FDA Issues ‘Black Box’ Warning for Serevent

The Food and Drug Administration issued a “black box” warning in 2003 for all drugs containing salmeterol, a long-acting beta-2 agonist bronchodilator (LABA). The FDA is urging patients to stop using any medication that contains salmeterol, including Serevent.

Intended to treat dilated bronchial muscles in asthma and chronic obstructive pulmonary disease (COPD) patients, salmeterol has been linked to 13 deaths in several clinical trials. It has also caused more severe asthma attacks in many patients. Research has suggested that salmeterol causes the opposite of the intended results, often constricting and tightening airways and inhibiting breathing.

Serevent Uses and Side Effects

Serevent is a prescription medication that is used to treat bronchospasms, or sudden narrowing of the airways. Many physicians prescribe Serevent to patients suffering from asthma or COPD. Serevent, manufactured by GlaxoSmithKline, is one of the most commonly prescribed salmeterol-based medications in the United States.

Patients can experience a wide range of Serevent side effects, including:

  • Asthma
  • Back pain
  • Bronchitis
  • Chest congestion
  • Cough
  • Diarrhea
  • Dizziness
  • Dry mouth
  • Headache
  • Insomnia
  • Nasal inflammation
  • Nausea
  • Pallor
  • Respiratory tract infection
  • Sinus headache
  • Sinus infection
  • Sore throat
  • Stomachache
  • Sweating
  • Tremor
  • Vomiting

Serevent and other salmeterol-based medications can also increase the risk of death caused by severe respiratory disease.

Contact a Serevent Lawyer

The law firm of Aylstock, Witkin, Kreis and Overholtz hold vast experience filing claims against defective drug manufacturers like GlaxoSmithKline. Drug companies are required to thoroughly test their products before they are released on the market, as well as properly warn consumers of any possible side effects. Companies that fail to do so, like GlaxoSmithKline, can be held negligent and are vulnerable to personal injury claims. In many instances, AWKO Law successfully completes compensatory damage claims on behalf of the victims, giving them compensation for expensive medical bills, lost income and emotional distress. To learn more about filing a claim against GlaxoSmithKline, contact our defective drug lawyers at (844) 794-7402.