Navigation Links
Regenstrief study finds that generic drugs often have incorrect safety labeling
Date:12/13/2012

INDIANAPOLIS -- Despite U.S. Food and Drug Administration regulations requiring generic medications to carry identical warnings to those on corresponding brand-name products, a study by Regenstrief Institute researchers has found that more than two-thirds of generic drugs have safety-warning labels that differ from the equivalent brand-name drug.

The investigators reviewed 9,105 product labels for over 1,500 drugs available on DailyMed, an online repository of labeling information maintained by the FDA and the National Library of Medicine. Of the 1,040 drugs with more than one manufacturer's label, 68 percent showed some discrepancies within their safety information.

The majority of generics showed relatively small differences across their labels, but nine percent showed differences of more than 10 side effects. Errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether.

"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," said Regenstrief Institute investigator Jon Duke, M.D., M.S., assistant professor of medicine at the Indiana University School of Medicine, who led the study. "We found that generic drug labels may contain incomplete or incorrect safety information. 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."

Information on medication side effects are often conveyed to patients by their doctors or by pharmacists through information sheets accompanying a pharmacy purchase. These information sheets are based on the medication labels.

Safety studies are conducted by the brand name manufacturer before the medication goes on the market. The FDA does not require that the generic manufacturer duplicate these studies.

The researchers extracted drug safety data from medication labels using the Structured Product Label Information Coder and Extractor, or SPLICER, a software application created by Dr. Duke and colleagues. In a previous study, SPLICER was shown to have an accuracy of 94 percent.

"The solution to the problem of labeling inconsistency may be a centralized listing of drug side-effects, maintained independently of individual manufacturer labels. 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," Dr. Duke said.


'/>"/>

Contact: Cindy Fox Aisen
caisen@iupui.edu
317-843-2276
Indiana University
Source:Eurekalert  

Related medicine news :

1. Merck and Regenstrief Institute establish evidence-based care collaboration
2. Regenstrief and IHTSDO start collaborative efforts
3. IU, Regenstrief automated system aims to improve child health
4. Study helps bridge gap in understanding of suicide risk for African-American women
5. Study Examines Link Between Breast Cancer and Diabetes
6. 2-Year Period After Parents Suicide Try Most Risky for Children: Study
7. Hidden HPV May Reactivate in Older Women, Study Suggests
8. Want to Sound Like a Leader? Speak Like a Man, Study Contends
9. Study Questions Standard of Care for Head Trauma
10. Gene Study Uncovers More Autism Clues
11. Mothers Pre-Pregnancy Weight Tied to Kids IQ, Study Says
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Regenstrief study finds that generic drugs often have incorrect safety labeling
(Date:10/17/2019)... ... October 17, 2019 , ... A clinical article reviewing the long-term performance of ... Award at Plastic Surgery - The Meeting 2019 in San Diego last month. The ... authored by Larry S. Nichter, M.D., Robert A. Hardesty, M.D., and Gregg M. Anigian, ...
(Date:10/15/2019)... ... ... In 2019, Unitek opened its doors to various nursing students from Brightwood ... who started in July were only entering their second term when the school closed ... start over. Then the leadership team at Unitek honored their commitment to the community ...
(Date:10/11/2019)... ... October 11, 2019 , ... A Topping Out event was hosted today ... general contractors Adolfson & Peterson Construction. The event celebrated reaching the final height of ... in Dallas. The first of its kind in Texas, STA’s facility will be home ...
(Date:10/8/2019)... ... October 08, 2019 , ... Safe Harvest soups ... Meyer, King Sooper, Fry’s, Roundy’s, Smiths and Dillons. , Safe Harvest reinvented classic ... , “Ingredient purity and fresh taste is paramount for us,” says Bryan Boches, ...
(Date:10/8/2019)... ... October 08, 2019 , ... Cognosante ... the Department of Veterans Affairs Community Care Referrals and Authorizations program. The new ... VA’s Health Share Referral Manager (HSRM), an enterprise-wide system used by community care ...
Breaking Medicine News(10 mins):
(Date:10/8/2019)... ... October 08, 2019 , ... Clements Ferry Dentistry has rebranded ... team are thrilled to create an atmosphere that is even more inviting and ... The mission of Sedation Dentistry of Charleston is to provide trusted, comprehensive dental ...
(Date:10/8/2019)... Vicksburg, MS (PRWEB) , ... October 08, 2019 ... ... Dentistry, recently participated in an advanced dental implant seminar to enhance his skill ... around the country, The Implant Dentistry Continuum™ is a four-part series of classes ...
(Date:10/8/2019)... ... October 08, 2019 , ... For many Americans, dental insurance ... procedures is paid out of pocket. Yearly insurance payouts are generally capped at around ... including 46 million people who are 65 or older. (Standard Medicare does not cover ...
Breaking Medicine Technology: