C.B. Fleet says its laxatives are safe

Six months after pulling two laxative drugs off drug store shelves, Lynchburg-based C.B. Fleet has collected thousands of cases of the products and is considering ways to put the drugs back on the market.

Meanwhile, 38 lawsuits against the pharmaceutical company were consolidated last week into one federal court so pretrial work can continue smoothly. The lawsuits allege that the drugs C.B. Fleet recalled have caused serious kidney damage.

Chris McDaniel, chief scientific officer for C.B. Fleet, said the company continues to assert that the recalled drugs are safe when used as directed. C.B. Fleet wants to sell them again if it can ensure that they would be used correctly, he said.

The drugs in question use a formula that C.B. Fleet has made in Lynchburg for more than 100 years. Fleet Phospho-soda is a laxative, and Fleet Phospho-soda E-Z Prep Bowel Cleansing System is a double dose of the laxative used to clean the intestines before a colonoscopy.

Both drugs are classified as oral sodium phosphates and were available without a prescription.

Ted Laszlo, principal partner in the Colorado law firm Laszlo & Associates, said Fleet’s Phospho-soda products were linked to kidney damage in the 1990s. His firm represents about 15 suits against the company in federal court, the first one filed about four years ago.

In December, the Food and Drug Administration warned that oral sodium phosphates have been linked to some cases of acute phosphate nephropathy — an acute kidney injury involving a buildup of calcium-phosphate crystals — when used in doses large enough for bowel cleansing. The agency said that the drugs have a long history of safe use, but that over-the-counter formulas should not be used for bowel cleansing.

After the FDA’s warning, C.B. Fleet recalled both of its Phospho-soda products. Although the FDA said these drugs could still be used as laxatives, the company recalled its laxative Phospho-soda to ensure it would not be used for bowel cleansing.

McDaniel said that “many thousands” of cases of Phospho-soda products have been returned to C.B. Fleet in Lynchburg, although he does not have an exact number. He said the company has collected nearly all of the Phospho-soda products it needs to collect.

McDaniel said that oral sodium phosphate formulas are safe for bowel cleansing, pointing out that the FDA still allows several brands to be used on a prescription basis. C.B. Fleet has had some discussions with the FDA about the possibility of making Phospho-soda products available under prescription.

“At this point we’re considering our options and considering their input,” McDaniel said. “No formal decision has been made about how we’re going to go forward with this.”

“Fleet’s priority is to ensure the safety of our customers and consumers in general,” McDaniel said. “… We would have to consider whether we felt comfortable that the product would be used safely and according to the labeling that we put out with the product.”

He said the company would need to “reinforce our message about how the product should be used appropriately, and only by the patient populations that it’s indicated for.”

The Phospho-soda products carried various instructions for how to use them properly. According to a labeling for the E-Z Prep Bowel Cleansing System, consumers were encouraged to drink large amounts of water — at least 72 ounces, or about 2 liters — to avoid dehydration during the drug’s two-day regimen. It also encouraged people to not use the drug if they had kidney problems, McDaniel said.

Still, dozens of lawsuits have been filed against C.B. Fleet in the past five years, claiming that the company knew the dangers of oral sodium phosphates and did not do enough to warn consumers. There are 38 suits in federal court. Others are in state courts where jurisdiction rules allow, Laszlo said.

On Tuesday, a judicial panel chose to move the 38 federal-level lawsuits into the Northern District of Ohio. The cases will share pre-trial proceedings and will be remitted to their original jurisdictions when they are ready for trial.

Laszlo said he has not heard an estimate of the total amount of money the lawsuits seek from C.B. Fleet, but the cases filed by his firm seek about $10 million each.

McDaniel said he couldn’t comment on the suits.

C.B. Fleet employs about 400 people in the Lynchburg area.