Juvenile Arthritis

June 21, 2017

Most people think arthritis only affects older people, but that is far from the truth.

Juvenile Arthritis has become a chronic childhood illness. About 300,000 children in the United States are diagnosed with arthritis. Typical symptoms include inflammation (swelling), joint pain, stiffness and tenderness. Morning time limping is also an early sign of juvenile arthritis.

Rheumatologist and FDA clinical team leader Nikolay Nikolov offers hope for those who have juvenile arthritis. Over the past few years, drug companies have been developing new treatments that can control the disease and its effects, which may reduce the onset of physical disability in later adult years.

The cause of juvenile arthritis is unknown, but what scientists do know is it is an autoimmune disorder in which the immune system attacks its own body tissue.

Juvenile Idiopathic Arthritis (JIA) is the name known for the collective group of conditions classified as juvenile arthritis that start before age 1 and has symptoms lasting for at least 6 weeks.

The wrists, ankles, knees and even smaller joints are impacted by JIA. Polyarticular JIA is the largest JIA subgroup because it impacts several joints. Systemic JIA is another subgroup that impacts the entire body and can cause skin rashes and fever.

Past treatment for juvenile arthritis included NSAIDS (non-steroidal anti-inflammatory drugs) like aspirin and ibuprofen. Corticosteroids and methotrexate are used in more severe cases to suppress immune response to the joints.

FDA-approved biologics (medicines originating from biological sources) are now being used to treat both systemic and polyarticular JIA.

Current JIA Treatments

Because of advanced science, doctors are now able to determine what encourages the occurrence of arthritis. Cytokines (molecules responsible for inflammation control in the body) like interleukins (IL), tumor necrosis factor (TNF) and other natural proteins that facilitate immune responses are the focus of new medicines.

Biologics are administered intravenously or subcutaneously (under the skin) over the course of several years to maintain symptom relief.  Not all biologics work the same on all subgroups of JIA.

Currently, there is no data on the long-term effects of these newer medications on children, but there is a lot of information on how these drugs affect adults with rheumatoid arthritis (RA). One also should be mindful that biologics suppressing the immune system can increase the risk of infections like tuberculosis in children.

All of us have had problems remembering something—like where we last put our car keys or where we last placed our glasses.

These occurrences are normal because the brain is always trying to sort, store, prioritize and retrieve information.  But where do we draw the line between normal memory loss and abnormal memory loss? The following checklist should help you make the distinction:

  • Does the memory loss interrupt your daily lifestyle (doing personal hygiene, balancing a checkbook and driving)?
  • Are there signs of confusion? Serious memory problems cause people to be lost even when they are in places they know. They may also move items to inappropriate locations (like putting deodorant in the refrigerator).
  • What’s being forgotten? The extent of the memory loss is another sign. When people start forgetting entire conversations, there’s a problem. Another sign is forgetting the names of people close, such as family and friends or repeating the same information in the same conversation.
  • How often do memory lapses occur? Forgetting where you parked every now and then is normal, but to forget your parking spot where you always park is abnormal.When you start forgetting regular appointments and events, those are signs your memory problems are disrupting your daily functions.
  • Is the memory loss getting worse? If it seems like the memory lapse episodes are occurring more frequently, then you need to seek medical help to get examined.

What Causes Memory Loss?

Anything that can impact mental functions—thinking, remembering and learning—can affect memory.  Therefore, doctors must employ a variety of strategies to determine what’s happening to cause the memory loss.

Medical history, neurological and physical exams, blood tests and urine tests are all used to help determine the cause. Computerized axial tomography (CAT) scans or magnetic resonance imaging (MRI) are brain imaging tools used to rule out tumors and strokes, which can also affect memory.

All these strategies are used to rule out other more dangerous causes of the memory loss. Some causes of memory loss happen alone or in combination with other causes:

  • Stress, especially the kind related to emotional trauma, can impact the ability to remember. In rare instances, patients can develop psychogenic amnesia, which causes wandering and an inability to remember one’s own identity. However, this condition does leave on its own over time.
  • Excessive use of alcohol creates vitamin B1 (thiamine) deficiency, which can create memory loss. Drug abuse can also impact the chemical makeup of the brain and impact memory.
  • Medications: prescription and OTC over-the-counter) sleeping pills, antihistamines, antidepressants, certain medicines used to treat schizophrenia, some post-surgery pain medications and anti-anxiety medicines can impair memory.
  • A blow to the head can cause temporary memory loss that gets better over time. More severe cases like frequent head blows (from boxing and football, for example) can create progressive and more long-term memory loss with a host of other conditions.
  • Depression, especially in the elderly) can create a decrease in focus and attention that may impact memory.  Anti-depression treatments will change the person’s mood and improve memory.
  • Deficiencies of vitamins B1 and B12 can cause memory loss, but the deficiencies can be remedied with injections or pills.
  • An overactive (or underactive) can interfere with remembering recent events.
  • Poor sleeping habits can have a negative impact on your memory.
  • HIV, tuberculosis, syphilis, herpes, and other infections affecting the lining or substance of the brain can create memory issues.

New Tobacco Rules

May 29, 2017

What does this new rule do?

The new tobacco rule establishes discourse taken over seven years ago concerning the regulation of cigarettes. As of  June 2009, The President and Congress passed the Family Smoking Prevention and Tobacco Control Act to give the FDA power to regulate the making, distribution, and selling of tobacco products (cigarettes, cigarette tobacco, smokeless tobacco ad roll-your-own tobacco).

This rule has several implications now.

This authority also applies to recent tobacco creations like e-cigarettes, ENDS (electronic nicotine delivery systems), cigars (even premium), hookah (also known as waterpipe tobacco), pipe tobacco, nicotine gels and dissolvables.

Health warnings are required on all tobacco-related products, and free samples are prohibited. Also, manufacturers of products that hit the market after February 15, 2007 must make sure their products meet FDA health standards to get FDA approval.

This act also prohibits the sale of all tobacco-related products to minors (people under age 18) and in vending machines not placed in adult-only locations. A government issued ID must be presented to verify age to purchase tobacco products.

What was the FDA’s point in doing this act?

Because of the detrimental effect of tobacco on public health, the FDA’s role in implementing the Family Smoking Prevention and Tobacco Control Act is to help reduce the risk of tobacco-related diseases and death.

FDA regulation does not equate to endorsing the products as being safe to use. However, it does stop the sale of products like hookah, cigars, and e-cigarettes to people under 18 years of age.  Although there is a significant decrease in traditional cigarette use among youth, there is a marked increase in the use of other tobacco-related products. The FDA and the Centers for Disease Control and Prevention. (CDC) report that over 16 percent of the high school population smokes e-cigarettes (up from 1.5% in 2011), and there is a great increase in the use of hookah.

But aren’t e-cigarettes safer than regular cigarettes?

The FDA realizes that not all tobacco-related products have the same level of potential harm. Therefore, the nature of tobacco regulation will change when the FDA has more information on the extent of harm all new tobacco-related products cause.

The FDA recognizes that some of these new technological tobacco products can be both beneficial and harmful. For example, e-cigarettes can reduce air pollution and encourage people to change from using real cigarettes. However, if products like these promote more youth encouragement to use tobacco and promote more encouragement for people to not stop using tobacco-related products, then their effect is negative on society.

The current goal of the FDA is to persuade manufacturers to consider new products that have a more beneficial impact on society than a negative one. The Family Smoking Prevention and Tobacco Control Act gives the FDA power to research the effect of these products on users and non-users and regulate how these products are marketed.

Think about using an over-the-counter (OTC) antacid product for upset stomach or heartburn that does not contain aspirin.

The U.S. Food and Drug Administration (FDA) says that if you use an aspirin-containing product for acid indigestion, upset stomach, sour stomach or heartburn, you risk the potential for having stomach or intestinal bleeding.

To date, stomach bleed cases are rare but possible. Since 2009, the FDA has warned about the potential for stomach bleeding risk when consuming aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). However, there have been reports of antacid products causing that same effect since the 2009 caution, and some people have had to get a blood transfusion.

Most people don’t consider the potential of stomach products causing more stomach problems because they don’t read the label. Therefore, when considering a product for treating a stomach ailment, always check out the Drug Facts label to see if the product contains aspirin. If it does, you may want to find another product that is friendlier to your stomach.

It’s not that the FDA does not want people to use aspirin at all. The FDA just feels it’s important consumers are educated about the risk antacid products with aspirin can have.

So, when considering which OTC antacid to take for upset stomach, all you have to do is read the Drug Facts label to see if the product has aspirin and has a warning about stomach bleeding. If the medicine contains aspirin, you still have a lot of other options out there that don’t.

Who’s at Higher Risk of Bleeding

The FDA believes antacids with aspirin influence stomach bleed episodes because aspirin acts as a blood thinner. People with risk factors for stomach bleeding are more prone to have a bleeding episode than others when using these products.

People at a higher risk for bleeding when using aspirin-containing aspirin products are people who:

  • Are age 60 or older.
  • Have a history of stomach bleeding or ulcers.
  • Take anticoagulants or blood thinners that reduce the body’s ability to form blood clots.
  • Take steroids to treat inflammation (like prednisone)
  • Take other NSAIDs (like naproxen or ibuprofen).
  • Consume three or more alcoholic drinks daily.

Signs of stomach/intestinal bleeding are abdominal pain, bloody (or black) stools, vomiting blood or feeling faint. If you experience any of these signs, get medical attention as soon as possible.

How to Settle an Upset Stomach

There are alternative treatments for soothing stomach ailments. Look for product labels that say the product is an acid reducer or antacid.

A lot of products on the market for stomach ailments only have antacids like magnesium hydroxide, calcium carbonate or some other antacid. If you suffer from frequent heartburn, you can get acid reducers like H2 blockers (ranitidine, famotidine, cimetidine) or proton pump inhibitors (esomeprazole, omeprazole or lansoprazole).

The Centers for Disease Control and Prevention (CDC) estimates that heart disease is the leading cause of death for women in the United States, which means one in four women will die from heart disease in America.

There are some preventive strategies you can adopt to reduce the risk of heart disease. The FDA has recommended the following tips to assist women in reducing the risk of death from heart disease.

Tips to Reduce Your Risk

Although heart disease can cause stroke and heart attack fatalities, there are some strategies you can employ to decrease the risk.

Take care of your current health issues. Conditions like high blood pressure, high cholesterol, and diabetes all increase the potential for heart disease if you don’t discuss with your health care provider the best treatment options for these conditions.

Quit smoking. The FDA’s website has great information on medical treatments to help you stop the habit.

Exercise regularly for healthy weight maintenance. Everybody may not be a gym fan and can complete all their exercises in one set. You may have to start out by walking or doing some other activity as your doctor recommends.

Know the symptoms of a heart attack in women.  Call 911 if you feel you are having the symptoms of a heart attack: nausea, ache or tight feeling in the chest (or jaw, neck or abdomen), or shortness of breath.

A daily aspirin regimen is not for everybody. Before committing to an aspirin regimen as a heart attack preventative, consult your doctor first.

Eat healthier.  A diet rich in fruits and vegetables and limited in fats and sugars is good prescription for healthier eating. Also, include more whole grains and less prepared and packaged/processed foods. Check out the food labels to see what you are consuming in the food products you buy. You may want to discuss your dietary needs with your health care provider.

Always consult your health care provider before committing to a clinical trial for heart medications or treatments.  A clinical trial is an experimental study requiring human volunteers to test out new medicines and treatments.

Menopause and Heart Health

The decrease in estrogen that occurs during menopause can be a contributing factor for the increased risk of heart disease in women. Weight gain is another menopause factor that may also contribute. To remedy the issue of decreased estrogen, hormone therapy is often done to remedy some of the ailments of menopause.

Children are prone to having colds, but if the symptoms last for weeks on end, the problem may be another culprit: allergies.

Long-term episodes of runny (or stuffy) nose and sneezing are often signs of allergic rhinitis—the combination of symptoms that affect the nose when you have an allergic reaction to something you inhaled (or something that lands on the inside of your nose).

Allergies can be either seasonal or year-round (perennial). In most of the US, plant pollens cause the most cases of seasonal allergies (often known as hay fever). Mold, pet dander and dust mites often cause most cases of perennial allergies.

The National Institute of Allergy and Infectious Diseases (NIAID) reports that up to 40 percent of children suffer from allergic rhinitis, and the potential for allergies is higher in children with a family history of allergies.

Although the U.S. Food and Drug Administration (FDA) regulates prescription and over-the-counter (OTC) allergy medicines, parents still should exercise caution when giving these medicines to their children.

Immune System Reaction

Allergies occur when our immune system responds to an allergen by releasing histamine and other chemicals that causes nose, lungs, sinus, throat, eyes, ears, skin or stomach lining symptoms.

Some children are more prone to suffer from asthma episodes (periods of wheezing or breathing difficulties) when their allergies are triggered.

Doctor for the FDA’s Division of Pulmonary, Allergy, and Rheumatology, Dr. Antony Durmowicz, cautions that parents treat allergies in children who have both conditions or else the asthma treatment will not be effective.

Allergy Medicines

OTC medicines are effective for treating childhood allergies. However, prescription treatments may be needed for more stubborn and persistent allergy cases. Seven options exist for pediatric allergy relief. And even if allergy medicine can be used in children as young as 6 months, you should always check the product label to determine if the medicine covers your child’s age group. Just because it’s a children’s medicine doesn’t mean it covers all age groups.

More Child-Friendly Medicines

Current pediatric legislation and FDA regulations for pharmaceutical companies promotes research and development of children’s medicines that have friendlier ingredients on the label. Since 1997, federal regulations have prompted the study of at least 600 products for minors.

Traumatic Brain Injury

April 2, 2017

Falls, football tackles, car accidents, etc. are known to cause head injuries. Anyone of any age can get a head injury that may also damage the brain.

Sudden head movements can make the brain twist in the skull and injure (or stretch) brain cells, which will alter the chemical makeup in the brain. This occurrence is known as Traumatic Brain Injury (TBI).

While children and parents are gearing up for fall school sports activities, the FDA (U.S. Food and Drug Administration) is studying TBI and promoting the discovery of innovative treatment options.

Symptoms and Diagnosis

Most TBI incidents happen after the head receives a jolt, blow, bump or explosive blast to the head. Sometimes, TBI comes from an existing head injury that changes brain function. Keep in mind that not all hits to the head will cause TBI. Sometimes, the occurrence is mild (like when people are somewhat disoriented); but in other instances, the damage is severe (with serious thinking and behavioral issues or change in consciousness or mental state. A concussion is a mild type of TBI.

In 2010, an estimated 2.5 million medical emergency room visits involved TBI. The Centers for Disease Control and Prevention (CDC)) states that almost 30% of all deaths related to injuries in the United States come from TBI.

TBI symptoms are confusion, blurred vision, headache and behavioral changes. Moderate and severe TBI are also accompanied by slurred speech, nausea or vomiting, arms or legs weakness and thinking problems. (Please refer to the National Institute of Neurological Disorders and Stroke for more information concerning TBI symptoms.)

Head injuries must be diagnosed via medical examination that will entail a neurological exam. Neurological exams included an examination of a person’s motor function, thinking, coordination, reflexes and sensory function.

To date, there is no universal diagnostic standard to diagnose TBI because some forms are harder to diagnose than others. However, there are some guidelines for TBI diagnostics that are established by the American College of Rehabilitation Medicine, the CDC and other companies.

Computerized tomography scans (“CT” scans), magnetic resonance imaging (MRI) tests and other imaging tests are not used to diagnose TBI but can rule out other conditions from the brain injury that may be fatal (like bleeding or other conditions that may require prompt medical attention).

There are short- and long-term effects on mental abilities after having a TBI. A first-time, mild TBI may only require simple rest for a short time span. Moderate and severe cases may require therapy (occupational, physical or psychiatric) and other treatments.