Safety Alerts & Recalls

What does this mean?

The new prescribing information for colchicine will help doctors and patients use colchicine more safely and reduce the risk of the toxic side effects of colchicine. If you are taking colchicine on a daily basis for any indication or if you are taking it as needed for gout attacks, please make an appointment with your doctor to review your use of this medication. Your doctor should review your medication list for possible drug interactions and may want to adjust your dose based on the new prescribing information.

The FDA has also provided the following recommendations for patients:

1) Understand that colchicine (Colcrys) is not a pain medication and should not be used for other causes of pain.

2) Understand that life-threatening and fatal drug interactions can occur with colchicine if it is given with certain medications. These interactions can occur even at prescribed colchicine doses, and with medications that are given for a limited time, such as antibiotics.

3) Review the Medication Guide that is provided with prescriptions of colchicine.

4) Discuss with your healthcare professionals all medications being taken and check with them before starting any new medications.

5) Avoid consuming grapefruit and grapefruit juice while using colchicine.

6) Pay close attention for any signs or symptoms of colchicine toxicity such as muscle weakness or pain, numbness or tingling in the fingers or toes, unusual bleeding or bruising, severe diarrhea or vomiting, feeling weak or tired, increased infections, and pale or gray color of the lips, tongue, or palms of hands. If any of these symptoms occur, seek medical attention right away.

New Safety Information for Colchicine

FDA has now approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares. Colchicine has been prescribed by healthcare practitioners for many years to treat gout but had not been approved by the FDA for this indication. Oral colchicine now has FDA-approved prescribing information, dosage recommendations, drug interaction warnings, and a Medication Guide.

First, the FDA has approved new colchicine dosing for treatment of acute gout attacks. Treating a gout attack with one dose of colchicine followed by single additional dose after one hour was shown to be just as effective but much less toxic than the previously used multiple hourly doses of colchicine.

Second, during a review of the safety data for colchicine, the FDA identified several drug interactions that could lead to toxic levels of colchicine in the body and may be life threatening. Examples of drugs that may interact with colchicine include: - Select antibiotics and antifungals, including clarithryomycin (Biaxin), erythromycin, telithromycin (Ketek), ketoconazole (Nizoral), and itraconazole (Sporanox)

- Calcium channel blockers, such as verapamil (also marketed as Calan, Covera HS, Isoptin SR, Veralan, Veralan PM) and diltiazem (also marketed as Cardizem, Cardizem CD, Cardizem LA, Cartia XT, Dilacor XR, Dilt-CD, Diltzac, Tiazac, Taztia XT)

- HIV protease inhibitors, including amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)

- Cholesterol lowering medications, including statins [atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor)], fenofibrate (Tricor), fenofibric acid (Trilipix), and gemfibrozil

- Other common medications, such as nefazodone (Serzone), cyclosporine (Neoral, Sandimmune), and digoxin (Lanoxin)

Finally, there have also been reports of colchicine toxicity in patients who take colchicine and drink grapefruit juice.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-07-31
Last Updated: 2009-12-05

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