Prevalite Side Effects

Generic Name: cholestyramine

Please note - some side effects for Prevalite may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Prevalite - for the Consumer

Prevalite Powder

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prevalite Powder:

Constipation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; irritation of the skin, tongue, or anal area; severe constipation; severe or persistent nausea; shortness of breath; stomach pain; unusual bruising or bleeding; vomiting.

Prevalite Side Effects - for the Professional

Prevalite

The most common adverse reaction is constipation. When used as a cholesterol-lowering agent, predisposing factors for most complaints of constipation are high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient, and controlled with conventional therapy. Some patients require a temporary decrease in dosage or discontinuation of therapy.

Less Frequent Adverse Reactions: Abdominal discomfort and/or pain, flatulence, nausea, vomiting, diarrhea, dyspepsia, eructation, anorexia, steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (one case of night blindness reported) and D deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue and perianal area. Rare reports of intestinal obstruction, including two deaths, have been reported in pediatric patients.

Occasional calcified material has been observed in the biliary tree, including calcification of the gallbladder, in patients to whom cholestyramine resin has been given. However, this may be a manifestation of the liver disease and not drug-related.

One patient experienced biliary colic on each of three occasions on which he took a cholestyramine for oral suspension product. One patient diagnosed as acute abdominal symptom complex was found to have a “pasty mass” in the transverse colon on x-ray.

Other events (not necessarily drug-related) reported in patients taking cholestyramine resin include:

 

Gastrointestinal—GI-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis.

 

Laboratory test changes—Liver function abnormalities.

 

Hematologic—Prolonged prothrombin time, ecchymosis, anemia.

 

Hypersensitivity—Urticaria, asthma, wheezing, shortness of breath.

 

Musculoskeletal—Backache, muscle and joint pains, arthritis.

 

Neurologic—Headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia.

 

Eye—Uveitis.

 

Renal—Hematuria, dysuria, burnt odor to urine, diuresis.

 

Miscellaneous—Weight loss, weight gain, increased libido, swollen glands, edema, dental bleeding, dental caries, erosion of tooth enamel, tooth discoloration.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects include constipation (28%), heartburn (17%), belching or bloating (11%), nausea (9%), eructation, anorexia, steatorrhea, hemorrhoids, rectal pain and irritation, diverticulitis, and bleeding from a known duodenal ulcer. Intestinal obstruction and pancreatitis are also reported in the literature.

Gastrointestinal side effects occur in the majority of patients treated with cholestyramine. Constipation is most common and can be severe. Intestinal obstruction has been reported in pediatric patients. Elderly patients are probably at risk for this as well. In one large study, gastrointestinal side effects diminished with continued therapy. If gastrointestinal side effects are significant, dosage reductions, even if temporary, may be beneficial.

Metabolic

Metabolic side effects include hyperchloremic metabolic acidosis, weight loss, and weight gain. Cholestyramine has been reported to decrease the absorption of thyroxine (T4).

Hyperchloremic metabolic acidosis has been reported in pediatric as well as adult patients. Onset of clinical illness ranged from days to several weeks after beginning cholestyramine therapy. In three out of four adult cases in the literature, spironolactone was used as concomitant therapy. Several patients had moderate underlying renal disease. With appropriate supportive care, correction of the acidosis, and discontinuation of cholestyramine, the patients recovered.

The mechanism by which cholestyramine causes metabolic acidosis has not been completely resolved. However, it may involve the release of chloride ions by cholestyramine (a chloride salt form) in addition to binding of bicarbonate and carbonate ions to the resin, creating a metabolic imbalance. Patients with impaired renal function may be at increased risk due to impairment of chloride elimination.

Hematologic

Hematologic side effects include rare cases of elevated prothrombin time, ecchymoses, and anemia.

Hepatic

Hepatic side effects of cholestyramine include rare cases of abnormal liver function tests although causality is unknown. In addition, calcification in the right upper quadrant and of the biliary tree has been reported, as has biliary colic.

Respiratory

Respiratory side effects include asthma, wheezing, and shortness of breath although causality is unknown.

Nervous system

Nervous system side effects include headache, anxiety, vertigo, dizziness, syncope, drowsiness, femoral nerve pain, and paresthesia although causality is unknown.

Renal

Renal side effects include hematuria, dysuria, burnt odor to the urine, and diuresis, as well as a case report of urethral calculi composed of uric acid.

Hypersensitivity

Hypersensitivity in the form of urticaria has been reported.

Musculoskeletal

Musculoskeletal side effects include osteoporosis, muscle and joint pain, muscle weakness, arthritis, and osteomalacia.

Other

Loss of dental enamel has been reported when cholestyramine was mixed with a relatively acidic liquid (in the case-report Kool-Aid was used).

Ocular

Ocular side effects include uveitis although causality is unknown.

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