THURSDAY, Oct. 13 -- The percentage of children with asthma in the United States who use a prescription "controller" medicine has nearly doubled since the late 1990s, a new federal government report finds.

The analysis of data from the Medical Expenditure Panel Survey showed that the use of controller drugs by these children increased from 29% in 1997-1998 to 58% in 2007-2008, according to the latest News and Numbers from the U.S. Agency for Healthcare Research and Quality.

Asthma controller drugs include: corticosteroids, which control inflammation and reduce the risk of airway spasms; beta-2-agonists, which make breathing easier; and leukotrienes, which help prevent asthma symptoms from occurring.

Use of inhaled corticosteroids among American children with asthma increased from 15.5% to 40%, use of leukotrienes rose from 3% to 34%, and use of beta agonists rose from 3% to 13%, according to the report.

During the same period, the use of reliever and oral corticosteroid drugs fell from 44% to 30% and from 17% to 9%, respectively, the investigators noted in an agency news release.

Average annual total spending for all asthma drugs more than quadrupled, from $527 million in 1997-1998 to $2.5 billion in 2007-2008. When broken down by category, spending for controller drugs rose from $280 million to $2.1 billion, spending for reliever drugs increased from $222 million to $352 million, and spending for oral corticosteroids fell from $25 million to $8 million, the findings revealed.

-- Robert Preidt

SOURCE: U.S. Agency for Healthcare Research and Quality, news release, Oct. 12, 2011

MONDAY, Sept. 26 -- Children hit with the double whammy of type 1 diabetes and asthma have an especially tough time keeping their blood sugar under control, a new study finds.

The reason why asthma might complicate pediatric diabetes care remains unclear, however, and is "something that needs to be explored more," said Dr. Anita Swamy, a pediatric endocrinologist and medical director of the Chicago Children's Diabetes Center at La Rabida Children's Hospital in Chicago.

She was not involved in the new study, which appears in the October issue of Pediatrics.

About 215,000 children in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention. Most children who have diabetes have type 1 diabetes, although type 2 diabetes is becoming more prevalent in kids. Type 1 diabetes is an autoimmune disease that causes the body to mistakenly attack the insulin-producing cells in the pancreas. Insulin is a hormone that helps the body process carbohydrates in food. Type 2 diabetes occurs when the body doesn't produce enough insulin, or when it stops using insulin effectively, according to the American Diabetes Association.

Asthma is a chronic disease that causes inflammation in the airways, and when someone with asthma is exposed to a trigger, the disease causes the muscles in the lungs to tighten, making breathing very difficult. About 7 million American children have asthma, the CDC reports.

According to the new study, which was led by Mary Helen Black of Kaiser Permanente Southern California, about 11% of children with diabetes also struggle with asthma. Her team theorized that the inflammation that's present with untreated asthma might make it harder to control blood sugar levels.

The study tracked almost 1,700 children diagnosed with type 1 diabetes and 311 diagnosed with type 2 diabetes between 2002 and 2005, and found that 10% of those children with type 1 diabetes and just over 16% of those with type 2 diabetes also had asthma.

In kids with type 1 diabetes, the average hemoglobin A1C levels were about 7.5 for children without asthma and 7.8 for those with asthma. A1C is a test that measures long-term blood sugar control. The higher the number, the higher the average blood sugar was. Non-diabetic people generally have an A1C below 6.

Overall, kids with type 1 diabetes and asthma were 37% more likely to have poor glycemic [blood sugar] control than to have good control, compared to children without the respiratory ailment. "Among youth with type 1 diabetes, asthma is associated with poor glycemic control, especially if asthma is untreated," the study authors concluded.

However, they did not find a statistically significant link between type 2 diabetes and asthma control. That might be because they had fewer children in the study with both of those conditions, the team suggested.

The use of asthma medications significantly impacted blood sugar control, reported the researchers. Seventy-two percent of children with type 1 diabetes and asthma who were treated with leukotriene modifiers (brand names are Accolate, Singulair, Zyflo) achieved good blood sugar control, according to the study. Leukotriene modifiers are preventive medications that need to be taken every day. They're not available in generic forms.

Still, one expert was skeptical of a true physiological link between asthma and blood sugar control.

"I don't think there's any biology behind this association," said Dr. Juan Celedon, chief of service, division of pediatric pulmonology, allergy and immunology at Children's Hospital of Pittsburgh. Instead, he said, "the ones taking these medications are the ones with better insurance and access to quality health care."

And, that's Celedon's issue with the study as a whole. "My concern is that there is confounding by socioeconomic status and access to health care. They needed to adjust the data for more things. When they adjusted for race and ethnicity, the associations went down. And, children with untreated asthma and poor glycemic control may be the kids who aren't getting adequate health care," he explained.

Swamy agreed, adding, "this is one of those studies that finds an association, but it's hard to know if it's causal. We don't know why they're linked."

In the meantime, she also pointed out that some asthma medications can raise blood sugar levels, which could affect blood sugar control if parents and children aren't aware of that possibility.

Corticosteroids, especially oral steroids, can raise blood sugar levels, though Swamy said recent research has noted a link between inhaled corticosteroids and higher blood sugar levels. Certain asthma rescue medications -- inhaled medications known as beta-agonists -- can also raise blood sugar levels, according to Swamy.

"I tell primary care doctors to let us [endocrinologists] know when a child with asthma and diabetes needs a change in medications. If I know, I can preemptively change the insulin regimen and blood sugar control can still be good. The same goes for when a child has an asthma flare," said Swamy.

She added that parents shouldn't hesitate to call their child's diabetes health care team to find out what changes, if any, need to be made to their child's insulin regimen to account for asthma medications.

SOURCES: Juan Celedon, M.D., chief of service, division of pediatric pulmonology, allergy and immunology, Children's Hospital of Pittsburgh; Anita Swamy, M.D., pediatric endocrinologist, and medical director, Chicago Children's Diabetes Center, La Rabida Children's Hospital, Chicago; October 2011, Pediatrics

THURSDAY, Sept. 22 -- Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs), which can damage the ozone layer, will not be made or sold after Dec. 31, the U.S. Food and Drug Administration announced Thursday.

The sole product affected is Primatene Mist, marketed by Armstrong Pharmaceutical Inc., because it is the only inhaler approved by the FDA to be sold without a prescription for the relief of occasional symptoms of mild asthma.

"With this phase-out, all of the other inhalers that could substitute for the CFC over-the-counter inhaler to relieve symptoms of mild asthma require a prescription," Dr. Andrea Leonard-Segal, director of the FDA's Division of Nonprescription Clinical Evaluation, said during a morning news conference.

Primatene Mist uses CFCs to propel epinephrine from the inhaler so it can be taken into the lungs.

"Consumers who use Primatene Mist need to take action now to see a health-care provider to get a prescription for a replacement product," Leonard-Segal said. "Primatene Mist may be even harder to find on store shelves even before Dec. 31, 2011."

People who have the product after Dec. 31 can continue to take it as long as it hasn't expired, Leonard-Segal said.

The product is being removed from the market to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer. This international agreement, signed by the United States, calls for phasing out chemicals that deplete the ozone layer, including CFCs.

Many manufacturers have replaced CFCs with an environmentally friendly propellant called hydrofluoroalkane (HFA). However, there are no HFA versions of over-the-counter epinephrine inhalers currently available, the FDA said.

While the other types of medications delivered through HFA inhalers are effective, there are some significant differences between HFA and CFC inhalers that people need to be aware of, Leonard-Segal said.

They include:

• Priming. When you first use an HFA inhaler, or if you haven't used it in awhile, you need to "prime" the pump to ensure that you're getting the accurate dose of medication. Priming entails spraying a dose or doses into the air, and priming requirements are different for each inhaler. Ask your pharmacist or check the package insert for your inhaler's priming requirements.
• Inhaling. The spray from HFA inhalers doesn't come out as forcefully, and some people have reported feeling as if they're not getting enough medication. For more detailed instructions on the proper technique for using an inhaler, ask your doctor or pharmacist, or check the package insert, which also has instructions for using the inhaler.
• Cleaning. HFA inhalers need to be cleaned more often than CFC inhalers.


Sale of Primatene Mist Will End Because the Over-the Counter Asthma Inhaler Uses CFCs

By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, MD

Sept. 22, 2011 -- The Primatene Mist inhaler is going away on Dec. 31, and prescription inhalers are the only alternative to the over-the-counter asthma drug.

Don't wait to get that prescription. The FDA warns that Primatene supplies may not last until the end of the year.

"All inhalers that might substitute require a prescription," the FDA's Andrea Leonard-Segal, MD, said at a news teleconference. "So those who use Primatene need to take action now to see a health care provider to get a replacement product." Leonard-Segal is the director of the FDA's division of nonprescription clinical evaluation.

"The clock is ticking on Primatene Mist, the only over-the-counter asthma inhaler," FDA press officer Karen Riley said at the news conference.

The problem with Primatene is that it contains chlorofluorocarbons or CFCs, which deplete the Earth's ozone layer. Environmental treaties signed by the U.S. banned products that emit CFCs. Most of these products already are gone. But medicines got a special extension.

That extension has expired for Primatene. Sales must end at the end of the year. Although the manufacturer of Primatene promises to come up with a version propelled by a safer chemical, the company has not yet done so.

This means that users of Primatene, which has epinephrine as its active ingredient, must switch to drugs based on albuterol. And a prescription is needed for albuterol-based inhalers. These include Accuneb, ProAir, Proventil, Ventolin, and Vospire.

While albuterol is a safe and effective asthma drug, it is different from epinephrine.

"I think patients will feel a difference," Leonard-Segal said.

"One person may feel a certain drug works better for them, but all FDA-approved drugs work in the populations for which they are approved," Sally Seymour, MD, deputy director for safety in the FDA's division of pulmonary, allergy, and rheumatology products, said at the news conference.

One difference users may feel is the price. A replacement cartridge of Primatene Mist sells for about $18. The albuterol inhalers sell for about $45 and up. However, patients with health insurance that covers prescriptions, and those covered by Medicare and Medicaid, may actually pay less for the drugs.

The FDA is not at all clear about how many Primatene users there are. Their best estimate is that 2 million Americans purchase 4 million Primatene units each year.

Here's the FDA's advice to Primatene Mist users:

• See a health care professional soon to get another medicine. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.
• Ask your health care professional to show you how to use your new inhaler or other medicine to make sure you are using it correctly and getting the right dose.
• Follow the directions for using and cleaning your new inhaler or other medicine to make sure you get relief of your asthma symptoms.
• If you haven't used up your Primatene Mist by Dec. 31, it's safe to continue using it as long as it hasn't expired. Check the expiration date, which can be found on the product and its packaging.