"The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemi"...
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received LOPID for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the LOPID group:
(N = 2046)
(N = 2035)
percent of subjects
|Acute appendicitis (histologically confirmed in most cases where data were available)||1.2||0.6|
|Adverse events reported by more than 1% of subjects, but without a significant difference between groups:|
Gallbladder surgery was performed in 0.9% of LOPID and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the LOPID group compared to the placebo group (1.9% versus 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the gemfibrozil group was seen also in the secondary prevention component (6 on gemfibrozil versus 0 on placebo, p=0.014).
Nervous system and special senses adverse reactions were more common in the LOPID group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among LOPID treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.
From other studies it seems probable that LOPID is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see WARNINGS), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS).
Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for gemfibrozil are listed below by system. These are categorized according to whether a causal relationship to treatment with LOPID is probable or not established:
|CAUSAL RELATIONSHIP PROBABLE||CAUSAL RELATIONSHIP NOT ESTABLISHED|
|Central Nervous System:||dizziness||confusion|
|Eye:||blurred vision||retinal edema|
|Genitourinary:||impotence||decreased male fertility|
|rhabdomyolysis (see WARNINGS and DRUG INTERACTIONS under PRECAUTIONS)|
|Clinical Laboratory:||increased creatine phosphokinase increased bilirubin||positive antinuclear antibody|
|increased liver transaminases (AST, ALT)|
|increased alkaline phosphatase|
|bone marrow hypoplasia|
|laryngeal edema||Lupus-like syndrome|
Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (see WARNINGS).
Read the Lopid (gemfibrozil) Side Effects Center for a complete guide to possible side effects
HMG-CoA Reductase Inhibitors: The concomitant administration of LOPID with simvastatin is contraindicated (see CONTRAINDICATIONS and WARNINGS). The risk of myopathy and rhabdomyolysis is increased with combined gemfibrozil and HMG-CoA reductase inhibitor therapy. Myopathy or rhabdomyolysis with or without acute renal failure have been reported as early as three weeks after initiation of combined therapy or after several months (see WARNINGS). There is no assurance that periodic monitoring of creatine kinase will prevent the occurrence of severe myopathy and kidney damage.
- Anticoagulants: CAUTION SHOULD BE EXERCISED WHEN WARFARIN IS GIVEN IN CONJUNCTION WITH LOPID. THE DOSAGE OF WARFARIN SHOULD BE REDUCED TO MAINTAIN THE PROTHROMBIN TIME AT THE DESIRED LEVEL TO PREVENT BLEEDING COMPLICATIONS. FREQUENT PROTHROMBIN DETERMINATIONS ARE ADVISABLE UNTIL IT HAS BEEN DEFINITELY DETERMINED THAT THE PROTHROMBIN LEVEL HAS STABILIZED.
- Repaglinide: In healthy volunteers, co-administration with gemfibrozil (600 mg twice daily for 3 days) resulted in an 8.1-fold (range 5.5-to 15.0-fold) higher repaglinide AUC and a 28.6-fold (range 18.5-to 80.1-fold) higher repaglinide plasma concentration 7 hours after the dose. In the same study, gemfibrozil (600 mg twice daily for 3 days) + itraconazole (200 mg in the morning and 100 mg in the evening at Day 1, then 100 mg twice daily at Day 2-3) resulted in a 19.4-(range 12.9-to 24.7-fold) higher repaglinide AUC and a 70.4-fold (range 42.9-to 119.2-fold) higher repaglinide plasma concentration 7 hours after the dose. In addition, gemfibrozil alone or gemfibrozil + itraconazole prolonged the hypoglycemic effects of repaglinide. Co-administration of gemfibrozil and repaglinide increases the risk of severe hypoglycemia and is contraindicated (see CONTRAINDICATIONS).
- Bile Acid-Binding Resins: Gemfibrozil AUC was reduced by 30% when gemfibrozil was given (600 mg) simultaneously with resin-granule drugs such as colestipol (5 g). Administration of the drugs two hours or more apart is recommended because gemfibrozil exposure was not significantly affected when it was administered two hours apart from colestipol.
- Colchicine: Myopathy, including rhabdomyolysis, has been reported with chronic administration of colchicine at therapeutic doses. Concomitant use of LOPID may potentiate the development of myopathy. Patients with renal dysfunction and elderly patients are at increased risk. Caution should be exercised when prescribing LOPID with colchicine, especially in elderly patients or patients with renal dysfunction.
Read the Lopid Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 11/13/2014
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