Asthma Drug Proven to Make Patients Worse than if taking Placebo

If you suffer from asthma, you may rely on prescription medication to lessen your symptoms. But there’s one particular drug out there that may actually make your asthma worse! The asthma drug,  Accolate (zafirlukast), shows benefits for the first five weeks, and then becomes ineffective.  Within seven weeks, the drug becomes completely ineffective and asthma symptoms worsen upon withdrawal of the drug. Keep reading for more details on this important discovery.

A drug prescribed for asthma could be worse than a placebo, according to a recent report. The asthma drug,  Accolate (zafirlukast), shows benefits for the first five weeks, and then becomes ineffective.  Within seven weeks, the drug becomes completely ineffective and asthma symptoms worsen upon withdrawal of the drug. 

These are results from an Australian study that was published in the Journal of Negative Results in BioMedicine.
Why was this drug approved for asthma?

Studies that have been conducted prior to this Australian study were based on shorter periods of time. According to the report, the studies "have been undertaken over short periods of six weeks or less, which may not have allowed sufficient time for tolerance . . . to develop or be recognized."

What are the side effects of Accolate?

• Headaches
• Nausea
• Diarrhea
• Churg-Strauss Syndrome (vasculitis of the lungs)
• Hepatitis and other liver disease
• Pneumonia

The FDA only requires a drug that is to be prescribed for long term use be tested a minimum of six weeks. Unfortunately, this drug has since been proven to offer no long term benefits and can actually cause damage to the liver. 

Why is the Journal of Negative Results in BioMedicine so different from other medical journals?
The Journal of Negative Results in BioMedicine is different in that it reports the negative results of failed studies.  This is important because people need to know when studies show a medication will not work.  It is rare to find negative results of studies published. 

All results should be considered as a valuable source, whether those results are positive or negative. 

Australian Study Details
The study conducted was a double-blind placebo-controlled study.  The first group consisted of 21 people that took only beta2, which was to relieve asthma attacks.  They ranged from ages 21-69, with a median age of 41.  There were 11 males and ten females. 

Group two consisted of 24 people who took both the beta2 to relieve asthma attacks and corticosteroids. They ranged in age from 19-64, with a median age of 42.  There were 10 males and 14 females.

Both groups were randomized to decide which would receive the Accolate and which would receive the placebo.
All of the people were asthmatics who had not benefited from the use of beta2-agonists alone for at least one year, or they took a moderate to high dose of inhaled corticosteroids plus beta2-agonists for at least four weeks prior to the trial.

How were people excluded from the trial?

Those people with:

• Upper respiratory tract infections
• Changes in asthma medication during the previous six weeks
• Usage of oral corticosteroids in three months prior to test   

Also, anyone who took the following medications was excluded from the study:

• Long-lasting beta2-agonist,
• Anticholinergic
• Cromone
• Theophylline

Five of the 43 people did not complete the study.  27 of the remaining subjects took Accolate and 13 took a placebo.

The trial test lasted 14 weeks.  This consisted of one screening week, 12 weeks of actually taking the drugs and one week seeing if there were any withdrawal effects. 

What did this new study reveal?
As stated above, the study revealed that Accolate does more harm than good with decreased effectiveness and a potential for liver damage.  This 14-week study proved that the standard the FDA uses on the time a drug is tested is not effective.  The FDA should consider other measurements for testing the effectiveness of long term drugs.  If a longer study would have been done, Accolate would have been proven to be ineffective from the very start.

If you are taking Accolate, it might be a good idea to check with your doctor to see if there is a better option. After all, your ability to breathe is nothing to mess with.