Navigation Links
Inconsistency Seen in Safety Labeling for Generic Drugs
Date:12/21/2012

FRIDAY, Dec. 21 (HealthDay News) -- More than two-thirds of generic drugs in the United States have safety warning labels that differ from the equivalent brand-name drugs, a new study finds.

These labels break U.S. Food and Drug Administration regulations that require generic drugs to carry warnings that are identical to those on brand-name drugs.

Researchers reviewed more than 9,000 product labels for more than 1,500 drugs listed on DailyMed, a website about drug-labeling information that is maintained by the FDA and the U.S. National Library of Medicine.

Of more than 1,000 generic drugs, 68 percent had some discrepancies in their safety labeling. Most had small differences in their labels compared to brand-name drugs, but 9 percent had differences of more than 10 side effects.

Other labeling errors included out-of-date information, incomplete data and, in one case, information for another drug, according to the researchers at the Regenstrief Institute in Indianapolis.

"Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions. They need to know about side effects, drug interactions and other safety issues," study leader Dr. Jon Duke, assistant professor of medicine at the Indiana University School of Medicine, said in an institute news release.

"We found that generic drug labels may contain incomplete or incorrect safety information," Duke added. "Until this problem is resolved, physicians and patients should rely on brand-drug labeling only, even when the patient is getting a generic version of a drug."

The study was published recently in the journal Pharmacoepidemiology and Drug Safety.

"The solution to the problem of labeling inconsistency may be a centralized listing of drug side effects, maintained independently of individual manufacturer labels," Duke said. "Drug labels would simply reference this common repository rather than attempting to maintain all the information within a single document. Clinicians could refer to this resource for the most up-to-date safety information regardless of generic manufacturer."

More information

The U.S. Food and Drug Administration has more about generic drugs.

-- Robert Preidt

SOURCE: Regenstrief Institute, news release, Dec. 13, 2012


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Semi Truck Accident Victims Center Now Offers Holiday Passenger Vehicle Drivers Some Vital Safety Tips When Sharing The Highway With A Semi Truck
2. Tennessee Dental Association and Succeed Management Solutions Partner to Deliver New Safety Software Solution for Tennessee Dentists
3. Regenstrief study finds that generic drugs often have incorrect safety labeling
4. Johns Hopkins to aid The Leapfrog Group in grading the safety and quality of US hospitals
5. Green scientists propose safety testing system for development of new chemicals
6. At Least 35 Common Medical Conditions are Contraindicated for Certain Yoga Poses: Prevent Yoga Injury Campaigns to Educate on Yoga Safety
7. Overprescribing of opioids impacts patient safety and public health
8. Findings support safety of whooping cough vaccine for older adults
9. Food Safety Tips For a Worry-Free Tailgating Party
10. Setting national goals to bolster patient safety with electronic health records
11. Penn researchers find error reporting improves perceptions of safety and may reduce incidents
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Inconsistency Seen in Safety Labeling for Generic Drugs
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her ... would lash out at his family verbally and physically. , “When something upset him, he ... he would use it. He would throw rocks at my other children and say he ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. ... accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, ... and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)...  VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ) reported ... required to build a strong and stable market for ... on the OTC Markets-pink current trading platform. ... are seeing an anomaly in market trading activities that ... the Company, but shareholders and market players as well. ...
(Date:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
Breaking Medicine Technology: