Regenstrief study finds that generic drugs often have incorrect safety labeling

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 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 Errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether.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 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. 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.

add to favorites email to friend print save as pdf

Related Stories

Information overload in drug side effect labeling

May 23, 2011

The lists of potential side effects that accompany prescription drugs have ballooned in size, averaging 70 reactions per drug, a number that can overwhelm physicians trying to select suitable treatments for their patients, ...

Prescription labels geared toward pharmacies, not patients

Sep 11, 2007

The labels on most prescription drug containers highlight the pharmacy’s name or logo rather than instructions on how to take the medication, reports a new study in the September 10 issue of the Archives of Internal Me ...

Recommended for you

Seniors successfully withdraw from meds

Sep 19, 2014

Elderly people have proved receptive to being de-prescribed medications, as part of a trial aimed at assessing the feasibility of withdrawal of medications among older people.

Flu vaccine for expectant moms a top priority

Sep 18, 2014

Only about half of all pregnant women in the U.S. get a flu shot each season, leaving thousands of moms-to-be and their babies at increased risk of serious illness.

Experts want restrictions on testosterone drug use (Update)

Sep 17, 2014

Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans ...

User comments