Study Finds Drug Side Effect Warnings Increased

A recent study has found that <"">drug side effect warnings have greatly increased, concluding that the enlarged information is likely due to drug makers’ fears of litigation over not appropriately advising consumers about a medication’s adverse effects. According to US News, adverse side effect warnings have increased about 70 percent per drug.

Initially meant to advise physicians and patients of possible drug dangers, the researchers believe that the warnings could be better presented and that the current overkill could be linked to lawsuit fears.

“Having a high number of side effects on a drug’s label should not suggest that the drug is unsafe. In fact, much of this labeling has less to do with true toxicity than with protecting manufacturers from potential lawsuits,” lead author Dr. Jon Duke, Regenstrief Institute investigator and assistant professor of medicine at the Indiana University School of Medicine, said in a university news release, quoted US News.

The team looked at over 5,600 drug labels and the 500,000 side effects listed and determined that today’s drug labeling includes approximately 70 different possible reactions per drug, with up to 100 reactions, in some more popular cases, a massive 525 reactions have been listed in drugs classified in the upper range, said US News.

Dr. Duke feels that the large amount of side effects could potentially overwhelm physicians who now have to wade through the data when treating patients, noted US News. The study was published in the May 23 issue of the Archives of Internal Medicine.

The team developed a list that detailed those drug likeliest to have the greatest number of side effects, such as, said US News, antidepressants, antivirals, and some emerging medications used in the treatment of conditions such as restless legs syndrome and Parkinson’s disease.

Dr. Duke does not feel the information should be eliminated, nor does he feel that the information is not valid; rather, he suggests that the information be better presented so that physicians and patients can make clearer, informed decisions.

Dr. Duke explained that “With current technology, drug labels could be transformed from lengthy static documents to dynamic resources, capable of delivering personalized patient information. Such labels could take into account the individual patient’s medical conditions and highlight those side effects that could be especially dangerous,” quoted US News. “We can’t stop the growing wave of drug information, but we can do a better job of presenting it efficiently to health care providers,” Duke added.

Meanwhile, we have been writing that some drug makers have been faulted for not appropriately reporting and listing significant adverse events. For instance, we just wrote that beleaguered drug giant, Johnson & Johnson was accused of neglecting to warn parents that its Children’s Motrin and Tylenol can cause a potentially deadly skin reaction—Stevens Johnson Syndrome (SJS)—that can lead to blindness, burns, disfigurement, and death. SJS can spread to internal organs, causing scarring and blindness. The most severe cases are referred to as TEN (toxic epidermal necrolysis) and involve over 30 percent of the body surface being covered in blisters. Both SJS and TEN usually require treatment in hospital burn units.

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