Asthma Drug Advair Safety Questioned

2012-11-19 11:24
Safety of Advair questioned

If you or your children have asthma, it's very likely you have been prescribed Advair (fluticasone/salmeterol), the largest selling asthma drug in the United States. But don't let the attractive, brightly colored purple packaging detract you from this drug's potential dangers, as a new review raises safety questions.

How do we treat asthma?

For the estimated 25 million children and adults in the United States who have asthma, there are several ways to help prevent and treat the inflammation and swelling of the lung's airways that characterize this respiratory disease. Two of them are long-acting beta-agonists (LABAs), which address narrowed airways; and corticosteroids, which treat inflammation.

Advair is a combination of a corticosteroid (fluticasone) and an LABA (salmeterol). It is also the most sold asthma drug on the market, topping $4 in sales annually since 2007.

The recommended first line of treatment for mild to moderate asthma is steroids alone (e.g., budesonide, mometasone, flunisolide, among others), while Advair and similar asthma drugs are recommended for severe asthma that has not responded well to steroids alone. However, a 2010 study conducted by Medco Health Solutions discovered that nearly 66 percent of people with mild asthma were taking the combination drug, usually without first trying a steroid.

As is often the case, taking more of something, whether it's drugs, natural supplements, or herbal remedies, typically does not result in a better response, and in fact can cause significant health problems. Such may be the case with Advair.

According to the Journal Sentinel/MedPage Today review, one reason why Advair and similar combination drugs may be dangerous, including the risk of death, is that LABAs like salmeterol may hide worsening lung inflammation. Therefore, although patients may feel better, they are actually getting worse.

Deaths due to asthma
Reports on the numbers of asthma deaths are conflicting, and one reason may be that reporting adverse events associated with drug use is voluntary. For example:

  • In 2008, one Food and Drug Administration (FDA) researcher, David Graham, MD, estimated that drugs contributed to 14,000 asthma deaths from 1994 to 2007. The well-known whistleblower noted that while experts have no way of knowing which patients will respond well to Advair, "we have no way of predicting who's going to end up in the cemetery because of Advair" either.
  • A private company called AdverseEvents Inc estimated that LABAs were linked to 1,900 asthma deaths from 2004-2011 and that LABAs were the main culprit in 3,500 hospitalizations. Advair was the asthma drug used in the vast majority of the cases.
  • The Centers for Disease Control and Prevention reported 3,388 asthma-related deaths in 2009.

Concerns about the safety of Advair and similar asthma drugs have triggered more studies, including FDA safety trials that will involve 46,800 individuals ages 12 and older and one for 6,200 children ages 4 to 11 years old. Results of these trials will not be available until 2017, however. So what should people do in the meantime? Is Advair safe?

Advair maker takes a stand
GlaxoSmithKline, which makes Advair, has insisted the drug is safe. However, the company recently (July 2012) agreed to pay $3 billion to settle civil and criminal allegations filed against it by the US Department of Justice, which claimed the pharmaceutical giant unlawfully promoted Advair and other drugs.

The specific claim about Advair was that GlaxoSmithKline promoted the asthma drug as a first-line treatment for people who have mild asthma even though the medication was not approved or medically appropriate for that use. Government officials also claimed the company paid kickbacks to doctors as an incentive to have them recommend Advair to patients.

According to a statement made by GlaxoSmithKline CEO Andrew Witty in response to these charges and the settlement, the company as "fundamentally changed" how it markets and sells its products. Company spokesperson Karen Collins noted that "The company reached this settlement with the government to avoid the delay, expense, inconvenience and uncertainty of protracted litigation of the government's claims."

Other forces were also behind the rise of Advair in the asthma-treatment market. For example:

  • The National Heart, Lung and Blood Institute published guidelines in 2007 for treating asthma, in which the 18-member group stated LABAs should be the preferred add-on treatment along with inhaled steroids for patients aged 12 and older. Fifteen of the group's members reportedly had financial ties to GlaxoSmithKline or other companies that sold LABAs.
  • The watchdog organization ProPublica reported that from 2009 through 2011, companies that made LABAs paid more than $400,000 to nine physicians in the guideline writing group
  • Since 2008, the American Academy of Allergy, Asthma & Immunology received $4.7 million from companies that market LABAs, and about $2.6 million was provided by GlaxoSmithKline.

The bottom line
The new Journal Sentinel/MedPage Today review highlights questions and concerns regarding the safety of the asthma drug Advair. If you or your children are using Advair, you may want to ask your doctor questions about the drug's safety and about possible alternative treatments.

SOURCES:
Centers for Disease Control and Prevention
Journal Sentinel
MedPage Today

Image: Morguefile

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Comments

Asthma is not caused by a lack of drugs, and prescribing drugs that hide symptoms is unscientific! As a Kinesiologist we look at causes of diseases. There are two culprits when it comes to asthma: cow's milk and lack of water. Cow's milk is the leading cause of asthma, especially in infants, and nearly everyone who stops consuming dairy products for 30 days sees their asthma improve dramatically or disappear altogether. Lack of water is the second leading cause, and the sad fact is that most asthma sufferers live their entire lives in a state of chronic dehydration. The constriction of capillaries in the lungs is the body's way of reducing water loss during respiration. This physiological response is frequently and inappropriately diagnosed as asthma by doctors. What doctors need to be prescribing is water, not steroids, and they need to be telling their patients to drink only water, not soft drinks, not juice, no coke, and certainly not cow's milk.
Thank you for your comments and for sharing enlightening information about the importance of avoiding cow's milk and increasing one's intake of water to help prevent asthma. I'm sure many people are unaware that these steps could help them with their battle with asthma.
Mary, as a kinesiologist you have but one approach. Please, let me just express an opinion that (appropriate) medications can be lifesaving until lifestyle changes take place. There is no one answer to approaching illness. Western medicine and drugs have an important place. It would be dangerous to suggest that MD's should do anything different than what they are doing, just as it would be dangerous for a kinesiologist to prescribe medications or do surgery - However, again - I do respect your passion and comments. :)
Ms. Blanchard has offered important information for readers to consider. Individuals who have asthma could do well to consider and investigate both conventional and alternative options to the prevention and treatment of asthma. Lifestyle modifications can be an integral part of one's management of asthma.
That brings up another interesting topic - for Mary - Isn't it sad how many people globally don't even have access to clean drinking water? That could be another entire discussion. Again, thank you!
And here, as you mentioned, we enter a different discussion, and we could go into the dangers of chlorine, and fluoride, and heaps of other 'goodies in our drinking water. But we'll leave that for another discussion.
:) Bless you Mary for your contributions.
Hi again, Kathleen, 18,000 needless deaths a year This infamous figure of 18,000 deaths per year was released in Federal Parliament by Minister for Health the Honorable Carmen Lawrence then published in the Medical Journal of Australia in 1995. The figure is actually extrapolated from a statistically valid sample of 14,179 hospital admissions. It is understood that this is the tip of the iceberg. Official Australian government reports reveal that preventable medical error in hospitals is responsible for 11% of all deaths in Australia, which is about 1 of every 9 deaths. If deaths from properly researched, properly registered, properly prescribed and properly used drugs were added along with preventable deaths due to private practice it comes to a staggering 19%, which is almost 1 of every 5 deaths. Put another way, more than 5 million people have been killed by Western medical practice in the past decade (Europe, USA, Canada, Australia, and NZ) and 20 million killed or permanently maimed. It goes to show you that 'appropriate' medication can be like Russian roulette. I might also point out that in 2011 the road toll for Australia was about 1500 and the death toll through Kinesiology was 0 I might add that
I think the message to health care consumers might be pay attention to your body and health needs and intervene early then. Otherwise...
As a Kinesiologist we are trained to look for causes of disease rather than hide symptoms behind a veil of drugs. Drugs are not scientific! It is not even pseudo-science! We find there are two culprits when it comes to asthma: cow's milk and lack of water. Cow's milk is the leading cause of asthma, especially in infants, and nearly everyone who stops consuming dairy products for 30 days sees their asthma improve dramatically or disappear altogether. Lack of water is the second leading cause, and the sad fact is that most people live their entire lives in a state of chronic dehydration. The constriction of capillaries in the lungs is the body's way of reducing water loss during respiration. This physiological response is frequently and inappropriately diagnosed as asthma by doctors. What doctors need to be prescribing is water, not steroids, and they need to be telling their patients to drink only water, not soft drinks, not juice, not punch, and certainly not cow's milk. The casein in cows milk is used to make glue! If you ever tried to get a label off a jar you will have noticed how tough the glue is? That is casein. It glues the capillaries in your lungs together. "In all respiratory conditions, mucous-forming dairy foods, such as milk and cheese, can exacerbate clogging of the lungs and should be avoided," writes Professor Gary Null in his Complete Encyclopedia of Natural Healing.