Advair Injuries

Synopsis of Prescription Drug Litigation

Advair and Serevent side effects could increase the risk of severe asthma attacks or asthma-related deaths, especially among children. The drugs are approved for use by adults and children as young as 4 for the long-term prevention of asthma. While these inhalers have been shown to decrease the number of asthma attacks, they could severely increase the severity of the attacks that do occur. As a result, there have been a number of reported deaths and hospitalizations directly associated with the use of Advair and Serevent.

Advair® (fluticasone and salmeterol): Manufactured by GlaxoSmithKline (GSK) and approved by the FDA in 2003, ADVAIR DISKUS is a combination steroid (fluticasone) that decreases inflammation in lung airways and a bronchodilator (salmeterol) that helps open constricted airways to help the patient breath. Salmeterol is in a class of drugs called Long-Acting Beta Agonist (LABA). The Diskus device is the delivery system for Advair. It delivers the drugs as a dry powder inhaler (DPI) that the patient orally inhales.

Why is this medication prescribed?: The combination of fluticasone and salmeterol is used to prevent wheezing, shortness of breath, and breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Salmeterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

FDA indications: ADVAIR DISKUS is indicated for the treatment of asthma in patients aged 4 years and older. ADVAIR DISKUS 250/50 is also indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated

What you should know before taking Advair:

• tell your doctor and pharmacist if you are allergic to fluticasone (Flonase, Flovent), salmeterol (Serevent), any other medications, milk protein, or any foods.
• tell your doctor if you use another LABA such as formoterol (Foradil) or salmeterol (Serevent). These medications should not be used with fluticasone and salmeterol inhalation. Your doctor will tell you which medication you should use and which medication you should stop using.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); diuretics ('water pills'); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); isoniazid (INH, Nydrazid); other medications for asthma or COPD; medications for seizures; metronidazole (Flagyl); nefazodone; oral contraceptives (birth control pills); telithromycin (Ketek); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Also tell your doctor and pharmacist if you are taking the following medications or have stopped taking them during the past 2 weeks: antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become weak and fragile), and if you have or have ever had high blood pressure, irregular heartbeat, seizures, hyperthyroidism (overactive thyroid), diabetes, tuberculosis (TB), glaucoma (an eye disease), any condition that affects your immune system, liver disease, or heart disease. Also tell your doctor if you have a herpes eye infection or any other type of infection and if you smoke or use tobacco products, if you do not eat a healthy diet, or if you do not exercise very often.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluticasone and salmeterol, call your doctor.
• if you are having surgery, including dental surgery, tell your doctor or dentist that you are using fluticasone and salmeterol.
• tell your doctor if you have never had chickenpox or measles and have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to these infections or if you develop symptoms of these infections, call your doctor immediately. You may need to get a vaccine (shot) to protect you from these infections.
• Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medication since there can be a potential interaction

Black Box  Warning:

Lawsuits: There have been several lawsuits launched on behalf of patients especially children, throughout the U.S. Some of these have been due to asthma related deaths and serious injury that involved one of the active ingredients in Advair and Serevent which is salmeterol. There have been reports of up to 4,000 fatalities linked to Advair/Serevent side effects.

When to call the Venardi Law Firm: If you have been damaged or hurt by the drug and need an Advair/Serevent attorney, call the Venardi Law Firm. Serious side effects as well as increased chances of severe asthma attacks to asthma-related deaths have occurred with patients using Advair or Serevent.