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Colcrys

"The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout f"...

Colcrys

Colcrys

SIDE EFFECTS

Prophylaxis of Gout Flares

The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea.

Treatment of Gout Flares

The most common adverse reactions reported in the clinical trial with COLCRYS for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%).

FMF

Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating COLCRYS, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses. Typical symptoms include cramping, nausea, diarrhea, abdominal pain, and vomiting. These events should be viewed as dose-limiting if severe as they can herald the onset of more significant toxicity.

Clinical Trials Experience in Gout

Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and may not predict the rates observed in a broader patient population in clinical practice.

In a randomized, double-blind, placebo-controlled trial in patients with a gout flare, gastrointestinal adverse reactions occurred in 26% of patients using the recommended dose (1.8 mg over 1 hour) of COLCRYS compared to 77% of patients taking a non-recommended high-dose (4.8 mg over 6 hours) of colchicine and 20% of patients taking placebo. Diarrhea was the most commonly reported drug-related gastrointestinal adverse event. As shown in Table 3, diarrhea is associated with COLCRYS treatment. Diarrhea was more likely to occur in patients taking the high-dose regimen than the low-dose regimen. Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the non-recommended high-dose colchicine regimen but did not occur in the recommended low-dose COLCRYS regimen.

Table 3 : Number (%) of Patients with at Least One Drug-Related Treatment Emergent Adverse Events with an Incidence of ≥ 2% of Patients in Any Treatment Group

MedDRA System Organ Class
MedDRA Preferred Term
COLCRYS Dose Placebo
(N=59)
n (%)
High
(N=52)
n (%)
Low
(N=74)
n (%)
Number of Patients with at Least One Drug-Related TEAE 40 (77) 27 (37) 16 (27)
Gastrointestinal Disorders 40 (77) 19 (26) 12 (20)
  Diarrhea 40 (77) 17 (23) 8 (14)
  Nausea 9 (17) 3 (4) 3 (5)
  Vomiting 9 (17) 0 0
  Abdominal Discomfort 0 0 2 (3)
General Disorders and Administration Site Conditions 4 (8) 1 (1) 1 (2)
  Fatigue 2 (4) 1 (1) 1 (2)
Metabolic and Nutrition Disorders 0 3 (4) 2 (3)
  Gout 0 3 (4) 1 (2)
Nervous System Disorders 1 (2) 1 (1.4) 2 (3)
  Headache 1 (2) 1 (1) 2 (3)
Respiratory Thoracic Mediastinal Disorders 1 (2) 2 (3) 0
  Pharyngolaryngeal Pain 1 (2) 2 (3) 0

Postmarketing Experience

Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous systems.

These most often occur with excessive accumulation or overdosage [see OVERDOSAGE].

The following adverse reactions have been reported with colchicine. These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine.

Neurological: sensory motor neuropathy

Dermatological: alopecia, maculopapular rash, purpura, rash

Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting

Hematological: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia

Hepatobiliary: elevated AST, elevated ALT

Musculoskeletal: myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis

Reproductive: azoospermia, oligospermia

Read the Colcrys (colchicine tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

COLCRYS (colchicine) is a substrate of the efflux transporter P-glycoprotein (P-gp). Of the cytochrome P450 enzymes tested, CYP3A4 was mainly involved in the metabolism of colchicine. If COLCRYS is administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicine are likely. Fatal drug interactions have been reported.

Physicians should ensure that patients are suitable candidates for treatment with COLCRYS and remain alert for signs and symptoms of toxicities related to increased colchicine exposure as a result of a drug interaction. Signs and symptoms of COLCRYS toxicity should be evaluated promptly and, if toxicity is suspected, COLCRYS should be discontinued immediately.

Table 4 provides recommendations as a result of other potentially significant drug interactions. Table 1 provides recommendations for strong and moderate CYP3A4 inhibitors and P-gp inhibitors.

Table 4 : Other Potentially Significant Drug Interactions

Concomitant Drug Class or Food Noted or anticipated Outcome Clinical Comment
HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, pravastatin, simvastatin Pharmacokinetic and/or pharmacodynamic interaction: the addition of one drug to a stable long-term regimen of the other has resulted in myopathy and rhabdomyolysis (including a fatality) Weigh the potential benefits and risks and carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during initial therapy; monitoring CPK (creatine phosphokinase) will not necessarily prevent the occurrence of severe myopathy.
Other Lipid Lowering Drugs: fibrates, gemfibrozil
Digitalis Glycosides: digoxin P-gp substrate; rhabdomyolysis has been reported

Drug Abuse And Dependence

Tolerance, abuse, or dependence with colchicine has not been reported.

Read the Colcrys Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 8/5/2011
This monograph has been modified to include the generic and brand name in many instances.

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