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Colcrys (Colchicine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 COLCRYS Dose Placebo
MedDRA Preferred Term High (N=52)
n (%)
Low (N=74)
n (%)
(N=59)
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



REPORTS OF SUSPECTED COLCRYS SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Colcrys. The information is not vetted and should not be considered as verified clinical evidence.

Possible Colcrys side effects / adverse reactions in 63 year old female

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient: 63 year old female

Reactions: OFF Label USE, Leukopenia

Suspect drug(s):
Colcrys



Possible Colcrys side effects / adverse reactions in 66 year old female

Reported by a individual with unspecified qualification from United States on 2011-10-26

Patient: 66 year old female

Reactions: Constipation

Suspect drug(s):
Colcrys



Possible Colcrys side effects / adverse reactions in 43 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-26

Patient: 43 year old male

Reactions: Drug Ineffective

Suspect drug(s):
Colcrys



See index of all Colcrys side effect reports >>

Drug label data at the top of this Page last updated: 2010-05-31

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