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Cialis Approved to Treat Benign Prostatic Hyperplasia

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Cialis (tadalafil) was approved today by the FDA for treating the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.

The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.

In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and in their ED compared to men who were treated with placebo. The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.

“BPH can have a big impact on a patient’s quality of life,” said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men.”

Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Cialis in combination with alpha blockers for the treatment of BPH is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.

The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is manufactured by Indianapolis-based Eli Lilly and Co.

Source: FDA

FDA Awards Grants to Encourage Pediatrics Medical Device Development

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The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children.

A panel of five experts with experience in medicine, business, and device development reviewed 10 applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development. The recipients and grant amounts include:

• James Geiger, M.D. and Andre Muelenaer, M.D. of the University of Michigan Pediatric Device Consortium and the Pediatric Medical Device Institute Pediatric Medical Device Consortium, $1.1 million a year for two years.
• Michael Harrison, M.D. and the University of California, San Francisco Pediatric Device Consortium, $500,000 a year for two years.
• Barbara Boyan, Ph.D. and the Atlanta Pediatric Consortium, $900,000 a year for two years.

“Congress provides FDA with this funding so that we can help connect innovators and their ideas to experienced professionals who can assist them through development,” said Debra Lewis, O.D., acting director of the FDA’s Office of Orphan Product Development. “Development of medical devices for children lags up to a decade behind similar devices used in adults.”

Children differ in terms of size, growth, and body chemistry and present unique challenges to device designers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the Office of Orphan Products Development, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.

Legislation passed by Congress in 2007 established funding for grants to nonprofit groups to help stimulate projects to promote the development and availability of pediatric medical devices. These grants are meant to encourage the development of multiple pediatric device projects. While a small portion of the grants fund specific projects, the real spirit of this grant program is to provide information clearinghouses to promote multiple projects.

This is the second round of this type of biennial grants to be awarded. Those receiving these grants will:

  • encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers
  • mentor and manage pediatric device projects through their development, including prototype design and marketing
  • connect innovators and physicians to existing federal and non-federal resources
  • assess the scientific and medical merit of proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.

As part of the legislation, each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.

Past grant awardees have assisted in the development of devices to treat scoliosis, pediatric valvular heart disease, and projectile vomiting in newborns, among other diseases.

 

Source: FDA

Rotavirus Vaccine Leads to Lower Doctor Visits and Health Care Costs

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Vaccinating infants against rotavirus has resulted in dramatic decreases in health care use and treatment costs for diarrhea–related illness in U.S. infants and young children, according to a new study by the Centers for Disease Control and Prevention. The study is published in the current issue of the New England Journal of Medicine.

“This is good news for parents and our health system overall,” said Dr. Umesh Parashar, medical epidemiologist and team leader for the Viral Gastroenteritis Team in CDC′s Division of Viral Diseases. “Rotavirus vaccine is one of the most effective ways to prevent severe diarrhea–related illness in young children and keep them healthy.”

Rotavirus is a major cause of severe diarrhea in infants and young children in the United States. Before vaccines were introduced in 2006, rotavirus was responsible for about 400,000 visits to doctor′s offices, 200,000 emergency room visits, 55,000 to 70,000 hospitalizations, and 20 to 60 deaths each year in children under 5 years old.

RotaTeq and Rotarix, the two U.S. licensed rotavirus vaccines, were 85 to 98 percent effective at preventing severe rotavirus disease in clinical trials in middle and high income countries, including the United States.

This new study used data from a large U.S. insurance database for 2001 to 2009 to assess rotavirus vaccine coverage and its impact on health care use and treatment costs for diarrhea–related illness in children under 5 years old. The study examined direct benefits to vaccinated children and indirect protective benefits to unvaccinated children. National declines in health care use and treatment costs were estimated by applying the declines seen in this study to children under 5 years old in the U.S population.

By the end of 2008, 73 percent of children under 1 year of age, 64 percent of 1–year–olds, and 8 percent of 2– to–4–year–olds had received at least one dose of rotavirus vaccine. Rotavirus–related hospitalizations decreased substantially compared with pre–vaccine levels in children under 5 years old—75 percent decline for 2007–2008 and 60 percent decline for 2008–2009.

Vaccinated children had 44 to 58 percent fewer diarrhea–related hospitalizations and 37 to 48 percent fewer emergency room visits for diarrhea than unvaccinated children during the 2008 and 2009 rotavirus seasons (January to June). Even in unvaccinated children, there were substantial declines in health care use during the 2008 rotavirus season compared with pre–vaccine levels—showing indirect protective benefits.

The study estimated that about 65,000 hospitalizations of children under 5 years old from 2007 to 2009 were averted nationally with a health care cost savings of about $278 million.

“This study provides more evidence that vaccinating against rotavirus substantially reduces suffering and health care costs for this common childhood illness,” said Dr. Mark Pallansch, director of CDC′s Division of Viral Diseases. “As more children get vaccinated against rotavirus, we expect to see even greater reductions in disease among all age groups.”

Source: CDC

FDA Warns Consumers Not to Eat Raw Oysters Harvested from Hood Canal Area 4 in Washington State

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Oyster recall affects 23 states

Fast Facts
• The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an area of Hood Canal in Washington State following an outbreak of illness in that state caused by Vibrio parahaemolyticus bacteria.

• Raw oysters harvested from “growing area 4” in Hood Canal from August 30 to September 19 have been linked to three confirmed and two possible cases of Vibrio parahaemolyticus illness.

• All ill persons reported consumption of raw oysters.

• There have been no reports of hospitalizations or deaths resulting from consuming the oysters.

• The Washington State Department of Health has closed the growing area associated with the illnesses. Commercial oyster harvesters and dealers who obtained oysters from this growing area have initiated a recall and notified their commercial customers in affected states of the recall.

• Shipping and other records provided by Washington State indicate that oysters harvested from this area were distributed to establishments in 23 states and four foreign countries. Washington State authorities have notified those states involved of the recall.

• Those who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing area.

What is the problem?
Raw oysters harvested and shipped from Hood Canal Area 4 in Washington State between August 30 and September 19 have been linked to illnesses caused by Vibrio parahaemolyticus bacteria.

What are the symptoms of Vibrio illness?
Illness is typically characterized by nausea, vomiting, and diarrhea. The symptoms begin from a few hours up to five days after consumption of raw or undercooked seafood, particularly shellfish, or after ingestion of surface waters.

Who is at risk?
Persons at risk are those who traveled to Washington State and consumed oysters that were harvested from Hood Canal Area 4 or who purchased oysters in a state to which these oysters were distributed and ate them.  Individuals with weakened immune systems, including people affected by AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease can be more susceptible to vibrio illness and should avoid eating raw oysters, regardless of where they are harvested.

What Do Consumers Need To Do?
Consumers in the affected states should inquire of the retailer, restaurant, or other facility about the source of the oysters offered for purchase. If the oysters were definitely or possibly harvested from Hood Canal Area 4 in Washington State, and have not yet been consumed, they should not be eaten. If the oysters were already consumed and no one became ill, no action is needed. If you develop a diarrheal illness within a week after consuming raw or undercooked shellfish, see your healthcare provider and inform the provider about this exposure.

Where Were the Oysters Distributed?
Records obtained by Washington State health officials indicate that raw oysters from this area of the Hood Canal in Washington State were distributed to 23 states: Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Illinois, Indiana, Maryland, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Virginia, Utah, and Washington. Oysters from this area were also distributed internationally to the People’s Republic of China, Indonesia, Thailand and Taiwan.

What is Being Done about the Problem?
The Washington State Department of Health has closed Area 4 of Hood Canal to shellfish harvesting. All product harvested and shipped between August 30 and September 19 has been recalled. Washington State has notified all other states where product was shipped that they should hold and destroy product.

Who Should be Contacted?
The FDA encourages consumers with questions about seafood safety to call 1-888-SAFEFOOD

Source: FDA

Flu Prevention for Children and Teens – Report

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Although children and teenagers rarely die from flu–related causes, many of the deaths could have been prevented if the children had been vaccinated against the flu, according to a report by the Centers for Disease Control and Prevention.

The study reports 115 influenza–associated deaths of people younger than 18, from September 2010 through August 2011 and highlights the importance of both annual vaccination and rapid antiviral treatment.

“It′s vital that children get vaccinated,” said Dr. Lyn Finelli, chief of the CDC′s Surveillance and Outbreak Response Team. “We know the flu vaccine isn′t 100 percent effective, especially not in children with high risk medical conditions. That′s why it′s essential that these two medical tools be fully utilized. Vaccinate first; then use influenza antiviral drugs as a second line of defense against the flu. Right now we aren′t fully using the medical tools at our disposal to prevent flu illnesses and deaths in children.”

The study in CDC′s Morbidity and Mortality Weekly Report provides details on the deaths. Since 2004, states have been required to report influenza-associated deaths in children and teenagers, giving the CDC a chance to look closely at factors that can increase risk.

Among the most notable findings was the infrequent use of the most important influenza prevention measure – vaccination. Despite a recommendation for vaccination of all children 6 months of age and older having been in place since 2008, only 23 percent of the 74 children older than six months with a known vaccination history had received their flu vaccine last season.

While many people believe that healthy children can withstand a bout of flu, this is not always the case. About half of the children who died last season were previously healthy and did not have a medical condition that would put them at risk for flu complications. However, the report underscores the fact that young age in itself is a risk factor. The report identified that 46 percent of the children who died were younger than 5 years and 29 percent were younger than 2 years.

The other half of the children who died did have a medical condition that predisposed them to being at greater risk of flu complications. Of 57 children with a medical condition, 54 percent had a neurological disorder, 30 percent had pulmonary disease, 25 percent had a chromosome or genetic disorder and 19 percent had congenital heart disease or other cardiac disease.

The report also identified issues with the use of antiviral drugs, which provide effective treatment for influenza. Of the 94 children who died in a hospital or emergency department, only 50 percent were prescribed antiviral drugs. Since the 2009 H1N1 pandemic especially, CDC has recommended immediate treatment with influenza antiviral medications in severely ill patients with suspected flu.

Another report in the Sept. 16 MMWR provides a summary of influenza activity from mid–May to the beginning of September. “If trends in that report continue,” Finelli says, “we should have a vaccine that will offer good protection against the viruses we expect will circulate this season.”

This season′s influenza vaccine protects against three influenza viruses, the 2009 influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus. These are the same three flu virus strains that were circulating in 2010–2011 – just the eighth time since 1969 this phenomenon has occurred. Moreover, it is important to note that vaccine immunity wanes over time so CDC is recommending that everyone get vaccinated this season, even if they got vaccinated last season, in order to be optimally protected.

Source: CDC

Lung Cancer Rates on the Decline

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The rates of new lung cancer cases in the United States dropped among men in 35 states and among women in 6 states between 1999 and 2008 Among women, lung cancer incidence decreased nationwide between 2006 and 2008, after increasing steadily for decades.

The decrease in lung cancer cases corresponds closely with smoking patterns across the nation. In the West, where smoking prevalence is lower among men and women than in other regions, lung cancer incidence is decreasing faster. Studies show declines in lung cancer rates can be seen as soon as five years after smoking rates decline.

The report also noted that states that make greater investments in effective tobacco control strategies see larger reductions in smoking; and the longer they invest, the greater the savings in smoking–related health care costs. Such strategies include higher tobacco prices, hard–hitting media campaigns, 100 percent smoke-free policies, and easily accessible quitting treatments and services for those who want to quit.

“Although lung cancer among men and women has decreased over the past few years,” said CDC Director Thomas R. Frieden, M.D., M.P.H. “too many people continue to get sick and die from lung cancers, most of which are caused by smoking.  The more we invest in proven tobacco control efforts, the fewer people will die from lung cancer.”

Lung cancer is the most commonly diagnosed cancer that affects both men and women, and is the leading cause of cancer death in the United States. Cigarette smoking and exposure to secondhand smoke cause most lung cancer deaths in the United States. To further reduce lung cancer incidence, intensified efforts to reduce smoking are needed.

For this report, researchers analyzed lung cancer data from CDC′s National Program of Cancer Registries and the National Cancer Institute′s Surveillance, Epidemiology, and End Results Program. They estimated smoking behavior by state using the CDC′s Behavioral Risk Factor Surveillance System.

Study findings include:

  • Among men, lung cancer rates continued to decrease nationwide.
  • From 1999 to 2008 lung cancer rates among men decreased in 35 states and remained stable in nine states (change could not be assessed in six states and the District of Columbia).
  • States with the lowest lung cancer incidence among men were clustered in the West.
  • After increasing for years, lung cancer rates among women decreased nationwide between 2006 and 2008.
  • Lung cancer rates decreased between 1999 and 2008 among women in California, Florida, Nevada, Oregon, Texas, and Washington.
  • Lung cancer rates among women remained stable in 24 states, and increased slightly in 14 states (change could not be assessed in six states and the District of Columbia).

Source: CDC

Two Doses of HPV Vaccine May Protect as Much as Standard 3-dose Course

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Two doses of the human papillomavirus (HPV) vaccine Cervarix were as effective as the current standard three-dose regimen after four years of follow-up, according to researchers from the National Cancer Institute (NCI), part of the National Institutes of Health, and their colleagues. The results of the study, based on data from a community-based clinical trial of Cervarix in Costa Rica, appeared online Sept.9, 2011, in the Journal of the National Cancer Institute.

Worldwide, approximately 500,000 new cases of cervical cancer are diagnosed every year, and about 250,000 women die from the disease. An overwhelming majority of these new cases and deaths occur in low-resource countries. Virtually all cases of cervical cancer are caused by persistent infection with HPV. Cervarix is one of two vaccines approved by the U.S. Food and Drug Administration to protect against persistent infection with two carcinogenic HPV types, 16 and 18, which together account for 70 percent of all cervical cancer cases. The vaccine is intended to be administered in three doses given over the course of six months. To date, investigators have observed up to eight years of protection from persistent HPV infection with the vaccine. Studies are ongoing to determine the maximum length of protection.

The cost of the vaccine as well as the logistical difficulties of administering three doses to an adolescent population in resource-poor countries is greater than administering two doses. Even in wealthier countries such as the United States, few adolescent females complete the entire course of three vaccinations. According the Centers for Disease Control and Prevention, although approximately 49 percent of American girls ages 13 to 17 received one dose of the vaccine in 2010, only 32 percent received all three doses. In the United States, the predominately used HPV vaccine is Gardasil, which has a different formulation than Cervarix. Gardasil also protects against up to 90 percent of genital warts because it targets HPV strains 6 and 11 as well as 16 and 18.

The NCI-sponsored Costa Rica Vaccine Trial was designed to assess the efficacy of Cervarix in a community-based setting. Women ages 18 to 25 years were randomly assigned to receive the HPV vaccine or a Hepatitis A vaccine as the control treatment. Although the investigators intended to administer all three doses of the assigned vaccine to all 7,466 women in the study, about 20 percent of the participants received only one or two doses of the HPV or control vaccine. A third of women did not complete the vaccine series because they became pregnant or were found to have possible cervical abnormalities, reasons that would not likely bias the findings.

The investigators found that, after four years of follow up, two doses of the vaccine conferred the same strong protection against persistent infection with HPV 16 and 18 as did the full three-dose regimen. From just a single dose, they also observed a high level of protection, but they are cautious about the long-term efficacy of a single dose because other vaccines of this type usually require a booster dose. Additional studies are needed to evaluate the efficacy of a single dose, as well as the duration of protection for both one and two doses.

“Our study provides evidence that an HPV vaccine program using two doses will work. It may be that vaccinating more women, with fewer doses for each, will reduce cervical cancer incidence more than a standard three-dose program that vaccinates fewer women,” said Aimée R. Kreimer, Ph.D., lead author and investigator in NCI’s Division of Cancer Epidemiology and Genetics. “The main question will be whether the duration of protection from fewer doses is adequate.”

Kreimer emphasized that findings from this study of the Cervarix vaccine in women in Costa Rica may not be relevant for all populations, such as those in which HIV infection, malnutrition, or endemic diseases may influence the immune response. In addition, it is not known whether the same results would be obtained with the other FDA-approved HPV vaccine, Gardasil, because the vaccine formulations are different.

“Further studies are needed to confirm our findings in other populations as well as to quantify the duration of protection for fewer than three doses,” said Kreimer. “If other studies confirm that fewer than three doses provide adequate protection against persistent cervical HPV 16 and 18 infection, we may be one step closer to prevention of cervical cancer, especially for women in resource-poor settings, where the need is greatest.”

It is important to note that regulatory agencies have approved the HPV vaccine based on prevention of cervical precancers, not persistent infections. From studying the natural history of HPV and cervical cancer, experts know that persistent infections are first steps toward precancer. Furthermore, vaccine recommendations take into consideration many factors and studies. In the United States, the CDC’s Advisory Committee on Immunization Practices determines federal recommendations regarding vaccination.

This study was carried out by an international team of experts from the NCI, the Costa Rica HPV Vaccine Trial, and colleagues at DDL Diagnostic Laboratory in the Netherlands.


Source: NIH

Violence During Pregnancy Can Lead to Reduced Infant Birth Weight

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Pregnant women who are assaulted by an intimate partner are at increased risk of giving birth to infants of reduced weight, according to a population-level analysis of domestic violence supported by the National Institutes of Health.

The study analyzed medical records of more than 5 million pregnant women in California over a 10-year period. Although the results showed a pattern of low-weight births among women who experienced an assault, the study was not designed to establish cause and effect, and so could not prove that violence caused the reduced birth weights. Similarly, the study was not designed to provide a biological explanation for how violence against an expectant mother might cause her child to be of lower birth weight.

Infants born to women who were hospitalized for injuries received from an assault during their pregnancies weighed, on average, 163 grams, or one-third pound, less than did infants born to women who were not hospitalized, the study found. Assaults in the first trimester were associated with the largest decrease in birth weight.

Infants born weighing less than 2,500 grams, or 5.5 pounds, are considered low birth weight and have an increased risk of death or of developing several health and developmental disorders. Low birth weight infants also are at greater risk for sudden infant death syndrome (SIDS) as well as breathing problems, cerebral palsy, heart disorders and learning disabilities. The study found that among infants born to mothers who had experienced an assault, about 15 percent weighed less than 2,500 grams at birth. This rate was higher than the rate of low birth weight infants among pregnant women who were hospitalized after a car crash or for other injuries (8 to 10 percent) and more than double the rate among women who were not hospitalized while pregnant (6 percent).

Although women’s education level, rates of smoking, and nutritional habits are known to affect birth weight, the study concluded that the lower birth weights seen in the study could not be accounted for by these factors and were most strongly linked to the violence itself.

“These findings suggest that violence experienced by pregnant women could put their infants at increased risk for low birth weight and its subsequent health problems,” said Rosalind B. King, Ph.D., of the Demographic and Behavioral Sciences Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NIH institute that funded the study. “It follows that programs to reduce violence against women might have the added benefit of reducing the number of low birth weight infants.”

The study was conducted by Anna Aizer, Ph.D., of Brown University, Providence, R.I. Her findings were published online in the Journal of Human Resources.

Using data collected between 1991 and 2002, Dr. Aizer compared the birth records in California to the records of pregnant women hospitalized in California as a result of injuries from assault.

She found that for every 100,000 women who gave birth in that period, 31 had been hospitalized for an injury from an assault while they were pregnant. Although these data did not distinguish between domestic violence and violence from other types of assault, previous research has shown that 87 percent of pregnant women with injuries were injured by an intimate partner.

The overall rate of assaults was 31 per 100,000 women. The study documented higher rates of assault among the poor (49.5 per 100,000), black women (157 per 100,000), and those without a high school education (39 per 100,000).

Dr. Aizer theorized that higher rates of violence among poor women might be a root cause of poor health and poverty that persists in some families from one generation to the next. A connection between violence during pregnancy, adult health, and future earnings is possible because all three factors are linked to low birth weight. Poor women are at greater risk for having low birth weight infants than are other women. In turn, when they reach adulthood, individuals born at low birth weight are at increased risk for such adult health problems as diabetes and heart disease. Also, when they reach adulthood, individuals born at low birth weight infants also earn less than their counterparts who were born at normal birth weight.

“The costs of violence against women may be borne not just by the victims but by the next generation as well,” said Dr. Aizer. “Given the importance of birth weight in determining adult education and income, these results suggest that the higher levels of violence experienced by poor women may also contribute to the intergenerational persistence of poverty.”

The American College of Obstetricians and Gynecologists has developed a slide presentation for physicians, advising them on how to screen patients for intimate partner violence, how to assess patients’ safety, and where to refer patients for additional help.

via Violence during pregnancy linked to reduced birth weight, September 8, 2011 News Release – National Institutes of Health (NIH).

Asthma Rates in U.S. Rising

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People diagnosed with asthma in the United States grew by 4.3 million between 2001 and 2009, with nearly 1 in 12 Americans diagnosed with asthma. In addition to increased diagnoses, asthma costs grew from about $53 billion in 2002 to about $56 billion in 2007, about a 6 percent increase. The explanation for the growth in asthma rates is unknown.

Asthma is a lifelong disease that causes wheezing, breathlessness, chest tightness, and coughing, though people with asthma can control symptoms and prevent asthma attacks by avoiding things that can set off an asthma attacks, and correctly using prescribed medicine, like inhaled corticosteroids. The report highlights the benefits of essential asthma education and services that reduce the impact of these triggers, but most often these benefits are not covered by health insurers.

“Despite the fact that outdoor air quality has improved, we’ve reduced two common asthma triggers—secondhand smoke and smoking in general—asthma is increasing,” said Paul Garbe, D.V.M., M.P.H, chief of CDC’s Air Pollution and Respiratory Health Branch. “While we don’t know the cause of the increase, our top priority is getting people to manage their symptoms better.”

Asthma triggers are usually environmental and can be found at school, work, home, outdoors, and elsewhere and can include tobacco smoke, mold, outdoor air pollution, and infections linked to influenza, cold-like symptoms, and other viruses.

Asthma diagnoses increased among all demographic groups between 2001 and 2009, though a higher percentage of children reported having asthma than adults (9.6 percent compared to 7.7 percent in 2009), Diagnoses were especially high among boys (11.3 percent). The greatest rise in asthma rates was among black children (almost a 50 percent increase) from 2001 through 2009. Seventeen percent of non-Hispanic black children had asthma in 2009, the highest rate among racial/ethnic groups.

Annual asthma costs in the United States were $3,300 per person with asthma from 2002 to 2007 in medical expenses. About 2 in 5 uninsured and 1 in 9 insured people with asthma could not afford their prescription medication.

“Asthma is a serious, lifelong disease that unfortunately kills thousands of people each year and adds billions to our nation’s health care costs,” said CDC Director Thomas R. Frieden, M.D., M.P.H. “We have to do a better job educating people about managing their symptoms and how to correctly use medicines to control asthma so they can live longer more productive lives while saving health care costs.”

This report coincides with World Asthma Day, an annual event sponsored by the Global Initiative for Asthma. This year’s theme is “You Can Control Your Asthma.” Reducing asthma attacks and the human and economic costs of asthma are key priorities for the U.S. Department of Health and Human Services and the focus of a collaborative effort involving many parts of HHS. In support of this effort CDC recommends:

  • Improving indoor air quality for people with asthma through measures such as smoke-free air laws and policies, healthy schools and workplaces.
  • Teach patients how to avoid asthma triggers such as tobacco smoke, mold, pet dander, and outdoor air pollution.
  • Encouraging clinicians to prescribe inhaled corticosteroids for all patients with persistent asthma and to use a written asthma action plan to teach patients how manage their symptoms.
  • Promoting measures that prevent asthma attacks such as increasing access to corticosteroids and other prescribed medicines.
  • Encourage home environmental assessments and educational sessions conducted by clinicians, health educators, and other health professionals both within and outside of the clinical setting.

The figures were reported in Vital Signs, released today by the Centers for Disease Control and Prevention.

Source: CDC

Medical Costs for Youth With Diabetes 6x Higher

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Young people with diabetes face substantially higher medical costs than children and teens without the disease, according to a recent article in the May issue of the journal Diabetes Care. The study found annual medical expenses for youth with diabetes are $9,061, compared to $1,468 for youth without the disease.

Much of the extra medical costs come from prescription drugs and outpatient care. Young people with the highest medical costs were treated with insulin, and included all those with type 1 diabetes and some with type 2 diabetes. People with type 1 diabetes cannot make insulin anymore and must receive insulin treatment. Some people with type 2 diabetes also are treated with insulin, because their bodies do not produce enough to control blood glucose (sugar).

Children and adolescents who received insulin treatment had annual medical costs of $9,333, compared to $5,683 for those who did not receive insulin, but did take oral medications to control blood glucose.

“Young people with diabetes face medical costs that are six times higher than their peers without diabetes,” said Ann Albright, Ph.D., R.D., director of CDC’s Division of Diabetes Translation. “Most youth with diabetes need insulin to survive and the medical costs for young people on insulin were almost 65 percent higher than for those who did not require insulin to treat their diabetes.”

The study examined medical costs for children and teens aged 19 years or younger who were covered by employer-sponsored private health insurance plans in 2007, using the MarketScan Commercial Claims and Encounters Database. The estimates were based on administrative claim data from nearly 50,000 youth, including 8,226 with diabetes.

Medical costs for people with diabetes, the vast majority of whom are adults, are 2.3 times higher than costs for those without diabetes, according to CDC’s National Diabetes Fact Sheet, 2011. Authors of the Diabetes Care study suggest that the difference in medical costs associated with diabetes may be greater for youth than for adults because of higher medication expenses, visits to specialists and medical supplies such as insulin syringes and glucose testing strips.

Among youth with diabetes, 92 percent were on insulin, compared to 26 percent of adults with diabetes. Insulin is a hormone produced by the pancreas that helps convert blood glucose into energy. Without adequate insulin, blood glucose levels rise and can eventually lead to serious health complications, including heart disease, kidney failure, blindness, nerve damage and amputation of feet and legs.

Type 1 diabetes develops when the body’s immune system destroys insulin-producing beta cells in the pancreas. Risk factors may be genetic or environmental. There is no known way to prevent type 1 diabetes.

In type 2 diabetes, the body no longer handles insulin properly and gradually loses the ability to produce it. Risk factors include obesity, older age, family history, physical inactivity, history of diabetes while pregnant, and race/ethnicity. Type 2 diabetes is extremely rare in children younger than 10 years. Although type 2 diabetes is infrequent in children and teens aged 10 to 19 years, rates are higher in this group compared to younger children, with higher rates among minorities.

Source: CDC; Diabetes Care, May 2011