From Rx-to-OTC: 13 drugs that made the switch in the past decade

Drugs that make the jump from prescription to over-the-counter (OTC)—known as the “Rx-to-OTC switch”—go through a data-driven, scientifically robust evaluation by the FDA. Medicines that make this switch must demonstrate efficacy as well as a broad margin of safety.

Contrary to what some may think, the FDA has no intention of miring drugs in prescription purgatory. In their own words, “The FDA believes that there is an important trend toward consumer participation in their own health care. It's part of the agency's mission to keep up with the consumers' wish to be more involved.”

The Rx-to-OTC switch allows consumers to have OTC access to an increasing number of medicines. Currently, more than 100 OTC ingredients, dosages, and indications are available compared with just 40 years ago, including more than 700 pain relievers, nicotine replacement, heartburn meds, and antifungal creams. According to a study by the Consumer Healthcare Products Association (CHPA), these switches result in savings of about $20 billion a year, which includes prescriptions, office visits, insurance costs, time taken from work, and travel expenses.

Let’s delve deeper into the subject and look at some drugs that made the Rx-to-OTC switch in the past decade.

A little history

The Federal Food, Drug, and Cosmetic Act of 1938 did not distinguish between prescription and OTC meds. Instead, it was the 1951 Durham-Humphrey amendments to this act that established OTC and prescription categories.

The reason that prescription drugs are controlled and not sold to patients OTC is that prescription drugs can be dangerous. They can be habit-forming/toxic, have serious adverse effects, or are used to treat medical conditions that cannot be self-diagnosed without a healthcare provider. OTC drugs, on the other hand, can be used safely and effectively by merely adhering to the instructions on the labels and are usually prescribed for conditions easy to diagnose without a physician, such as upset stomach, headache, or cold and fever. 

It wasn’t until 1972 that regulators established the OTC drug review to continuously assess the safety and efficacy of nonprescription drugs. This review process also allows for prescription drugs to be switched over for OTC use. In this fashion, nearly 40 previously prescription drugs have switched to OTC.

Alternatively, OTC approval can be attained via a new drug application (NDA) process. During this process, drugmakers provide the FDA with data supporting self-administration of the drug by the public. Submitted studies typically demonstrate that the product’s label can be read, comprehended, and adhered to without the advice of a physician. Additionally, the FDA looks at any new data, as well as previous data from prescription use.

With new drug applications, even drugs that are eventually destined to become OTC are first approved as prescription drugs.

Rx-to-OTC switch

The key to the FDA’s decision to switch a drug from prescription to OTC involves a benefit-risk analysis. Importantly, no formula exists to determine benefit-risk. Instead, decisions are made for individual drugs. Factors that are considered in this decision include the ability for a patient to accurately self-diagnose/recognize symptoms and whether medical exams or lab tests are needed. If adverse effects are a concern, lowering OTC doses compared with prescription alternatives can be an option. 

In addition, drug labels must make clear any potential problems with the drugs, as well as be easy-to-understand and truthful. Notably, the FDA propounds that with some OTC drugs, labels provide even more information than is available from a physician. For instance, the nicotine patch not only provides information about nicotine withdrawal but also informs the consumer about behavioral aspects: when they will feel the urge to smoke, what to do instead of smoking, and information on support services.

Interestingly, the FDA has only once in its history attempted to switch a drug from prescription to OTC on its own accord. In 1982, the FDA published a tentative final monograph that greenlit OTC metaproterenol for asthma. However, the backlash was swift, and the move was quickly rescinded.

“Theoretically, FDA could make a recommendation to switch a product,” notes the CHPA. “However, the agency would need to follow a resource-intensive, complex process. There are unresolved and debated questions concerning such an approach, including the use of proprietary data, formal hearing rights, under what authority FDA would seek to do so, and the lack of regulations.”

Rx-to-OTC switch in the past decade

Per the CHPA, the following 13 drugs went OTC in the last decade, here listed in chronological order:

1.     Advil Congestion Relief (ibuprofen and phenylephrine HCl, Pfizer): This analgesic/decongestant is promoted as decreasing swelling due to sinus pressure and nasal congestion. 

2.     Allegra (fexofenadine hydrochloride, Chattem): This antihistamine serves as symptom relief for seasonal allergy.

3.     Allegra D 12-Hour (fexofenadine hydrochloride and pseudoephedrine HCl, Chattem): This iteration of Allegra can be taken twice a day.

4.     Allegra D 24-Hour (fexofenadine hydrochloride and pseudoephedrine HCl, Chattem): This iteration of Allegra is taken once a day.

5.     Oxytrol for Women (oxybutynin, Merck): This bladder-specific muscarinic antagonist is used to treat overactive bladder. It should not be taken with alcohol.

6.     Nasacort Allergy 24HR (triamcinolone acetonide, Chattem): This intranasal steroid is used to treat allergic rhinitis and is taken once a day.

7.     Nexium 24HR (esomeprazole magnesium, Pfizer): This acid reducer is used to treat frequent heartburn and is taken once a day.

8.     Flonase Allergy Relief (fluticasone propionate, GlaxoSmithKline): This intranasal steroid is used to treat upper respiratory allergies.

9.     Rhinocort Allergy Spray (budesonide, McNeil): This intranasal steroid is used for the treatment of allergic rhinitis.

10.  Differin Gel (adapalene, Galderma): This acne medication is promoted as preventing breakouts, comedones, and so forth to restore skin tone.

11.  Flonase Sensimist Allergy Relief (fluticasone furoate, GlaxoSmithKline): This nasal mist is used for allergy relief.

12.  Xyzal Allergy 24HR (levocetirizine dihydrochloride, Chattem): This antihistamine is taken once at night to stop allergy symptoms during the day.

13.  Lumify (brimonidine tartrate, Bausch + Lomb): This medication is used for the relief of redness of the eye due to minor eye irritations.