Abstract
The polymer polyvinylpyrrolidone (PVP) is an excipient widely used in prescription drugs. Depending on the molecular weight (MW), parenterally administered PVP may accumulate in various tissues. Consequently, moderate and high MW PVP have only been used in oral preparations since the late 1970s. Surprisingly, starting in 2009, pathology departments in Norway received biopsies revealing PVP deposition, all from patients with a history of intravenous drug use. We identified 13 patients with PVP deposition and re-evaluated 31 biopsies and two autopsies. Common indications for biopsy were renal insufficiency, anemia, pathological fractures, and abdominal complaints. We observed PVP deposits in all biopsies (kidney, hematopoietic bone marrow, bone, gastrointestinal tract, lymph node, and skin) and all sampled tissue from the autopsies. Overall, the clinical findings could be related to PVP deposits in the biopsies. In the most seriously affected patients, PVP deposition caused severe organ dysfunction and contributed to the fatal outcomes of two patients. All patients except for one were prescribed opioid substitution drugs (OSDs), and most of the patients admitted to having injected such medications. Several OSDs contain PVP. One methadone formulation that was marketed in Norway from 2007 to 2014 contained large amounts of very high MW PVP, making it the most likely source of PVP deposition. Although the presumed source of PVP in these patients has now been withdrawn from the market, pathologists should be aware of PVP deposits when evaluating biopsies from this patient group.
Highlights
Background and introductionStarting in 2009, pathology departments in Norway received an increasing number of diagnostic biopsies showing deposits of polyvinylpyrrolidone (PVP)
We studied two PVP-containing opioid substitution drugs (OSD) preparations marketed in Norway at that time: a methadone syrup containing PVP K90 and buprenorphine tablets containing PVP K30
Based on the findings presented in this case series, this methadone preparation was withdrawn from the market in Norway and the European Union in 2014 [33]
Summary
Starting in 2009, pathology departments in Norway received an increasing number of diagnostic biopsies showing deposits of polyvinylpyrrolidone (PVP). It is widely used as an excipient in tablets and other oral medications [1]. It is neither absorbed from the gastrointestinal (GI) tract nor degraded enzymatically. Elimination is only possible by renal excretion [2]. While PVP of low molecular weight (MW) will be completely excreted, high MW PVP will accumulate in the body’s tissues [2]. Because of the discovery of PVP deposition, high MW PVP has not been used in parenteral preparations since the end of the 1970s, at least not in the Western world [3]
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