The nasal influenza vaccine FluMist (MedImmune) is now approved to in clude children between two and five years of age. Approval had previously been limited to healthy children five years of age and olderand to adults up to age 49. The vaccine contains a weakened form of the live virus and is sprayed into the nose.
New clinical standards for treating patients with cystic fibrosis (CF) have been released.
A disease, CF affects the lungs and other organs. It is characterized by thick, sticky mucus. CF is always fatal, but thanks to advances in therapy over the last 60 years, life expectancy has increased from a few years to 36 years. Lung disease accounts for 85% of the mortality rate among patients with CF.
Aerosolized antibiotics, recombinant human DNase (dornase alfa), hypertonic saline inhalation, anti-inflammatory agents, macrolide antibiotics, bronchodilators, and N-acetylcysteine were evaluated for safety and efficacy. Because of the scarcity of studies performed in children younger than six years of age, the recommendations apply to patients six years of age and older.
The treatments with the most consistent results yielding “A” and “B” grades and positive recommendations included inhaled tobramycin, dornase alfa, hypertonic saline, and beta2-adrenergic receptor agonists.
The guidelines recommend against using systemic corticosteroids in children, inhaled corticosteroids (excluding patients with concomitant asthma), and prophylactic anti-staphylococcal antibiotics. All other treatments lacked sufficient evidence to recommend for or against their use.
The guidelines are scheduled to be updated every five years.
(Source: Am J Respir Crit Care Med, American Thoracic Society, November 15, 2007.)
An Early Communication has been issued about varenicline (Chantix, Pfizer), which is approved as an aid to smoking cessation drug. This notice does not mean that the FDA perceives a causal relationship between the drug and the emerging safety problem.
Abbott Laboratories has announced the FDA’s approval of a lower-strength tablet formulation of its HIV protease inhibitor lopinavir/ritonavir (Kaletra). Kaletra is also marketed as Aluvia in developing countries.
The new formulation complements Kaletra oral solution, which has been available for pediatric use since its approval in 2000 in the U.S. The tablets will contain lopinavir 100 mg and ritonavir drug 25 mg; the original tablet contains lopinavir 200 mg and ritonavir 100 mg, the form most commonly used by adults.
A supplemental New Drug Application (sNDA) has been approved for sorafenib tablets (Nexavar, Bayer/Onyx) to treat unresectable hepatocellular carcinoma. This form of liver cancer is responsible for almost 90% of primary malignant liver tumors in adults.
Hepatocellular carcinoma is extremely aggressive. If the cancer isn’t removed completely through surgery, patients usually die within six months.
The FDA is warning health care professionals of liver injury associated with the use of the antithyroid propylthiouracil (PTU) for the treatment of Graves’ disease. An increased risk of liver damage was identified with this drug when compared with methimazole, an alternative therapy for Graves’ disease.
The FDA has approved a vaccine for 2009-2010 seasonal influenza in the U.S. This vaccine does not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization on June 11,
2009.