findings provide support for the use of simple, personalized interventions in primary care practice settings to increase CRC screening use among adult patients who are not up to date with CRC screening guidelines," the study authors concluded.

The study was expected to be published in the Nov. 1 issue of the journal Cancer.

More information
The U.S. National Cancer Institute has more about colorectal cancer screening.


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Gene Test Could Boost Myeloma Treatment

(HealthDay News) -- Analyzing the activity of a small subset of genes may help identify patients with the worst cases of multiple myeloma, U.S. researchers say.

It may also help guide their treatment, noted the team from the Myeloma Institute for Research and Therapy at the University of Arkansas for Medical Sciences.

Multiple myeloma is a cancer that affects the blood plasma cells in bone marrow that produce antibodies. There is wide variation in how well multiple myeloma patients respond to treatment.

This study included 532 patients who were followed for seven years after they had a blood stem cell transplant. The researchers created a genetic profile of each patient to chart the severity of their multiple myeloma.

They found that the activity of as few as 17 genes could determine whether a patient was at high or low risk for a poor prognosis.

The findings were to be presented this week at an American Association for Cancer Research conference in Atlanta.

"There are enormous differences between how different people fare with multiple myeloma. While most do very well, others have a highly aggressive form of the disease, and this is not recognized well with current prognostic variables," lead researcher John D. Shaughnessy Jr., a professor of medicine at the Myeloma Institute for Research and Therapy, said in a prepared statement.

"If we can categorize a patient's risk early, we can better guide that patient toward therapies that might be more effective for them based on the genetic profile of the disease," he explained.

More information
The American Cancer Society has more about multiple myeloma.

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Mouthpiece Could Help Ease Snoring

(HealthDay News) -- A plastic "dental splint" mouthpiece may help keep some people from snoring through the night, Scottish researchers report.

The device might help many troubled chronic snorers avoid a cumbersome nighttime breathing mask or surgery, the team added.

"The take-home message is that we don't have to operate on all snorers," said study lead author Stuart M. Robertson, a surgical trainee at Crosshouse Hospital, Kilmarnock, Scotland. "We try first a [mouthpiece], and if that doesn't work, we try the breathing mask, and if that doesn't work, we offer them surgery," he said.

Snoring is often harmless but can be a sign of sleep apnea, a condition in which breathing is disrupted during sleep.

The new study looked at patients whose snoring doesn't cause health problems but does aggravate their partners, perhaps forcing a spouse to sleep in another room, Robertson said.

Typically, he said, doctors performed surgery on the snoring patients, but the operations didn't always work. In the new study, conducted over two years, 20 patients were split into two groups. One group underwent three months of treatment with a mouthpiece and then three months using a special breathing mask; the other group did the opposite.

The study findings were scheduled to be released Monday at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, in Washington, D.C.
The mouthpiece, known as a splint, is similar to a mouth guard worn by a boxer, Robertson said.
But it protects both the upper and lower teeth and "moves your jaw forward, it allows you to breath more easily at night and reduce your snoring," he explained.

The mouthpieces cost about $400 and have to be replaced about once every two years, he said.

They can cause discomfort and move the teeth around; Robertson recommends that patients regularly see a dentist.

The breathing mask, which costs $400 to $600, is hooked to a machine and sends air through a nasal mask into the throat where it forces the airway to stay open. "The masks do work very well, but they're so uncomfortable that I don't think a lot of patients can wear them, and they don't get the benefit of them," Robertson said.

Eight of the patients preferred the mouthpiece, and five chose the breathing mask. Seven didn't like either treatment.

As compared to Scotland, "a lot of Americans are more keen on the surgery, but they, too, are realizing that they can treat a lot of snorers with a splint or a breathing mask."

Dr. Ronald D. Chervin, a physician who treats sleep disorders at the University of Michigan, cautioned that mouthpieces aren't typically as effective as the breathing masks.

"It would be encouraging if they did even as well" as breathing masks," he said. "But they can be very effective for some individuals."

More information
Learn more about snoring from the American Academy of Otolaryngology-Head and Neck Surgery.

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Gene Mutations May Cause Rare Neonatal Diabetes

(HealthDay News) -- Mutations in an insulin-linked gene can cause permanent neonatal diabetes, say American and U.K. researchers.

They have identified 10 such mutations in 21 people from 16 families.

Permanent neonatal diabetes is a rare form of diabetes that affects infants and leads to lifelong dependence on insulin injections. This is the first study to link insulin gene mutations to severe diabetes with onset early in life, the researchers said.

The mutations may influence the way insulin folds during its synthesis. These improperly folded proteins interfere then with other cellular processes in ways that eventually result in the death of cells that produce insulin, the researchers said.

The findings were published online by the journal Proceedings of the National Academy of Sciences and were expected to be in an upcoming print issue.

"This is a novel and potentially treatable cause of diabetes in infants," study author Dr. Louis Philipson, professor of medicine at the University of Chicago, said in a prepared statement.

This research "is exciting, because each of these patients has one normal insulin gene as well as one mutated gene. If we could detect the disease early enough and somehow silence the abnormal gene, or just protect insulin-producing cells from the damage caused by misfolding, we might be able to preserve or restore the patient's own insulin production," Philipson said.

More information
The U.S. National Diabetes Information Clearinghouse has more about neonatal diabetes.

Education Linked to Cancer Death Rates

(HealthDay News) -- If you have a college degree, you have up to a 76 percent reduced risk of dying from cancer, a new study found.

Higher education lowers the risk for black and white women and men, according to the report in the Sept. 11 online edition of the Journal of the National Cancer Institute.

"Cancer mortality varies a great deal for all cancers by individual level of education," said study co-author Elizabeth Ward, the American Cancer Society's director of cancer surveillance. "If we could get everyone's cancer mortality to the level we see among the best educated, it would make a huge impact on cancer in the United States."

Education is tied to socioeconomic status and access to medical care, Ward noted. The new study finding makes it clear that many of the factors that influence cancer mortality are preventable, she said.

"They are preventable by social policies -- things we can change, such as smoking prevention, access to cancer screening and opportunities to good nutrition and physical activity," Ward said.

In the study, Ward and her colleagues used data from death certificates and the U.S. Census Bureau to look at the associations between education level and death rates from lung, breast, prostate and colorectal cancer. The researchers collected data on 137,708 cancer deaths from 2001 involving black and white men and women between the ages of 25 and 64.

The researchers found that more education was associated with lower death rates from cancer among all race and gender groups. The greatest difference was found between people with 12 or fewer years of education and those with more than 12 years of schooling, Ward's team found.

Compared with those with the lowest levels of education, those with the highest levels of education cut their risk of dying from cancer. For the highest educated white men, the risk was cut by 48 percent, for white women it was cut by 76 percent as it was for black men, and the most educated black women had a 43 percent lower risk of dying from cancer, the researchers reported.

This difference in cancer deaths is most likely due to a relationship between education and other factors directly associated with risks of developing and dying from cancer, such as smoking, cancer screening, and access to health care, the researchers speculated.

Although cancer death rates were higher among blacks than whites with the same level of education, they were almost the same for black and white men with zero to eight years of education, the researchers said.

"The difference between blacks and whites is most certainly due to socioeconomic conditions and access to care," Ward said.

Sholom Wacholder, an epidemiologist with the National Cancer Institute and author of an accompanying editorial in the journal, thinks the study findings account for some -- but not all -- cancer disparity rates between blacks and whites.

"I asked myself if I could use this data to figure out the difference between blacks and whites in cancer mortality," said Wacholder. "And the answer is that it is probably not possible."

The problem is that there are too many unanswered questions, Wacholder said. "We can't answer the question whether additional education by itself is the explanation or whether people with access to education have lower cancer mortality beyond the effect of education," he said.

More information
For more on cancer, visit the American Cancer Society.

Family History Has Strong Effect on Cardiac Risk

(HealthDay News) -- Paying attention to the heart risk factors of close relatives of people with coronary heart disease could prevent more than 40 percent of early heart deaths, Scottish researchers say.

"If you want primary prevention, you have to go through the population to find groups with high risk," explained Dr. Jill Pell, professor of epidemiology at the University of Glasgow and lead author of a report in the Sept. 8 issue of the British Medical Journal.

"The 14 percent of families that have a history of coronary heart disease account for 72 percent of all premature deaths from heart disease," Pell pointed out.

That number comes from previous studies, which showed that 48 percent of major coronary events such as heart attacks occur in those families, Pell added. A brother or sister of someone who has a heart attack or other coronary event has twice the normal risk of having such an event, she said.

"So, instead of going through the entire population [for screening], we can go through the closest relatives of coronary disease patients," she reasoned.

Screening those close relatives and taking steps against risk factors such as high cholesterol, smoking, diabetes and high blood pressure could prevent more than 80 percent of the early heart attacks that occur in Britain each year, the Glasgow group estimated.

They plan to put that belief to a practical test with a pilot project to screen siblings and children of coronary heart disease patients, select those with obvious risk factors, and then work to bring those factors under control, Pell said.

"We would aim at global risk, all the factors together -- smoking, cholesterol, diet, exercise," she said.

In theory, working physicians are aware of the importance of family history in predicting coronary risk, Pell said. And they know that they should put that information to use with the close relatives of heart patients.

However, "the reality is that all of the studies to date show that it just isn't happening," she said.
People with coronary heart disease often show up in emergency rooms or outpatient clinics, the researchers noted. It would be easy to flag them as members of a family requiring counseling. In fact, such a flagging system is used for cancers that are known to have an inheritable background, the report's authors noted.

It would be easy to ask a heart patient if any close relatives have such a condition, Pell said, and to give basic advice when that is the case: "Tell your brother to check out his risk factors and modify them if necessary."

In the United States, the Sibling Family Heart Study, which has followed more than 800 people for more than a decade, has seen "a doubling of the number of heart attacks, deaths and events that need to be corrected with bypass surgery or angioplasty," added Dr. Dhananjay Vaidya, assistant professor of internal medicine at the Johns Hopkins University, Baltimore, and a member of that study team.

"One surprising thing we found was that people who had early heart attacks and had a family history of heart disease had very little knowledge of how they were at greater risk," Vaidya said.
After all other risk factors are taken into account, having a close family member with coronary heart disease increased a person's risk of a major cardiac event by 45 percent, he said.

More information
There's more on the role of family in cardiac risk at the American Heart Association.

(HealthDay News) -- An experimental lung cancer screening test designed to look for precancerous genetic damage could help better identify patients at

(HealthDay News) -- A new class of antidepressants dramatically cut the time needed to take effect when they were tested on rats, a study found.

The study authors, from McGill University in Montreal, Canada, said they hope the finding will spur research into the family of drugs, raising the prospect of faster-acting antidepressants.

But, as always with studies involving animals, the findings must first be confirmed in humans.

"The only way we'll know is when a clinical trial is done" involving humans, said Gerald Frye, Joseph H. Shelton professor of neuropharmacology and neurotoxicology at the Texas A&M Health Science Center College of Medicine's department of neuroscience and experimental therapeutics. "It looks promising from an animal standpoint, and the animal systems they're using are pretty good, but this can only predict. There's no guarantee."

Frye was not involved with the study, which is published in the Sept. 6 issue of the journal Neuron.

Antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs), which include Prozac and Celexa, are widely prescribed but can take up to six weeks to take effect, and they don't work for everyone. Many patients have to try several different drugs before achieving success, and only about 65 percent of people end up responding to a drug, according to an accompanying editorial in the journal.

That time lag can be critical for someone suffering from depression. "During that time, there is a risk of suicide," Frye said. "Anything you can do to get a faster response" is desirable, he added.

SSRIs work by enhancing the action of the neurotransmitter serotonin in the brain.

The new study looked at a new class of drugs known as serotonin4 (5-HT4) receptor agonists, which have a more specific effect.

"SSRIs interfere with the serotonin system and increase naturally transmitted serotonin to help the system readjust itself," Frye explained. "The new drugs act only on one receptor. They're more selective."

For the study, the researchers tested two serotonin receptor agonist compounds, called RS 67333 and prucalopride, in rats, comparing the drugs against the action of Celexa. Using different measures of depression, the researchers found that the two new drugs acted four to seven times faster and also seemed more powerful.

In one test, the researchers found that one of the serotonin receptor agonists took effect after only three days and completely erased the depressive symptoms after one week.

For instance, mild stress has been shown to reduce consumption of sugar water by rodents -- a behavior alleviated by weeks of SSRI treatment. But the McGill researchers found that one of the serotonin receptor agonists produced effects within three days and seemed to removed the depressive symptoms within a week.

The new drugs, however, may have side effects. "There are potential side effects, and that's where the rub could be with clinical trials," Frye said.

More information
For more on depression, visit the U.S. National Institute of Mental Health.

New Drug Treats Rare Hormonal Disorder

(HealthDay News) -- The U.S. Food and Drug Administration has approved Somatuline Depot (lanreotide acetate injection) to treat a rare growth hormone-related disorder called acromegaly, the agency said Friday.

The disorder, caused by an abnormal secretion of the hormone, is characterized by enlarged hands, feet, facial bones, and internal organs such as the heart and liver. If untreated, people with the disorder often die prematurely because of heart and respiratory problems, diabetes, or colon cancer, the FDA said. The disorder affects about 15,000 people in the United States and Canada.

The drug's safety and effectiveness were evaluated in two clinical trials involving 400 people. The most frequent side effects were diarrhea, gallstones, skin reactions, slow heart rate, and changes in blood sugar levels.

Samatuline Depot is marketed by Beaufour Ipsen, based in Paris, France.

More information
The FDA has more about the approval.