What Makes Side Effects Actionable?

With increasing profits to be made in drug development and manufacturing and escalating reliance upon pharmaceutical treatment by the medical community, it seems that new drugs are entering the market every day to treat every type of disease and condition imaginable. Unfortunately, many of these drugs come with a litany of side effects — some of which can be more severe than the very condition the drug is intended to treat. The appearance of side effects in at least some patients is nearly unavoidable. This is why drug companies frequently conduct large-scale clinical trials before their products can receive FDA approval — to test the safety of their drugs and to identify and disclose side effects.

It would be impractical — and even unwise — to keep a drug off the market simply because it showed side effects in some patients. Side effects are an inherent risk in any pharmaceutical treatment and doctors are usually able to determine whether the risk outweighs the potential benefits for particular patients. But when drug companies fail to disclose known side effects, minimize the severity or frequency of side effects, or fail to adequately test their products to discover and document their side effects, doctors receive imperfect information and people get hurt.

Whether the side effects of a drug are actionable comes down to disclosure and severity. In the case of Pradaxa, for example, bleeding risk was a known and disclosed side effect of the drug — as it is with any anticoagulant. What brought about Pradaxa lawsuits was the increased severity and frequency of those side effects, including substantial increases in the risk of major bleeding events as well as over 200 Pradaxa-related deaths.