Navigation Links
'Black Box' Drug Warning Labels Applied Inconsistently: Study

FRIDAY, Feb. 4 (HealthDay News) -- Safety labels that outline concerns about medications, known as "black box warnings," are not always consistent within drug categories, a new study suggests.

These warnings should be rendered uniform for all medications within a single class of drugs, according to a team of researchers from Greece and the United States. The team also advised that supplemental warnings (for example, following a drug withdrawal) should be added in a reasonable timeframe.

The research team published their report Feb. 2 in the Journal of General Internal Medicine.

"Our findings imply that the process of black box warning acquisition requires transparent and systematic rules, as well as clear justification for the presence of, or lack of evidence for, specific major risks for individual drugs," the research team led by Orestis Panagiotou from the University of Ioannina's School of Medicine in Greece, said in a journal news release.

The authors pointed out that black box warnings are the strongest tool the U.S Food and Drug Administration has to issue consumer safety warnings and outline drug risks. Most warnings are issued per class of drugs, rather than for an individual drug, because concerning side effects usually apply broadly to a type of drug rather than to a single medication.

Therefore, the team focused on analyzing black box warning labels placed on drugs that all fell within the same drug class.

The investigators examined 20 different drug classes that in total covered 176 medications, all chosen from data included in the USA's "Top 200 Drugs for 2008 by Sales" report.

Half of the 20 drug classes had at least a single black box warning issued; the other half had no such warnings.

Black box warning inconsistencies were found in nine drug classes, with 15 specific warnings not uniformly evident on the labeling of all drugs that fell within each specific class.

In two-thirds of these (10 of the 15), the information was, in fact, noted on the labels in a different place, as either a simple warning or plain text. The rest did not include the warnings anywhere on the label.

What's more, specific drugs subject to a withdrawal from the market were not typically outfitted with a black box warning prior to a withdrawal, the team found. And drugs similar to the withdrawn medication were frequently not labeled with a relevant black box warning referencing the concerns that led to the withdrawal in question.

A significant time lag in the posting of black box warnings was also commonly observed (ranging from two months to 14 years) for drugs that fell into classes in which similar drugs were subject to the warning.

The authors suggested that if a drug is in the same class as another drug that requires a black box warning, but the warning does not apply to that particular medication, the warning label should specifically explain why this is the case to ease consumer confusion.

More information

For more information on black box warnings, visit the U.S. Agency for Healthcare Research and Quality.

-- Alan Mozes

SOURCE: Journal of General Internal Medicine, news release, Feb. 2, 2011

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Burden of HIV Highest for Blacks, CDC Reports
2. Blacks Still Hit Hardest by Cancer
3. Study Examines Reasons Some Black Men Avoid Doctors
4. Survival After Stroke Better for Blacks
5. Gene Mutation May Protect Blacks From Heart Disease
6. Distrust of Health System Keeps Black Males From Getting Care
7. Wiley-Blackwell announces 102 additional products available through Research4Life
8. Blacks with liver cancer more likely to die, study finds
9. Liver Cancer Survival Rates May Be Worse for Blacks
10. Black, Low-Income Patients More Disabled by Parkinsons Complications
11. New American Chemical Society podcast: Black rice bran may reduce inflammation
Post Your Comments:
Related Image:
'Black Box' Drug Warning Labels Applied Inconsistently: Study
(Date:11/26/2015)... ... November 26, 2015 , ... ... for mental health and wellness consultation, has collaborated with Women’s Web – ... their reader’s queries on topics on mental and emotional well-being relationship, life ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... where preparing the perfect dish and pleasing the palates of attendees is of ... bringing a dish to a seasonal get-together, give these recipes a try this ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dr. John Pierce, Medical Director ... about hair loss treatment with the Capillus272™ Pro laser therapy cap. FDA cleared for ... and fuller hair, without the need for surgery, prescription pills, or topical foams. ...
(Date:11/25/2015)... ... November 25, 2015 , ... According to an article published November ... more widely heralded as a breakthrough for performing hernia repairs. The article explains that ... surgery is that it can greatly reduce the pain that a patient might otherwise ...
(Date:11/25/2015)... Raton, Florida (PRWEB) , ... November 25, 2015 ... ... diagnostic testing for physicians and athletic programs, launches new Wimbledon Athletics ... importance of testing young athletes for unsuspected cardiac abnormalities. About 2,000 people under ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , Nov. 25, 2015  Amgen (NASDAQ: ... License Application (BLA) with the United States ... ABP 501, a biosimilar candidate to Humira ® ... biosimilar application submitted to the FDA and represents Amgen,s ... Sean E. Harper , M.D., executive vice president ...
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, ... optimizing treatment outcomes for patients suffering from chronic pain, ... for a Temporary Restraining Order (TRO) enjoining Express Scripts ... two companies. --> --> ... all of its legal options. --> ...
(Date:11/25/2015)... 25, 2015 On Tuesday, November 24, ... trial against Wright Medical Technology, Inc. for product ... metal-on-metal hip implant device, awarded $11 million in ... week trial and three days of deliberations, the ... was defectively designed and unreasonably dangerous, and that ...
Breaking Medicine Technology: