Safety Alerts & Recalls

What does this mean?

Although this is not a recall alert, the safety of unapproved drugs is unknown and you should review your colchicine prescription to see if you are taking one of the unapproved products or the FDA-approved Colcrys. Colcrys is a purple film-coated, capsule-shaped tablet with 'AR 374' marked on one side and scored on the other side.

If you are taking an unapproved single-ingredient product, please be aware that this product will not be available in the near future. The cost of the FDA-approved Colcrys may be different than the unapproved single-ingredient oral colchicine products you may have received in the past. The manufacturer of Colcrys has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine. Specific information on these programs can be found at www.colcrys.com, www.needymeds.org, or by calling 1-888-811-8423.

If you have any questions or concerns about unapproved single-ingredient oral colchicine or the FDA-approved Colcrys, please follow up with your pharmacist or doctor.

Withdrawal of Unapproved Oral Colchicine Products

The U.S. Food and Drug Administration (FDA) took action against companies that manufacture and distribute unapproved single-ingredient oral colchicine. It is a priority for the FDA to get unapproved medications, such as older versions of single-ingredient oral colchicine, either updated to conform to FDA's current approval standards or off the market. The companies are expected to stop manufacturing these single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product within 90 days.

Currently, Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market.

To view, the FDA's question and answer webpage, please visit: more information here

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-10-01
Last Updated: 2010-10-01

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