The Inside Story

  • by: |
  • 11/09/2011

A new report in the Chicago Sun-Times raises an important question in the looming debate over generic interchangeability – the non-active ingredients in pharmaceuticals.

Just as there are bioeqivalance issues between innovator and generics – so too are there important differences between generics of the same molecule.  And an important issue in both cases is the variety of fillers, colors and additives in these products that have nothing to do with the reason it is prescribed but can have unintended and undiagnosed consequences that can range from stomach pains to headaches to hyperactivity.

“It’s frequently overlooked by medical professionals and patients because, when we prescribe medication, we’re prescribing the active ingredient,” said Dr. John Saran, who specializes in internal medicine with Edward Medical Group. “(But) there may be 15 other things in there.”

While patients generally are asked if they have allergies to any medications, the allergy refers to the drug, not necessarily the fillers in it.

For instance, lactose is a common filler in pills and capsules. If a patient is lactose intolerant, the patient might believe they cannot tolerate the drug, when in fact, it is the filler that is causing cramping. Neither the doctor nor the patient may be aware that the pill contained lactose because, according to Saran, many times the additives and filler information are not included on the handout from the pharmacy.

According to the Sun-Times report, “Common additives … can lead to asthma attacks, anaphylaxis, runny nose and adversely affect children with learning disorders. Artificial sweeteners can affect those who have hyperactivity. Vegans may not want capsules because they are gelatin based. Even dye-free versions of medicine may still contain preservatives that can cause reactions. Children’s medications are especially a problem because they are flavored and colored to make them more palatable."

As if adverse event reporting wasn’t tough enough already.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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