Critical Information may be Missing from Prescription Drug Labels

Friday, November 20, 2009 by: Deanna Dean
Tags: prescription drugs, labels, health news

(NewsTarget) Prescription drug use, sadly, is rising among people in the United States with one in six using three or more medications. Of special interest then is a recent commentary published last month in The New England Journal of Medicine which states that the Food and Drug Administration (FDA) has critical information when a drug is approved that may not make it onto the drug label or package inserts that come with the medications. Information often is lost between the approved label and FDA review. Doctors Lisa Schwarz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire write that omission of this crucial information about a medicine's effectiveness and the severity of its side effects can result in medicines appearing safer and more effective than they really are.

"Sometimes what gets lost is data on harms," said Schwartz and Woloshin in their commentary. One example is the Novartis cancer drug Zometa. It was approved in 2001 with a warning label noting the 8- milligram dose posed a greater risk of kidney damage than the 4-mg dose. But the degree of risk was not explained. Mortality data did appear in 98 pages of FDA medical and statistical reviews but it wasn't until seven years later in 2008 that the label was changed to explicitly tell doctors not to use the higher dose. The warning statement read, "Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4 mg." A glaring omission was any reference to the 8-mg dose being associated with a higher rate of death than the 4-mg dose.

There are obvious problems because the most expedient way for clinicians to receive prescribing information is directly from the FDA. Though the FDA did revise label design in 2006 to highlight indications and warnings, Woloshin and his colleagues say they have developed a better format to help consumers understand more clearly the scope of risks and benefits.

Last year, the FDA's Risk Advisory Committee voted unanimously to endorse the proposed format and will meet with Woloshin and his colleagues to further discuss the issue next month.

If we all lived in a way that promoted a natural, healthy lifestyle with organic whole foods, exercise and stress management maybe we could preclude prescription drug use altogether.

Lawblogs.slu.edu/healthlaw/?p=646
Saint Louis University Journal of Health Law & Policy
October 22, 2009 Drug & Device, Health Information, Life Sciences

Fwf.org/pioneer/produd.jsp?id=49608

cdc.gov/nchs/pressroom/04news/hus04.htm

reuters.com - Key Information missing from drug labels -
October 22, 2009

In good health,
Deanna Dean CNHP

About the author

Deanna Dean is the Wellness Director for Your Health Coach, a company dedicated to health and wellness education.
website: yourhealthcoachdee.com
Dee is a Wellness & Weight Loss Coach, a Certified Natural Health Professional, is pursuing an ND degree-Naturopathic Doctor, is a certified Raw Chef, certified in Dietary Guidelines from the Cooper Institute for Aerobics Research, former Personal Trainer, Yoga and Fitness Studio Owner, TV and Radio Guest, Health Columnist.
Deanna develops customized programs to enhance the health of her clients, educates, and coaches dieters for safe weight loss.