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Free The Meds: 5 Drugs You Should Be Able To Buy Over The Counter
The Food and Drug Administration (FDA) approves not only which drugs can go to market but also whether they require a prescription from a doctor. The agency gets this power from the Durham-Humphrey Amendment of 1951. Meant to protect patients, the law has turned into a license to make life difficult. Here are five low-risk drugs that the FDA could make available over the counter today.
(Illustration: Wikimedia)
Albuterol: Research shows that albuterol is vastly superior at relieving asthma symptoms compared to other inhalers, which is why it's offered over the counter in Singapore, Australia, Slovenia, and South Africa. It's also available in the United Kingdom under the name Salbutamol. There is no logical safety-related reason why albuterol sits behind the counter while its competitors, the epinephrine drugs Primatene Mist and Asthmanefrin, are available without a prescription.
Insulin: Two outdated versions of insulin are sold over the counter because they were grandfathered in after the passage of the Durham-Humphrey Amendment, but those aren't the products that today's diabetics want or need. As insulin prices have skyrocketed in the U.S., a black market for insulin has emerged. Products like insulin can and should be sold through online retailers like Amazon, especially given the long wait times to see the medical specialists who prescribe the drug.
Tobramycin: Tobramycin eye drops are used to treat conjunctivitis, more commonly known as "pinkeye." It's pretty obvious when someone has pinkeye, but patients still have to go to the doctor to get a prescription for these unharmful eye drops. That often means parents either have to go to the emergency room or miss work to take their kid to the pediatrician.
Simvastatin: Heart disease is the leading cause of death in the U.S., and statins—cholesterol-lowering drugs—can reduce the risk of a heart attack and other common deaths from heart disease. Simvastatin (and other statins like lovastatin) are prescribed for cardiovascular disease. This particular drug has been over-the-counter in the U.K. Since 2004 but has failed to get approval for unrestricted usage in the United States. A 2016 study published in the American Journal of Managed Care estimated that over-the-counter statin access could prevent over 250,000 major coronary events over 10 years.
Birth control: With over 9 million users, daily-use oral contraception, or the birth control pill, is the most common form of contraception in the United States. The American College of Obstetricians and Gynecologists, which represents birth control prescribers, says it "supports over-the-counter access to hormonal contraception without age restrictions." On July 13, the FDA did approve the progestin-only Opill brand for over-the-counter use, which is a step in the right direction.
The post Free the Meds: 5 Drugs You Should Be Able To Buy Over the Counter appeared first on Reason.Com.
CVS Will No Longer Sell Medications That Contain Phenylephrine As The Only Active Ingredient
CNN —
CVS is removing some over-the-counter allergy and cold medicines from their shelves one month after an independent advisory committee to the US Food and Drug Administration declared that phenylephrine, a popular ingredient in these medications, is ineffective when taken orally.
"We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores," a CVS spokesperson told CNN in a statement on Thursday.
The company will continue to sell other "oral cough and cold products" in order to "meet consumer needs," the statement continued.
"We are aware of the FDA Advisory Committee's position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations," the statement from CVS said.
CNN reached out to other retail pharmacies to see if they are planning to take similar action. In a statement Friday, a Walgreens spokesperson told CNN, "Walgreens follows FDA regulations. We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps."
While the FDA has found that the ingredient is safe to use, many doctors have questioned phenylephrine's effectiveness for years. These products generated nearly $1.8 billion in sales last year alone, according to data from the FDA that was presented to the Nonprescription Drugs Advisory Committee during the committee's two-day meeting in September.
Last month, the advisory committee voted no on the specific question: "Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant."
The FDA told the committee it would take its advice into consideration, although it did not give a timeline. The agency has not issued a final decision regarding phenylephrine and has not asked manufacturers or retail pharmacies to remove products containing the ingredient from store shelves.
The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines and dietary supplements as well as consumer medical devices and opposes a change, previously said in a statement that it was disappointed in the committee's decision.
The group encouraged the FDA, before it made any regulatory changes, to "be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE's regulatory status."
A CHPA spokesperson, Logan Ramsey Tucker, told CNN in a statement Thursday, "Until FDA makes a determination on the committee's recommendation, oral PE remains a Category 1 OTC ingredient, which is generally recognized as safe and effective (GRASE)."
CNN's Jen Christensen contributed to this report.
OTC Sinus Infection Drugs: Which Is Best?
Medically reviewed by Femi Aremu, PharmD
Sinusitis affects around 1 in 8 adults in the United States. Infection is a frequent cause of sinusitis, affecting about 29 million Americans yearly.
Antibiotics may not be necessary unless the sinus infection is severe and leads to a bacterial infection. Instead, guidelines recommend management strategies aiming to ease symptoms.
Over-the-counter (OTC) medications often help ease sinus-related symptoms, such as pain relievers for sinus headaches and antihistamines for runny nose or postnasal drip.
These and other OTC medications may be used alone or in varying combinations for maximal symptom relief.
You can consult a pharmacist or healthcare provider for help finding the proper medications to ease your symptoms.
Read on for a more in-depth look at sinusitis, its causes, treatments, and how to manage sinus-related symptoms.
Professional Studio Images / Getty Images
Understanding Sinus InfectionsThe sinuses are small air pockets behind your nose, cheeks, eyes, and forehead. When the lining of the sinuses becomes swollen, it's called sinusitis.
With a sinus infection, germs (bacterial, viral, or fungal microorganisms) enter and spread within your sinus cavity.
Your immune system launches an attack against the infection, releasing immune cells and triggering inflammation.
This leads to symptoms that can range from pesky to downright miserable.
SymptomsCommon symptoms of sinus infections include facial pain, congestion, headache, and postnasal drip.
Other symptoms are fever, runny nose, itchy throat, sore throat, cough, and excess mucus.
You might only need antibiotics if your sinus infection persists for longer than a week or becomes more severe. As such, watchful waiting is often the best approach for mild cases in adults.
Most people improve naturally, with antibiotics only slightly increasing symptom relief.
Commonly Used OTC MedicationsBecause of this, advice from experts is to focus on making yourself feel better by using OTC medicines to relieve your sinus symptoms.
OTC medicines include:
Sinus headache, facial pain, or fever: Try analgesics, such as Tylenol (acetaminophen), or nonsteroidal anti-inflammatory medications (NSAIDs), such as Motrin or Advil (ibuprofen) or Aleve (naproxen).
Sneezing, runny nose, cough, postnasal drip: Try an antihistamine, such as Benadryl (diphenhydramine), Claritin (loratadine), or Zyrtec (cetirizine).
Nasal congestion or stuffiness: Nasal corticosteroid sprays, such as Flonase Allergy Relief (fluticasone) can be helpful. You may also consider orally administered decongestants like Sudafed (pseudoephedrine) or nasal spray forms like Afrin (oxymetazoline), but consult a healthcare professional first since these products carry risks for certain people.
Chest congestion: Guaifenesin, a mucolytic found in Mucinex and Robitussin (dextromethorphan), among other products, can help thin mucus and make it easier to clear.
Dry cough: Try a cough suppressant containing dextromethorphan, such as Delsym.
These medicines, aimed at treating symptoms, and self-care methods like rest may allow you to cope with a sinus infection without a healthcare provider visit or prescription.
Healthcare providers may prescribe antibiotics, such as Augmentin (amoxicillin/clavulanic acid), or other antimicrobials in more severe sinus infections that persist for more than one or two weeks.
This article will discuss some of the best OTC medicines for sinus infections.
DecongestantsDecongestants help manage symptoms of sinus pressure and related headaches. They work to relieve congestion by constricting blood vessels in the nasal passages to reduce swelling in the sinuses.
There are two main decongestants: topical (nasal sprays or drops) and oral (tablets or capsules you swallow).
Topical decongestants, such as Afrin (oxymetazoline nasal spray), offer quick relief from sinus discomfort, and make it easier to breathe through your nose.
You should use decongestants for no longer than three to five days. Exceeding this limit can lead to rebound congestion and make congestion worse instead of better.
Due to dosage differences among various brands, follow the dosing instructions and age limits on the label for your specific product. A common side effect is temporary stinging or burning sensations in the nose.
What Is Sudafed?Sudafed (pseudoephedrine, or PSE) is the most commonly recommended oral decongestant. PSE helps unblock your nasal passages and sinuses, making breathing easier.
It can also reduce the amount of mucus in your nose and help the Eustachian tube (a part of your ear) stay open.
In terms of side effects, PSE stimulates the body's fight-or-flight response, leading to:
Due to these effects, decongestants should only be used in the short term, and some people should refrain from using them.
Consult a healthcare professional before using a decongestant if you have:
In addition, PSE is not recommended for children younger than 2 years old, and the extended-release (ER) formulation is not recommended for those younger than 12 years old.
In fall 2023, a panel of experts at the Food and Drug Administration (FDA) issued a report that the oral decongestant ingredient phenylephrine isn't effective.
Phenylephrine is the active ingredient in Sudafed PE and many other OTC cold medicines, such as DayQuil. However, generations of pharmacists have recommended pseudoephedrine over phenylephrine for those who were cleared to take it.
When you select an oral decongestant, please look for products containing pseudoephedrine (sold at your pharmacy counter and unavailable on store shelves) instead of phenylephrine.
Phenylephrine is also an ingredient in topical decongestant nasal sprays, but the FDA's discussion and recommendations pertain only to oral forms of phenylephrine—not the nasal spray.
AntihistaminesAntihistamines are the go-to medications for the "runny or itchy" symptoms: sneezing, runny nose, postnasal drip, itchy throat, and watery eyes. Some or all of these symptoms can accompany sinus infections.
Antihistamines are a class of medications designed to block the effects of histamine, a natural substance released by the body's immune system when it encounters allergens.
Histamine is responsible for allergy symptoms, such as sneezing, itching, and a runny or stuffy nose. Antihistamines work by blocking histamine receptors.
This prevents histamine from binding to cells throughout the body, including those in the eyes and nasal passages. By blocking histamine, antihistamines reduce the severity and frequency of symptoms like sneezing and runny nose.
Types of AntihistaminesOral formulations of antihistamines include tablets, capsules, chewable tablets, and liquids.
Remember that the FDA doesn't specifically approve antihistamines for sinus infections. However, healthcare professionals often recommend them to relieve symptoms of colds and sinusitis.
The following main groups of antihistamines are available without a prescription:
First-generation (older) antihistamines, such as Benadryl (diphenhydramine), effectively reduce sneezing and runny nose. They also have significant downsides, including drowsiness or dizziness as side effects and requiring multiple daily doses.
Second-generation (newer) antihistamines, such as Claritin (loratadine), Zyrtec (cetirizine), and Allegra Allergy (fexofenadine), are considered just as adequate as the first-generation but are considered non-drowsy. They provide long-lasting relief, usually once-daily dosing, without causing excessive sleepiness. Some people may experience mild drowsiness, headache, or dry mouth.
For context, Benadryl is FDA-approved for use in children 6 years and older.
Claritin and Zyrtec are approved for use in children 2 years and older.
Claritin and Zyrtec are similarly effective. However, it's important to note that individual responses to these medications can differ, and what works better for one person might not for another.
Studies suggest that second-generation antihistamines are safer for children than first-generation, with cetirizine being more likely to cause drowsiness than the other newer-generation antihistamines.
To ensure proper use of antihistamines, follow the recommended dosage and age guidelines on the medication label or personalized instructions from a healthcare provider.
Tips for Sinus Infection ReliefTry to follow preventive measures to help reduce the risk of sinus infections and promote sinus health, such as:
Maintaining good hygiene: Wash hands frequently and avoid close contact with sick individuals.
Keeping nasal passages moist: Use nonmedicated saline rinses, saline sprays, humidifiers, and steam inhalation.
Stay hydrated and nourished: Drink plenty of fluids and eat a nutrient-rich diet, like fruits and vegetables, to support immune health.
Manage seasonal or year-round allergies according to a healthcare provider's advice, including reducing your exposure to allergens and irritants.
Avoid being around smoke or quit smoking, manage stress, and get adequate rest to prevent running down your immune system.
OTC sinus relief medications can interact with various prescription medications, potentially leading to harmful effects.
While not an all-inclusive list, here are five key examples of prescription medications that can interact with OTC sinus medications:
Blood Pressure and Heart MedicationsNasal decongestants, like pseudoephedrine, can raise blood pressure.
Combining blood pressure medications for high blood pressure or other heart conditions with cold or allergy medications can raise your blood pressure and lower the effectiveness of antihypertensive medications.
Examples include beta-blocker medications, such as Toprol XL (metoprolol), or calcium channel blockers, such as Norvasc (amlodipine).
AntidepressantsCold and sinus medications, especially those containing the decongestant pseudoephedrine, can increase blood pressure and heart rate.
When taken with antidepressants commonly used to treat depression and anxiety, there is an increased risk of worsening these cardiovascular effects.
Examples include: selective serotonin reuptake inhibitors (SSRIs), such as Prozac (fluoxetine) and Lexapro (escitalopram).
AnticoagulantsSome cold and allergy medications contain ingredients like aspirin or NSAIDs like ibuprofen.
These ingredients can increase the risk of bleeding when taken with anticoagulant medications (blood thinners), such as Jantoven (warfarin) or Xarelto (rivaroxaban).
Monoamine Oxidase Inhibitors (MAOIs)When MAOIs are combined with decongestants, there is a risk of a hypertensive crisis, which can be life-threatening.
This interaction risk exists even if you took an MAOI in the past two weeks.
Examples of MAOIs include the antidepressant Marplan (isocarboxazid) and the antibiotic Zyvox (linezolid).
OpioidsCombining sedating antihistamines like Benadryl with prescription pain medications can lead to severe sedation and respiratory depression.
Examples of opioid analgesics include: Tylenol 3 (acetaminophen-codeine), morphine, and oxycodone.
Many other prescription medications may interact with cold or allergy medications.
To be safe, always read the product's labeled warnings and consult a healthcare professional or pharmacist before taking OTC cold or sinus medications, especially if you're taking prescription medications.
SummarySinusitis commonly affects 1 in 8 people in the United States each year. It often results from infections that trigger uncomfortable symptoms like congestion, facial pain, and headaches.
The good news is that antibiotics are not always necessary, and current guidelines recommend a symptom-focused approach to managing mild sinus infections.
If your symptoms worsen or do not improve while taking OTC medications for relief, or if you experience persistent fever, contact a healthcare provider.
They can help identify the cause of your symptoms and determine if antibiotics, such as Augmentin, or other prescription medications would be beneficial.
Frequently Asked QuestionsHow should orally administered OTC decongestants be stored?
Generally, oral OTC decongestants should be stored in a safe, dry place and kept at room temperature (68–77 F) away from children or pets.
Furthermore, avoid storing your OTC decongestant in a place susceptible to high moisture levels, such as a bathroom.
If I am currently pregnant or breastfeeding, can I take an OTC decongestant?
The safety of decongestants may vary depending on the type of medication you use, along with how far along you are in pregnancy or how commonly you breastfeed your child. For example, phenylephrine is generally not recommended during the first 13 weeks of pregnancy.
Therefore, consult your healthcare provider before proceeding with an OTC decongestant.
Read the original article on Verywell Health.
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