A 61-year-old Caucasian woman was transported to the emergency department after intentionally ingesting several different prescription drugs. She had been found by her husband in an unconscious state with empty bottles of extended-release venlafaxine, extended-release nifedipine, sertraline, and atorvastatin. She was intubated in the emergency department and transferred to the intensive care unit. After 36 hours in the intensive care unit, she was stabilized and brought to a general medical ward. She later developed profound recurrent hypotension with systolic blood pressures ranging from 40-70 mm Hg and diastolic blood pressures of 0-40 mm Hg. She was readmitted to the intensive care unit, where a computed tomography scan revealed a mass in her stomach. A gastroenterology consultation was obtained, and an esophagogastroduodenoscopy (EGD) was performed, during which a large drug bezoar was discovered and removed. The drugs were identified as extended-release nifedipine with a few granules of extended-release venlafaxine. Unfortunately, the patient died 3 days after the EGD from multisystem organ failure related to the overdose. Clinicians who encounter drug overdoses should be aware of the possibility of drug bezoar formation and should consider endoscopic removal as a potential treatment option.
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http://dx.doi.org/10.1592/phco.26.12.1802 | DOI Listing |
CPT Pharmacometrics Syst Pharmacol
February 2024
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Proton pump inhibitors (PPIs) can affect the release of drugs from their dosage forms in vivo by elevating the gastric pH. Our recent clinical study has demonstrated that drug-drug interactions (DDIs) exist between a PPI, omeprazole, and nifedipine extended-release formulations, where systemic exposure of nifedipine was increased in subjects after multiple-dose pretreatment of omeprazole. However, the mechanism of the observed DDIs between omeprazole and nifedipine has not been well-understood, as the DDI may also be mediated through CYP3A4 enzyme inhibition in addition to the elevated gastric pH caused by omeprazole.
View Article and Find Full Text PDFBasic Clin Pharmacol Toxicol
February 2024
Clinical Pharmacology, Graduate School of Medicine, Yamaguchi University, Ube, Yamaguchi, Japan.
In this study, we examined the pharmacokinetics of nifedipine and investigated the maternal and foetal background factors that prolong pregnancy in pregnant women undergoing long-term tocolysis. This prospective observational study included 38 pregnant women hospitalised for threatened preterm labour and treated with nifedipine extended-release tablets in combination with an intravenous ritodrine infusion. Maternal plasma nifedipine concentrations were determined using high-performance liquid chromatography.
View Article and Find Full Text PDFAm J Obstet Gynecol MFM
December 2023
Division of Maternal-Fetal Medicine, Brigham and Women's Hospital, Boston, MA (Drs Yoselevsky, Robinson, and McElrath).
Background: Postpartum hypertension is a common medical complication of pregnancy and is associated with increased healthcare use, including unplanned interactions with the medical system and readmission, which can add significant stress to both a newly postpartum patient and the medical care delivery system. We currently do not know what the best antihypertensive treatment for postpartum hypertension is and tend to use antihypertensives commonly used during pregnancy. However, the mechanism of action of angiotensin-converting enzyme inhibitors may be well suited for the pathophysiology of hypertension in the postpartum period and may help to provide better control of hypertension and, in turn, decrease healthcare use.
View Article and Find Full Text PDFClin Pharmacol Ther
November 2023
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Oral extended-release (ER) dosage forms have been used to sustain blood drug levels, reduce adverse events, and improve patient compliance. We investigated potential effects of comedication on pharmacokinetic exposure of nifedipine ER products with different formulation designs and manufacturing processes. A clinical study compared a generic version of nifedipine ER tablet with pH-dependent dissolution behavior with an osmotic pump product with pH independent drug release under fasting condition.
View Article and Find Full Text PDFHypertens Pregnancy
December 2023
Department of Obstetrics & Gynecology, Nassau University Medical Center, East Meadow, NY, USA.
Background: Blood pressure medication is often prescribed to patients with preeclampsia. We are not aware of any study on readmission of those with preeclampsia to the hospital that considers blood pressure medication use or dose.
Methods: This was a retrospective study of 440 preeclampsia patients diagnosed during the antepartum, intrapartum, or immediate postpartum period prior to discharge from the hospital.
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