Archive for February, 2007
The FDA recently approved a new amphetamine-based drug for hyperactivity disorder that will be harder to abuse than older stimulants, according to pharmaceutical company Shire. Vyvanse remains inactive until swallowed, after which it gradually releases its active ingredient d-amphetamine. It is activated after coming into contact with enzymes in the digestive tract.
Vyvase is expected to stop the potential for abuse by individuals who snort or inject crushed pills. The newly developed drug will be listed as a Schedule II drug, a category including cocaine, methadone, methamphetamines, and other ADHD medicines such as Adderall and Ritalin. Vyvanse will carry a “black-box†warning because of safety concerns related to amphetamine abuse, as well as the risk of sudden death in patients with heart defects.
The FDA approval of Vyvanse took place in the same week when the agency required manufacturers of other ADHD drugs to warn patients and parents of potential mental and heart problems associated with these medications in a small percentage of users.
FDA statistics indicate that ADHD affects about 3 to 7% of schoolchildren and 4% of adults. The principal symptoms are hyperactive behavior, difficulty paying attention, and problems with impulse control. Medications approved to treat ADHD have major benefits for many patients but for some, they can also pose serious risks.
New warning instructions required for ADHD medications will be included for Adderall, Concerta, Daytrana, Dexedrine, Focalin, Metadate, Methylin, Ritalin, and Strattera. It is hoped these new cautionary guidelines will not keep people who need these drugs from taking them.
Sources:Â Yahoo News; Medical News Today
February 27th, 2007
Pharmaceutical companies who make Ritalin, Adderall, Strattera and other ADHD drugs have been advised to give patients and parents additional warnings about the potential for serious psychiatric and heart problems. Patients would be given a 2-page medication guide with each new prescription.
Drug companies are expected to comply with the new requirement within 30 days. The announcement covers 15 drugs, including those offered in extended-release, patch and chewable versions.
Serious side effects for ADHD drugs are rare. However, the new warnings advise calling a physician immediately in case of chest pain, shortness of breath, fainting or hallucinations. A sudden change in behavior should also be noted and promptly reported.
Of the 3.3 million children taking ADHD medications, more than 2,500 went to emergency rooms in 2004. About a fourth of them had serious heart or blood pressure problems, according the Centers for Disease Control. Of the 25 deaths thought to be linked to the drugs, 19 involved children. In the 54 patients who experienced serious heart problems, some had prior heart conditions.
Proposed guidelines are to state that these amphetamine-based drugs have been linked to stroke and heart attacks in adults and sudden death in patients with heart problems or defects. A few children and teens reported hearing voices, growing suspicious or becoming manic while on ADHD medication. About 1 child in 1000 may experience hallucinations.
It is vital that patients give doctors a full history of cardiovascular or mental problems. In addition, they should make it known if they take antidepressants, seizure medications or blood thinners. The FDA emphasizes that persons with heart disease, blood pressure problems, hyperthyroidism or glaucoma should not take ADHD medications.
The FDA emphasizes that new requirement for expanded warnings is precautionary and should not discourage patients from taking these drugs, which are safe in appropriate patients.
Source:Â San Francisco Chronicle; Feb. 22, 2007 (article from Baltimore Sun)
CNN.com Â
February 24th, 2007
Researchers in Germany have used a technique called diffusion tensor imaging (DTI) in a study that examined brains of healthy volunteers and those with chronic back pain. They discovered that the brain in patients with chronic back pain had a more complex, active microstructure in regions associated with pain-processing, emotion and stress response.
The study findings were presented at the annual meeting of the Radiological Society of North America, held in Chicago recently. Researchers indicated that DTI demonstrates chronic pain is real and could help treatment research. Patients who suffer back pain sometimes have difficulty convincing their physicians, relatives, and insurance carriers of their genuine distress. Spinal MRI images do not always clearly demonstrate the source of pain.
According to the lead researcher, a radiologist in Munich, Germany, the objective and reproducible correlates in brain imaging should change the way chronic pain is perceived. It need no longer be a subjective experience. For pain diagnosis and treatment, the consequences could be huge. As a result, clinicians may direct therapeutic attention from the spine to the brain.
What is unclear is whether the brain in certain individuals is predisposed to developing chronic pain, whether ongoing pain causes hyperactivity and change in the brain’s organization or a combination of both.
Physicians who treat patients with chronic back pain have long known that chronic pain can begin with a serious injury. Even after healing has occurred, the brain continues to send pain signals for these individuals. The new imaging technology DTI will be able to validate their theory that the nervous system has been “rewired.â€
This study adds to the growing body of research showing that chronic pain is associated with physical changes in the brain. Chronic is defined as lasting more than six months.
In some cases, back pain plagues individuals for many years after their initial injuries.
This study helps the medical community to understand how the central nervous system is involved in back pain. More research is needed to determine what the brain’s physical changes mean and how to most effectively treat the pain.
Source:Â BBC News
February 20th, 2007
Neither of my two children in public schools in the 1970s gave stellar performances. I knew that both were bright. Yet, their elementary school report cards failed to reflect their intelligence. My husband and I helped them with homework, gave them outside tutoring, and even moved them to a different elementary school where test scores were better. In the summers I gave my daughter and son “homework†of my own, with math and language drills and assigned book reports. My eight years as a public school teacher before my younger child was born motivated me to supplement their studies.
My son at age 8 could easily have been labeled a child with attention deficit disorder (ADD or ADHD) — a term not widely used in the late 1970s. His third grade teacher often sent me notes about his daydreaming or doodling in class. He was never placed on medication such as stimulants or antidepressants to influence his behavior. Away from school, absorbed in his own interests, he was clearly able to focus on what he liked to do. It took several years of mediocre grades before he was able to see the value of academic achievement.
My daughter came into her own in high school, when we enrolled her in a parochial school. The smaller school with a female-only student body and many extracurricular activities helped her learn to excel and to develop leadership skills.
After high school graduation, both youngsters were accepted at top colleges in California and have excelled in their post-graduate careers. My daughter is now in a doctoral program while working full-time as a high school vice principal. My son is a successful entrepreneur and computer programmer. Our family was fortunate. In some cases, a child’s early problems can extend into adulthood and without proper treatment, adversely affect the individual’s work and personal life.
 My point is to not be too hasty in putting your child on drugs, unless there is truly a problem that cannot be dealt with through other resources. If your child is quite inattentive, hyperactive and/or disruptive, some behavior modification classes or techniques might be helpful initially. A good child/adolescent psychiatrist can help you discover the root of the problem, and medications can be prescribed when needed. Work closely with teachers, school counselors or administrators and your child’s physician to ensure that appropriate medication or other treatment is used.
My account is based on my perspective as a parent, teacher, and health care professional. Here are some wonderful resources from an authority in the field to help guide you:Â
I heard recently from Mohab Hanna, M.D., who visited my blog. Dr. Hanna is Board-certified in Child and Adolescent Psychiatry. His medical training was completed at the prestigious Johns Hopkins University School of Medicine. You can go to his blog (impressive!) at http://www.add-adhdtreatment.blogspot.com/. I found his initial entry to be especially helpful. Here are some highlights from Dr. Hanna’s entry of February 2, 2007:
AD/HD Medications: What is a Parent to Do?â€
 “A thorough evaluation is the first and most essential step in the process. It is impossible to treat any condition without knowing what you are treating. It is not prudent to ‘try a medicine to see if it works.’ That is an inappropriate way to proceed and can actually be harmful. Many children who appear to have some ADHD symptoms actually have a different condition, such as anxiety or depression. Furthermore there are some kids who have anxiety in addition to the ADHD. In either scenario, it is essential to determine the diagnosis prior to initiating any kind of medication trial…
“…Every medication has potential side effects. It is important to understand the different potential negative effects. In order to proceed with a medication trial, the potential benefit should outweigh the potential negative effects. Once the diagnosis of ADHD has been established and it has been determined that the potential benefit outweighs the potential negatives, the parents need to understand the risks of not treating the ADHD. Many studies have been conducted to examine the consequences of untreated ADHD. It is clear that there are numerous potential consequences such as academic failure, peer rejection, depression, accidents, substance abuse, etc…These consequences are significant and are typically not transient; they tend to continue to manifest into adolescence and adulthood.â€
Dr. Hanna has also written a book titled Making the Connection: A Parent’s Guide to Medication in AD/HD
.
“My goal with the book and the blog is to empower patients to be proactive in the decisions that are made,†says Dr. Hanna. “I also hope to provide them with balanced (non-marketed), unbiased information.†Dr. Hanna lives in Maryland and may be reached by telephone at 410-583-2623, ext. 3, or fax at 410-583-2949.
Source:Â Dr. Mohab Hanna;
February 18th, 2007
A study in the New England Journal of Medicine indicates that a new version of the nasal spray vaccine FluMist prevents influenza better than tradition needle vaccinations in most children. But for babies age 6 months to 1 year or older children who sometimes wheeze in breathing, the research showed that old-fashioned shots are safer.
In a worldwide test on 8,400 preschoolers completed during the 2004-2005 flu season, 8.6% of children receiving shots developed flu, while only 3.9 children given the spray succumbed to the virus. The spray was shown to dramatically reduce the risk of flu-related ear and lower respiratory tract infections, as well.
Needle vaccinations are made of killed virus particles that provided less protection to children under age 5 than to adults. Preschoolers given the needle also exhibited more side effects. The nasal spray uses live, weakened viruses.
Researchers at the St. Louis University School of Medicine in Missouri found that both treatments reduced children’s flu rates, but half as many of those who received the nasal spray became ill as those getting flu shots. So, for children over a year old who don’t have a history of wheezing (about 80% of children), it appears that the intranasal vaccine is better.
The spray vaccine could carry special risks for children younger than 12 months. They are more likely to develop wheezing and more than twice as likely to be hospitalized for any cause if they received FluMist instead of needle vaccination.
For children who are able to benefit from FluMist, the induction of antibodies into the nose is helpful. The nose is generally the area where the flu virus enters the body, and the nasal spray appears to induce more complete immune response. The spray was also found to work against flu strains that had mutated slightly over time, giving high protection even when circulating strains aren’t a perfect match to the vaccine.
In this study, researchers used a new version of FluMist that only needs refrigeration instead of freezing for storage. The FDA approved this version of the nasal vaccine in January 2007 for healthy children over 1 year old and for adults to age 49.
Health officials have in the past year been encouraging flu vaccinations for those age 6 months to 5 years to prevent the spread of influenza. This study helps give parents and clinicians valuable information to make informed decisions for either shots or nasal vaccines for their children.
Source:Â CNN.Com
February 17th, 2007
The U.S. government has stocked a supply of Tamiflu and other antiviral medications, some 21 million doses, to be used in case of a flu pandemic such as the 1918 Spanish Flu. It is believed these drugs would be effective for treatment or prevention of wide-scale “avian†or bird flu if it arrives on our shores. Countries such as Great Britain have done a commendable job in obtaining enough Tamiflu and other antivirals to treat its population.
As governments around the world prepare for the potential emergence of a deadly flu pandemic, they are looking at several strategies. A different class of antivirals known as ion channel inhibitors (amantadine and rimantadine) used in combination with neuraminidase inhibitors such as Tamiflu, could play an important role. An article published in the British Medical Journal indicated that taking only amantadine or rimantadine would be more likely than Tamiflu to produce unacceptable side effects and to be associated with a rapid emergence of resistance. British researchers emphasized the benefits of a combination therapy – ion channel inhibitors and neuraminidase inhibitors.
The World Health Organization also endorsed combined use of the two types of antivirals, especially in planning for some future flu pandemic. In laboratory tests, the combined antivirals even prevented emergence of resistant strains of the highly pathogenic avian influenza H5N1 virus. These chemically stable, antiviral drugs have a long shelf life and could be stored for long periods.
The U.S., the U.K., and Greece are already stockpiling ion channel inhibitors in addition to neruraminidase inhibitors such as Tamiflu. Research scientists and governments are cooperating to confront the potential emergence of a virus that could be spread by migrating birds and people on international flights. If the H5N1 virus eventually changes into a form easily transmitted from one person to another, the resulting flu pandemic would rapidly sweep around the globe.
Sources:Â Science Daily;
February 17th, 2007
Last fall, the media inundated us with fears of bird flu virus mutating to a form easily transmissible from person to person. To date, this has not occurred. Recent testing of 75,000 wild birds in the U.S. and Canada showed no signs of the highly lethal H5N1 avian or bird flu. Less than 200 persons worldwide have died from avian flu since 2003, and no reported cases have been confirmed in the U.S.
In contrast, the usual viral strains of flu that we can expect to occur each season will in a typical year kill about 36,000 in the U.S. (mostly elderly) and over 500,000 worldwide. You can do much to protect yourself and family members from this actual threat by getting flu shots before the flu season hits hard in the winter months.
Another protection available to families is to have on hand a prescription of Tamiflu (oseltamivir). This drug in tablet or liquid suspension form has proven effective in lessening the symptoms of flu and speeding recovery, and even preventing the disease after exposure to influenza. Tamiflu can improve or decrease the ailments that occur with flu – weakness, headache, cough, fever and sore throat – in just the first day of use.
Tamiflu is generally taken for 5 days to treat flu or half the dosage for 7 days to prevent the virus after having been exposed. Children may take a smaller dose, based on their weight and medical conditions as approved by the physician consulted. You should not stop taking the medication suddenly because you begin to feel better. If serious or very distressing side effects are noted, discontinue the medication and check with your doctor about what to do next.
If you are pregnant or trying to get pregnant, you should not take Tamiflu. Discuss with your doctor whether it would be safe for your baby if you take Tamiflu while breastfeeding. If you have serious medical conditions such as heart, kidney, or lung problems, liver disease or other viral infections aside from Influenza A or Influenza B, your doctor can tell you whether Tamiflu is appropriate for you.
Sources:Â MSNBC.com;
February 17th, 2007
Xenical is a prescription weight loss drug primarily intended for adults who are obese, with a body mass index of 30 or higher. It can also be used effectively in those who are considered overweight (BMI of 27-29). Persons with other risk factors such as high blood pressure, high cholesterol, heart disease or diabetes can also benefit from taking Xenical (orlistat) for weight loss.
Xenical must be taken in conjunction with a regular exercise program and a nutritionally balanced diet containing no more than 30% calories from fat. Taking a daily multivitamin supplement is also important, as Xenical reduces the absorption of vitamins from food.
This weight-loss drug works differently from other diet drugs, as it does not suppress your appetite. Instead, Xenical blocks the absorption of a portion of your dietary fat intake to produce weight loss. As a result, Xenical produces gastrointestinal side effects that usually occur in the first weeks of treatment. Side effects usually taper off after the first few months. You may experience side effects such as gas with oily discharge, underwear stains, and an increased number of bowel movements. These side effects can be minimized by staying within the 30% dietary fat guidelines.Â
If side effects become distressing, discuss the symptoms with your prescribing doctor or pharmacist. You should not take Xenical if you are pregnant, nursing, have food absorption problems or reduced bile flow. Children should not be given Xenical for weight loss.
Several clinical studies have shown that after 52 weeks, persons on a reduced fat diet who took Xenical as prescribed lost an average of twice as much weight as those (in the control group) on the diet alone. That is, 13 pounds, compared to about 6 pounds. Within the first three months, those on Xenical had lost 3% of their body weight. There is clear scientific evidence to demonstrate that obese or significantly overweight persons who lose as little as 5% to 10% of their body weight can improve their health.
The clear health benefits of the effects of weight loss with Xenical on other weight-related health problems such as high cholesterol, type 2 diabetes and high blood pressure have been assessed in seven studies of 1 to 2 years. These studies involved multicenters, double-blind, and placebo-controlled clinical trials. More than 4,100 patients took part.
Clearly, there is now a weight loss drug that effectively takes weight off and helps improve general health if your excessive pounds put you at risk. The question is, will the side effects be tolerable to you? Will you be motivated to do the following:
- Set realistic, achievable weight-loss goals with your doctor?
- Take Xenical three times daily with meals?
- Record your food intake each day, and eat a reduced-calorie diet with 30% or less calories from fat?
- Take one multi-vitamin daily — 2 hours before or after taking Xenical or at bedtime?
- Maintain a realistic exercise program?
An over-the-counter version of Xenical, a reduced-strength version, is now being sold under the name “alli.†This drug is approximately half-strength of the prescription version. Alli is also intended for use along with diet and exercise programs. Taking the drug without the other components is unlikely to produce the desired results.
The FDA recently approved the sale of alli without prescription. The agency cautioned that people who had organ transplants should not take orlistat (Xenical) or alli because of possible drug interaction side effects. Those taking blood-thinning medications or being treated for diabetes or thyroid disease should also consult a doctor before using alli, according to the agency.
Sources:Â xenical.com; cnn.com
 More Information
February 12th, 2007
