Colcrys® vs. Unapproved Colchicine: What You Need to Know
COLCRYS® is the only single-ingredient colchicine to be reviewed and approved by the FDA, and conforms to modern FDA standards of safety, efficacy, purity, consistency and labeling. The same cannot be said for unapproved colchicine products. Read below to learn more about the important differences between COLCRYS versus unapproved colchicine and see links to FDA press releases.
The first and only single-ingredient colchicine product approved by the FDA
- COLCRYS is the first and only single-ingredient colchicine to be approved by the FDA for the prophylaxis and treatment of gout flares as well as treatment of familial Mediterranean fever (FMF). Other colchicine products currently on the market have never been approved by the FDA. Unapproved drugs have not undergone the FDA review and approval process to assure current standards of safety, efficacy, quality, purity or potency and can pose a significant risk to patients.
- Unapproved colchicine products are sometimes incorrectly referred to as “generic” colchicine. The term “generic” drug means a drug that has been approved by FDA. In reality, there are no generic colchicine tablets.
- COLCRYS received approval from FDA for the treatment of acute gout flares on July 30, 2009; approval for the prophylaxis of gout flares on Oct 16, 2009; and approval for familial Mediterranean fever (FMF) on July 30, 2009.
- No scientific studies have been conducted on unapproved colchicine products to prove their safety or efficacy.
Therefore, critical information that is routinely available for FDA-approved products – including correct information on safety and effectiveness, tolerability, dangerous side effects and interactions with other medicines – cannot be determined from unapproved colchicine.
- URL Pharma conducted the research and made discoveries that enable the appropriate use of colchicine, resulting in FDA-approved COLCRYS. The AGREE study, a Phase III clinical trial conducted by URL Pharma in over 50 clinical centers across the US, partnering with several leading rheumatologist investigators, demonstrated that colchicine (as COLCRYS®) can be given at lower doses than traditionally prescribed, substantially reducing the risks of toxicity while retaining effectiveness.
- Our researchers also made important findings about commonly-used drugs that may have serious and potentially fatal interactions with colchicine, providing the medical community with extensive guidance on how to safely administer colchicine with other medications such as those taken for hypertension, infectious disease (antibiotics) and HIV/AIDS.
- URL Pharma’s research and subsequent FDA approval of its New Drug Application (NDA) for COLCRYS aligns with an initiative the FDA launched in 2006 to bring unapproved products under its regulatory framework by requesting that manufacturers conduct studies to demonstrate safety and efficacy of unapproved products. The initiative also grants FDA the authority to remove untested, unapproved products from the market. With the scientific discoveries and subsequent FDA-approval of COLCRYS, not only has an FDA-approved version of colchicine now become available to American patients, but medical textbooks now need to be re-written.
- More information about the FDA’s approval of COLCRYS, the risks of unapproved colchicine, and the benefits of COLCRYS are available via the following links:
- FDA Alert: Colchicine (marketed as COLCRYS®) Information 7/30/09
- FDA Information for Healthcare Professionals: New Safety Information for Colchicine
(marketed as COLCRYS®) 7/30/09
- FDA Press Release and Video Oct. 2009 – New Colchicine Product and Dosing Regimen
- FDA’s Concerns about Unapproved Drugs
- Letter from URL Pharma CEO to President of American College of Rheumatology Regarding Dangers of Unapproved Colchicine
- Letter from URL Pharma CEO to Hikma Pharmaceuticals PLC and West-Ward Pharmaceutical Corporation, calling for an immediate end to the manufacture of their illegal, unapproved colchicine product
- Letter from URL Pharma CEO to Hikma Pharmaceuticals PLC and West-Ward Pharmaceutical Corporation, calling for an immediate end to the continued endorsement of unapproved and illegal colchicine tablets
- FDA’s 90 Minute Video about Unapproved Drugs
- The DoctorsChannel.com Video
about Colchicine New Dosing and Drug Interactions