SILVER SPRING, Md.,
Feb. 14, 2020 /PRNewswire/ -- The
U.S. Food and Drug Administration today approved three drugs for
nonprescription, or over-the-counter (OTC), use through a process
called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren
Arthritis Pain (diclofenac sodium topical gel, 1%) for the
temporary relief of arthritis pain; Pataday Twice Daily
Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the
temporary relief of itchy and red eyes due to pollen, ragweed,
grass, animal hair or dander; and Pataday Once Daily Relief
(olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary
relief of itchy eyes due to pollen, ragweed, grass, animal hair or
dander, for nonprescription use.
"As a result of the Rx-to-OTC switch process, many products
sold over-the-counter today use ingredients or dosage strengths
that were available only by prescription 30 years ago," said
Karen Mahoney, M.D., acting deputy
director of the Office of Nonprescription Drugs in the FDA's Center
for Drug Evaluation and Research. "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. This includes
providing the millions of people that suffer with joint pain from
arthritis daily over-the-counter access to another non-opioid
treatment option."
The process of changing the status of a drug from prescription
to nonprescription is called an Rx-to-OTC switch. It is usually
initiated by the manufacturer of the prescription drug. For a drug
to switch to nonprescription status, the data provided must
demonstrate that the drug is safe and effective for use in
self-medication as directed in proposed labeling. The manufacturer
must show that consumers can understand how to use the drug safely
and effectively without the supervision of a healthcare
professional.
Voltaren Arthritis Pain is a nonsteroidal anti-inflammatory drug
(NSAID) and works by reducing substances in the body that cause
pain and inflammation. This product, previously referred to as
Voltaren Gel 1%, was first approved by the FDA in 2007 as a
prescription drug and was indicated for the relief of the pain of
osteoarthritis of joints responsive to topical treatment, in
particular, the joints of the hands, knees and feet. It has not
been shown to work for strains, sprains, bruises or sports
injuries.
Voltaren Arthritis Pain is intended for the temporary relief of
joint pain due to the most common type of arthritis,
osteoarthritis, which increases with age, affects millions of
people in the U.S., and can generally be self-diagnosed. Arthritis
is the swelling and tenderness of one or more of your joints.
Symptoms of arthritis include pain, swelling, stiffness, and
difficulty moving a joint.
Voltaren Arthritis Pain is not for immediate relief and may take
up to 7 days to work. Consumers should stop use and seek medical
attention if their arthritis pain is not improved in 7 days or they
need to use the product for more than 21 days. The active
ingredient in Voltaren Arthritis Pain, diclofenac, may cause a
severe allergic reaction, especially in people allergic to aspirin.
If an allergic reaction occurs, consumers are advised to stop use
and seek medical care immediately. Liver damage may occur if this
product is used more or longer than directed or when using other
products containing diclofenac. This product contains an NSAID,
which may cause severe stomach bleeding. NSAIDS, except aspirin,
increase the risk of heart attack, heart failure and stroke. These
can be fatal. The risk is higher if consumers use more than
directed or for longer than directed. If pregnant or breastfeeding,
consumers should talk to a health care professional about use. This
product should not be used during the last 3 months of pregnancy
unless the consumer is definitely directed to do so by a doctor
because diclofenac may cause problems in the unborn child or
complications during the delivery.
Pataday Twice Daily Relief was first approved by the FDA in 1996
under the name Patanol as a prescription drug and was indicated for
the treatment of the signs and symptoms of allergic conjunctivitis
(referring to ocular redness and itching due to allergies). Pataday
– now Pataday Once Daily Relief – was first approved by the FDA in
2004 as a prescription drug and was indicated for the treatment of
ocular itching associated with allergic conjunctivitis. These drugs
are mast cell stabilizers, which work by preventing the release of
histamine and therefore prevent or control allergic disorders.
Ocular itching caused by allergens is a common ailment in the U.S.,
affecting millions of people. Consumers are advised to stop use and
talk to their health care professional if they experience eye pain,
changes in vision, increased redness of the eye, worsening of
itching or itching lasting for more than 72 hours.
All three products will be marketed in the U.S. as
nonprescription drugs and will no longer be available as
prescription drugs. Consumers should read and follow the Drug Facts
labels for the nonprescription products. Patients who currently
take prescription versions of these products and have questions
about the Rx-to-OTC switch should talk to their health care
professional.
The FDA granted the approval of nonprescription Voltaren
Arthritis Pain to GlaxoSmithKline plc. The FDA granted the
approvals of nonprescription Pataday Twice Daily Relief and Pataday
Once Daily Relief to Alcon.
Media Contact: Amanda
Turney, 301-796-2969
Consumer Inquiries: Email or 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs; vaccines and other biological products for human
use; and medical devices. The Agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, and products that give off electronic radiation; and
for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration