Asthmatics Beware: FDA Says Clinical Studies Show Drugs Increase Risk Of Injury & Death

Thousands of asthma deaths occur in the United States every year and the FDA has approved several new asthma drugs over the past several years to combat the problem. But are they safe? If you think the answer to that question is yes, you may want to think again – especially after the FDA's most recent warning on 2/18/10.

Popular asthma drugs may not be as safe as you think

There are several different drugs on the market that address asthma or chronic obstructive pulmonary disease (COPD) such as Advair and Serevent (marketed by GlaxoSmithKline), Foradil (marketed by Merck and Novartis AG) and Symbicort (marketed by AstraZeneca). All of these drugs have serious side effects and already contain FDA black box warnings, the most serious warning the FDA can issue – meaning that medical studies indicate that a drug carries a significant risk of serious injury or death.

Even with those warnings, the FDA recently released new safety information about the drugs, is requiring manufacturers to conduct additional studies and to update labeling information. Here's what the FDA's announcement contained:

Increased risk of asthma exacerbations, hospitalizations and death. The FDA has determined that, after reviewing clinical trials, the use of these drugs should be limited due to an increased risk of asthma exacerbations, hospitalizations and death.

Label changes to LABAs. The FDA is requiring LABA (long acting beta agonist) manufacturers to change the labeling of their products to warn consumers that:

• Children who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications
• Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone
• LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications
• LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms

More clinical studies needed. The FDA has told manufacturers to conduct additional studies on how LABAs are used with inhaled corticosteroids.

Serevent Deaths / Advair Deaths

Product liability attorneys say that there have been numerous deaths linked to Serevent and Advair – the most popular asthma medications on the market – and other salmeterol-based drugs. They also say that, for reasons not yet understood by researchers, African American adults may be at greater risk. If your loved one has died due to the use of Advair, Serevent, Foradil or Symbicort, contact a product liability lawyer in your state to discuss your situation. While you may be entitled to compensation for your loss, keep in mind that every state has its own statute of limitations in which you must file a lawsuit or be barred from so.