By: Bob Schwartz

ZPAK has been the hottest and most effective common cold-killing drug.  It first received Food and Drug Administration (FDA) approval on May 24, 2002, under the brand name Zithromax.  Since its approval, however, it has had six label revisions.  The latest one comes on the heels of the FDA’s recently issued statement on the risk of cardiovascular death from a common cold-buster.  The FDA’s concerns were based on a May 17, 2012, article published in the New England Journal of Medicine that reported an increased risk in cardiovascular deaths for people treated with the popular five-day-course antibacterial drug.  The cardiovascular deaths were caused by what is called a “QT interval prolongation.”  As the measurement of time between the start of the Q wave (depolarization) and the end of the T wave (repolarization) in the heart’s electrical cycle, the QT interval prolongation is a well-understood form of drug toxicity.

The study showed that during the five-day ZPAK course of treatment there was a small but absolute increase in cardiovascular deaths.  This risk, the study showed, was most pronounced among patients with a high baseline risk of cardiovascular disease.  The question presented is whether the benefit of killing the common cold is outweighed by the “absolute increase” of risk in cardiovascular deaths.  Clearly and resoundingly, the answer is no.  For centuries humans have struggled with the common cold, and there likely have always been home remedies that work just as well as simply letting the bug run its course.  Never, under any circumstances, would the benefit of a ZPAK be worth the risk of suffering a heart attack.

The issue in being able to hold the manufacturer responsible is that, since that 2002 FDA approval of the brand name drug, 13 generic manufacturers have obtained FDA approval for 29 generic forms of azithromycin that are now on the market.  Some of the more common generic manufacturers are Apotex Corp., Mylan, Plivia, Sandoz, Teva and Wockhardt. The generic manufacturers cannot be held liable for their drug’s inadequate warnings because the U.S. Supreme Court has recently held that liability is the responsibility of the brand-name manufacturer.  Worse yet, the Court did not bridge the gap it created in its ruling by allowing innocent victims to sue the brand-name manufacturer when they only took the generic form of the drug.  That legal issue is now left up to the individual state courts to determine, and more courts than not are finding that there is no liability.

So, in the age in which insurance companies demand that pharmacies fill prescriptions with generics, and when the physicians readily prescribe generics over the brand names, innocent victims are again innocently and silently victimized by having no recourse for serious injuries suffered from a generic drug.  The solution is to insist that the doctor who prescribes your medications only prescribes the brand-name drug and never the generic.

If you suffered a heart attack while taking a ZPAK, and you took the brand-name drug (Azithromycin 3-Day Dose Pack, Azithromycin 5-Day Dose Pack, Zithromax, Zithromax TRI-PAK, Zithromax Z-Pak, Zmax, manufactured by Pfizer), contact the pharmaceutical department at Bailey and Galyen to discuss your legal rights.

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