Serevent Diskus Lawsuit

Serevent Diskus Side Effects

              Servent Diskus, a salmeterol xinafoate inhalation powder, is a plastic inhalation delivery system that is specially designed containing a double foil blister strip of powder formulation used to treat asthma and to prevent bronchospasm in patients. The powder formulation consist of 50mcg sameterol assalmeterol xinafoate salt in 12.5mg of formulation containing milk protein.

Serevent Diskus is indicated for maintenance treatment of asthma and to prevent bronchospasm. Serevent Diskus can only be used in patients 4 years of age or older and who have reversible obstructive airway disease. This includes patients with symptoms of nocturnal asthma.

Serevent Diskus should be used only as an additional therapy for patients whose athsma is not adequately controlled on other asthma-controller medications, such as low or medium dose inhaled corticosteroids, or whose severity clearly warrants initiation of treatment with 2 maintenance therapies, Serevent Diskus included.

Serevent is to be inhaled by the oral route only and patients should not ever exhale into the Diskus. Diskus should only be used in a horizontal, leveled position.

Serevent Diskus is provided in a unit containing 60 blisters that is teal green. The product is packaged in a plastic-coated, moisture-protective foil.         

In the case of an overdose, Serevent Diskus should be discontinued and the appropriate symptomatic therapy should begin. The judicious use of a cardioselective beta-receptor blocker may be considered but such medication can produce bronchospasm. There is not enough evidence to determine if dialysis is beneficial for overdosage of Serrevent Diskus. Cardiac monitoring is suggested in cases of an over dose.

Some signs and symptoms of overdose of Serevent Diskus are those of excessive beta-adrenergic stimulation of seizures, tachycardia with rates up to 200 beats/min, angina, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, hypertension or hypotension, fatigue, malaise, and insomnia. Exaggeration of the pharmacologic adverse effects associated with beta-adrenoceptor agonists, including tachycardia and/or arrhythmia, headache, tremor, and muscle cramps may be expected as a result of an overdose of Serevent Diskus. An overdose of Serevent Diskus can lead to clinically significant prolongation of the QTc interval and can produce ventricular arrhythmias. Cardiac arrest and even death may be associated with abuse of Serevent Diskus, as with all sympathomimetic medications.

Side effects lawsuit

The harmacologic effects of beta2-adrenoceptor agonist drugs are in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP).

A U.S. Food and Drug Administration (FDA) panel has called for restrictions on serevent. The FDA posted documents detailing nine patients under the age of 16 where injured while taking Serevent. Of these five died after the medication was approved for children in 2006. The FDA wanted a study to assess the benefits and risks of Serevent and Advair but it accepted that it would be difficult to find enough children to participate in such a clinical trial. A more formal analysis of data regarding Serevent and Advair was recommended to be conducted. A label with new language more specific to children was the ultimate recommendation by the FDA.

Side effect and adverse reactions of Serevent include:

 Nasal/sinus congestion
pallor
Rhinitis
Headache
Asthma
Tracheitis/bronchitis
Influenza

Side effects lawsuits