Since at least 2009, researchers have been aware that MiraLax, an over-the-counter laxative manufactured by Bayer Corp., is not safe for patients who suffer from kidney disease. But this did not stop the company and is affiliates from allowing the drug to be taken by patients–under supervision from a doctor–whose medical history would put them at risk.
Samuel Woniewala, a patient with pre-existing kidney disease, began taking MiraLax for constipation on his doctor’s recommendation in 2009, and continued the course of treatment for about four years. He began experiencing abdominal pain in February 2013, and when it intensified in May 2013, he sought help. Doctors performed a biopsy and sent it to the Mayo Clinic, where researchers suggested Woniewala has oxalate nephropathy, which may have been caused by PEG-3350, MiraLax’s active ingredient.
Oxalate nephropathy is a serious illness, and can cause renal failure, which occurs when one’s kidneys fail to properly filter waste from the blood. Renal failure is also associated with bodily swelling, loss of calcium, anemia, bone health, and increased risk of heart disease. “As a result,” a recent Law360 article explains, “he will require ongoing treatment and dialysis, and he also faces the prospect of a kidney transplant.” Woniewala, who is represented by Mark Tanner of Feldman Shepherd, alleges in a lawsuit that the defendants–Bayer, Merck (which is owned by Bayer), and Braintree Laboratories–“manufactured, marketed, sold, and advertised MiraLax without sufficiently investigating the effect of MiraLax on kidney function and/or without acknowledging this deadly side effect.”
The suit acknowledges that MiraLax’s packaging warns against its use by those with existing kidney problems, but it also notes that this is not a concern if the medication is taken on a doctor’s orders. However, Woniewala’s doctors had no idea that MiraLax presented a risk of oxalate nephropathy. Accordingly, the suit reads, “The failure of the defendants to identify this specific and life-threatening risk in patients who have kidney disease renders the aforementioned language in their labeling meaningless, as the healthcare community was not sufficiently informed so as to be able to properly advise or supervise the use of this product in patients.”
Stepping beyond this accusation, Woniewala and his attorneys, point out that there have been no shortages of complaints against MiraLax and its manufacturers to the Food and Drug Administration. The reports (which are themselves emblematic of the FDA’s failure to monitor drugs after they have secured initial approval) “should have compelled [the Administration] to investigate the link between the drug and patients with chronic kidney disease.”
It is clear that awareness of this issue needs to be greater. For example, a University of North Carolina Kidney Center pamphlet explains to readers that they “can use MiraLax if needed,” a combination that has already proven dangerous in a number of cases. The FDA should fully investigate and publicize this issue, but it seems–as in so many other cases–that plaintiffs and their attorneys are the last line of defense when individuals are harmed through no fault of their own by dangerous drugs.
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