A new label warning will caution users of four widely used asthma drugs to avoid using these medicines as a sole or long-term means of symptom control, the U.S. Food and Drug Administration announced Thursday.

The medicines are GlaxoSmithKline’s Advair and Serevent, Novartis’s Foradil and AstraZeneca’s Symbicort. All are in the class of drugs known as long-acting beta agonists (LABAs). Serevent and Foradil are single-agent LABAs while Advair and Symbicort also contain an inhaled corticosteroid.

LABAs should no longer be used alone in treating adults and children, the FDA said. In making its decision, the agency cited studies that found that using the drugs alone can actually increase the severity of asthma, leading to hospitalizations and even death.

The drugs should only be used for the shortest time possible, until asthma symptoms are under control, and be “discontinued, if possible, once asthma control is achieved,” the agency said in a statement. People should then switch to another medication to maintain symptom control, the FDA said.

“We think the overall public health benefit is to reduce the use of LABAs,” Dr. John Jenkins, director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research, said during an early afternoon press conference Thursday.

“As we weighed the risks against the benefit of the drug, we recognized that there is still benefit for these products in patients who aren’t adequately controlled on asthma controller medications,” Jenkins said. “We wanted to maintain availability of these products, while also encouraging the safe use of the product.”

According to Jenkins, most people should only require an inhaled corticosteroid to control their symptoms.

LABAs work to improve breathing and reduce asthma symptoms by relaxing the lung’s airway muscles.

One expert said the announcements don’t signal a radical departure for asthma care, although the recommendation to stop LABA use as soon as possible could bring problems for some.

“This could complicate care in certain settings,” said Dr. Norman Edelman, chief medical officer for the American Lung Association. “This will require careful tailoring of treatment to individuals’ disease and circumstance. Physicians should be aware of new guidelines and do so.”

The makers of the four drugs will have to add this information to their product labels:

* These drugs must be used along with other asthma medications such as an inhaled corticosteroid.
* The drugs should only be used in people whose asthma is not controlled by other drugs.
* They should be used for the shortest time possible to bring asthma under control, and then other asthma drugs should replace them.
* Children and adolescents who need these drugs should use only combination drugs that contain both a LABA and a corticosteroid.

Although the drugs are also approved for use in chronic obstructive pulmonary disease (COPD), this warning only applies to their use by asthma patients, the agency said.

In addition, the FDA is requiring that manufacturers of these drugs do more studies to determine the safety of the medications when combined with inhaled corticosteroids.

One industry representative said her company supported the FDA move.

“AstraZeneca supports the efforts of the FDA to share additional benefit/risk information within the product label and will work closely with the FDA to make the appropriate changes,” said company spokeswoman Dana Settembrino. “AstraZeneca is confident in the positive benefit-risk profile of Symbicort, which has been demonstrated by extensive clinical trial data and through use by millions of patients worldwide.”

Thursday’s announcement follows an FDA advisory panel decision in December 2008. The panel found that the risks linked to single-agent Serevent and Foradil outweighed their benefits for children and adults. At the time, Advair and Symbicort were excluded from that decision.

Technorati Tags: advair, Asthma Drugs, Asthma Drugs Warning, Serevent

New research suggests that young children and teenagers with type 1 diabetes could benefit by using an artificial pancreas device to lower the risk of dangerously low blood sugar levels during sleep and help them control their disease.

The findings, which appear in the Feb. 5 issue of The Lancet, examined use of an artificial pancreas by people aged 5 to 18 in a hospital setting.

The device, which combines blood sugar sensors and insulin pumps, give doses of insulin as needed to patients as they sleep.

Controlling blood sugar at night is a challenge for people with type 1 diabetes. If blood sugar levels drop to dangerously low levels, diabetics can suffer from seizures, coma and even death.

The researchers found that the study participants spent twice as much time during the night at targeted glucose levels when they used the artificial pancreas system compared to when they tried a “manual” approach.

“These studies show that automated systems not only can help people manage diabetes by maintaining good control, they will also improve quality of life for the people with type 1 diabetes and their families by lowering the risk for hypoglycemia,” principal investigator Roman Hovorka, of the Institute of Metabolic Science at the University of Cambridge in England, said in a news release from the journal. “These results suggest that closed-loop devices may be able to significantly lower the patient’s risk of developing complications later in life by reducing or even overcoming the burden of hypoglycemia.”

Technorati Tags: Artificial Pancreas, hypoglycemia, manage diabetes, Type 1 Diabetics

People who buy prescription medications over the Internet, especially drugs purporting to treat erectile dysfunction, are playing Russian roulette with their lives, a new study contends.

At best the drugs won’t help you and at worst they could kill you, the review article said.

“You may be wasting your money or you may actually be hurting yourself,” said Dr. Margaret E. Wierman, professor of medicine at the University of Colorado at Denver and chief of endocrinology at the Denver VA Medical Center, who was not involved with the study.

Counterfeit Internet drugs are a mushrooming problem. Seizures of fake drugs in Europe quadrupled between 2005 and 2007. And the number of investigations undertaken by the U.S. Food and Drug Administration increased by a factor of eight between 2000 and 2006, according to the study, published in the International Journal of Clinical Practice.

The sale of counterfeit drugs has almost doubled in the last five years, and will hit $75 billion in 2010, according to one estimate, making it one of the more lucrative illicit drug markets.

As many as 2.5 million men in Europe may have taken counterfeit sildenafil (Viagra), the study authors stated.

“It’s a very significant problem and I think there are people who are being injured,” said Dr. Ira D. Sharlip, a spokesman for the American Urological Association and clinical professor of urology at the University of California, San Francisco. “The only way to avoid the problem is not to buy on the Internet.”

Viagra-like tablets bought on the Internet aren’t necessarily any cheaper than the real thing, but they do allow buyers to avoid the shame factor often associated with asking for this type of drug.

“The motivation is the anonymity of buying drugs on the Internet. It’s embarrassing to some men to go to a pharmacy and pick up his Viagra prescription, and it’s also embarrassing for some men to go to a doctor and say, ‘I have erectile dysfunction. I need some Viagra,’” Sharlip said.

The problem of fake drugs isn’t limited to impotence treatments. According to the study, two pregnant women died after they were given injections of a counterfeit iron preparation for anemia, and 51 children died in Bangladesh of kidney failure after taking paracetamol syrup that was contaminated with diethylene glycol, which is often used as antifreeze in cars.

So many things can go wrong with Internet purchases.

“The purity of the medication or the quality of the medication is under no sort of scrutiny or any type of oversight to determine if, first of all, it is the correct medication. And second, if it is correct is it in the correct dosage?” said Dr. Michael Chehval, chief of urology at St. Louis University.

Study author Dr. Graham Jackson, a cardiologist at London Bridge Hospital in the United Kingdom, said: “The first danger is people don’t know what’s in it. Some are just talcum powder or brick dust, while some have a bit of Viagra or Cialis and some chemicals that have nothing to do with it. One batch actually contained amphetamine, which is an addictive drug. Tablets are made shiny with road paint or shoe polish. The content of the medication could be anything.”

In 2008, four men in Singapore died after ingesting counterfeit impotence drugs that had been contaminated with a blood-sugar-lowering agent, the study reported.

And bypassing the involvement of a competent doctor means red flags could be missed.

“Erection problems can be an early warning sign of heart disease or diabetes,” Jackson said. “If you do have a problem and don’t see a doctor, diagnosis of those important conditions can be missed. Men with no symptoms at all who get an erection problem usually are an average of three to five years away from a heart attack. Instead of going to the Internet, they should be going to their doctors to find out if they are at risk and to do something about it.”

Problems also can occur when the impotence drugs actually do contain phosphodiesterase type 5 inhibitors (PDE5), the main ingredient in Viagra, as well as vardenafil (Levitra) and tadalafil (Cialis).

“People with underlying heart problems are at risk for cardiac events if they take this class of medication,” Chehval said.

According to the review article, about one-third of men reported sidestepping a health-care professional when buying erectile dysfunction drugs.

“This is a really serious issue. We can fix the erectile dysfunction and we can also fix the chances of getting a heart attack,” Jackson said.

Jackson is editor of the journal and reported multiple ties to pharmaceutical companies, including Pfizer, which makes Viagra. The review article covered more than fifty studies published between 1995 and 2009 and was conducted by British, Swedish and American researchers.

Technorati Tags: buy prescription medications, cialis, erectile dysfunction drugs, fake drugs risks, Levitra, Viagra