Generic Drugs: Don’t Let Appearances Fool You

Public Citizen’s Health Research Group has always endorsed generic drugs as cheaper but equally effective alternatives to brand-name drugs. Since 1984, when Congress passed laws to promote the development of lower-cost generic medications, sales of generics have risen dramatically, saving consumers and the health care system more than $1 trillion.[1]

For many brand-name drugs, multiple generic versions are available, each made by a different manufacturer. Although these different generic versions contain the same active ingredient and have been deemed by the Food and Drug Administration (FDA) to be interchangeable with their brand-name counterparts and one another, they often come in different colors and shapes. Historically, the FDA has taken the stance that it does not regulate the appearance of pharmaceutical products.[2]

An intriguing study published July 15 in the Annals of Internal Medicine suggests that such differences in the appearance of different generic versions of the same drug may cause some patients to discontinue a beneficial medicine when one generic version is substituted for another.[3] The researchers analyzed prescription drug data for patients who started taking a generic version of any of four different types of medications known to provide significant long-term benefit after a heart attack. The researchers found that over a one-year period after the heart attack, more than a quarter of patients had at least one change in the shape or color of one of their drugs when obtaining refills. When such changes occurred, patients were significantly more likely to stop taking the drug or not to refill it than they were when no change occurred. The odds of such discontinuations rose 34 percent after a change in color and 66 percent after a change in shape.

Stopping beneficial medications because of concern about a change in the appearance of pills at the time of refill threatens patient health.

Ideally, doctors and pharmacists would alert patients that different generic versions of the same drug may vary in color or shape. If you note a change in the appearance of one of your prescription drugs and are concerned, speak to the dispensing pharmacist or the prescribing physician immediately. To address this problem more broadly, the FDA should encourage generic companies to develop products that are similar in appearance to their brand-name drug counterparts.

References

[1] Dicken JE. Drug pricing: research on savings from generic drug use (GAO-12-371R). January 31, 2012. http://www.gao.gov/assets/590/588064.pdf. Accessed August 18, 2014.

[2] Kesselheim AS, Bykov K, Avorn J, et al. Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case-control studies. Ann Intern Med. 2014;161(2):96-103.

[3] Ibid.