Angie Caudill stopped drinking soda from cans. She had her tap water tested. She scoured labels on her food and makeup, avoiding products containing one potentially toxic ingredient: aluminum.
And yet the aluminum level in her blood continued to rise. “I did everything they told me to do,” said Caudill, of Harrison, Ohio, “and it kept getting higher and higher.”
Last month, Caudill, who has kidney disease and spent a year on a home dialysis system, learned that a concentrated dialysis fluid she used contained more aluminum that it should have. NxStage Medical Inc. of Lawrence, which sold the fluid, said 140,000 to 150,000 units of the fluid made between April 2013 and February 2014 were involved but declined to estimate how many patients were affected.
On May 15, NxStage voluntarily recalled the fluid, which is used in a home dialysis system it manufactures. The company said it is working with regulators to determine how the problem occurred.
NxStage said there is no evidence that patients were harmed. But the recall has shocked and upset patients, who, because their diseased kidneys can’t clean wastes from blood, rely on NxStage’s products almost daily.
Aluminum, found in many products, including cookware, baking soda, anti-perspirants, and antacids, is generally not harmful. But with high exposure over time, aluminum can build up in the body and cause memory loss, bone disease, and dementia. People without working kidneys are particularly vulnerable because they can’t excrete the metal.
Patients said bad concentrate raised their aluminum levels to two, three, or even four times their normal levels, causing them to feel anemic and sick. No one has sued the company.
“[Patients] are mad that there was no check in place because it’s something people depend on,” said Caudill, who used NxStage’s home dialysis system for a year before her kidney transplant in March. “Their life depends on it.”
Mark Wetzel of Elma, N.Y., who has relied on dialysis on and off for nine years, believes the aluminum made him weak and his mouth dry and metallic-tasting.
“As patients, we’re all under the assumption that there should be quality control,” he said. “Patients right now are very disappointed in NxStage.”
Fewer than 2 percent of the more than 400,000 Americans on dialysis use NxStage’s machines, according to the company. Most patients get treatment at clinics three times a week. Aluminum toxicity was a problem decades ago, when dialysis patients commonly took drugs that contained aluminum, but it is very rare today. Doctors still monitor aluminum levels of people with compromised kidney function.
“If you have chronic exposure, it is a concern,” said Dr. Li-Li Hsiao, director of the Asian Renal Clinic at Brigham and Women’s Hospital.
Founded in 1998, NxStage makes the only portable home dialysis machine on the market. It generated $263 million in revenue last year, but it has yet to make a profit. The company expects to grow as more dialysis patients switch to home treatment, which can be more convenient than going to a clinic.
Patients typically use NxStage’s machine, the System One, about five days a week, for several hours at a time. The recalled product is a clear, electrolyte-packed fluid that is mixed with water and used to flush the waste out of blood.
The concentrate normally contains some aluminum, but it’s unclear whether manufacturing problems, packaging errors, or other causes led to unacceptably high amounts in some batches. Michigan-based Rockwell Medical Inc., which manufactures the concentrate for NxStage, did not respond to a request for comment. NxStage packages the product in Tijuana, Mexico.
NxStage chief executive Jeffrey Burbank said the company changed some procedures after learning of the aluminum problem, but he declined to provide details. “We’re working very hard to make sure this never happens again,” Burbank said.
NxStage didn’t learn of the problem until it was notified in recent months by its customers, including Fresenius Medical Care of Waltham and DaVita HealthCare Partners of Denver, which operate dialysis clinics and manage the care of patients on home dialysis.
“Our surveillance process detected a small rise in serum aluminum levels among patients receiving NxStage therapy,” DaVita spokesman David Tauchen said. “These levels were well below a level that would cause harm.”
Patients are questioning how the aluminum problem went unnoticed by NxStage for more than a year. They said NxStage has done little to restore their faith in the safety of its products.
“What if in the future there’s some sort of manufacturing error and they do not have the proper quality control in place to correct errors before that product goes out to patients?” said Peter Laird, a retired doctor and NxStage patient in Idaho. “What if the next time it’s another component that turns out to be a deadly component?”
Robert Boudrie of Natick said he first learned of the recall on an Internet message board and from his nurse. He received a letter from NxStage a couple weeks later.
“I’m a little bit surprised at how long it took because NxStage is usually responsive,” said Boudrie, an engineer at EMC who has been on dialysis for about two years. “Other than this issue, this little machine they have is the greatest thing since sliced bread.”
NxStage remains the only option for people who want a portable home dialysis machine, said Kevin Ellich, senior research analyst at Piper Jaffray, a Minneapolis investment bank.
He said he doesn’t expect the recall to have much of an effect on NxStage’s earnings.
“If patients really are upset, what would you typically do? Switch to another product,” he said. “But if there’s nobody else, what are you going to do? I can’t imagine NxStage would lose that many customers.”