Asthma Drug Advair Safety 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.