medwireNews: The US FDA has approved nonprescription diclofenac sodium topical gel, 1% for temporary pain relief in patients with osteoarthritis.
This nonsteroidal anti-inflammatory drug was initially approved as a prescription drug in 2007, but can now be obtained over-the-counter (OTC) following a prescription-to-OTC switch process demonstrating that it is suitable for self-medication following directions on the label.
“Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription,” said Karen Mahoney, from the FDA’s Center for Drug Evaluation and Research, in a press release.
Diclofenac gel is indicated for pain relief in joints responsive to topical treatment, particularly those in the hands, knees, and feet, and may take up to 1 week to work.
The FDA notes that patients should seek medical assistance if their osteoarthritis pain does not improve after 1 week of using the gel, or if more than 21 days of use is required, and warns that diclofenac can cause serious allergic reactions, particularly among people with an allergy to aspirin.
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