- The FDA has announced that two versions of Pataday allergy eye drops will now be sold as over-the-counter medications.
- The change is part of an FDA program designed to make some prescription drugs available as OTC medications.
- Experts caution consumers that just because a medication is sold over the counter doesn’t mean it doesn’t have side effects.
- They add that the switch to an OTC status doesn’t necessarily mean that a drug will cost less.
As spring closes in and pollen and other allergens start their annual clash with sensitive human eyeballs, the Food and Drug Administration (FDA) is making things a little easier for consumers.
The FDA has
Two versions of Pataday eye drops (Twice Daily Relief and Once Daily Relief) are now available without a doctor’s approval.
“Pataday becoming an OTC medication is good news for consumers as it provides them another option (from current OTC eye drops) that is potentially more effective in treating these common conditions and providing temporary relief,” Ramzi Yacoub, the chief pharmacy officer at SingleCare, told Healthline.
The FDA approved the drugs as OTC last week through a process called prescription
Pataday Twice Daily Relief first hit the market in 1996 under the name Patanol, to treat allergic conjunctivitis (ocular redness and itching caused by allergies).
Pataday Once Daily Relief was approved by the FDA in 2004.
Both versions of Pataday are made by Alcon and are mast cell stabilizers, which prevent the release of histamine and prevent or control allergic reactions.
“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 Dr. Karen Mahoney, acting deputy director of the FDA’s Office of Nonprescription Drugs, in a
“Approval of a wider range of non-prescription 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,” she added.
“One in five Americans — 66 million — suffer from eye allergies,” said Dr. Michael Cooper, an optometrist with Solinsky Eye Care in Hartford, Connecticut, and an Alcon consultant. “Only about 10 percent use an over-the-counter eye allergy drop to assist in relieving their itchy eyes.”
“This news is rather important for both doctors and people with eye allergies,” he told Healthline. “The last time we saw an Rx-to-OTC switch in the allergy space was more than a decade ago, making this a rather unique moment in time.”
Dr. J. Allen Meadows is an allergist in Alabama and the president of the American College of Allergy, Asthma, and Immunology.
He said one of the reasons consumers like Pataday is it’s easy on the eyes.
“A lot of eye products burn,” he said. “The preservative they use (in Pataday) is extraordinarily comfortable.”
He said Pataday is effective and “has a better side effect profile” than other OTC drops.
That doesn’t mean, however, that Pataday won’t have any side effects.
“It was reported to have some side effects, such as change in vision, burning sensation in eyes, and irritation,” said Jagdish Khubchandani, PhD, MPH, MBBS, a professor of public health at Ball State University in Indiana. “Thankfully, these happen in less than 1 percent of the cases and are not life-threatening.”
Yacoub said there can be drug interactions to other medications.
“They are generally indicated for short-term relief, so if you need to continue to take these medications, it’s best to speak to your physician or pharmacist,” he said.
Yacoub said the generic version of Pataday — olopatadine Hcl — is available at SingleCare for about $100 for a 2.5 ml bottle.
“But expect this price to drop as many other OTC antihistamines are available today for under $20,” said Yacoub.
Meadows said a push for making more prescription drugs available over the counter came during the Obama administration after passage of the Affordable Care Act.
He said a renewed push is likely coming from manufacturers.
“One thing I’m concerned about is the expense,” said Meadows, adding he expects prices to go down in about 6 months. “It may be a little more expensive than a co-pay, at least initially.”
Pataday’s conversion to OTC is “part of a larger trend we’ve seen recently of common maintenance medications being approved for over-the-counter use,” Jessica Nouhavandi, PharmD, the lead pharmacist and chief executive officer of the online pharmacy Honeybee Health, told Healthline.
“From a convenience standpoint, this makes it easier for patients to access certain popular medications. However, from a cost perspective, over the counter does not always mean lower prices,” she said. “In fact, many medications are actually cheaper with a prescription.”
Which may not be the case for long, as more prescription drugs go OTC, patents expire and competition ramps up, Khubchandani said.
“A lot more of this (has been) happening since the 2000s as it relates to anti-allergy medication,” he said. “Pharma companies benefit as they eventually end up losing patent restrictions and have greater competition for their products.”
“Going OTC is another route for a certain drug manufacturer to have large volume sales and generate enough revenue, despite the lower costs of their OTC medications,” Khubchandani said.
“It is a major gift for consumers,” he added. “Think of how much they can save on insurance costs, doctor’s visits, transportation, and time. Above all, we cannot put a dollar value on immediate comfort gained from OTC medications when needed without the aforementioned hurdles.”