This expert report discusses the actions that Fleet did and didn’t take with respect to Phospho-Soda and its association with kidney problems. It comes from Bracey v. Fleet, and the expert is Suzanne Parisian.
31.) Dr. Caswell's statement to health care providers in his 2002 letter regarding post-marketing experience confirming the product as "safe and effective", incorrectly implies that Fleet Phospho-soda was approved for marketing by FDA through a New Drug Application (NDA) with a commitment for post marketing. He fails to more precisely inform health care providers that Fleet Phospho-soda, unlike competitor bowel preparation products marketed via approved NDAs, Fleet Phospho-soda remains on the market "grandfathered" as safe, able to support efficacy as an active ingredient with limited data and considered by FDA as "generally recognized as safe and effective"(GRASE). Despite the tome of the letter, Dr. Caswell was unaware when Fleet Phospho-soda had first become actively promoted for colon preparation. (Caswell April 5, 2006, Volume I testimony, page 124, lines 13-19). He indicated letter that there were only 40 USA based serious adverse events reported to Fleet from 1991 through 2001. However, Dr. Caswell was unfamiliar with the nature of those reports, unable to provide the types of procedures being performed when the events occurred, the dosing, type of populations involved or any other signal associated with possible increased risk. He also was unaware of methods of rehydration being used by patients in the adverse event reports. (Caswell April 5, 2006, Volume I testimony, page 125, lines 14-25).
32.) Fleet did not provide United States physicians with information described in the Australian Adverse Drug Reactions Bulletin, Vol. 16, No. 1 (February 1997) warning about the risks of electrolyte shifts with Fleet Phospho-soda. According to Dr. Caswell's testimony above, he considered the risks for electrolyte shifts with a single dose of Fleet Phospho-soda Solution as "known" since 1968. However, the Australian agency, unlike Dr. Caswell, felt that it was safety information which needed to be conveyed to health professionals in 1997. The Australian bulletin had been prepared by the Adverse Drug Reactions Advisory Committee (ADRAC) (Exhibit 122, CBFL-0000125-8). Heading 1. ELECTROLYTE DISTURBANCES WITH ORAL PHOSPHATE BOWEL PREPARATION.
In recent years, the use of oral sodium phosphate solution (Fleet Phospho-Soda Buffered Saline Laxative Mixture) as a bowel preparation for colonoscopy has become more common. Over the past 18 months, ADRAC has received three serious reports, two with fatal outcomes, highlighting severe electrolyte disturbances associated with this oral bowel cleansing solution. The product is available without prescription and can also be used as a laxative at a lower dose…..