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:  Yahoo News; Medical News Today

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:  San Francisco Chronicle; Feb. 22, 2007 (article from Baltimore Sun)
CNN.com  

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. 

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:  xenical.com; cnn.com

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In a study of almost 1,000 heart patients believed to have stable heart disease, those with the highest blood levels of the protein were eight times more likely to have a heart attack, stroke or heart failure during the 3.7-year study than those with the lowest levels of NT-proBNP.

Among the study participants, patients with highest NT-proBNP level had the strongest association with heart failure. Eighty cases of heart failure were reported during the study, compared with only three cases among patients with the lowest protein levels. There were four times as many heart attacks and four times as many strokes in study patients with the highest NT-proBNP levels, compared to those with lower protein measurements.

The test is already in use in hospital emergency departments to assist ER doctors in identifying heart failure in patients presenting with shortness of breath and other established symptoms. In addition to echocardiograms, stress tests, and other protein biomarkers, the new blood test may be able help physicians to pinpoint heart patients with the highest risks.

Looking at other risk factors such as sex, age, smoking, and elevated cholesterol levels, this new maker provides additional information that other tests don’t reveal. It is still unclear, however, whether the test is valuable for predicting risk in asymptomatic heart patients thought to have stabilized their heart disease.

Also unknown is whether the test could prove useful for identifying heart disease risk in the general public. At this point, it is best utilized with patients with established heart disease. Its role in disease management is still not clear. Those with elevated NT-proBNP can be treated very aggressively, but most patients with serious heart conditions are already being treated in that manner.

More study is needed to determine the value of the NT-proBNP test, the subject of the study at the University of California, San Francisco and the San Francisco VA Medical Center.

Source:  WebMD

High blood pressure consists of a reading of 140/90 mm Hg or higher. Also called hypertension, high blood pressure is a major risk factor for heart disease or stroke.

The new “pacemaker-type” device is currently being studied by the chief of vascular surgery at the University Hospital in Berne, Switzerland, in patients who do not respond to available medications.

Surgeons place electrodes outside the carotid artery and implant an internal pulse generator into the chest wall. Using electrical current to stimulate the carotid sinus, messages are sent to receptors in the brain. Preliminary results have shown remarkable results in a swift drop of blood pressure.

The first 16 patients experienced an average drop of 29 millimeters of mercury after receiving the new device. In patients taking drugs, reducing their blood pressure by
9 millimeters is considered an outstanding result. Researchers call the device, developed by Minneapolis-based CVRx, “very promising.”

Source:  Oakland Tribune     November 2006

 

When a person with an ICD experiences dangerously abnormal cardiac rhythm, the device delivers an electrical jolt that shocks the heart back to normal rhythm. Sudden cardiac death kills about 325,000 adults in the U.S. each year – primarily persons who do not have the implanted device.

Until now, cardiac screening of large populations for risk of sudden cardiac death has been expensive and impractical. This new technology could make such screenings more affordable and feasible.

A study involving 500 patients with some heart damage using the more invasive electrophysiological screenings as well as the new, computerized technology came to a close recently. The new testing techniques proved to be just as accurate, according to a professor of medicine at the American Heart Association’s annual meeting.

In the older test, a catheter is inserted through a small incision in the vein and threaded to the heart to measure electrical activity. The new test, called the microvolt T wave alternans (MTWA), measures the electrical discharge of a person’s T-waves from one beat to the next. This individualized risk information allows doctors to determine which patients might benefit from an implanted ICD.

The predictive accuracy of both tests is comparable. The main difference is that the latest test is simple, noninvasive and cheap, while the other is invasive, expensive and risky. In complicated cases, some doctors use both tests. When both technologies confirm the need for an ICD, the surgery is performed.

Physicians hope that in the future, the newer technology may be able to replace electrophysiological screening altogether. At this point, two tests are still better than one.
Source:  WebMD

Four years after the heart attack, in study participants who had a delayed angioplasty, 17% of them had died, suffered another heart attack or developed heart failure. Nearly 16% of the group taking drugs without the surgery had the same adverse effects as the group receiving angioplasty. Results could be considered statistically the same.

When angioplasty is performed during the first 72 hours of a heart attack, the procedure saves many lives, especially when clot-dissolving drugs are not effective. But angioplasty performed weeks or months after a vessel becomes blocked apparently produces results no better than taking standard medications.

Balloon angioplasty is done by threading a catheter through the groin to the blocked artery to reopen it and putting in place a mesh stent to keep the vessel open.

Nearly 1 million heart attacks occur in the U.S. annually.  If you suspect a heart attack, don’t stay home and take antacids. Go immediately to emergency, and do not try to drive yourself there.   
 

Source:  WebMD

The Johns Hopkins Medical Letter, Health After 50, February 2006 (Call 1-800-829-0422 for subscription inquiries.)    

The four-year study involved 7,290 women – in which 4,843 took raloxifene and the others a dummy pill. Raloxifene is a designer estrogen that blocks that hormone’s action to the breast, for example, while providing beneficial effects to the bones.

The drug appeared to lower stroke risk in those with highest levels of a form of estrogen called estradiol, the most potent kind in estrogen circulating in the bloodstream. Women taking placebo pills had no detectable postmenopausal levels of estradiol at the study’s conclusion. Dr. Lee’s results factored in the women’s weights, their ages and other heart and stroke risk factors.

Dr. Lee estimates that if recent results prove true in additional studies, perhaps one stroke might be prevented for every 78 women given raloxifene. The drug is used to treat osteoporosis and also inhibit development or recurrence of estrogen-dependent breast cancers. Preliminary evidence suggests that taking hormones after menopause is especially risky for women with naturally high estradiol levels.

San Francisco Chronicle, 2/18/06 (Marilynn Marchione, Associated Press report)

The costs of their care can quickly drain a family’s financial resources. Recognizing the symptoms of a stroke and getting appropriate treatment rapidly can determine the severity of the outcome. New treatments are offering hope for a full recovery within days or months.

In the past decade, the clot-buster TPA has been administered to dissolve brain clots. Originally used for heart attacks, TPA was shown to be also effective for strokes if given intravenously during the first three hours after onset of symptoms. It doesn’t always work for the patient and sometimes causes bleeding in the brain.

In 2005, a new stroke treatment – a corkscrew device to physically remove the clot – came into use for certain patients with major strokes. Now, an experimental treatment gives doctors even more options to help save lives and minimize the disabilities that strokes can produce.

Doctors involved in clinical studies are now delivering TPA precisely to the clot area and dripping the dissolving agent directly onto the blockage. Similar to angioplasty, in which a catheter is threaded through a vessel in the groin to the heart blockage, a tube is guided to the brain instead. TPA is delivered through a specialized tube to the clot, instead of making its way there through the bloodstream.

Many patients given this experimental treatment made stunning recoveries by the next day – often without the speech loss and paralysis that can result from stroke. One study found that after this novel treatment, 65 percent of patients were able to walk, talk and function normally after three months, compared to those given standard care.

According to study leader Dr. Doojin Kim, one-fourth of 128 patients given this localized treatment at UCLA over ten years at UCLA showed dramatic improvement of stroke symptoms within a day of administering TPA with the drip method.

Ninety percent of them survived, compared with 74 percent of stroke patients receiving standard intravenous TPA. Not only did they survive, they had excellent final outcome. Bleeding in the brain was less common with the new approach.

In a second study, 73 patients with severe strokes first got intravenous TPA, followed by the dripped treatment if needed. Some also received ultrasound through the TPA tube to further break up the clot. Bleeding was a more common side effect, but the twice as many clots were dissolved.

The new dripping technique is suggested for patients under age 80 who suffer a major stroke. Using those criteria, doctors estimated that up to half of stroke patients might qualify for the procedure. Only about 30 percent of clots dissolve with intravenous TPA alone, according to Dr. Gergory Del Zoppo, a stroke expert from Scripps Research Institute in La Jolla, CA.

Now physicians must decide which individuals would do best with various clot-dissolving strategies instead of using the corkscrew type device to pull out the clot.

Both the dripping technique and the corkscrew device promise to give stroke patients another option if their initial treatment with intravenous TPA fails. Doctors involved with the new treatment strategies agree that relative risks and benefits of each need further study.

Sources:  San Francisco Chronicle, 2/17/06 (original article by Marilynn Marchione, Associated Press wire service)