FDA adds boxed warning to Plavix
ROCKVILLE, Md. A popular drug for preventing blood clots may be less effective when taken by a small percentage of patients, the Food and Drug Administration warned healthcare professionals and patients Friday.
The Food and Drug Administration is adding a boxed warning, the strongest possible warning label that a drug can have, to the safety labeling for Bristol-Myers Squibb’s and Sanofi-Aventis’ Plavix (clopidogrel). The action follows recent data showing that patients with reduced functioning of a liver enzyme may not be able to fully metabolize the drug, leaving them at continued risk for heart attack, stroke and cardiovascular death. The FDA added a warning for these so-called “poor metabolizers” in May 2009, but the boxed warning upgrades it.
Plavix requires the enzyme, called CYP2C19, in order to break down the drug in the body, but between 2% and 14% of the U.S. population has reduced CYP2C19 functioning.
“We want to highlight this warning to make sure healthcare professionals use the best information possible to treat their patients,” FDA Center for Drug Evaluation and Research analyst Mary Southworth said in a statement.
Plavix was the third top-selling drug in the United States in 2008, according to IMS Health, with $4.9 billion in sales.
Kinney Drugs offering free glucose testing to customers
GOUVERNEUR, N.Y. Kinney Drugs will offer free glucose testing at its stores in Vermont under a partnership with six local hospitals, the regional retail pharmacy chain announced Thursday.
All of Kinney’s stores in Vermont will have a diabetes clinic on March 23 from 11 a.m. to 1 p.m. The clinic includes a test to determine whether customers are at risk, a finger-stick blood glucose test and diabetes education. Customers also will receive free samples and a “How to Live Well with Diabetes” booklet from the Vermont Health Department.
“We are very grateful for the relationship we have with our local community health agencies,” Kinney marketing manager Penny Perrone-Gray said. “Combined with their expertise in the diabetes field and our pharmacists’ medication knowledge, the program will be very informational to those who may be at risk of developing diabetes.”
Berry awarded NACDS Congressional Leadership Award
WASHINGTON During the National Association of Chain Drug Stores 2nd Annual RxIMPACT Day on Capitol Hill, NACDS honored Rep. Marion Berry, D-Ark., with the NACDS Congressional Leadership Award for his strong commitment and lifetime support of pharmacy.
As the only licensed pharmacist in the United States Congress, Rep. Berry has been a champion for pharmacy’s healthcare priorities, from Medicaid average manufacturer price reform to preserving seniors’ access to durable medical equipment such as diabetes testing supplies from neighborhood pharmacies, NACDS said Thursday.
“As over 250 pharmacy advocates descend on Washington, D.C., for RxIMPACT Day to meet with their respective Members of Congress to advance pharmacy’s priorities, it is only fitting we recognize one of our most vocal advocates in Congress –– Representative Marion Berry,” said NACDS president and CEO Steve Anderson. “It is an honor to spotlight one of pharmacy’s true allies on Capitol Hill. Rep. Berry’s commitment, leadership and voice will be missed by pharmacy and by all who are concerned about healthcare delivery.”