PHARMACY

New USP standards to decrease heparin potency, FDA warns

BY Alaric DeArment

ROCKVILLE, Md. New standards for heparin will reduce the potency of the blood thinner, the Food and Drug Administration has warned.

The FDA alerted healthcare professionals Thursday that new manufacturing standards for heparin adopted by the United States Pharmacopeia to ensure its quality and guard against contamination would decrease the potency of the drug, requiring adjustments to achieve the desired anticoagulant effects.

Supplies of heparin conforming to the new standards will begin shipping Oct. 8.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that healthcare professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said John Jenkins, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Clinical trial results conclude Novartis’ MS drug yields ‘significant’ results

BY Alaric DeArment

BASEL, Switzerland Patients taking an investigational drug for multiple sclerosis experienced “significant” reductions in relapses and disability progression, according to results of a late-stage clinical trial released Wednesday.

Novartis said initial results of a phase 3 study of the oral MS drug FTY720 (fingolimod) reduced relapse rates by 54% to 60%, compared to placebo, and reduced disability progression by 30% to 32%.

The company said the reduction in relapses was greater than in patients taking interferon beta-1a, a standard of care. A biologic, interferon beta-1a is marketed in various forms under such brand names as Biogen Idec’s Avonex, Merck KGaA’s Rebif and Bayer HealthCare’s Betaseron.

“We are proud to have reached this critical milestone in the development of FTY720, a novel oral therapy that has the potential to transform the treatment of this ultimately disabling disease,” Novartis Pharma global head of development Trevor Mundel said in a statement.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Study finds diabetes most prevalent in southern United States

BY Allison Cerra

NEW YORK Diabetes prevalence is highest in the Southern and Appalachian states, and lowest in the Midwest and the Northeast of America, a new study found.

Researchers writing in BioMed Central’s open access journal Population Health Metrics used two public data sources to investigate the prevalence of diagnosed and undiagnosed diabetes mellitus at the state level.

Goodarz Danaei, from the Harvard School of Public Health in Boston, worked with a team of researchers to combine the data from the National Health and Nutrition Examination Survey and the Behavioral Risk Factor Surveillance System.

“Diabetes mellitus is the sixth leading cause of death in the United States, accounting for approximately 70,000 annual deaths,” Danaei said. “To our knowledge, this is the first study to estimate what the true level of diabetes disease is in every state and how the different states perform in terms of diagnosed versus undiagnosed diabetes.”

Age-standardized diabetes prevalence was highest in Mississippi, West Virginia, Louisiana, Texas, South Carolina, Alabama and Georgia, ranging from 15.8% to 16.6% for men and 12.4% to 14.8% for women. The lowest prevalences were found in Vermont, Minnesota, Montana, and Colorado, just 7% for women in the Northeast and some Western states. These results currently provide the only estimates of total diabetes and undiagnosed diabetes in U.S. states.

According to Danaei, “States like Mississippi and Alabama with the highest estimated diabetes prevalence in our analysis also have the highest levels of blood pressure and cardiovascular disease risk. This concentration of cardiovascular risks and diabetes points to the need for lifestyle and health care interventions in these states.”

The researchers hope their figures will provide motivation, guidance, and benchmarks for designing, implementing, and evaluating diabetes prevention and state level control programs at the state level.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?