PHARMACY

FDA updates labeling for birth control patch to reflect risk of blood clots

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved additional changes to the labeling for the Ortho Evra patch, made by Ortho McNeil Pharmaceuticals, to include the results of a new study that found users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism, which can lead to a pulmonary embolism.

The Boston Collaborative Drug Surveillance Program on behalf of Johnson & Johnson conducted the study. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.

Ortho Evra is a prescription patch that releases the hormones ethinyl estradiol and norelgestromin through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including VTE.

Women should discuss with their health care providers the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.

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Study shows positive results from adding Lipitor early to blood pressure treatment

BY Drew Buono

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.

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Taro submits Flo-Pred application to FDA in new PLR format

BY Adam Kraemer

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.

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