SILVER SPRING, Md., Sept. 30 /PRNewswire-USNewswire/ — 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 flare-ups, and
for the treatment of Familial Mediterranean Fever (FMF).
The companies are expected to stop manufacturing
single-ingredient oral colchicine within 45 days and must stop
shipping this unapproved product in interstate commerce within 90
days. A small amount of unapproved colchicine is expected to be
available after these dates until supplies are exhausted.
Many single ingredient oral colchicine products have been used
by the medical community for decades. These and a variety of other
medications have not received the mandatory modern-day FDA-approval
required of all prescription drugs.
Colcrys is the only FDA-approved single-ingredient oral
colchicine product available on the U.S. market. Approved by the
FDA in 2009, Colcrys’
prescribing information contains important safety data and
recommendations on drug interactions and dosing not available with
The manufacturer of Colcrys, Mutual Pharmaceutical/URL Pharma,
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. The company also has
informed FDA that it will maintain the programs at a minimum until
there is FDA-