home
RSS
February 18th, 2010
07:49 PM ET

FDA announces new asthma medication labeling

By Saundra Young
CNN Medical Senior Producer

If you are an asthmatic who uses long-acting beta agonists–or LABAs– to treat your asthma symptoms, your medication may be doing more harm than good.

The Food and Drug Administration announced new safety warnings Thursday saying the medications should never be used alone by children or adults. The agency says it will require manufacturers to add additional warnings to the product labels, and ask doctors and patients to scale back overall use of the drugs.

"Patients with asthma should try to get on a single-agent steroid inhaler," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "And not try to get on combination medications with LABAs unless they really need them"

According to the FDA, LABAs put asthma patients at increased risk of severe, worsening symptoms; they lead to increased hospitalizations and even death. The LABAs in question contain the single drug Serevent or Foradil and can be in the combination medications Advair and Symbicort, which also contain inhaled corticosteroids. Corticosteroids supress inflammation and help reduce symptoms in inflammatory ailments such as asthma and arthritis. Advair contains Serevent, whose active ingredient is Salmeterol. Symbicort has Foradil; its active ingredient is Formoterol.

"Although these medications play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death." said Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research.

Children are of particular concern, said Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics. "Parents need to know that their child with asthma should not be on a LABA alone."

The new labels will warn that:
*LABA use is contraindicated unless used with asthma controller medication such as an inhaled corticosteroid. Single-agent LABAs should be used only in combination with an asthma controller medication, never alone.

*Long-term use should be only in patients whose asthma can't be controlled by controller medications

*LABAs should be used only for the shortest amount of time possible, and discontinued once asthma has been controlled. Patients should then be maintained on an asthma controller medication.

*Pediatric and adolescent patients who need a LABA in addition to inhaled corticosteroids should use a combination product that contains both a LABA and an inhaled corticosteroid

Novartis, maker of Foradil, released a statement saying, "Novartis and Merck will work closely with the FDA to assess the guidance provided in the Communication and determine appropriate next steps. We are committed to helping ensure that healthcare providers and patients have the most accurate and complete information regarding the safe and appropriate use of FORADIL. We will continue communicating with patients, caregivers and healthcare providers about FORADIL in ways that will help inform their decisions about appropriate treatment choices."

GlaxoSmithKline (GSK), which makes both Serevent and Advair, says it has 30 days to agree with the proposed changes - or say why they aren't necessary.

"We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease," said Dr. Katharine Knobil, vice president for Respiratory Clinical Research at GSK. "It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma."

According to the FDA, in a 2008 trial of more than 13,000 patients who took Salmeterol, there were 13 deaths. But GSK says in 10 years of clinical studies, there were no asthma-releated deaths in the nearly 18,000 patients who took Advair.

Drug makers will now have to do additional safety studies that look at LABAs when used with inhaled corticosteroids. And, the agency says it will continue to scrutinize prescribing patterns to make sure the new safety controls are being followed. LABAs are also approved to treat people with chronic obstructive pulmonary disease or COPD. However, the new recommendations apply only to treating asthma patients.


February 18th, 2010
05:21 PM ET

WHO recommends H1N1 be part of next seasonal flu vaccine

By Miriam Falco
CNN Medical News Managing Editor

The World Health Organization is recommending that the H1N1 flu virus that’s currently circulating be included in the next seasonal flu vaccine for the Northern Hemisphere.

The WHO meets twice a year to determine which flu strains are the most dominant and chooses three strains to include in the regular flu vaccine.

Based on recommendations from flu experts from around the world, it was decided at the meeting Thursday in Geneva, Switzerland, that the pandemic H1N1 influenza strain go into the vaccine for the coming fall and winter, according to the Special Adviser on Pandemic Influenza to Dr Keiji Fukuda, director-general of the WHO.

The two other flu strains to be included into the next flu shot or flu
spray are an H3N2 virus and a B-virus. Fukuda said that the fact that the new H1N1 flu strain will be included in the next seasonal flu vaccine does not mean that the H1N1 pandemic is over.

He told reporters in a teleconference that parts of Eastern Europe, parts of Northern and Western Africa and parts of Asia are seeing the highest levels of pandemic H1N1 flu activity.

In a meeting in September, the WHO had already recommended that the seasonal flu vaccine for the Southern Hemisphere contain the H1N1 strain.

Fukuda said so far, "over 200 million people have been vaccinated with
the H1N1 vaccine" and the safety profile of the vaccine has been very good.

While the WHO recommends which strains go into the next flu vaccine, it's up to individual countries to decide whether they want to combine all three recommended strains into one shot, or if they want to have each strain in doled out separately. The pandemic H1N1 strain was not included in this year's flu strain because it emerged in April, about two months after the three seasonal flu strains had been selected for the 2009/2010 flu season.

The Food and Drug Administration's Vaccines and Related Biological
Products Advisory Committee (VRBPAC) is meeting next Monday to decide which flu strains will be included in the next seasonal flu vaccine for the United States.


February 18th, 2010
02:17 PM ET

How do I pick a fish oil supplement?

As a feature of CNNhealth.com, our team of expert doctors will answer readers' questions. Here's a question for Dr. Gupta.

From Stanley in New Jersey:

“With all the different information available on the Web, how does one determine what to look for in a fish oil supplement?

Answer:

Stanley, I’m glad you’re being proactive about your health and considering fish oil. It’s actually one of the few vitamins and supplements I take and there’s plenty of scientific evidence to show it can be a powerful tool in preventing disease. Fish oil supplements contain omega-3 fatty acids, which have been shown to reduce a person’s risk of heart attack and heart disease and protect against stroke, dementia and other cognitive problems.

The American Heart Association even recommends that people with high triglyceride levels take 2 to 4 grams of fish oil supplements containing EPA & DHA. EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) are the two fatty acids in fish oil thought to have the biggest benefits.

However, before taking any supplement you should speak with your health care provider. In the case of fish oil supplements, the FDA warns not to take more than 2 grams of fish oil per day. If you take high doses there can be side effects such as excessive bleeding or possibly an interaction with another medication you’re taking.

To get specifics on what you should look for when choosing your supplement I asked Dr. Brent Bauer. He’s the director of the complementary and integrative medicine program at the Mayo Clinic. He said he recommends three things to his patients:
No. 1 Go big. Look for large manufacturers, which will most likely have been in the business longer and are not a “fly-by-night” outfit you might solely on the Internet.
No. 2 Look for the seal. Companies including USP and NSF analyze supplements for the real vitamin level and for any impurities. The seal on the label tells you an independent company has reviewed the supplement.
No. 3 Check them out. There are groups that offer independent reports (for a fee) of different brands on the market.

I should also add that all the experts I’ve talked to say, if possible, it’s better to get your omega-3s from fatty fish such as salmon and tuna rather than from a supplement.


Advertisement
About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.

Advertisement
Advertisement