FDA looks into possible suicide links to asthma, allergy drug  
 

THE ASSOCIATED PRESS
MARCH 28, 2008

WASHINGTON- The Food and Drug Administration said Thursday it is investigating a possible link between Merck's top-selling Singulair and suicide.

The FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the allergy and asthma drug.

Merck has updated the drug's labeling four times in the past year to include information on a range of reported side effects:  tremors, anxiousness, depression, and suicidal behavior.

The FDA said it asked the White-house, N. J. based company to dig deeper into its date on Singulair for evidence of possible links to suicide.  The agency said it has not established a "causal relationship" between Merck's drug and suicidal behavior.  An agency spokeswoman said the review was prompted by three or four suicide reports it received since October.

It could take up to nine months before agency scientists can draw conclusions, the agency said on its Web site.

The FDA recently began notifying the public earlier about possible safety issues.  The policy change came after it was criticized for acting too slowly on information about the risks of Merck's painkiller Vioxx and GlaxoSmithKline plc's diabetes pill Avandia.

Merck officials stressed that the FDA's inquiry is based on reports, not clinical studies, which are the standard tool for evaluating drug safety.  The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.

"We have no indication that anything about the mechanism of Singulair is consistent with those events," said George Philip, director of research and product development.

Merck said it recently added reports of suicide to Singulair's label, which already listed suicidal thinking and behavior as reported side effects.

In clinical trials of asthma patients, the most common side effects were headache, flu, abdominal pain and cough.

"Patients should not stop taking Singulair before talking to their doctor," the FDA said in its statement, adding that doctors should monitor patients for suicidal behavior and mood changes.

 

 

 
  Asthma Medications Have Side Effects  
 

Instead of relying on asthma and allergy drugs that carry the risk of debilitating side effects, here are a few viable alternatives and guidelines to help you prevent or manage your asthma naturally.

  1. Apples and selenium – Research has found that eating at least two apples per week can reduce your asthma risk by 22 to 32 percent. And, people with the highest intakes of selenium ( 54 to 90 micrograms a day) have been found to be about half as likely to have asthma as those who consumed the least amount of selenium (about 23 to 30 micrograms daily)
  2. Vitamin E -- Since asthma involves increased levels of free radicals (oxidants), antioxidants such as vitamin E may reduce the likelihood of asthma by reducing levels of these compounds
  3. Healthy exposure to bacteria and viruses – There’s a strong hypothesis that exposure to viral infections or endotoxins in early childhood is protective against the development of asthma. It seems clear that you need exposure to bacteria for a healthy immune system, as natural bacteria and viruses act as natural vaccines
  4. Breast feeding -- Research has found that introducing milk other than breast milk to infants younger than 4 months old increases their risk of developing asthma
  5. Avoid antibiotics -- If allergies are making your life unbearable and you find you can't go a day without your inhaler, the real culprit might not be your congested head; it could be the microbes in your gut. Scientists have shown that antibiotics can change the balance of microbes in your gastrointestinal tract, which in turn has an impact the way your immune system responds to common allergens in your lungs.
  6. Avoid fish but take Omega-3 -- Frequent fish intake has been linked with asthma, which is most likely due to heavy mercury contamination However you can obtain your animal omega-3 from other cleaner sources like krill oil.
    Address Underlying emotions. There are a number of good case studies documenting the effectiveness of EFT for asthma. Here are two:
    Asthma Relief Without Medications
    How a New Multi-Purpose Healing Method Relieved an Asthma Attack in Minutes
 
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