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Other labeling errors included out-of-date information, incomplete data and, in one case, information for another drug, according to the researchers at the Regenstrief Institute in Indianapolis.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:5/2/2016)... ... 02, 2016 , ... In honor of National Physical Fitness and Sports Month ... share their fitness journey on social media. , The foot care company, which ... $100 product voucher each week during May to one winner. , “Whether the goal ...
(Date:5/2/2016)... (PRWEB) , ... May 02, 2016 , ... East Los ... dental extractions. Currently, patients can visit Dr. Assili to receive any dental extraction treatment ... offer, and it expires June 30, 2016. With the lower price, patients can more ...
(Date:5/2/2016)... ... , ... Dr. Rassouli, dentist in Orange County, CA comments on ... which was published in the “Journal of the American Geriatrics Society,” more than a ... have Alzheimer’s disease. The study found that dental problems may increase the risk of ...
(Date:5/2/2016)... ... , ... Pregnancy Awareness Month offers a great time to get familiar with ... are ready to have a baby, it’s best to get started before age becomes ... Personal Conception & Pregnancy Organizer, written for women who plan on becoming pregnant to ...
(Date:5/2/2016)... ... 2016 , ... Dr. Jonathan Kulbersh of Carolina Facial Plastics isn’t surprised that Charlotte, NC, the ... of “ 5 US Cities with the Highest Plastic Rates .” The other cities ... results were calculated using a survey by RealSelf and combining that data with ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... TOKYO , April 28, 2016 ... and Ste phen ... ArisGlobal®, a leading provider of cloud-based software solutions for ... and Pharmacovigilance team to bring a wealth of insight to a ... unparalleled pharmacovigilance knowledge. George Phillips joined ArisGlobal ...
(Date:4/28/2016)... April 28, 2016 TapImmune,Inc. ... innovative peptide and gene-based immunotherapeutics and vaccines for the treatment ... presenting at the 3rd Annual Growth Capital Expo ... , 2016 at Caesars Palace in Las Vegas, Nevada.  ... Wednesday, May 4 th by Dr. John N. ...
(Date:4/27/2016)... 27 Avril 2016   ... de +5% sur le trimestre, soutenu par une ... Croissance de +16% des ventes aux ... Mauna Kea Technologies (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), ... annonce aujourd,hui son chiffre d,affaires pour le premier ...
Breaking Medicine Technology: