Health trends

Oral gout treatment halted

The United States (US) Food and Drug Administration (FDA) on September 30 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 US market. Approved by the FDA in 2009, Colcrys' prescribing information contains important safety data and recommendations on drug interactions and dosing not available with unapproved products.

- Source: The US Food and Drug Administration

Warning to mouth-rinse makers

The United State Food and Drug Administration (FDA) on September 28 issued warning letters to three companies that manufacture and market mouth-rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action). These mouth-rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities, but has not found this ingredient to be effective in removing plaque or preventing gum disease.

"It is important for the FDA to take appropriate enforcement action when companies make false or unproven product claims to ensure that consumers are not misinformed or misled," said Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research.

Source: The US Food and Drug Administration