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 Errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether.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:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association ... Featuring a collection of specialty vendors and unique items from across the nation, this ... health and wellness services offered by the VNA. The boutique will be open ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, ... Development, has been awarded a contract by the Center for Medicare and Medicaid ... to accelerate the enterprise use of Agile methodologies in a consistent and high ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information ... we intend to develop to enable prevention of a major side effect of ... loss, especially in pediatric patients. For cisplatin, hearing loss is FDA listed on-label ...
(Date:10/12/2017)... ... 12, 2017 , ... Women-owned and Grand Rapids-based workplace wellness ... in Wellness® by Best and Brightest. OnSite Wellness will be honored at the ... 7:30 a.m. to 2 p.m. at the Henry Autograph Collection Hotel, located at ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... EXTON, Pa. , Oct. 10, 2017   ... leader in innovative solutions for injectable drug administration, today ... of West,s ID Adapter for improving the intradermal administration ... the Fourth Skin Vaccination Summit in May 2017 by ... Team Lead, Polio Department, World Health Organization (WHO), and ...
(Date:10/5/2017)...  In response to the nationwide opioid epidemic, ... (AAOMS) released prescribing recommendations that urge ibuprofen – ... a first-line therapy to manage a patient,s acute ... Recognizing the value and importance of the ... Acute and Postoperative Pain Management" stresses that practitioners ...
(Date:10/4/2017)...  According to the Centers for Disease Control and Prevention (CDC), ... Urgent Care is helping communities across Massachusetts , ... offering no-cost* flu shots through the end of the month. ... regulations. ... a flu shot is by the end of October, according to the ...
Breaking Medicine Technology: