I’d like to begin this episode with a brief discussion on what are the differences between prescription medications and non-prescription medications or what we call over the counter medications from a standpoint of the FDA. And the reason why I want to go through this is there were going to be episodes, in the future, concerning medications that don’t require prescriptions. We need to know how one gets a medication or what does a medicationhave to do or be non-prescription. How does the FDA look at that, and what are the requirements that the FDA has for both prescription and non-prescription.
So let me begin with prescription medications, generally it takes about 10 years for a medication to become what we call a legend medication, it takes about 10 years from the time of being in a pharmaceutical companies lab table top to being at a pharmacy available at a pharmacy row to pharmacy shelf. During those ten years, and we call those ten years the medication or drug pipeline, the pharmaceutical company has to do extremely rigorous testing on the chemical nature of the new drug, safety and effectiveness testing, various phase clinical trials and all of this has to be submitted during those ten years to the FDA to be reviewed by an expert panel to make sure that the pharmaceuticalcompany is manufacturing this properly, and that the test data proves or shows levels of safety and effectiveness and stability of a chemical. This is all very detailed and very involved reporting and finally after the ten years the pharmaceutical company brings all this information gathers to the FDA for an advisory panel review. The advisory panel is made up of several experts in that field that this drug is going to be treating and they decide whether or not the drug is approved. Once approved it goes to commercialization and to the pharmacy shelves, and even after that there is continuous monitoring of the medication for safety and effectiveness. Any issues that come up after that they can investigate, with nonprescription medications or over the counter medications none of this occurs.
The FDA understands the value of over-the-counter medications and how it plays within our health system. The FDA basically says over- the-counter medications or nonprescription medications are safe and effective for the public without having to have to go to a health care provider. They know that self-medication in this country is rather important and currently according to the latest FDA bulleting on their website, which all of this information will be in the show notes and links to that website, there are over 300,000 individual over- the -counter nonprescription medicationsavailable to the American public.
So how does the FDA take this huge number of individual products and oversees it, well what they do is they break all these different medications into 80 what we what we call 80 therapeutic classes. So, what’s a therapeutic Class? A therapeutic class is a title, or a category name given to a group of medications in what they treat, so a therapeutic class would be for example, analgesics which treat pain, a therapeutic class would be antitussives which would be used to treat cough, and another therapeutic class is nasal decongestants obviously taking care of stuffy noses. So what they do is they taken all of these OTC medications and break these medications into 80 therapeutic classes of what they treat and then write a kind of a recipe or guidelines for manufacturers of over the counter products to follow. The FDA indicates what they feel is safe and effective for their medications and what ingredients they should have in it, what strengths they should have in it, and what the label should say on the package that’s about it. So if you’re a manufacturer of a medication, cough medication, you would get this paper specifically for that cough medication or specifically for cough medications and see what the FDA uses as a guide to manufacture this. There’s no submission of any testing, there’s no submission of any safety or an effective testing of these medications, there is no submission on how you manufactured it ,there’s no FDA inspectors coming to your company and looking at your manufacturing plant. What you do submit to the FDA is the label because you know they don’t want somebody putting in a label that this cures cancer so it has to have it has to have some type of approval of what that label says and how it’s designed and what it lists as ingredients, and that’s the difference really between prescription and nonprescription medications in terms of how the FDA views it. Now this does not mean that manufacturers of over the counter products that it’s “wrong or right”, it’s an expedient way because the FDA could not possibly check and test and review over 300,000 individual medications and products. So I just wanted to bring that to your attention because it is important in some of the subjects that we’re going to be talking about in future episodes. That you understand how the FDA overseas over the counter products, how it breaks it down into the 80 different therapeutic classes, and gives suggested guidelines recipes to these manufacturers of what should be included in this particular medication.
With that said we’re going into the winter months, and I’d like to talk about nasal decongestants which are probably one of the most purchased over the counter medication and non prescription medication during these seasonal months. There are things that you need to know about nasal decongestants as well as other over the counter products because you’re not going to a health care provider that can look over and decide what he or she made prescribe. Treating stuffy nose generally what occurs is there’s some type of irritant whether it be a bacteria, virus or whether your allergies to like hay fever, pollen, animal allergies what occurs is there’s an irritation in the lining of your nose and the body reacts by sending blood to that area the lining of your nose to fight off that irritation. What occurs here is the blood vessels in your nose start to enlarge, they get swollen as well as the lining of your nose gets swollenand what this does is it decreases the passageway the breathing passageway in your nose and you start to get difficulty in breathing. Treating stuffy noses can be important because what can occur is, if it’s severe enough, you can’t get rid of the mucus in your sinus is which are located cheek area and in the forehead area and this area can become infected and get what we call sinusitis. Opening up your sinus is with a nasal decongestant opening up your nasal passageways allows the drainage of mucus from the sinus and will prevent or help prevent infections in your sinus.
I’d like to talk about a couple of home remedies that you can try before you go to an actual over the counter nasal decongestant, one of them is inhaling a warm water vapor. Now why this is important? You can do this by placing a towel over your head and breathing in warm water vapor in a bowl, you can also do this by going into a shower and breathing in that warm water vapor. Two things occur first the warmth is a soothing mechanism for the inner lining of the nose, so it decreases some of the inflammation, it also keeps the inner lining of the of the nose moist. If the inner lining of the nose starts to become dry it can cause further irritation and then it causes further swelling, so that’s the theory and that’s the practice behind inhaling warm water vapor also applying warm compresses on the face and around the nose and eyes, the warmth again is a soothing mechanism reducing inflammation of the lining of the nose.
Important to drink plenty of fluids this is something that we should be doing no matter what but drinking plenty of fluids especially water. What this does is it reduces the viscosity or it dilutes the mucus in your sinus is so that they can discharge, they can drain, even if you have a narrow passageway any kind of drainage is important. When you concentrate mucus, it becomes very thick and it can’t go through a narrowed nasal passageway, so if you continually drink water dilute it or fluids diluted it can now it breaks up becomes less thick and would be able to drain which is important to prevent any potential of sinusitis or an infection in the sinus.
There is Normal Saline nasal spray you can buy that over the counter, again this is to keep the inner lining of the nose moist, so it doesn’t dry out and cause further inflammation. These are home remedies that you can try prior to going to purchasing or getting an over-the-counter medication nasal decongestant
How do nasal decongestants work? What they do is they causes the blood vessels in the lining of the nose to constrict or to narrow and therefore opening the nasal passageways. This is the method or mechanism of action of nasal decongestants. Nasal decongestants do come in variety of different formulations, they come in pill, tablets, spray, liquids, and capsules but they all work the same way by affecting the blood vessels in the lining of the nose, and constricting them therefore opening up the nasal passageways allowing you to breathe easier and allowing the mucusto drain. In my show notes I’ll have a list of the active ingredients more common nasal decongestants. There’s only one that really stands out that there are certain precautions that the government has taken, and that is pseudophedrine “SudafedÒ” which is the trade name pseudophedrine was unfortunately used in the manufacture of illicit drugs, so they’ve taken that decongestant and put it behind the pharmacist counter. If that’s something you’re looking for you would have to go to the pharmacist get it dispensed from them, and there’s a procedure that they must control the amount of Sudafed being dispensed to an individual.
Let’s talk a little bit about the formulations again, Nasal Decongestants can come in a pill form, capsule form, it can come in a liquid form it can come as a nasal spray or a nasal drop. A few points I want to make about these formulations, first if you’re using a nasal spray I want you to understand that even though it may be more local you’re not taking it orally like a liquid or a pill which has to be absorbed, and hits a number of our systems in our body. That doesn’t mean that it does not have what we call a systemic effect, in essence effects other parts of our body, so just because it’s a nasal spray or nasal dropper and it’s going directly to the area that you want to basically have it work on doesn’t mean that it doesn’t affect other areas of your body. The other thing about liquids, and this goes for any over the counter product if the liquid, if thee comes with a spoon or has a measuring cap please use that spoon or measuring cap. You can’t substitute that spoon with let’s say a kitchen spoon, all those materials used for measuring of the products and products that come with measuring devices spoon or measuring cap are designed by the manufacturer to give you the correct dosage. Substituting anything other than what was given with that liquid you could be overdosing or underdosing with that with that medication. Also, keep that in mind to always keep those measuring devices with that medication.
Some of the side effects, common side effects with these with nasal decongestants are a nervousness, some dizziness, maybe some sleeping problems, some heart palpitations. Those are some general of the side effects or more common side effects that you have with nasal decongestants. It would be best not to use them just prior to bedtime, also to cut down on some of the coffees the teas anything that has a stimulant in it like caffeine, this would also reduce some of the side effects added onto using a nasal decongestant.
What you should be aware of treating yourself if you should have a chronic condition, the first is high blood pressure. High blood pressure, part of the reason for high blood pressure is the narrowing of blood vessels that creates more workload for the heart and the heart has to generate a higher pressure. What these nasal decongestants do is narrow blood vessels so they can affect your blood pressure very easily. It’s important that you contact your health care provider let them know that your problem is a stuffed up nose if it is OK if they take a nasal decongestant. Other chronic conditions that you need to make sure that your health care provider knows that you’re going to be taking a nasal decongestant are diabetes and glaucoma. Make sure that your health care provider is informed that you’re looking to take a nasal decongestant if you have thyroid problems or have a prostate problem. These are the kinds of things you have to be aware of when taking over the counter medications and self-medicating. It’s not a good idea to treat children younger than six with nasal decongestant. Be aware of drug interactions, this is again something that there are several drug interactions that can occur with nasal decongestants. Before using, talk to or contact your health care professional also speak to the pharmacist letting them know that you’re thinking on taking this, and they can look at your drug medication profile and find out if there are any drug interactions. In terms of food other than caffeine or caffeine containing drinks there really is no drug interaction with food you want to limit the number of caffeinated drinks that you have that you’re planning on taking. As with any of these side effects if they continue, if they’re persistent please contact your health care provider immediately let them know especially if you’re starting to get heart palpitations, dizziness, weakness in any way, heartburn and Dry mouth please contact your health care provider.
So let’s recap on nasal decongestants as an over the counter non- prescription medication nasal decongestantsare used to treat stuffed up nose. Stuffy noses are usually caused by some type of irritation, it can be the cold, can be of the flu, it can be an allergy. What occurs is the nasal lining the lining of the nose gets inflamed and irritated the blood of the body sends blood to the nose. The blood vessels get larger swell up the lining swells up closing the nasal passageway therefore making it difficult to breathe, also making it difficult for mucus to drain from the nose and out. This could lead to potentially sinusitis which is an infection of the sinus. With a nasal decongestant what it does is it basically narrows the blood vessels or constricts the blood vessels thereby opening up the nasal passageways making it easier to breathe and making it easier to for mucus to drain. These medications comes in a variety of different forms it comes in pill form, it comes in liquid form, comes in capsule and spray and dropper all of these can affect the body as a whole so just because it’s a spray or a dropper nasal dropper. Using a spray or dropper form doesn’t mean that it won’t affect the entire body, so there can be a systemic effect with all of them. The general side effects are nervousness, restlessness, and difficulty sleeping so it’s important probably not to take this medication prior to bedtime. Also, it’s important in terms of dietary to reduce or eliminate for a period of time any caffeinated drinks. With regards to chronic conditions, if you should have them prior to taking any nasal decongestant if you have high blood pressure, glaucoma,diabetes, if you have a thyroid condition, if you have a prostate condition, you should be contacting your health care provider prior to taking any type of nasal decongestant.
Try using the home remedies prior than OTC Nasal Decongestants if you have any chronic conditions that might be worsened by using these medications. Inhaling of water warm water vapor the use of a nasal saline a normal salinespray, drinking plenty of fluid to reduce the viscosity or dilute the mucus so it can drain easier. These are all tips and recommendations if you don’t want to go to using that of a nasal decongestant