Pfizer updates Chantix labeling
NEW YORK Pfizer’s smoking cessation drug Chantix has updated its label to include a warning that patients who are attempting to quit smoking with the drug should be observed for serious neuropsychiatric symptoms, including changed in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior, based on post-marketing reports.
The current update, based on Pfizer and FDA’s ongoing safety review of post-marketing reports, is provided to better ensure that healthcare providers and patients will appropriately consider this information in their discussions about Chantix. A causal relationship between Chantix and these reported symptoms has not been established. In some reports, however, an association could not be excluded.
In the clinical trial, more than 5,000 patients were treated with Chantix and changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior occurred at a rate comparable to placebo-treated patients.
According to Pfizer’s chief medical officer, Joe Feczko, “Chantix is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today’s labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication.”
Study shows positive results from adding Lipitor early to blood pressure treatment
NEW YORK According to a new study, when Lipitor was added as an early treatment to lower blood pressure, the drug showed a 36 percent reduction in the risk of fatal or non-fatal heart attacks over five years.
The study, entitled Anglo-Scandinavian Cardiac Outcomes Trial, was conducted over a five-year period in Europe with over 19,000 patients, with the first three years being dedicated to comparing Lipitor, a Pfizer product, with a placebo. The additional two years were used for post-study follow up. At the start of the study, patients had high blood pressure and additional cardiovascular risk factors but no coronary heart disease.
“This study highlights the importance of initiating medical treatment for both blood pressure and cholesterol as soon as possible, and raises questions about medical guidelines that do not focus on early intensive treatment of multiple risk factors, notably blood pressure and cholesterol, in patients with moderate cardiac risk,” according to Bryan Williams, chairman of the British Hypertension Society Guideline working party and professor of medicine, University Hospitals NHS Trust, Leicester, United Kingdom.
Patients in ASCOT-LLA had normal to mildly elevated cholesterol levels, were not candidates for lipid-lowering treatment at the time of the study initiation, and received Lipitor 10 mg or a placebo at the outset of the trial.
At the end of the follow-up period, LDL-C or bad cholesterol levels were similar in both groups as a result of Lipitor treatment and the average blood pressure level was significantly reduced from 164/95 mmHg to 137/78 mmHg with the blood pressure lowering therapy.
Taro submits Flo-Pred application to FDA in new PLR format
WASHINGTON Taro Pharmaceuticals applied Thursday to the Food and Drug Administration seeking approval for its new oral solution, Flo-Pred.
Flo-Pred (prednisolone acetate oral suspension) is an anti-inflammatory or immunosuppressive agent indicated for a variety of diseases and conditions, including allergic, dermatologic, gastrointestinal and hematologic.
The medication also enjoys the distinction of—pending approval—being the first oral steroid label in the FDA’s new physician labeling rule format. The PLR format, which went into effect June 19, requires new content, new structure and new highlights information, as compared to the former structured product labeling.