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Other labeling errors included out-of-date information, incomplete data and, in one case, information for another drug, according to the researchers at the Regenstrief Institute in Indianapolis.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:4/28/2017)... Cary, NC (PRWEB) , ... April 28, 2017 ... ... to announce its new partnership with the Home Care Association of America (HCAOA). ... Hospice, and Private Duty Accreditation services, as well as discounts on Accreditation University ...
(Date:4/28/2017)... ... 2017 , ... Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ) announced ... its outlook as “stable.” At the same time, the ratings agency cautioned that the ... dip below “capital adequacy” thresholds required for its strong rating. , “Horizon is committed ...
(Date:4/28/2017)... ... April 28, 2017 , ... Ushio America proudly ... offer an instant energy-saving solution for F32T8 fluorescent lamps on most instant-start and ... These 50,000 hour rated lamps utilize the existing electronic ballast, saving labor and ...
(Date:4/28/2017)... ... April 28, 2017 , ... The Texas Cord Blood Bank (TCBB), ... labor and delivery team at Women’s Hospital at Renaissance in Edinburg for their outstanding ... the hospital and decide to donate. , “Women’s Hospital at Renaissance has been ...
(Date:4/28/2017)... ... April 28, 2017 , ... Bill Howe started his ... the coastal communities. After Tina Howe joined the team, the Bill Howe brand was ... services at affordable rates, and giving back to the San Diego community in which ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... , April 19, 2017 The Mobile X-Ray product ... a healthy CAGR during the forecast period Mobile ... the global digital mobile X-Ray devices market, which is estimated ... 2017, expanding at a CAGR of 7% over the forecast ... opportunity of more than US$ 100 Mn in 2017 over ...
(Date:4/19/2017)... April 19, 2017 Global Surgical Drainage Device ... tubes used to remove excess liquid and air. The ... urine, bile or lymph. Surgical drains are used in ... as orthopedics surgery, cardiovascular surgery, neurosurgery, plastic surgery etc. ... to prevent accumulation of fluid e.g. blood or pus. ...
(Date:4/19/2017)... , Tenn. and DALLAS , April 19, ... Inc., announced that the first patients in ... EndoStim device in the Lower Esophageal Sphincter Stimulation for ... minimally-invasive implantable device designed to provide long-term reflux control ... GERD affects nearly 65 million people in ...
Breaking Medicine Technology: