The recent article about drug labels and the accompanying editorial1,2were factual and well written. However, a major flaw in the drug labeling and package insert process is that it is virtually static. Most physicians will not refer to a textbook that is more than 5 yr old. Why spend time reading a package insert that you know has not been updated for 10 or 20 yr?

There have been occasional instances of new risks or dangers being amended to the package insert or the label. Adding a new indication, however, is virtually impossible; especially if the medication is near the end of its patent. A pharmaceutical company would prefer to synthesize a congener or concoct a new formulation and market this as a “new” drug before they would add a new indication to an existing drug. The difficulties that we in the United States have encountered with spinal bupivacaine are an excellent example of this regrettable phenomenon.3 

When bupivacaine was first brought to market in the United States in 1963, it bore a bold “Not for Spinal Use” warning on the label. The motivation for this warning is now lost in the fog of time. Although bupivacaine is the most widely used spinal anesthetic in the world, bottles of bupivacaine still bear the “Not for Spinal Use” caveat in the United States. The same bottle in Canada does not have this warning. It is true that a physician may use the drug off-label, but most anesthesia physicians in the United States are reticent to contravene the bold “Not for Spinal” warning as an off-label application. Rather than petition the Food and Drug Administration to remove the “Not for Spinal” warning, the US manufacturers obtained Food and Drug Administration approval to market a “new drug,” Spinal Marcaine, which is simply the same drug packaged in a 2-ml ampule rather than in a 30-ml single-use vial.

It probably makes sense for pharmaceutical companies and the Food and Drug Administration to prepare the initial label and package insert for a new drug. For established medications, the US government should amend the regulatory process. At regular intervals after a medication’s initial approval (e.g. , 7–10 yr), an independent panel of experts should be convened to update the package insert and label, based on current medical knowledge.

Farms Anesthesia and Pain Management, P.C., Grosse Pointe Farms, Michigan.

Chang NS, Simone AF, Schulteis LW: From the FDA: What’s in a label? A guide for the anesthesia practitioner. Anesthesiology 2005; 103:179–85
Roizen MF: What’s wrong with this label? Anesthesiology 2005; 103:4–5
Baumgarten RK: Regulatory agencies should reassess all local anesthetics for spinal use (letter). Anesth Analg 1995; 80:431