The FDA should ensure a "complete and objective" scientific investigation into the musty-odor Tylenol recalls and then publicize the results, says the nonprofit Institute for Safe Medication Practices. The size of the recalls and the re-emergence of a form of contamination (the pesticide byproduct 2,4,6-tribromoanisole), as well as the large number of adverse event reports, warrant such measures.
In its QuarterWatch publication, the institute says it counts 1,066 reports made to the FDA of serious injury associated with drug product problems in the first quarter of the year. Nearly half involved over-the-counter Tylenol products, primarily in tablet or caplet form, although previous FDA reports mentioned only non-serious reports of nausea, stomach pain, vomiting and diarrhea. A link between the serious reports and the contaminated Tylenol products can be neither established nor ruled out based on available data, says QuarterWatch.
The institute identifies three plausible explanations for the serious case reports speculating why J&J's analysis of returned samples and animal toxicity studies led it to believe that too little of the contaminant was present to make people sick. First, some people might be unusually sensitive to TBA; second, some tablets may have contained higher concentrations of it. Finally, given known quality problems at the manufacturing plant, other contaminants might be involved.
Separately, at a Reuters health summit, FDA Commissioner Margaret Hamburg said that J&J's phantom Motrin recall was a departure from the company's history of responsible behavior when it comes to public health.
- here's the report (PDF)
- see the report of Hamburg's comments