Trusted Pharmacy Blog|New Drugs, Drug News, Health, Medications, Diseases

The FDA has expanded the approved age range for Menactra (Sanofi-Pasteur), a bacterial meningitis vaccine, to include children two to 10 years of age.

Menactra was first approved in January 2005 for children and adults from 11 to 55 years of age. Previously, Meno-mune was the only meningococcal vaccine available in the U.S. for use in children two years of age and older. Both vaccines offer protection against four groups of Neisseria meningitidis, the bacterium that can cause meningitis.

Read the rest of this entry »

The first generic versions of oxcarbazepine (Trileptal drug, Novartis), an anticonvulsant drug, have been approved. Oxcarbazepine is indicated for use alone or in combination with other medications to treat partial seizures in adults and children four years of age and older.

The tablets will be available in three strengths (150 mg, 300 mg, and 600 mg) and are manufactured by Roxane Laboratories, Glenmark Pharmaceuticals Ltd., and Sun Pharmaceutical Industries Ltd.

(Source: FDA, October 10, 2007.)

The U.S. Food and Drug Administration (FDA) has approved Afluria, a seasonal influenza vaccine for immunizing people 18 years of age and older against influenza type A and type B flu viruses.

Manufactured by CSL Ltd. of Australia, the vaccine received accelerated approval. In this case, the company demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Read the rest of this entry »

In October, the FDA stated that it had received 30 reports of acute pancreatitis in patients taking exenatide (Byetta, Amlyn Pharmaceuticals) for the treatment of type-2 diabetes. Of 30 patients, 27 had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, or alcohol use.

In six patients, the pancreatitis symptoms began or worsened soon after the dose of exenatide was increased from 5 mcg twice daily to 10 mcg twice daily. Twenty-one patients were hospitalized.

Read the rest of this entry »

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.)

Although imatinib mesylate (Gleevec, Novartis) has been a boon to many patients with chronic myelogenous leukemia, it does not always succeed in prolonging life. But now patients with imatinib resistance may have another reason for hope: tipifarnib (Zarnestra, Johnson & Johnson).

In a phase 1 study at MD Anderson Cancer Center in Houston, Texas, 26 patients who did not respond to imatinib were treated with imatinib plus tipifarnib for three to 150 weeks. The combination demonstrated significant clinical activity: 17 of 25 evaluable patients (68%) showed complete hematological responses. Nine patients (36%) achieved cytogenetic responses. The median duration of response was three months (range, 2 to 30+ months).

Read the rest of this entry »

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.

Read the rest of this entry »