Adderall and "Black Box" Warnings

The makers of Adderall, Shire Pharmaceuticals, says it wants more studies done to see id there are possible adverse effects from its ADHD drug. This came after the FDA advisory panel said such drugs for ADHD should carry a black box warning.
Shire said in a statement, "While we fully support full disclosure ad adequate warning, Shire believes that the interests of physicians and patients would be better served by further study to determine whether there is, in fact, a relationship between these medicines and cardiovascular events. Obtaining this information is crucial prior to taking what would be an unprecedented action to include something in a black box that has not been supported by sufficient data."
Although the FDA doesn't have to follow the panel's recommendation, they will consider the highlighted warning by a black box, which is the most serious typed for prescription drugs. Panel members stated that because Adderall and other ADHD drugs are amphetamines or chemically similar, they can raise blood pressure which is often a precursor to severe heart problems. The FDA states that right now about 1 million adults and 2 million children get ADHD prescriptions every month.
Shire says it already carries a black box warning stating misuse may lead to sudden death or serious cardiovascular events and believe no other warning is needed. Some believe it should say use not misuse of this product can cause sudden death.

Exercise Helps Moderate Depression

Research has shown that exercise, and it's well known physical benefits, is an effective and under used treatment for mild to moderate depression. It has been proven to reduce stress, relieve anxiety, ease depression, boost self esteem and improve sleep if done on a regular basis.
Researchers at Duke University studied those suffering from depression for four months. They found that 60 percent who exercised three times a week overcame their depression with out the use of medication. Even without depression, people can get substantial mental health benefits. Even short workouts can help lower sadness, tension and anger. One reason exercise helps depression is the role it plays with the brain chemical serotonin, which regulates such things as appetite and mood. Regular exercise can alter your levels of serotonin and can lead to improved feelings of well being. Studies have also sown that those who continue to exercise have a greater chance of their depression not returning. But if symptoms are severe, you should seek professional help.

Increased Health Risks For Insomniatic Teens

Researchers at RTI International studied over 1,000 13-16 year olds and discovered almost 11 percent suffered from insomnia. Onset for this typically started at 11 years old. The study found that this appears to increase the risks of ADHD symptoms, psychiatric disorders, and other health problems. They found insomnia to be a common chronic problem among adolescents. Insomnia reduces cognitive function and performance in teens and it also increases the risk for depression and substance abuse. Adolescents require more sleep than anyone. Without it, they are at risk of serious health issues.
The study also found that girls were twice as likely as boys to develop insomnia after beginning menstruation. Also, more than half of the teens suffering from insomnia also suffer from a psychiatric disorder. For a majority of the teens, 88 percent were potential chronic sufferers. Due to the high prevalence of insomnia, it not only impacts daytime functioning, but it increases the possibility of other psychiatric disorders. Therefore, many feel that we need to rethink the needs of teens and their schedules. The treatment and prevention need to be important priorities for adolescent health.

Memory Erasing Treatments for Depression?

Reported in the journal of Science, researchers at the University of Texas Southwestern Medical Center reported that depressed mice become more sociable after a memory molecule was deleted from their brain. This suggests that memory erasing treatments could also cease depression in people. The molecule in a region of the brain, known as the reward pathway, was focused on. Deleting this molecule meant the mice were no longer depressed or fearful, even when conditions were set up that normally made them run and hide. After anesthetizing the mice, they injected a virus into this particular part of the brain and disabled the molecule.

ADHD Not Easy To Diagnose

Amid claims it has dangerous side effects such as abdominal pain anxiety, dizziness, psychosis, headaches, heart failure and death, thousands of children, some under six, are being wrongly labeled hyperactive and are being prescribed Ritalin. Many feel that giving these kids Ritalin is crazy because their brains aren't fully developed and they're being given a mind altering drug.
The reason for alot of this is parents being anxious,thinking they are to blame for the unruly behavior. It's not easy to diagnose ADHD because symptoms can be similar to other behavior problems. There is great concern that doctors are inaccurately diagnosing ADHD when many are just behaving as a normal part of growing up. The overprescribing of Ritalin and other ADHD medicines is leading to widespread abuse. Lack of a proper investigation by doctors and pressure from parents lead doctors to over-rely on checklists to diagnose inappropriately.

Black Box Warnings

With at least two million children and one million adults being prescribed ADHD medication every month, the Food and Drug Administration advisory panel voted 8-7, with one absentee, in favor of a “black box” warning to be put on Ritalin and other stimulant drugs. This was after hearing about the 25 deaths, 19 of which were children, that occurred while on AHDH medicine. One committee member believes that not disclosing the uncertain risks while taking these drugs is unethical.
Although it usually does, the FDA is not required to follow recommendations given by the advisory committee. The FDA also believes that the committee just wants a more forceful, informative warning label on methylphenidates, such as Ritalin and Concerta. Since 2004, there has been black box labels on Adderall and Adderall XR, which are the same type of drugs.
Novartis, the company who has been making Ritalin since 1955, says that after reviewing fifty years of records, they’ve found no increase in cardiovascular problems among their patients. And they point out that their drug already has a caution label advising against use for those with pre-existing heart conditions.
Some believe that a black box warning will help the out of control growth of ADHD drugs. Besides the 25 deaths reported between 1999 and 2003, the council also discovered there were 54 cases of cardiovascular problems, which included heart attacks, strokes, and hypertension.
Opponents of this vote say that they’ve found fewer than one death or injury for every 1 million prescription filled. They also say that the reports don’t warrant regulatory action. They feel that the agency’s analysis only suggests a possible link between the drugs and cardiovascular problems, and they want more answers.

New Way to See Effects of Psychological Stress

Researchers have found a non-invasive way to see the effects of psychological stress in an area of the brain that is linked to anxiety and depression. These findings have important implications for how doctors treat the numerous long term health consequences of chronic stress.
Using functional magnetic resonance imaging (FMRI), researchers can detect increased blood flow in the prefrontal cortex of those subjected to stress. Also, the increased flow continued when the stressor was removed. This suggests the effects of stress are more persistent than once thought. This research will help pave the way to develop new strategies to help prevent or possibly correct the long term health consequences of chronic stress.

Studies To Compare Natural Supplements To Ritalin

Previous studies have shown that certain long-chain fatty acids are critical for normal brain development. Deficiencies or an imbalance of these fatty acids contribute to ADHD.
A study in January 2006 examined 30 children diagnosed with ADHD and 30 healthy children. They were all given flax oil supplements that contained 200 mg of alpha linolenic acid and 25 mg of vitamin C for two times a day for three months. A clinical psychologist analyzed their behavior before and after three months. To determine the change in fatty acids, the children’s blood cells were also analyzed before and after the tree months.
Findings concluded that after three months there was a significant increase in both EPA and DHA, which are key amino acids needed for normal brain development. Researchers found that all ADHD measures had improved after the three months. Individual problems with inattention, impulsivity and learning problems were deceasing in the post-supplementation group. All children completed the study with the supplements being taken by all with no side effects. Researchers concluded that polyunsaturated fatty acid supplements brought an improvement in educational and behavioral problems among children with developmental coordination disorder and a reduction in ADHD symptoms.
A study at Ichilov Hospital in Tel Aviv had children putting chocolate fish oil on bread. After three months, 20 out of 30 showed a significant improvement when a psychological re-evaluation was performed. Although the research results were exciting, the doctors cautioned that his was preliminary findings and believe more research is needed.
Another study showing the benefits of fish oil was conducted on children n Durham, U.K. The study was conducted on children that were behind a year from their peers, many which had ADHD. Research results showed a dramatic improvement in speech, behavior, and reading. The fatty acid supplements used contained omega-3 and omega-6.
These studies show that there are alternatives to Ritalin. Almost 10 million Ritalin prescriptions are filled each year in the U.S. Ritalin, or methylphenidate, is a central nervous system stimulant. It has the effects of caffeine, but more potent. In the 1990’s, sales of Ritalin and similar ADHD drugs rose by more than 500 percent. Even back in 1996 the World Health Organization warned that it was being overused. According to research, long term se could cause seizures, suppress growth, cause angina, cause changes in blood pressure and causes depression.
Finally, a natural alternative to Ritalin has been tested at Tel Aviv’s Sourasky Medical Center. It’s a natural oil-based alternative used to treat ADHD symptoms such as a short attention span and and inability to focus.
This research was in progress for a year and a half and commissioned on behalf of an unnamed company, who hopes to develop a product. Their goal is to come up with the right combination of oils which would effectively change the impulses going through the cell membrane. A double blind study was conducted on about 90 children, divided into three groups, who were off of their Ritalin for the summer. The children had either been taking Ritalin or were diagnosed through a computerized test called the Test of Variables Attention (TOVA). TOVA is a computerized assessment, along with teacher and parent behavior rating scales, that is a highly effective screening tool for ADD.
One group was given Canola oil. The second group was given fish oil, which is high in omega-3 fatty acids and deficient in children with ADHD. And the third group was given a mixture under study. All dosages were mixed with chocolate to get the children to comply for the three month period. At the end of the three months the TOVA test was given again and results were compared. They found no change in the group who took the canola oil, a slight improvement in those taking the fish oil, and they found significant improvement in those who received the special mixture. Researchers believed that 60 percent of the children ended up in the normal TOVA range.

Link Between Depression And Coronary Heart Disease

According to a Swedish study, those between 25-50 and have depression, are at an increased risk of developing coronary heart disease later in life. Taking into account socioeconomic status and gender, the risk was the greatest for those diagnosed before 40.
Researchers examined hospital discharge records of all patients from 1987-2001. First they discovered that 44,826 cases were for depression. Next they found that 1,916 of them had developed coronary heart disease. They also found that those with depression were 1.5 times more likely to develop coronary heart disease than those without depression. The study showed that young to middle aged people that were hospitalized for depression had a high risk of developing coronary heart disease. They believe that those with clinical depression shouldn’t be given only short-term treatment, but that they receive maintenance therapy to help prevent a re-laps or recurrence of depression.

Parents Get Little Sleep With ADHD Kids

Recent research has revealed that many parents of hyperactive children are getting by on just a few hours of sleep a night, putting pressure on family relationships. A survey found that almost six out of ten mothers and fathers of children with ADHD had six hours of sleep a night or less. While 30 percent say they get six hours, 27 percent say they get five hours or less on average. This compared to almost half of parents with a child without ADHD who said they got at lest eight hours sleep a night. The research poll involving 100 parents of ADHD children aged 5-16, suggests that tens of thousands of parents could be struggling by on minimal sleep as they try to cope with a hyperactive child.

Exercise Out Of Depression

Each year there are millions of people who are stricken with depression. Although it may be debilitating, those who suffer may want to run, walk or even swim the problem away. Studies now show that when exercise is performed in group setting, it’s as effective as standard antidepressant medications in reducing symptoms of major depression.
Other studies have shown that even solitary exercise, not matter what the duration, can be just as effective as group activities when it comes to beating the blues. One study published five years ago found that 10 months of moderate exercise outperformed the antidepressant Zoloft in those diagnose with moderate to severe depression. A study by researchers at the University of Texas Southwestern Medical Center at Dallas found that 30 minutes of aerobics 3-5 times a week reduced symptoms by 50 percent in young adults.
It is believed that while workouts affect brain chemicals like serotonin and dopamine, exercise may also cause positive changes in other areas as well. Depression is often characterized by low energy, tension, and tiredness. But exercise seems to ease that anxious but lethargic state. Although it may not be enough to relieve stress, moderate exercise, such as a 10 minute brisk walk, will result in boosting your energy. Exercise such as a 45 minute aerobic workout does effect your mood by reducing tension. It may leave you tired, but researchers say there’s something called the rebound effect an hour or so later where your energy is increased. They also point out how working out can give you a psychological boost, including better self esteem and having a greater sense of accomplishment.
Still, experts agree that it is hard for a depressed person to start exercising mostly due to lack of energy. But the key to this problem is to start small. Don’t think about a fitness center and all the machine you’ll have to learn about. Start with maybe a walk around your block. Social support, peer pressure, and family support can all be helpful, especially when getting people to maintain exercise.
Doctors say that exercise is not a substitute for drug therapy, especially for those who are severely depressed. But they also point out that about one third of depressed people won’t gain any help from medication. For those patients, exercise may be a viable alternative.

Stress Lowers The Immune System

What’s been suspected for years scientists have now confirmed-stress can make you sick. Researchers at Sydney’s Garven Institute have made the direct connection between the nervous system and the immune system. The study, published I the Journal of Experimental Medicine, explains how stress can lead to the build up of a hormone that stops the body’s ability to fight off bacteria and viruses. Australian scientists have now made the link between stress and the immune system. The impact that stress puts on the body is best observed in athletes.
The study included elite and recreational athletes over a period of five months and found that the elite athletes were more susceptible to respiratory diseases. They found that elite athletes put themselves through the physical stress of training and the emotional and psychological stress of feeling the pressure of wanting to compete and do their best.
Pressures from work and even home can cause emotional and mental stress that can be damaging as well. About one third of work absenteeism is due to illness, having a huge impact on the workforce and the employees. If the employees are always stressed or constantly under pressure, they’re more likely to get sick. Researchers warn people to minimize their stress before it becomes a problem. They suggest trying relaxation techniques such as yoga or exercise.

FDA Studies ADD Drugs

Due to sudden deaths, strokes, hypertension and heart attacks in children and adults that take medicine to treat their ADHD, a new government study on the safety of these medications has begun.
In recent years, sales of ADHD drugs have increased sharply, with adult use growing at a faster rate. This is according to a recent study done by Medco Health Solutions, which is a prescription benefit manager. Spending for these ADHD drugs has gone from 759 million in 2000 to 3.1 billion in 2004, according to IMS Health, which is a pharmaceutical information and consulting firm.
Although no additional details were immediately available, the FDA said it had received reports of serious adverse events, including death, associated with the therapeutic use of the drugs.
Health Canada pulled the drug Adderall XR off the shelves for six months last year after reports of 20 sudden deaths and 12 strokes in adults and children while using the drug. A number of these incidents involved children with structural heart defects. Health Canada concluded that there was inadequate evidence of any increased harm from Adderall XR compared to other ADHD medications. This is the same conclusion reached by the FDA based on the given data.
The U.S. regulatory agency is asking the Drug Safety and Risk Management advisory committee to study the potential cardiovascular risks of the medications. The FDA says that the few studies that have looked at long term use of ADHD drugs has provided little information on the risks. Some feel that this is comparable to the cox-2 inhibitor incident where painkillers like Bextra and Vioxx were pulled from the shelves do to evidence that they can raise the risk of heart attack or stroke.
The FDA committee will meet February 9th and 10th in Gaithersburg, MD. Some feel that the issue of treatment for ADHD has been a controversial one already. And now it will add the issue of cardiovascular risk too.
The FDA website does not identify any of the drugs by name. However, the most common ADHD drugs include Adderall XR, which is made by Shire Pharmaceuticals, and Ritalin, that is produced by Novartis Pharmaceutical Corp. The makers of Adderall had not been told about the meeting, but they still may send representatives.
The February 10th meeting will have updates on FDA actions on cox-2 medicines and a new patient, doctor and pharmacist registry program for an anti-acne drug called Accutane and it’s competitors. There are now numerous lawsuits pending in regards to the side effects of these drugs. Some of these side effects include inflammatory bowel disease and rectal bleeding, Crohns Disease, ulcerative colitis, cirrhoses, birth defects and depression-related side effects just to name a few.
The committee will also discuss the FDA’s Drug Safety Oversight Board. This is an internal government panel created almost a year ago that is supposed to monitor the FDA approved medicines once on the market. They’re also supposed to keep physicians and patients updated with important new information on risks and benefits. Some say there are concerns regarding the boards impartiality and independence, along with its relationship to the committee and the similar work it provides.

How The Brain Truly Develops

Shattering assumptions held for generations about the adolescent mind, recent brain research is fueling the battle over the mental health of teens, the rights of a parent, and the effectiveness of treatments. This research is forcing scientists to redraw the line between normal teen behavior and severe mental illness, still while questioning how does the brain truly develop.
Researchers now believe that a teens brain is not merely awash in hormones, but it is also in the middle of a overhaul. Scientists now believe that these transitions are so significant, that they may unlock the many mysteries of mental illness, including why some teens commit suicide, why some hurt their classmates and loved ones, or why some have crippling mental disorders that don’t emerge until later in life. Behavior that may seem normal in a teen, might be called pathological in a 30 year old. The question then becomes where do you draw the line? What’s typical in a teen and what’s not? Have millions of children been wrongly medicated to control their behavior?
The old way of thinking was that an adolescent’s brain was fully formed. It needed only facts, figures, and experiences to fill it to an adult mind. But at the same time many didn’t believe that young people were even capable of developing a mental illness.
But now, new research shows that a teens brain is in transition with a volatile and vulnerable composition. Scientists say that it’s not even clear that the brain is ever finished developing. They say the teens brain isn’t adult like until the early 20’s. They say that if a teenager acts young and stupid, it may be because areas that dampen impulsivity and govern rational thought are among the last to mature. Researchers believe that if a teens brain fails to reinvent itself as an adult brain, teens are vulnerable to developing mental illness.
Many now believe that several severe mental illnesses have roots in the development of the teen brain, even if symptoms aren’t seen until years or decades later. What has many concerned is the possibility that parents, teachers or others are mistaking early warning signs as typical teen behavior? Treating the disorders early could stop the worst manifestations of the disease. This would give young adults a better chance at a productive life. For example, if an adult loses a year of function due to depression, they usually get back close to where they were. But if a child loses a year, it can be very hard for him/her to catch up again in terms of development.
But the ethical issue of determining when and how to respond to adolescent warning signs could have explosive implications. Some parents fear that a child they view as normal may be incorrectly labeled as mentally ill. There is also much skepticism over whether mental illness in an adolescent can be accurately diagnosed or even treated. These doubts increase as more children are put on medication for behavior problems. Some say the system tolerates a hasty diagnoses, often by a physician who has no mental health expertise.
The stigma that accompanies mental health treatment is partly due to people who have doubts about various disorders even existing. What must be done is to elevate the status of mental health by boosting public confidence in accurately diagnosing and the efficacy of treatment. Right now family doctors and pediatricians are doing most of the diagnosing and medicating in office visits lasting only 15-30 minutes.
The field of adolescent mental health suffers from credibility. Much skepticism is from the fact that doctors have no blood tests, brain scans, or chemical analysis to base their conclusions. Psychologists still rely on interviews and observations. Parents often fear that their child might be falsely labeled. There is also fear from many that too many children are being medicated for problems such as ADD.