1/5. Judicious evaluation of adverse drug reactions: inaccurate assessment of 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor-induced muscle injury.Adverse reactions in two patients who received HMG CoA reductase inhibitor therapy were reinvestigated because of their rarity. A case of permanent forearm myalgia was thought to be caused by atorvastatin. Closer evaluation and work-up revealed underlying lateral epicondylitis, and atorvastatin was not considered the cause of the disability. In another patient, rhabdomyolysis was suspected to be secondary to simvastatin. However, after an extensive review, the reaction was believed to be compartment syndrome of the anterior tibial area. An adverse drug reaction report requires careful and judicious assessment to assign the correct probability for the event.- - - - - - - - - - ranking = 1keywords = probability (Clic here for more details about this article) |
2/5. Fluvastatin-induced rhabdomyolysis.OBJECTIVE: To demonstrate a case of rhabdomyolysis with acute renal failure in a patient receiving fluvastatin and to present evidence that this was an adverse drug reaction to fluvastatin. CASE SUMMARY: A 51-year-old white man with a past medical history significant for hyperlipidemia treated with fluvastatin presented with malaise, myalgias, nausea, and lumbar back pain. The patient had azotemia with elevated creatine kinase (CK), lactate dehydrogenase, and transaminases. He developed hematuria and proteinuria. Laboratory results demonstrated a normal antinuclear antibody, rheumatoid factor, angiotensin-converting enzyme, antineutrophil cytoplasmic antibody, and thyroid-stimulating hormone. cytomegalovirus and Epstein-Barr virus titers were negative for recent infection. There were no signs of systemic infection; the white blood cell count was normal and blood and urine cultures were negative. Renal ultrasound showed hyperechoic renal cortices with no obstruction. The discontinuation of fluvastatin and hemodialysis led to a rapid decrease in CK and improvement in symptoms. DISCUSSION: Hydroxymethylglutaryl coenzyme a (HMG-CoA) reductase inhibitors have the potential to cause rhabdomyolysis. However, fluvastatin is rarely associated with rhabdomyolysis when compared to other statins. Differences in biochemical and pharmacokinetic properties between fluvastatin and other HMG-CoA reductase inhibitors may be important in the development of rhabdomyolysis. CONCLUSIONS: Fluvastatin was the precipitating factor causing rhabdomyolysis in this case report. This patient had no other findings to suggest infection or other disorder inducing rhabdomyolysis. An objective causality assessment revealed that the adverse drug reaction was probable as determined by the Naranjo probability scale. Fluvastatin has the potential to cause serious adverse effects. Therefore, a heightened awareness by the patient and physician for potential signs of myopathy is recommended.- - - - - - - - - - ranking = 1keywords = probability (Clic here for more details about this article) |
3/5. rhabdomyolysis causing AV blockade due to possible atorvastatin, esomeprazole, and clarithromycin interaction.OBJECTIVE: To report rhabdomyolysis (RML) causing third-degree atrioventricular block secondary to a possible interaction between atorvastatin, esomeprazole, and clarithromycin. CASE SUMMARY: A 51-year-old white woman presented to the emergency department with severe weakness, near syncope, shortness of breath, and chest pain. On admission, her electrocardiogram demonstrated bradycardia (40 beats/min) and third-degree heart block. A creatine kinase (CK) level was >7000 U/L. Her medication history was significant for long-term use of atorvastatin (>1 y), a 6-week history of esomeprazole use, and three 500-mg doses of clarithromycin just prior to admission. Her symptoms of weakness, shortness of breath, and chest pain coincided with starting the esomeprazole. During her hospitalization, the woman required pacemaker placement and her CK continued to rise to >40,000 U/L. Screening for other causes of RML, such as thyrotoxicosis, infection, and immune or hepatic diseases, was negative. She gradually improved over a 26-day hospitalization. DISCUSSION: This is a case of RML resulting in third-degree atrioventricular blockade. An objective causality assessment of the adverse reaction via the Naranjo probability scale revealed a probable association with atorvastatin and a possible association with esomeprazole and clarithromycin. The pharmacokinetic profiles of these agents suggest that a possible contribution to this reaction was p-glycoprotein (PGP) inhibition by esomeprazole altering atorvastatin's normally significant first-pass clearance. CONCLUSIONS: PGP drug interactions with atorvastatin and other hydroxymethylglutaryl coenzyme a reductase inhibitors (statins) may be associated with unreported risks for RML. Further investigation into PGP impact on HMG-CoA appears warranted.- - - - - - - - - - ranking = 1keywords = probability (Clic here for more details about this article) |
4/5. rhabdomyolysis caused by commiphora mukul, a natural lipid-lowering agent.OBJECTIVE: To report a case of rhabdomyolysis caused by commiphora mukul, a natural lipid-lowering agent. CASE SUMMARY: A 55-year-old man was taking an extract of C. mukul 300 mg 3 times daily to lower his cholesterol level. He developed rhabdomyolysis with hemoglobinuria after 2 weeks of treatment. Laboratory tests showed creatine kinase 144600 IU/L (reference range 24-195), myoglobin >3000 ng/mL (28-72), lactate dehydrogenase 7157 IU/L (230-460), aspartate aminotransferase 1115 IU/L (10-35), and alanine aminotransferase 205 IU/L (10-35). Analysis of a urine sample was 2 positive for hemoglobin. All parameters returned to normal after the herbal preparation was discontinued. DISCUSSION: The Naranjo probability scale indicates C. mukul as the possible cause of rhabdomyolysis in our patient. Drug-induced rhabdomyolysis is an established but rare adverse effect of high doses of cholesterol-lowering agents (statins) or interactions between drugs (eg, statins and fibrates). As of May 28, 2004, to our knowledge, this is the first reported case of rhabdomyolysis following C. mukul ingestion. CONCLUSIONS: Our report describes a case of rhabdomyolysis possibly caused by C. mukul and underlines the need for active surveillance of natural products.- - - - - - - - - - ranking = 1keywords = probability (Clic here for more details about this article) |
5/5. Acute rhabdomyolysis associated with ofloxacin/levofloxacin therapy.OBJECTIVE: To report a case of ofloxacin/levofloxacin-induced rhabdomyolysis and to compare other reported cases from the literature. CASE SUMMARY: A 19-year-old male patient developed ofloxacin/levofloxacin-induced rhabdomyolysis during admission for periorbital cellulitis. Symptoms of myalgia, weakness, and swelling of the arms developed after 3 days of treatment with ofloxacin 800 mg/day. Laboratory analysis confirmed the presence of urine myoglobin (381.2 microg/L) and a marked increase in serum myoglobin (590.8 microg/L), along with marked elevations in serum creatine kinase (up to 16 546 IU/L). DISCUSSION: In addition to ruling out other possible etiologic factors one by one, we assessed the probability of ofloxacin/levofloxacin-induced rhabdomyolysis by observing the close time relationship between drug administration and the development of symptoms/signs, as well as the close time relationship between drug withdrawal and the disappearance of symptoms/signs. An objective causality assessment by use of the Naranjo probability scale revealed that the adverse drug reaction was probable. CONCLUSIONS: Although ofloxacin/levofloxacin-induced rhabdomyolysis appears to be rare, patients with muscle pain, swelling, or weakness during therapy should be closely monitored for this adverse effect.- - - - - - - - - - ranking = 2keywords = probability (Clic here for more details about this article) |