Tag Archives: FDA

Why Isn’t There a Coronavirus Vaccine?

Infectious Disease, Public Health, , , , , , ,

Introduction

Creating a coronavirus vaccine seems like such a simple thing, doesn’t it? However, creating any vaccine is among the most complicated and arduous endeavors in medicine. As opposed to most medicines, a successful vaccine will be distributed to billions of people worldwide. In this Straight, No Chaser, we’ll look at the general process of vaccine creation as a means of understanding what has to happen prior to having a safe and effective coronavirus vaccine.

The Decision to Make Any Vaccine

The decision and process of making a vaccine is quite involved. I’ll summarize several of the considerations here.

Rationale and Target Immunization Rates

  • First, there has to be a public health rationale for a vaccine. There has to be an infectious disease present that’s severe and frequent enough to pursue a vaccine beyond other preventive strategies. That’s why there’s no vaccine for the common cold. Although everyone gets it, the body handles it just fine.
  • The ability to achieve target immunization rates has to seem reasonable. The World Health Organization has a target of 90% coverage for all vaccines by 2020. That level of coverage ensures protection for the others in the population who can’t receive the vaccines due to allergies or other reasons. If this goal can’t be approximated by the verbalized support of target populations around the world, the effectiveness of the vaccine may not be enough to justify the process of developing it.

Efficacy and Side Effects

  • Efficacy of the vaccine in preventing the disease sounds like a given, but it’s not. First, a vaccine needs to stimulate an immune system response that doesn’t under react or overreact. Either scenario could be deadly, so a level of precision is a must. This also involves discovering if a live vaccine or inactivated particle proteins from the virus can be used to stimulate that response. Furthermore, good efficacy takes into consideration that viruses are quite adept at mutating. The art of vaccines involves adjusting to keep current with the different viral strains and the viruses’ efforts to stay alive. We can expect this coronavirus to be an adaptor and/or mutator because it’s an animal virus. It’s already proven able to adapt from the environment of bats to humans.
  • The frequency and severity of vaccine side effects and adverse reactions are equally as important as efficacy. Can you imagine the consequences of giving a deadly vaccine to billions of people without having fully tested it? In a world prone to medical skepticism anyway, it’s a must that at least the medical, public health and regulatory communities are in agreement about safety considerations based on science, even if the public is not. Typically, each stage of studies (including pre-clinical, animal and human trials) will need to be replicated at multiple medical institutions in multiple different types of populations to ensure the results of one anecdotal case or study weren’t a dangerous random event.

Remembering that a pharmaceutical company is pursuing the development, testing and distribution of a vaccine, there has to be a business case for one. Vaccines don’t get made just because a new disease shows up. The costs of development ultimately will need to be recouped. However, the public will be equally insistent that the vaccine be cost-effective. There’s a lot to consider. There certainly appears to be justification for creating a coronavirus vaccine.

The Incentives to Make Any Vaccine

Here’s where I remind you that it’s not a governmental endeavor to make vaccines. These are decisions made by pharmaceutical companies. Potential vaccines are subject to approval by the equivalent of FDAs (Food and Drug Administrations) countries around the world. There are many regulatory hurdles to be cleared by the FDA before a coronavirus vaccine could be given widely to the US population.

This process is so arduous that it historically has taken between two and fifteen years to develop a vaccine. In fact, the most recent vaccine with which you may be familiar (the varicella vaccine, for prevention of chicken pox) took about 11 years to be licensed by the US FDA.

Considering all of that, think of the investment that must be made into making a coronavirus vaccine. There’s the study of a new virus, with the need to learn its genetic code, the means of causing disease and how it reacts to different threats. Mutation and other modes of adaptation need to be considered. There is a ton of work to be done before the process of creating a vaccine can even begin. Then the process has to go through animal models and rounds of human clinical trials prior to approval. As noted, the “chickenpox vaccine” took about an 11-year investment that needed to be paid for by the pharmaceutical manufacturer. That’s a long time and a big financial risk to take. Even while the public is demanding cost-effectiveness, somehow the manufacturer has to recoup its investment and make a profit.

The Prospects of a Coronavirus Vaccine

Now having discussed these things, consider where we are with a vaccine for the virus causing COVID-19. It’s named SARS-CoV-2, by the way. As a reminder, the world outside of China first gained access to the RNA sequence of the virus in January – just two months ago. There are now facilities in the US, Europe, Australia and possibly China already beginning the arduous process of learning enough about the virus that a vaccine may be proposed, developed, tested and approved.

Honestly, there is no way to predict when a SARS-CoV-2 vaccine will be available because there are multiple substantial steps to be taken. Each of these steps come with challenges, potential obstacles and potential setbacks. It would be irresponsible to even present a best-case scenario (but a target of 12-18 months has been placed as a challenge). However, you can rest assured that multiple entities across the world are putting forth their best efforts. In the meantime, prevention and early detection remain our best defenses while efforts continue on a coronavirus vaccine and effective treatment.

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Feel free to #asksterlingmd any questions you may have on this topic. Take the #72HoursChallenge, and join the community. As a thank you, we’re offering you a complimentary 30-day membership at www.72hourslife.com. Just use the code #NoChaser, and yes, it’s ok if you share!

Order your copy of Dr. Sterling’s books There are 72 Hours in a Day: Using Efficiency to Better Enjoy Every Part of Your Life and The 72 Hours in a Day Workbook: The Journey to The 72 Hours Life in 72 Days at Amazon or at www.jeffreysterlingbooks.com. Receive introductory pricing with orders!

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Straight, No Chaser: Expiration Dates on Food, Medicines and Cosmetics

Health Prevention, General Health and Wellness, Cardiology/Heart, , , , ,

expired-medication-by-HazPhotos

We’re all faced with the decision. When you’re sick, have you ever rummaged through the medicine cabinet and discovered an old prescription? Perhaps you wanted to wear your extra special makeup and discovered the expiration date has passed. Or perhaps you came back from out-of-town, and reached into the refrigerator to cook your favorite meat and discovered it’s a few days past the expiration date.
No lectures today. Let’s engage in some straight talk and answer the questions you have.

 Expiration_Date

1. Why do foods have an expiration date?
Expiration dates provide an assertion of a guarantee of freshness, assuming the absence of other considerations. In other words, expiration dates are meant to suggest “best quality.”
2. Why do some stores sell foods beyond their expiration date?
Because they can. The U.S. Food and Drug Administration (FDA) does not require the coordination of expiration dates with assertions of safety (or lack of safety).
3. So is it safe or not safe to eat foods beyond their expiration date?
This is where things get tricky. The problem with “bad food” is contamination to the extent where sufficient bacteria are present to cause an infection. An expiration date is only a rough measure of that. If you leave food unrefrigerated or exposed to heat, it will go bad well before the expiration date. Even after the expiration date, sufficient bacteria may or may not be present to cause problems, but it becomes more likely as time passes.
4. Are there different considerations for different foods?
Use this list as a quick reference.

  • Countertop food (e.g., bakery goods containing custards, meat, vegetables, or frostings made of cream cheese, whipped cream, or eggs) should be kept refrigerated. Others not containing these (e.g., breads, muffins) can be kept at room temperature for a few days, but watch for mold that will develop over time.
  • Unprocessed pantry foods (e.g., cereal, dry beans, grains, mixes, nuts and pastas) should be good up to a year if unopened. Once opened they must be stored in air-tight containers.
  • Processed pantry foods (e.g., canned foods, cake mixes, crackers, dried foods) are safe until opened. Discard cans that are cracked, bulging or squirt liquid when opened.
  • Refrigerated foods (e.g., milk, chicken) may have both sell-by and use-by dates. Although generally safe to eat after both dates, the risk of problems is higher, so check for odor, discoloration or a bad flavor.
  • Freezer foods, according to the FDA, are safe indefinitely as long as they haven’t partially thawed. In this example, the sell-by and use-by dates apply to quality and retained nutritional value. For best results, if you’re going to freeze, do so early.

cosmexpdate

5. So cosmetics expire? I’ve never noticed an expiration date.
The FDA doesn’t require cosmetic manufacturers to print expiration dates on the labels of cosmetic products, but they do have the responsibility to determine shelf life for products, as part of their responsibility to substantiate product safety. The issue isn’t “expiration” as much as increasing risk for infections (of the eyes in particular).
6. For how long can I safely use cosmetics?
The better question is what increases the risk when using cosmetics. Here are some guidelines:

  • Manufacturers usually recommend discarding mascara two to six months after purchase.
  • If mascara becomes dry, discard it. Do not attempt to prolong its usefulness by adding water or saliva. Doing so will introduce bacteria into the product and onto your eyes when applied.
  • If you have an eye infection, stop using all eye-area cosmetics and discard those you were using when the infection occurred. Seek medical attention.
  • “All-natural” (i.e., plant-derived cosmetics) are more likely to have a shorter shelf life and to be conducive to bacterial growth with subsequent infection.
  • Poorly stored (e.g., exposed to high temperatures, previously opened) cosmetics may deteriorate before the expiration date. Conversely, those stored under optimal conditions may be acceptable long after the expiration date has been reached.
  • Sharing makeup increases the risk of contamination. A good example of this are the “testers” commonly found at department store cosmetic counters. If you feel you must test a cosmetic before purchasing it, apply it with a new, unused applicator, such as a fresh cotton swab.

expdatemedicine-19

7. What happens after a medication expiration date?
When it comes to antibiotics, I hope you never find out. You should always take your medications as prescribed, which generally means until all pills are gone. The medication date actually is more of a “freshness” (actually, safety and potency) consideration than a danger warning. However, in the wrong patient, a medicine that has less than the 100% guarantee of its needed strength, as the expiration date represents, could have fatal results. The expiration date doesn’t really indicate a point at which the medication is no longer effective or has become unsafe to use, with significant exceptions (e.g., tetracycline, nitroglycerin, insulin, and liquid antibiotics).
Feel free to ask your SMA expert consultant any questions you may have on this topic.
Take the #72HoursChallenge, and join the community. As a thank you for being a valued subscriber to Straight, No Chaser, we’d like to offer you a complimentary 30-day membership at www.72hourslife.com. Just use the code #NoChaser, and yes, it’s ok if you share!
Order your copy of Dr. Sterling’s new books There are 72 Hours in a Day: Using Efficiency to Better Enjoy Every Part of Your Life and The 72 Hours in a Day Workbook: The Journey to The 72 Hours Life in 72 Days at Amazon or at www.72hourslife.com. Receive introductory pricing with orders!
Thanks for liking and following Straight, No Chaser! This public service provides a sample of what http://www.SterlingMedicalAdvice.com (SMA) and 844-SMA-TALK offers. Please share our page with your friends on WordPress, like us on Facebook @ SterlingMedicalAdvice.com and follow us on Twitter at @asksterlingmd.
Copyright © 2018 · Sterling Initiatives, LLC · Powered by WordPress

Straight, No Chaser US Dietary Guidelines

Health Prevention, General Health and Wellness, Diet and Nutrition, , , , , , ,

Dietary-Guidelines-16-x-9

The guidelines on eating recommendations are jointly released every five years by the US Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA). Overall, these guidelines advise Americans to follow an eating pattern that includes a variety of fruits and vegetables, grains (at least half of which should be whole), a variety of proteins (including lean meats, seafood, nuts), and oils. However, these recommendations come with a bit of nuance to which you’d be well advised to pay attention.

dietary-guidelines

Here are the details, with simple rationale attached:
Alcohol: Moderate alcohol consumption now can be quantified up to one drink per day for women and up to two drinks per day for men. The recommendation is you stay at or under this amount.
Dairy products: If you’re eating dairy, the guidelines continue to recommend low and no-fat dairy products.
Dietary cholesterol: In a new recommendation, the guidelines no longer recommend a specific limit for dietary cholesterol. Among the foods you may frequently eat, dietary cholesterol is present in eggs and other animal products.
Fruit juice: The guidelines say one cup of 100% fruit juice counts as 1 cup of fruit. However, be advised that fruit juice is lower than whole fruit in dietary fiber and other nutrients, and it is typically very high in sugar, which you are now advised to limit, as noted below.
Red meat and processed meat: In an interesting reversal of the recommendation of its Guidelines Advisory Committee, the final recommendations suggest no limit is recommended for the consumption of red meat or processed meat. Be advised that recent evidence strongly link these foods with heart disease and cancer.
Saturated fats: The guidelines do not encourage a low total fat diet, but do recommend a low saturated fat diet. You should consume less than 10% of your calories per day from saturated fats. The evidence is clear that replacing saturated fat with unsaturated fat is associated with reduced risk of cardiovascular disease.
Sodium (Salt): The guidelines recommend you limit sodium intake to less than 2,300 milligrams (mg) per day.
Sugar: For the first time, the guidelines advise Americans to consume less than 10% of your daily calories from added sugars. You certainly are aware of sugar’s impact on the development of diabetes, high blood pressure and other diseases.

diet guidelines-pmpng-208055af61a3dd99

Eat healthy and be healthy. That’s the simplest recommendation I can offer. Here’s to your health!
Feel free to ask your SMA expert consultant any questions you may have on this topic.
Take the #72HoursChallenge, and join the community. As a thank you for being a valued subscriber to Straight, No Chaser, we’d like to offer you a complimentary 30-day membership at www.72hourslife.com. Just use the code #NoChaser, and yes, it’s ok if you share!
Order your copy of Dr. Sterling’s new books There are 72 Hours in a Day: Using Efficiency to Better Enjoy Every Part of Your Life and The 72 Hours in a Day Workbook: The Journey to The 72 Hours Life in 72 Days at Amazon or at www.72hourslife.com. Receive introductory pricing with orders!
Thanks for liking and following Straight, No Chaser! This public service provides a sample of what http://www.SterlingMedicalAdvice.com (SMA) and 844-SMA-TALK offers. Please share our page with your friends on WordPress, like us on Facebook @ SterlingMedicalAdvice.com and follow us on Twitter at @asksterlingmd.
Copyright © 2018 · Sterling Initiatives, LLC · Powered by WordPress

Straight, No Chaser In The News: New US Dietary Guidelines

Health Prevention, General Health and Wellness, Diet and Nutrition, , , , , , , ,

Dietary-Guidelines-16-x-9

In the news are the 2015 guidelines on eating. The recommendations are jointly released every five years by the US Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA). Overall, these guidelines advise Americans to follow an eating pattern that includes a variety of fruits and vegetables, grains (at least half of which should be whole), a variety of proteins (including lean meats, seafood, nuts), and oils. However, these recommendations come with a bit of nuance to which you’d be well advised to pay attention.

dietary-guidelines

Here are the details, with simple rationale attached:
Alcohol: Moderate alcohol consumption now can be quantified up to one drink per day for women and up to two drinks per day for men. The recommendation is you stay at or under this amount.
Dairy products: If you’re eating dairy, the guidelines continue to recommend low and no-fat dairy products.
Dietary cholesterol: In a new recommendation, the guidelines no longer recommend a specific limit for dietary cholesterol. Among the foods you may frequently eat, dietary cholesterol is present in eggs and other animal products.
Fruit juice: The guidelines say one cup of 100% fruit juice counts as 1 cup of fruit. However, be advised that fruit juice is lower than whole fruit in dietary fiber and other nutrients, and it is typically very high in sugar, which you are now advised to limit, as noted below.
Red meat and processed meat: In an interesting reversal of the recommendation of its Guidelines Advisory Committee, the final recommendations suggest no limit is recommended for the consumption of red meat or processed meat. Be advised that recent evidence strongly link these foods with heart disease and cancer.
Saturated fats: The guidelines do not encourage a low total fat diet, but do recommend a low saturated fat diet. You should consume less than 10% of your calories per day from saturated fats. The evidence is clear that replacing saturated fat with unsaturated fat is associated with reduced risk of cardiovascular disease.
Sodium (Salt): The guidelines recommend you limit sodium intake to less than 2,300 milligrams (mg) per day.
Sugar: For the first time, the guidelines advise Americans to consume less than 10% of your daily calories from added sugars. You certainly are aware of sugar’s impact on the development of diabetes, high blood pressure and other diseases.

diet guidelines-pmpng-208055af61a3dd99

Eat healthy and be healthy. That’s the simplest recommendation I can offer. Here’s to your health!
Feel free to ask your SMA expert consultant any questions you may have on this topic.
Order your copy of Dr. Sterling’s new book Behind The Curtain: A Peek at Life from within the ER at jeffreysterlingbooks.com, iTunes, Amazon, Barnes and Nobles and wherever books are sold.
Thanks for liking and following Straight, No Chaser! This public service provides a sample of what http://www.SterlingMedicalAdvice.com (SMA) and 844-SMA-TALK offers. Please share our page with your friends on WordPress, like us on Facebook @ SterlingMedicalAdvice.com and follow us on Twitter at @asksterlingmd.

Straight, No Chaser: Expiration Dates on Food, Medicines and Cosmetics

General Health and Wellness, Health Prevention, Cardiology/Heart, , , , , ,

expired-medication-by-HazPhotos

We’re all faced with the decision. When you’re sick, have you ever rummaged through the medicine cabinet and discovered an old prescription? Perhaps you wanted to wear your extra special makeup and discovered the expiration date has passed. Or perhaps you came back from out-of-town, and reached into the refrigerator to cook your favorite meat and discovered it’s a few days past the expiration date.
No lectures today. Let’s engage in some straight talk and answer the questions you have.

 Expiration_Date

1. Why do foods have an expiration date?
Expiration dates provide an assertion of a guarantee of freshness, assuming the absence of other considerations. In other words, expiration dates are meant to suggest “best quality.”
2. Why do some stores sell foods beyond their expiration date?
Because they can. The U.S. Food and Drug Administration (FDA) does not require the coordination of expiration dates with assertions of safety (or lack of safety).
3. So is it safe or not safe to eat foods beyond their expiration date?
This is where things get tricky. The problem with “bad food” is contamination to the extent where sufficient bacteria are present to cause an infection. An expiration date is only a rough measure of that. If you leave food unrefrigerated or exposed to heat, it will go bad well before the expiration date. Even after the expiration date, sufficient bacteria may or may not be present to cause problems, but it becomes more likely as time passes.
4. Are there different considerations for different foods?
Use this list as a quick reference.

  • Countertop food (e.g., bakery goods containing custards, meat, vegetables, or frostings made of cream cheese, whipped cream, or eggs) should be kept refrigerated. Others not containing these (e.g., breads, muffins) can be kept at room temperature for a few days, but watch for mold that will develop over time.
  • Unprocessed pantry foods (e.g., cereal, dry beans, grains, mixes, nuts and pastas) should be good up to a year if unopened. Once opened they must be stored in air-tight containers.
  • Processed pantry foods (e.g., canned foods, cake mixes, crackers, dried foods) are safe until opened. Discard cans that are cracked, bulging or squirt liquid when opened.
  • Refrigerated foods (e.g., milk, chicken) may have both sell-by and use-by dates. Although generally safe to eat after both dates, the risk of problems is higher, so check for odor, discoloration or a bad flavor.
  • Freezer foods, according to the FDA, are safe indefinitely as long as they haven’t partially thawed. In this example, the sell-by and use-by dates apply to quality and retained nutritional value. For best results, if you’re going to freeze, do so early.

cosmexpdate

5. So cosmetics expire? I’ve never noticed an expiration date.
The FDA doesn’t require cosmetic manufacturers to print expiration dates on the labels of cosmetic products, but they do have the responsibility to determine shelf life for products, as part of their responsibility to substantiate product safety. The issue isn’t “expiration” as much as increasing risk for infections (of the eyes in particular).
6. For how long can I safely use cosmetics?
The better question is what increases the risk when using cosmetics. Here are some guidelines:

  • Manufacturers usually recommend discarding mascara two to six months after purchase.
  • If mascara becomes dry, discard it. Do not attempt to prolong its usefulness by adding water or saliva. Doing so will introduce bacteria into the product and onto your eyes when applied.
  • If you have an eye infection, stop using all eye-area cosmetics and discard those you were using when the infection occurred. Seek medical attention.
  • “All-natural” (i.e., plant-derived cosmetics) are more likely to have a shorter shelf life and to be conducive to bacterial growth with subsequent infection.
  • Poorly stored (e.g., exposed to high temperatures, previously opened) cosmetics may deteriorate before the expiration date. Conversely, those stored under optimal conditions may be acceptable long after the expiration date has been reached.
  • Sharing makeup increases the risk of contamination. A good example of this are the “testers” commonly found at department store cosmetic counters. If you feel you must test a cosmetic before purchasing it, apply it with a new, unused applicator, such as a fresh cotton swab.

expdatemedicine-19

7. What happens after a medication expiration date?
When it comes to antibiotics, I hope you never find out. You should always take your medications as prescribed, which generally means until all pills are gone. The medication date actually is more of a “freshness” (actually, safety and potency) consideration than a danger warning. However, in the wrong patient, a medicine that has less than the 100% guarantee of its needed strength, as the expiration date represents, could have fatal results. The expiration date doesn’t really indicate a point at which the medication is no longer effective or has become unsafe to use, with significant exceptions (e.g., tetracycline, nitroglycerin, insulin, and liquid antibiotics).
Feel free to ask your SMA personal healthcare consultant any questions you have on this topic.
In the meantime, if you’d like to read Behind the Curtain ahead of its national launch, we are now shipping orders made exclusively on www.jeffreysterlingbooks.com!
Thanks for liking and following Straight, No Chaser! This public service provides a sample of what http://www.SterlingMedicalAdvice.com (SMA) and 844-SMA-TALK offers. Please share our page with your friends on WordPress, like us on Facebook @ SterlingMedicalAdvice.com and follow us on Twitter at @asksterlingmd. Preorder your copy of Dr. Sterling’s new book Behind The Curtain: A Peek at Life from within the ER at jeffreysterlingbooks.com.

Straight No Chaser In The News: New Weight Loss Pill On The Market, aka The Problem With How We Approach Our Health

Diet and Nutrition, General Health and Wellness, , , , , ,

WEIGHT-LOSS-PILL1

The headlines say that the U.S. Food and Drug Administration (FDA) has approved a new weight-loss pill. The marketing will attempt to convince you that your health can be secured by what’s in a pill bottle. The Straight, No Chaser view is this roll out illustrates a few of the problems with our approach to health.

weight loss Miracle-Cure-Pill

Problem #1: We react after the fact and look for miracle cures.
There are now three weight-loss pills approved by the FDA. They all are appetite suppressants. Aside from the fact that safe and healthy ways to control one’s appetite exist, I’ve told you on many occasions that you won’t find your health in a pill bottle. The medicines you take are largely meant to treat disease. Even your vitamin pills can be replaced by vitamins in the healthy foods you eat, and you don’t need those pills unless you have a documented vitamin deficiency or have been directed to take them by your physician.

detox-diet1

Problem #2: We don’t try hard enough to simply reverse what caused the problems we’re having.
Diet and exercise, exercise and diet. If you are not beginning and ending the conversation with these considerations – and only incorporating any supplements or medications as bridges to facilitate the transition to a healthier lifestyle – you are going to be disappointed. Look at this quote from the manufacturer’s press release: “When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, (New Drug that I’m not promoting) provides another treatment option.” The quote could have just read the following: “…a commitment to a healthy lifestyle that includes a reduced-calorie diet and exercise will always give you the best chance to produce the results you desire (and certainly more than any reliance on medication)…”

weight loss 1 day diet SERIOUSLY?

Problem #3: The purported solutions don’t fully address the problem they claim to address.
You don’t even have to read the fine print. None of the weight-loss drugs approved by the FDA even promise massive weight loss. In other words, you’re just taking the pills and hoping for the best.

fenphencover

Problem #4: The purported solutions sometimes cause different problems than they address.
According to the FDA, the warning label for the newly approved drug will come with a warning that it might increase suicidal thoughts. Other possible side effects include increasing heart rate and blood pressure. Guess what? Obesity already increases heart rate and blood pressure; you don’t need a pill for that. Even worse, in the past some obesity drugs (remember fen-phen?) have been linked to serious heart problems and were pulled from the market.
By no means am I attempting to be flippant here. My concern is real. Consumers are prone to grab at whatever hope is offered, and a slickly marketed weight-loss pill is a great way to attract consumers, even at $200/month and when many insurers won’t cover the cost. Some of you will even swear by your pills. You can do much better for yourself by making a commitment to a lifestyle change that involves healthy eating, moderate exercise, stress reduction and all around better choice.
Feel free to ask your SMA expert consultant any questions you may have on this topic.
Thanks for liking and following Straight, No Chaser! This public service provides a sample of what 844-SMA-TALK and http://www.SterlingMedicalAdvice.com (SMA) offer. Please share our page with your friends on WordPress, Facebook @ SterlingMedicalAdvice.com and Twitter at @asksterlingmd.
Copyright © 2014 · Sterling Initiatives, LLC · Powered by WordPress.

Straight, No Chaser: Do You Take Antidepressants? Learn About the "Black Box" Warning Label.

Medical Treatment, Mental Health, , , , , , ,

antidepressantblackbox

It’s important to note that most recent group of antidepressants known as SSRIs are a marked leap forward in safety from their predecessors. Even still, they retain undesired effects, particularly in adolescents and young adults. The U.S. Food and Drug Administration (FDA) conducted a comprehensive review of controlled clinical research trials of antidepressants that involved nearly 4,400 children and adolescents. The review revealed that 4% of those taking antidepressants thought about or attempted suicide, compared to 2% of those receiving placebos (a simulated but medically inactive treatment).
In 2005, this information prompted the FDA  to adopt its most serious level of warning on all prescription antidepressant drugs, known as a “black box” warning. This warning means to alert the public about the potential increased risk of suicidal thinking or attempts in children and adolescents taking antidepressants. Specifically, makers of all antidepressant medications must post the warning regarding users up through age 24.
What does this mean for you? Regardless of your age, during the initial treatment period (e.g., the first month), you should have a family member closely follow you and look for any abnormalities or changes in behavior. In particular, worsening depression, suicidal thoughts or action, insomnia, increased agitation or withdrawal should be noted and considered a prompt to receive immediate medical attention.
In the event you’re wondering why such drugs would still be available to the public, it’s basically the risk/benefit ratio. These considerations aren’t taken lightly. It’s a testament to positive benefits of these medications that they remain popular and continually used for children and young adults (in particular) with depression and anxiety. Just be sure to have a detailed conversation with your physician or psychiatrist prior to use. These are not medications that you should just receive a prescription for and walk out of the office.
Thanks for liking and following Straight, No Chaser! This public service provides a sample of what http://www.SterlingMedicalAdvice.com (SMA) offers. Please share our page with your friends on WordPress. We are also on Facebook at SterlingMedicalAdvice.com and Twitter at @asksterlingmd.

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Straight, No Chaser: Five Important Questions About Contact Lenses

Health Prevention, Ophthalmology/Eyes, , , , , , ,

eyeinfxncontacts
Question: Which is better: disposable or regular contact lenses?
The development of disposable contact lenses has lessened the risk of various eye problems. This isn’t the same as saying regular lenses aren’t good or even just as good. Daily use (i.e. disposable) contacts don’t require cleaning solutions, which were commonly used for contacts in the past to increase the longevity of them. When you’re next ready for lenses, ask about silicon hydrogel lens. Evidence suggests they are even better for comfort and lower risk for eye problems.
Question: Can I wear my contact lenses when I go swimming?
You can, but you shouldn’t, according to the FDA (Food and Drug Administration). Swimming can cause absorption of chemicals (including chlorine) and bacteria from the water, leading to an eye infection. Additionally, contacts can adhere to the eye after swimming. This can lead to ulceration of parts of the eye (e.g. cornea).
Question: Can I wear my contact lenses while I sleep?
You can use extended wear contacts while you sleep if this has been approved in advance by your optometrist or ophthalmologist; they can be used for up to seven days if recommended as such. Daily wear contacts must be removed prior to sleep – even a nap.
Question: What steps help prevent fungal infections caused by contact lenses?
First, you should understand your risks, which include prior eye damage or a diminished immune system. Fungal infections are a particular concern for those wearing soft contact lens with risk factors. To reduce your risk, be sure to thoroughly wash your hands with soap and water. Be especially careful to avoid lint on your hands before handling your contacts. Avoid extending the use of your contact lens beyond the recommendations of your eye provider. Be sure to keep your lens case clean, and replace the case every 3-6 months. In the unlikely event you’re still using Bausch & Lomb ReNu ® with MoistureLoc® Multi-Purpose Solution, discard it. It’s been recalled due to an increase rate of eye fungal infections.
Question: How do I know if my contact lenses have caused an eye infection?
Be on the lookout for redness, swelling, tearing and/or eye discharge, light sensitivity, blurred vision and pain that doesn’t improve after removal of the contacts. If you have symptoms like this, remove the contacts and get medical assistance.
Remember to pause before inserting anything in your eyes. The consequences of bad decisions can be devastating and irreversible. I welcome your questions or comments.
Copyright © 2013 · Sterling Initiatives, LLC · Powered by WordPress