Tamiflu May Be Linked to Risk for Self-Injury and Delirium

November 14, 2006 — The US Food and Drug Administration (FDA) and Roche Laboratories Inc have notified healthcare professionals regarding safety labeling revisions for oseltamivir phosphate (Tamiflu capsules and suspension) that warn of the potential risk for neuropsychiatric events associated with its use.

The warning was based on postmarketing reports (primarily from Japan) suggesting that patients with influenza receiving oseltamivir, particularly children, may be at increased risk for self-injury and delirium.

Although the role of the drug remains unclear, patients receiving oseltamivir should be closely monitored for signs of abnormal behavior, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Oseltamivir is indicated for the prophylaxis of influenza and treatment of uncomplicated acute illness in those who have been symptomatic for no longer than 2 days. It is approved for use in patients aged 1 year and older.

Adverse events potentially related to use of oseltamivir should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.




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Saludos Cordiales
Dr. José Manuel Ferrer Guerra

Lyrica May Relieve Fibromyalgia Pain say Denise Mann

Nov. 14, 2006 (Washington, D.C.) -- The seizure drug Lyrica may offer extended pain relief for people with fibromyalgia.

That's according to New research presented at the 2006 annual meeting of the American College of Rheumatology.

Fibromyalgia is a chronic pain syndrome marked by widespread aches, pains, stiffness, fatigue, and trouble sleeping. About 2%-4% of the U.S. Population has the condition, according to the American College of Rheumatology.

There is no FDA-approved treatment for fibromyalgia. People with fibromyalgia are treated with a variety of medications approved for other conditions, including low doses of antidepressants, antianxiety medications, and analgesics.

The New study suggests that Lyrica may improve pain in people with the disorder and that these improvements may last at least six months.

Exactly how Lyrica works in fibromyalgia is not fully understood. Fibromyalgia may be caused by abnormalities in the central nervous system that affect how people process painful stimulation; Lyrica acts on the central nervous system.

Long-Term Pain Relief

The New study was conducted in two parts. The first part comprised 1,051 people with fibromyalgia who took 300, 450, or 600 milligrams of Lyrica daily for six weeks. Participants who showed a greater than 50% reduction in their pain and said that they felt "much" or "very much" better were moved into a six-month study in which they received a dummy pill (placebo) or an optimal dose of Lyrica.

Most of the participants were white women, with an average age of 50 and an average duration of fibromyalgia of 7.8 years.

One-fourth of people who received a placebo saw a worsening of their symptoms in seven days, compared with 34 days among people who took Lyrica.

Overall, 61% of people taking placebo pills lost the response they had seen in the first part of the study, compared with 32% percent of those who took Lyrica, the study showed.

Twice as many people who took Lyrica experienced long-term pain relief compared with their counterparts who took a placebo.

"[Lyrica] demonstrated durability of pain relief in patients who responded and it was generally well-tolerated," says researcher Leslie J. Croffiord, MD, professor of rheumatology and women's health at the University of Kentucky in Lexington. Side effects included dizziness, sinusitis, joint pain, anxiety, and sleepiness.

Calling the New findings "interesting," Eric Ruderman, MD, an associate professor of medicine at the Northwestern University Feinberg School of Medicine in Chicago, tells WebMD that "based on this preliminary trial, a lot of people will be looking at this drug in fibromyalgia and the advantage of this agent is that it has a certain durability to it."

He adds that "this is the second study to show benefit in terms of pain and, in general, it was well-tolerated and provided pretty durable pain relief."

Though six months is not a lifetime, the ideal scenario for chronic disease like fibromyalgia is to find something you can remain on without cumulative side effects.

Lyrica is also FDA-approved for diabetic nerve pain and nerve pain following shingles. It is manufactured by Pfizer. Pfizer is a WebMD sponsor.


--------------------------------
SOURCES: 70th annual meeting of the American College of Rheumatology, Washington, D.C., Nov. 10-15, 2006. Leslie J. Croffiord, MD, Gloria W. Singletary Professor of Rheumatology and Women's Health, University of Kentucky. Eric Ruderman, MD, associate professor of medicine, Northwestern University Feinberg School of Medicine, Chicago.

Reviewed by Louise Chang




Saludos Cordiales
Dr. José Manuel Ferrer Guerra

Statin Use Associated with Reduced Risk of Common Type of Cataract

Statins are widely used to decrease serum cholesterol for cardiovascular disease prevention. Statins have also been shown to have antioxidant activity. Oxidative stress (a condition in which antioxidant levels are lower than normal) has been thought to be a risk factor for age-related cataract, particularly nuclear cataract (the most common type of age-related cataract, which occurs in the Center of the lens). Some evidence has suggested an association between nutritional intake of antioxidants and age-related cataract, according to background information in the article.

Barbara E. K. Klein, M.D., M.P.H., of the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues analyzed data from the Beaver Dam Eye Study to determine if statin use is associated with a reduced risk of age-related cataract. The analysis included 1,299 persons who were examined as part of the study in 1998-2000 and were deemed to be at risk of developing nuclear cataract within 5 years.

A total of 210 persons developed incident nuclear cataract in the interval from 1998-2000 to 2003-2005. The five-year incidence of nuclear cataract was 12.2 percent in statin users compared with 17.2 percent in nonusers; the odds of developing cataract were 40 percent lower for statin users after adjusting for several factors. Because smoking and diabetes increase risk of nuclear cataract, the authors analyzed results in never smokers without diabetes, and found the odds of developing nuclear cataract was 60 percent lower among statin users after adjusting for other factors. The incidence of two other types of cataracts, cortical and posterior subcapsular cataracts, did not differ significantly between statin users and nonusers.

To further explore the relationship between statin use and nuclear cataract, the authors suggest that clinical trials of statins used for lipid lowering should assess nuclear cataract. In addition, they state “further study of the relationship of cataract and statin use is needed in which each type of cataract is considered individually. Further follow-up of our cohort, with anticipated increase in number of persons with cataract and wider use of statins, will permit us to evaluate whether our finding persists.”
(JAMA. 2006;295:2752-2758. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: The National Eye Institute provided funding for the entire study; Research to Prevent Blindness, New York, N.Y., provided further additional support for data analyses.

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations@jama-archives.org .



Contact Barbara E. K. Klein, M.D., M.P.H., call Sayward Proctor at 608-265-7344.




Saludos Cordiales
Dr. José Manuel Ferrer Guerra

Inhaled Insulin Effective for Diabetes

Nov. 7, 2006 -- Although inhaled insulin is comparable to injected insulin in controlling high blood sugar, its use should be reserved for diabetic patients who cannot or will not use needles, according to a New study.

That's because its long-term safety has yet to be established, says Lisa Ceglia, MD, of the Tufts-New England Medical Center in Boston, a researcher on the study.

"For the time being, the most worrisome concern is the effect inhaled insulin may have on lung function," Ceglia tells WebMD. The review article shows that one of the most common side effects of such therapy is increased coughing and a mild decrease in test scores that measure lung function.

"Are there other things to worry about? Possibly," Ceglia says. "But pulmonary toxicity is the issue we focused on because of the way the therapy is administered."

The findings are published in the November issue of the Annals of Internal Medicine.

Short-Term Trials

Ceglia's team reviewed 16 trials of inhaled insulin involving 4,023 patients with type 1 or type 2 diabetes.

Most of the trials lasted only 12-24 weeks. The longest trial lasted two years. It evaluated Exubera, Pfizer Inc.'s inhaled insulin delivery system. Pfizer is a WebMD sponsor.

In January 2006, Exubera became the first New insulin delivery option to be approved by the FDA since insulin was discovered in the 1920s. Pfizer launched the drug in the U.S. Market in September 2006.

"All of the trials were open-label, meaning that the patients knew what they were getting," Ceglia says. None of the trials used the so-called "double-dummy" technique, in which patients receive an inhaler and injections without knowing which one contains insulin.

Although that other technique may have produced more definitive results, it was not used because the trial designers considered it "logistically difficult and cumbersome."

"What these trials were designed to do is prove non-inferiority," says Larry Deeb, MD, president of medicine and science at the American Diabetes Association in Alexandria, Va. Deed was not connected with the study. "All Pfizer had to do was prove that inhaled insulin was as good as subcutaneous insulin, not that it was superior."

Inhaled Insulin Worked

Ceglia's analysis showed that inhaled insulin was "comparable" to injected insulin in controlling blood sugar. Its effects were "just slightly less" than those of injected insulin, Ceglia says.

Though injected insulin had a small advantage over inhaled insulin in reducing blood sugar, the same number of patients on either therapy achieved a benchmark of diabetes control: a hemoglobin A1c level of less than 7%.

"Clearly, inhaled insulin is not an improvement over subcutaneous insulin, a drug [with] which we've had 80 years of experience," Deeb tells WebMD. "Doctors should tell patients who are already doing well on subcutaneous insulin that they shouldn't expect to do any better if they switch to inhaled insulin."

But Ceglia's analysis also showed high levels of patient satisfaction with inhaled insulin therapy.

She suggested this may be related to the "novelty of the New delivery method" and cautioned it remains to be seen if patients will be as enthusiastic and adherent to inhaled insulin therapy over the long term.

"It's exciting that this New therapy is out," Ceglia says. "It's been in development for a long time. We'll just have to wait and see how it goes."

Safety Concerns

Ceglia's analysis doesn't raise any immediate alarm. "Certainly there was nothing in the first two years that was frightening," she says.

But that doesn't mean there are no concerns. Leading the list is inhaled insulin's long-term effect on lung function.

Even in the short term, patients on inhaled insulin are more than three times as likely as those on injected insulin to develop a dry cough. "This appears to be an immediate reaction to the inhalation and doesn't seem to progress over time," Ceglia says.

Lung Damage?

More worrisome, patients on inhaled insulin were more likely than those on injected insulin to experience a mild decrease in lung function. The mild decrease in lung function happened early in the study and did not worsen over two years.

Another potential problem is severe hypoglycemic reactions, which were shown to be as likely with inhaled insulin as with injected insulin. That could be because inhaled insulin devices don't yet allow for finer dosing adjustments that may be necessary to avoid hypoglycemia, according to the study.

"Based on the trials we analyzed, we can't make any definitive conclusions about the safety of inhaled insulin," Ceglia says. "Like any New drug, however, inhaled insulin is going to have to be tested further and assessed for its long-term efficacy and safety."

Recommendations

Because of long-term safety concerns, Ceglia's team recommends that inhaled insulin be reserved for patients without pulmonary problems, who oppose injections and would otherwise not receive appropriate and timely therapy for their diabetes.

When contacted by WebMD, Pfizer officials said they were reviewing Ceglia's analysis. They issued a statement reiterating their belief that Exubera "represents a major advance in the treatment of diabetes.

"In clinical trials, Exubera was found to be as effective as short-acting subcutaneous insulin injections, and to significantly improve blood sugar control when added to oral medications," the statement reads. "This is reflected in the Exubera product labeling in the United States and European Union."


--------------------------------------------------------------------------------

SOURCES: Lisa Ceglia, MD, division of endocrinology, diabetes, and metabolism, Tufts-New England Medical Center, Boston. Larry Deeb, MD, president of medicine and science, American Diabetes Association, Alexandria, Va. Pfizer statement from Rebecca Hamm, U.S. Pharmaceuticals Public Relations, Pfizer, New York. Ceglia, L. Annals of Internal Medicine, November 2006; vol 145: pp 665-675.

Reviewed by Louise Chang




Saludos Cordiales
Dr. José Manuel Ferrer Guerra

Solving the SIDS Mystery

New clues reveal that sudden infant death syndrome may be a disease-not a tragic mistake
By Nancy Shute

Posted Sunday, November 5, 2006

Sudden infant death syndrome, better known as SIDS, is a cruel killer, striking infants as they sleep. More than 2,000 babies in the United States die of SIDS each year. Autopsies reveal no infection or other hidden health problem. Over the years, many suspects have been put forward, as benign as too-soft pillows that smother the child or as sinister as child abuse. Scientists have been struggling for decades to discover a physical cause. Now, they have unearthed the strongest evidence yet that the brain region that controls breathing develops abnormally in many infants who die of SIDS.

Researchers at Children's Hospital Boston and Harvard Medical School, working with colleagues at the University of California-San Diego School of Medicine and other institutions, autopsied the brains of 31 infants in San Diego who died of SIDS and 10 who died of other causes. They zeroed in on the medulla, an area in the brain stem that controls involuntary actions like breathing, blood pressure, and heart rate and that has been the focus of scrutiny. Their findings, reported in last week's Journal of the American Medical Association, showed that the medullas of SIDS babies were far more likely to have abnormalities in nerve cells that respond to serotonin, a chemical that plays a key role in regulating breathing and sleep. "SIDS is not a mystery," says Hannah Kinney, an associate professor of neuropathology at Children's Hospital Boston and Harvard Medical School and coauthor of the JAMA study. "It's not something that parents did. SIDS is a disease. It's a scientific problem, and it can be tackled with scientific methods."

The irregularities Kinney and her colleagues found were more extensive than had been discovered in earlier studies. What's more, the SIDS baby boys in the study had more deficiencies than the SIDS girls, which may help explain why boys are twice as likely to die of SIDS as girls. If these flaws do indeed cause SIDS, perhaps a test could be developed to identify babies at risk in the first weeks of life. But any such test is many years away, according to John Kattwinkel, a professor of pediatrics at the University of Virginia, because no one has yet pinpointed an early-warning signal for SIDS. "You've got to figure out how to detect it."

When Kyra Oliver Hitzeman heard news reports about the SIDS study, she was thrilled-and overwhelmed by the memories it revived. Her son Hayes died in 2002, while he took a nap at his day-care provider's home. He was 4 1/2 months old, a chubby, joyful little boy. "He was awesome," says Hitzeman, 39, owner of a graphic design firm near Richmond, Va. "There was no indication that anything was wrong. He was a perfectly healthy baby."

Indeed, no one knows what prompts seemingly healthy babies to suddenly die in their sleep. Most SIDS deaths occur between 2 and 4 months of age. Epidemiological data gathered over the years has shown that babies are more likely to succumb to SIDS if they are put to sleep face down, if they sleep with an adult, or if there are toys or soft bedding in the crib. The thought has been that SIDS babies don't rouse themselves when the bedding traps carbon dioxide near the face, and they suffocate.

At the same time, researchers have hunted biological causes and have found genetic variations in some SIDS babies that suggest a hereditary component. Other scientists have found metabolic problems in the liver that may account for 3 to 5 percent of SIDS cases. Michael Ackerman, a pediatric cardiologist at the Mayo Clinic, has examined 93 SIDS cases, and found that 9 percent of the babies had a genetic defect that causes Long Q-T syndrome, a heart defect that can result in sudden, fatal arrythmia. Last week's JAMA study brings the most concrete evidence yet that SIDS is a disease, not just the result of a tragic mistake.

Multiple causes. Kinney, who has been trying to solve the SIDS riddle since the early 1980s, thinks the aberrations in the brain's serotonin system develop in utero and can be caused by maternal cigarette smoking, which impairs fetal brain development. Other researchers think the problems could be caused by a genetic predisposition, or by lack of oxygen or other stress at birth. In the end, many prominent researchers believe SIDS will turn out to have multiple biological causes that make babies more susceptible to environmental risks like soft bedding or cigarette smoke.

Kinney says that her group's findings reinforce the "Back to Sleep" program, created by a consortium led by the National Institute of Child Health and Human Development and introduced in 1992. It aims to reduce the risk of SIDS by telling parents and caregivers to put infants to sleep face up and to keep soft bedding like quilts and pillows out of the baby's crib. A child without the brain variations would have no problem sleeping face down, but a SIDS-prone child might. "Why would putting a baby on its back save a life?" asks Kinney. If that baby has a defect in its brain arousal system, it might asphyxiate if laid face down. "A normal baby would sense the low oxygen and turn its head and wake up."

Although the Back to Sleep campaign is credited with reducing SIDS deaths by 50 percent since its inception, 77 percent of the children who died of SIDS in Kinney's study were sleeping on their stomach or side, shared a bed with an adult, or both. Kattwinkel, who is chairman of the American Academy of Pediatrics's SIDS Task Force, says the fact that the bulk of SIDS deaths are related to risk factors like cosleeping, soft bedding, or sleeping face down is actually encouraging. "We can do something about it," he says. Thanks to the Back to Sleep program, the number of newborns put to sleep on their stomachs has shrunk to 12 to 14 percent. But that number increases when babies are 2 to 3 months old-right when many mothers go back to work. "We think a fair amount of the reason for the increase is secondary caretakers, like grandmothers and day-care centers," Kattwinkel says. As a result, he says, Back to Sleep has been targeted more toward caretakers in the past decade. The situation is improving, he says, "but it's still not where it should be."

Hitzeman knows that all too well. Hayes's babysitter put him to sleep on his stomach before he died, even though she had asked that her baby be put to sleep on his back. She says she doesn't blame the sitter for not recognizing the seriousness of the request. After her son's death, Hitzeman and her husband created a foundation to support SIDS research and awareness. And she has given the foundation's public face a flourish making use of her talents as a designer: a onesie embellished with a smiling, sleeping baby that reads, in English or in Spanish, "This Side Up."



Saludos Cordiales
Dr. José Manuel Ferrer Guerra

More Good News Coming About Diet Pill Acomplia (Rimonabant) as Diabetes Drug

While highly anticipated diet pill Acomplia (rimonabant) remains stalled at the U.S. Food and Drug Administration, with no early approval in sight, more positive news appears to be on the way about the drug's benefits in aiding glycemic control in newly diagnosed type 2 diabetes patients.

Results of the so-called Serenade trial (Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients), a six-month study which began in March 2005 with 281 participants, are scheduled to be presented next month at the 19th World Diabetes Congress in Cape Town, South Africa.

Judging by the coy manner in which Sanofi-Aventis executives responded to questions about the study when they briefed financial analysts on October 31st, the results certainly seem to have been encouraging.

The primary objective of this fairly small trial was to assess whether giving newly diagnosed type 2 diabetics Acomplia -- together with a reduction in caloric intake of 600 calories a day -- brought their blood glucose as measured by the HbA1C test under better control than reducing caloric intake alone.

"This is a key study . . . The first study of treatment of patients suffering from type 2 diabetes," said Hanspeter Spek, Sanofi's head of pharmaceutical operations. "It will be presented at an international congress. We are looking forward to the presentation with a lot of optimism and confidence."

Pressed by analysts about the 99.99 percent probability that Sanofi already is well aware of the results of the study, Spek said: "It is good practice not to talk about the study until it is exposed to the professional audience and the public.

"Of course we are looking forward to this study with a lot of confidence," he repeated. "It is a landmark study."

So once again, the news from Sanofi's clinical trials of Acomplia appears to be extremely positive. If only Sanofi was equally forthcoming about what is holding up Acomplia at the FDA, we might be in a better position to assess the future of what may be a multi-faceted drug.





Saludos Cordiales
Dr. José Manuel Ferrer Guerra

More Good News Coming About Diet Pill Acomplia (Rimonabant) as Diabetes Drug

While highly anticipated diet pill Acomplia (rimonabant) remains stalled at the U.S. Food and Drug Administration, with no early approval in sight, more positive news appears to be on the way about the drug's benefits in aiding glycemic control in newly diagnosed type 2 diabetes patients.

Results of the so-called Serenade trial (Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients), a six-month study which began in March 2005 with 281 participants, are scheduled to be presented next month at the 19th World Diabetes Congress in Cape Town, South Africa.

Judging by the coy manner in which Sanofi-Aventis executives responded to questions about the study when they briefed financial analysts on October 31st, the results certainly seem to have been encouraging.

The primary objective of this fairly small trial was to assess whether giving newly diagnosed type 2 diabetics Acomplia -- together with a reduction in caloric intake of 600 calories a day -- brought their blood glucose as measured by the HbA1C test under better control than reducing caloric intake alone.

"This is a key study . . . The first study of treatment of patients suffering from type 2 diabetes," said Hanspeter Spek, Sanofi's head of pharmaceutical operations. "It will be presented at an international congress. We are looking forward to the presentation with a lot of optimism and confidence."

Pressed by analysts about the 99.99 percent probability that Sanofi already is well aware of the results of the study, Spek said: "It is good practice not to talk about the study until it is exposed to the professional audience and the public.

"Of course we are looking forward to this study with a lot of confidence," he repeated. "It is a landmark study."

So once again, the news from Sanofi's clinical trials of Acomplia appears to be extremely positive. If only Sanofi was equally forthcoming about what is holding up Acomplia at the FDA, we might be in a better position to assess the future of what may be a multi-faceted drug.



Saludos Cordiales
Dr. José Manuel Ferrer Guerra

Racial differences in reaching target low-density lipoprotein goal among individuals treated with prescription statin therapy

Racial differences in reaching target low-density lipoprotein goal among individuals treated with prescription statin therapy.

Yood MU, McCarthy BD, Kempf J, Kucera GP, Wells K, Oliveria S, Stang P.

EpiSource, Hamden, CT, USA. muyood@muyood.com

BACKGROUND: Studies indicate that, overall, African Americans are less likely to achieve control of hyperlipidemia compared with whites. No population-based studies have examined the effect of race on achieving target low-density lipoprotein (LDL) goals among treated individuals. METHODS: Using computerized encounter and laboratory result data, we identified all African American and white patients in a Midwestern health system filling a statin prescription from January 1, 1997, through June 30, 2001 (index prescription), with no prescriptions filled 1 year before index prescription. We followed LDL results for 1 year after index prescription. RESULTS: A total of 16052 New statin users (32.5% African American) were identified. Mean baseline LDL was higher for African Americans (170.2 +/- 36.6) than for whites (161.8 +/- 37.2) (P < .001). Whites were more adherent to therapy, with 48.6% of white patients exposed to statins >80% of follow-up time (31.2% of African Americans) (P < .001). By the end of follow-up, 49.5% of African Americans and 71.1% of whites reached LDL goal. A proportional hazards model adjusting for age, sex, median household income, physician specialty, clinic site, baseline LDL, starting dose, and target LDL indicated that African Americans were less likely to reach goal compared with whites (hazard ratio 0.64, 95% CI 0.61-0.68). Results persisted after controlling for racial differences in statin adherence and LDL testing (hazard ratio 0.60, 95% CI 0.57-0.63). CONCLUSIONS: African American patients initiating statin therapy are less likely to achieve LDL goal, even after controlling for adherence differences and other factors, suggesting that African Americans may require different pharmacologic management.

PMID: 16996858 [PubMed - indexed for MEDLINE]



Saludos Cordiales
Dr. José Manuel Ferrer Guerra

Low intake of milk during pregnancy linked to decreased birth weight

A New study published in the Canadian Medical Association Journal gives expectant mothers yet another reason to drink their milk. Researchers found that women who rarely drank milk during their pregnancy gave birth to smaller babies compared to women who drank more milk.

Low birth weight affects one out of every 13 babies born each year in the United States, and it's a factor in 65 percent of infant deaths, according to the March of Dimes. This New study suggests that drinking the recommended amount of milk each day - three 8-ounce glasses -may help increase birth weight.

The Canadian researchers followed 279 women throughout their pregnancy. They found that women who limited their intake of milk to one cup or less per day consumed significantly less protein and vitamin D, and they gave birth to babies that weighed less compared to women who drank more milk.

Milk consumption and vitamin D intake from fortified milk and supplements during pregnancy were found to be each associated with infant birth weights, independently of other risk factors. Analysis of the data predicted that each cup of milk consumed daily was associated with a 41 gram increase in a baby's birth weight.




Saludos Cordiales
Dr. José Manuel Ferrer Guerra