Juvenile Arthritis: Discoveries Lead to Newer Treatments

X-ray of a 6-year-old’s knee with juvenile idiopathic arthritis (JIA).

Arthritis is a disease that mostly affects older people, right? Not necessarily.

Juvenile arthritis is one of the most common chronic illnesses affecting children. In fact, nearly 300,000 youngsters nationwide have been diagnosed with the disease. The most common symptoms include joint pain, inflammation (swelling), tenderness and stiffness. One early sign may be limping in the morning.

Nikolay Nikolov, a rheumatologist and clinical team leader at the Food and Drug Administration (FDA), says that children with juvenile arthritis and their parents have reason to be optimistic. In the last several years, new therapies have been developed by drug companies and approved by the FDA that moderate the effects and control the disease, likely preventing significant disability in later years.

While no one knows exactly what causes juvenile arthritis, scientists do know it is an autoimmune disorder. The immune system, which normally helps the body fight infection, attacks the body’s own tissue.

There are several subgroups of juvenile arthritis. Known collectively as Juvenile Idiopathic Arthritis (JIA), these diseases start before age 16 and cause swelling in one or more joints lasting at least six weeks.

JIA affects large joints such as knees, wrists, and ankles as well as small joints. Polyarticular JIA, the largest JIA subgroup, affects many joints. Another subgroup is Systemic JIA, which affects the whole body, and usually causes fever and skin rashes.

In the past, the first line of treatment for children with juvenile arthritis has been to relieve pain and inflammation with non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen. Children with severe juvenile arthritis have been treated also with drugs that suppress the body’s immune response such as corticosteroids and methotrexate.

But polyarticular and systemic JIA are now also treated with newer medicines called biologics, which are manufactured in or extracted from biological sources.

Biologics: New Treatments for Juvenile Arthritis

“As science at the molecular level has advanced, we’ve learned more about what drives arthritis—the mechanism of the disease—and we are able to identify important targets,” Nikolov says.

These targets include cytokines (molecules that control and drive inflammation in the body) such as tumor necrosis factor (TNF), interleukins (IL), and other naturally occurring proteins involved in stimulating the body’s immune response. Biologics used in the treatment of juvenile arthritis are generally given intravenously or subcutaneously (under the skin), and usually are taken for years. Different biologics tend to work better for different subgroups of the disease. In recent years, FDA has approved several of these treatments. Here are their names, the type of JIA they treat and approval dates:

• Humira (adalimumab) for polyarticular JIA, February 2008
• Orencia (abatacept) for polyarticular JIA, April 2008
• Enbrel (etanercept) for polyarticular JIA, May 1999
• Actemra (tocilizumab) for systemic JIA, April 2011 and polyarticular JIA, April 2013
• Ilaris (canakinumab) for systemic JIA, May 2013.

“In addition to improving the signs, symptoms and physical functioning of patients, many of these biologics have been shown to reduce joint destruction in adults with rheumatoid arthritis (RA), a disease that is related to juvenile arthritis, and thus to change the natural history of the disease,” Nikolov says.

While researchers don’t yet have a lot of long-term safety information on use of these drugs in children, there is significant experience with their use in adults with RA. Biologics used for the treatment of patients with juvenile arthritis are potent drugs that suppress the immune system and can increase the risk of serious infections, including opportunistic (unusual) infections and tuberculosis

Expanding Use of New Treatments to Children

When a drug is found to benefit adults with RA in large clinical trials, drug manufacturers may study it in children with juvenile arthritis to find out if the drug works for them too. In addition, FDA considers the known and potential risks of the drug to determine whether its benefits in treating juvenile arthritis outweigh these risks.

“It’s possible that safety issues might come up in kids that we have not found in adults. For example, these drugs may affect the developing body and immune system in children, and that may warrant changes in the labels to let both health care providers and patients know what are the risks involved, and how to recognize and respond to potential problems,” Nikolov says.

Meantime, scientists continue to work on improving existing treatments for children and search for new treatments that will work better with fewer side effects.

“We don’t have a cure for juvenile arthritis—we’re not there yet,” says Nikolov. “But we’re making progress.”

Goodman And Gilman's The pharmacological Basis of Therapeutics

Dear Doctor,

You can download and use thesebooks for your personal use as such without any modification. But please give the authors the credit they deserve and do not change the author’s name.


An appeal :If any of you have these type of books or links in your collection please mail to us : mijjumaniyar@gmail.com

                                               




                                                                         Click Here

Surgery Notes With Anatomy and Instruments

                 
Dear Doctor,

You can download and use thesebooks for your personal use as such without any modification. But please give the authors the credit they deserve and do not change the author’s name.


An appeal :If any of you have these type of books or links in your collection please mail to us : mijjumaniyar@gmail.com



                                           



                                                           Click Here

FDA Regulatory Affairs

   
                                    
             








                                                          Click Here

British National Formulary Children

       
Dear Doctor,

You can download and use thesebooks for your personal use as such without any modification. But please give the authors the credit they deserve and do not change the author’s name.

An appeal :If any of you have these type of books or links in your collection please mail to us : mijjumaniyar@gmail.com




                                        


                                                         Click Me                        
 


                           

Can an Aspirin a Day Help Prevent a Heart Attack?

• Can an aspirin a day help you ward off a heart attack or stroke?

               That depends.

Scientific evidence shows that taking an aspirin daily can help prevent a heart attack or stroke in some people, but not in everyone. It also can cause unwanted side effects.

According to Robert Temple, M.D., deputy director for clinical science at the Food and Drug Administration (FDA), one thing is certain: You should use daily aspirin therapy only after first talking to your health care professional, who can weigh the benefits and risks.

Who Can Benefit?

"Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence," Temple says. (A dose ranges from the 80 milligrams (mg) in a low-dose tablet to the 325 mg in a regular strength tablet.) This use is known as "secondary prevention."

However, after carefully examining scientific data from major studies, FDA has concluded that the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called "primary prevention." In such people, the benefit has not been established but risks—such as dangerous bleeding into the brain or stomach—are still present.

Caution Needed With Other Blood Thinners

When you have a heart attack, it's because one of the coronary arteries (which provide blood to the heart), has developed a clot that obstructs the flow of blood and oxygen to the heart. Aspirin works by interfering with your blood's clotting action.

Care is needed when using aspirin with other blood thinners, such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis).

What about people who have not had heart problems or a stroke but who, due to family history or showing other evidence of arterial disease are at increased risk? Is an aspirin a day a safe and effective strategy for them?

Again, Temple emphasizes, the clinical data do not show a benefit in such people.

He adds, however, that there are a number of ongoing, large-scale clinical studies continuing to investigate the use of aspirin in primary prevention of heart attack or stroke. FDA is monitoring these studies and will continue to examine the evidence as it emerges.

In the Meantime

The bottom line is that in people who have had a heart attack, stroke or cardiovascular problems, daily aspirin therapy is worth considering. And if you're thinking of using aspirin therapy, you should first talk to your health care professional to get an informed opinion, Temple says.

Finally, how much aspirin you take matters. It's important to your health and safety that the dose you use and how often you take it is right for you. Your health care professional can tell you the dose and frequency that will provide the greatest benefit with the least side effects.

If your health care professional recommends daily aspirin to lower the risk of a heart attack and clot-related stroke, read the labels carefully to make sure you have the right product. Some drugs combine aspirin with other pain relievers or other ingredients, and should not be used for long-term aspirin therapy.

Warning: Aspirin-Containing Antacid Medicines Can Cause Bleeding

The next time you reach for an over-the-counter (OTC) product to treat your upset stomach or heartburn, consider whether you should use one of the many antacids that don’t have aspirin.

Why? Aspirin-containing medicines to treat heartburn, sour stomach, acid indigestion, or upset stomach can cause stomach or intestinal bleeding, especially in some people, warns the U.S. Food and Drug Administration (FDA).

Cases of bleeding are rare. In 2009, FDA issued a warning about serious stomach bleeding risk with aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). Despite that warning, when FDA reviewed its Adverse Event Reporting System database, it found eight new cases of serious bleeding caused by aspirin-containing antacid products since that 2009 warning. Some of those patients required a blood transfusion.

“Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” says Karen Murry Mahoney, MD, Deputy Director of the Division of Nonprescription Drug Products at FDA. “Unless people read the Drug Facts label when they’re looking for stomach symptom relief, they might not even think about the possibility that a stomach medicine could contain aspirin.”

Mahoney adds: “Today we’re focusing on bleeding risk specifically with antacid-aspirin products used to treat upset stomach or heartburn. We’re not telling people to stop taking aspirin altogether.”

How will you know what OTC medicine to take to get relief from indigestion? Again, it’s important to read the Drug Facts label. It will tell you if the product contains aspirin, and it lists the risk factors for bleeding. If the medicine has aspirin, consider looking for something else  There are plenty of stomach medicines that don’t contain aspirin.

Who’s at Higher Risk of Bleeding

Because aspirin thins the blood, FDA believes the aspirin in these combination medicines is contributing to major bleeding events. People with one or more risk factors have a higher chance of serious bleeding with aspirin-containing antacid products.

You are at higher risk for bleeding with these products if you:

• Are 60 or older.
• Have a history of stomach ulcers or bleeding problems.
• Take drugs that reduce the ability of your blood to clot (also known as anticoagulants or blood-thinning drugs).
• Take steroid medicine, such as prednisone, to reduce inflammation.
• Take other medicines containing NSAIDs, such as ibuprofen or naproxen.
• Drink three or more alcoholic drinks every day.

Warning signs of stomach or intestinal bleeding include feeling faint, vomiting blood, passing black or bloody stools, or having abdominal pain. These are signs that you should consult a health care provider right away.

What if you’ve been taking these products for a long time?

“Some people may have been taking aspirin-containing antacid products frequently for a long time. Apart from the bleeding risk, it’s not normal to have frequent or chronic upset stomach or heartburn. You should talk to a health care provider if that’s happening,” says Mahoney.

Take aspirin regularly? If your health care provider has advised you to take an aspirin a day to help prevent a heart attack or other condition, don’t stop without talking with your doctor first, Mahoney says. Make sure you discuss what kind of medicine you can take in case you get an upset stomach.

How to Settle an Upset Stomach

Consumers have many alternatives for treating heartburn, sour stomach, acid indigestion, and upset stomach. Read the Drug Facts label and look for products that contain an “antacid” or “acid reducer.”

For example, Mahoney says, there are numerous OTC medicines that contain only an antacid, such as calcium carbonate, magnesium hydroxide, or another antacid. These can be used to treat heartburn, sour stomach, acid indigestion, and upset stomach. For frequent heartburn, there are acid reducers, such as proton pump inhibitors (esomeprazole, lansoprazole, omeprazole), or H2 blockers (cimetidine, famotidine, ranitidine).

What Else FDA Is Doing

In 2009, a warning about the risk of serious bleeding was added to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products.

FDA is continuing to evaluate this safety issue and plans to convene an advisory committee of external experts in 2017 to provide input regarding whether additional regulatory action is needed, such as adding warnings to the labeling or other actions.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products. 

June 6, 2016

Life as a Medical Student: 12 Things You Really Have to Know

Becoming a medical student can be a daunting prospect; university is a very 

different environment to school, with unique opportunities and challenges.

Being a medical student will involve working harder than you’ve ever worked in your life – but chances are, it’ll also involve having more fun than you’ve ever had before. There are plenty of off-putting myths about being a medical student, but in reality it’s enjoyable, interesting and highly rewarding, especially in light of what you’re working towards. In this article I will describe 12 things about being a medical student that I hope will reassure and excite you about the prospect of studying medicine.

1. You will be able to use what you learn for the rest of your life

Studying is satisfying when you know the knowledge will be important long after you’ve finished your exams.

This might seem like a fairly trivial point, but it should not be overlooked. The truth for many courses is that you are only really studying in order to pass your exams and once you have managed this the information which you have tried so hard to learn is largely useless to you. This is very much not the case in medicine, with areas of study including anatomy, physiology, biochemistry, pharmacology and pathology all being directly applicable in diagnosing, understanding and treating a disease. Not only is this a great incentive to learn the core course material well, in order that you will be a competent doctor, it is also an incentive to go beyond the basic lecture material and satisfy your curiosity about what you have been taught. As a medic this extra detail could one day be put into practice in a clinical situation and could make a crucial difference to a patient. When you are studying medicine you are not just studying for the next exam but taking the first steps on a course of lifelong learning, building your basis of professional knowledge throughout your medical career.

2. Sometimes it’s hard work

Studying medicine comes with a certain expectation to work harder on average than most other students. There are generally more contact hours than other subjects (this year I have a 9-5 day every Friday) with practicals and lectures taking up a great deal of time. Of course it’s not just the contact hours when you are working: lecture notes need to be read over, essays have to be written, practicals should be prepared for and keeping on top of it all can be a challenge. This is especially the case as your work load will vary from week to week, sometimes being set a great deal of work and sometimes having a whole week with very little to do. Therefore it’s important to be flexible with how you work and appreciate that sometimes you will have to put in a long stint of work in order to have the time off when you need it. There’s also a reasonable amount of pressure on to pass exams. In most subjects other than medicine what you are really studying and aiming for is the best grade possible. Obviously this is true to an extent in medicine, but there is an additional challenge, which is the very high pass marks for the “2nd MB” exams, the ones you have to pass in order to become a doctor. By being passed in these you are essentially being certified as competent enough in a subject area to continue towards a professional medical career. Passing these exams can often require cramming a great deal of knowledge in a small space of time and this can be stressful, but the reward after exams is a long summer to enjoy. Medicine can be challenging, but…

3. It’s not all hard work!

Medical students learn to manage their time very well, which means you should still have time for your hobbies.

Don’t panic, medicine can be challenging but you’ll still have plenty of time to enjoy being an undergraduate, an experience that many people say is the best time of their life. The level of work in the course is such that you will have time to make the most out of other activities atuniversity, such as sports, music and the huge range of other societies that are on offer at university. All that you need to do in order to manage these other activities is be efficient with the time you spend working; don’t spend a whole afternoon watching YouTube videos if you know you have a music rehearsal that evening. University is about a lot more than simply gaining a degree, you will learn a lot about yourself and other people and hopefully build yourself into someone who is capable of being a good doctor.

4. Being a medical student isn’t all about studying medicine

All these activities that you can do in your spare time aren’t just about having fun, however. While the main reason you do them is to enjoy yourself and take your mind off work they are actually very important in your “personal development”. This is, as mentioned above, working on skills that are outside the scope of academic study but are still vital to being an effective doctor. For example, by taking part in music or theatre you will become accustomed to performing in front of a large crowd of people and as a consequence if you ever have to present at a conference or even to a team of your colleagues, you will be able to stand up with confidence and say what you need to. Equally, playing in a sports team will help you function with other people, some of whom you may have a personality clash with or strongly differ in opinions. You become used to a position of responsibility, with other people relying on you to perform your role, sometimes under pressure. Sports and societies also provide an opportunity to take a leadership and organisational role, which once again will become very important in a clinical context, whether it is organising ward staff or running a practice as a GP. Medicine is a career in which it is vital to emerge from university as a functional person who is capable of interacting well with others. This will not be achieved by sitting in your room every evening and studying the lecture notes: there is an important balance to be struck between working and having a life.

5. Studying anatomy involves more than looking at pictures

Anatomy can be rather full-on, especially at traditional institutions such as Cambridge, where throughout the course of your first year you dissect a “subject” who has decided to donate their body to training medical students. This means getting involved with a scalpel yourself and doing what can occasionally be a rather unpleasant task. Some people might be really excited by the idea of getting stuck in and having a really practical course in anatomy, but for those who don’t you shouldn’t panic. Most other universities use only pre-prepared dissections (prosections), which you will still have to learn the structures of and examine, but without necessarily getting your hands dirty.

6. You will make some of your closest friends studying medicine

Make sure you take the time to make the most of the people you’re at university with. They don’t necessarily have to be medics; many people become very close with people in their sports team or society, but medics do seem to end up hanging around together. Unfortunately this can sometimes lead to slightly geeky “medic chat” where before you know what’s happening you end up discussing what happened in the morning’s lectures, or how you found last week’s practical. This can be a good way to remind yourself what happened in the lecture earlier (no one can concentrate all the way through a full one hour lecture), but sometimes it’s just light-hearted discussion about which lecturer makes it very hard to stay awake!

7. Studying medicine brings you up to date with the latest medical research

The chance to be involved in medical research attracts many people to studying medicine.

For those of you who are really interested in the biological sciences, studying medicine is a great opportunity to be brought very close to the frontier of current scientific knowledge, beyond what you will find in textbooks. Your lecturers are all actively involved in their field of interest and as such it is part of their job to stay up to date with all the latest advances and studies that are going on in that area. Therefore they can teach things well before they are published in textbooks and make you aware of very up-to-date and relevant research papers. Be it the latest cell reproduction pathways associated with tumours or the most recently discovered ion channels in the heart, you will be brought up to the current level of understanding.

8. Medicine is a long course

Studying medicine is very much a marathon, not a sprint. It is a 5 or 6 year course, where in your final few years holidays become a lot shorter and you are studying almost all year round (instead of having three months off a year). The reason the course is so long is because of the volume of material that needs to be learned; both the basic scientific principles and the clinical skills needed to apply them must be taught. While this may seem like a fairly monumental task the truth is that while at university time seems to pass incredibly rapidly, probably because the average student is so busy they don’t have time to notice each term flying past. While this is nice as it feels as if you’re making rapid progress through your studies it also means it’s very easy to get behind on work and not catch up until the holidays come around. Fortunately the holidays come around so quickly due to the short length of the terms you can usually get away with this and the holidays are often a valuable opportunity to make sure you understand the past term’s work before the chaos of term time starts again. Some academic staff even go as far as to say…

9. You have a vacation, not a holiday

The amount of studying you’ll need to do may sometimes seem daunting.

What they mean by this is that the Christmas and Easter breaks are simply the times when you vacate your accommodation and not a complete holiday from work. Of course, this does not necessarily have to be true. If you’ve managed your work very well during term time and stayed on top of everything there is no reason why you can’t enjoy a well earned rest for a few weeks. If, however, you prefer to do as many activities as you can while in residence the vacations can be an important opportunity to pay back the time you borrowed during the term. Most importantly, it’s about finding a balance. You don’t want to start the term feeling fatigued from working too hard over the holidays, but equally you don’t want to start the term not having a clue what’s going on.

10. Organisation is key

Studying at university is a real contrast to being a student at school and one of the real challenges is organising your work and activities. You can no longer rely on your parents to keep a calendar of everything that’s going on and instead you must sort things for yourself. Add to this the fact that a significant proportion of time at university will be spent feeling tired, due to excessive studying or partying, and there is a recipe for potential disaster. Tutorials may clash with rehearsals, practicals may coincide with sports matches or a MedSoc event might be happening when you’re meant to be seeing your family. The most important thing is to have some kind of system, whether it is a paper diary you keep with you or a calendar on your phone. Make sure you’re not the one who is always nearly missing things or running round at the last minute trying to work out where you’re supposed to be.

11. If you pass your exams you’ll become a doctor

Medical students have much less to worry about regarding future employment prospects.

Bar any kind of disaster, if you pass all your exams while studying medicine you will go on to become a doctor. This may well seem like stating the obvious, but it’s worth taking a step back and thinking about this. By passing you in an exam a university is certifying that you are competent enough in that subject area to continue on the path to becoming a doctor. What does this mean for you? First of all it means that it can be quite difficult to pass your exams. In other subjects you are certified as competent by scoring a decent grade (usually a 2:1), however in medicine if you pass you will be guaranteed to continue down the path of clinical school and continue on to a professional medical career. While there is the drawback of having an especially tough time passing exams this is also a very exciting prospect. If you manage to continue at a reasonable level, putting enough work in, you will qualify as a doctor. Compare this with a subject such as law, where if you pass your law degree with a 2:1 you are not guaranteed to become a lawyer; you are not even guaranteed a job. This is also the case with engineering, while you may become a certified engineer it does not mean you have any kind of reassurance that you will go on to have a job in engineering. If things get tough and you think you might struggle to pass just remember that by passing you are taking one step more towards being a doctor.

12. Most of your peers will be very intelligent

Medical students represent an extremely limited selection of people your age and they will tend to be both very capable and hard working. This can sometimes result in you feeling rather demoralised when comparing yourself to other medics, especially as you will tend to notice the ones working harder than you more than the rest. Remember, the people you are comparing yourself to represent the very top fraction of students in the country and as such you should not be disheartened if some of them are better than you. In fact there will be plenty of other medical students at the same level as you who are making the most out of university to develop themselves as a person, not just as a student.

Being a medical student puts you in a very privileged position, among the very top students across the country. It generally seems to be the case that medics follow the mantra “work hard, play hard”. Most importantly, remember that being a student is not only a means to an end, but an end in itself. Make sure you make the most of being an undergraduate!