Indonesia's Suharto in Hospital

Former Indonesian dictator Suharto was hospitalized with anemia and intestinal swelling Friday after being treated at home for several days, doctors said.

Suharto's condition was not considered life-threatening, but he would spend at least one night under observation at Pertamina Hospital, said Dr. Marjo Subiandono, head of the country's presidential medical team.

The 86-year-old, who brutally ruled Indonesia for more than three decades until being toppled by a pro-democracy uprising in 1998, has been in and out of the hospital in recent years for strokes and intestinal bleeding. He is said to have suffered permanent brain damage and some speech loss from the ailments.

Hospital spokesman Dr. Joko Sanjoto told reporters that tests were being carried out to determine why Suharto was suffering from anemia and intestinal swelling.

The former strongman was stable and conscious, he said, adding that he was admitted "because we are concerned."

His feet and other parts of his body were also experiencing some swelling, said Dr. Joko Raharjo, a member of Suharto's medical team at the hospital.

Suharto lives a secluded life in a mansion on a leafy lane in Jakarta and is rarely seen in public. During recent Islamic holidays, he received a stream of high-profile guests and gave a rare media interview in November after winning a defamation lawsuit against Time magazine.

Two years after his ouster, Suharto was indicted for allegedly embezzling $600 million, but legal proceedings were suspended due to his poor health.

Source:ap.google.com

A new way to boost red blood cell numbers

A common treatment for anemia — a deficiency in red blood cells (rbcs) caused by their insufficient production, excessive destruction, or excessive loss — is administration of recombinant erythropoietin (Epo), a hormone that stimulates the production of rbc precursors by the bone marrow. Unfortunately, many patients with anemia do not respond to treatment with Epo. However, a new study in mice, by Anne Angelillo-Scherrer and her colleagues at the University Hospital Center and University of Lausanne, Switzerland, has indicated that the protein Gas6 might augment or replace Epo in the treatment of patients who are hyporesponsive or resistant to Epo, respectively.

It was shown that following treatment with Epo, mouse rbc precursors released Gas6, which increased cell signaling in response to Epo treatment. In addition, mice deficient in Gas6 had decreased sensitivity to Epo and a reduced ability to recover from anemia. Administration of Gas6, either alone or in combination with Epo, was successful at treating both chronic and acute anemia in mice. The authors therefore concluded that Gas6 has a role in rbc formation and might have valuable therapeutic potential for the treatment of individuals with anemia who fail to respond to treatment with Epo.

Source:www.eurekalert.org

Amgen CEO Says '07 Profits Beat Forecast

Biotech company Amgen Inc. predicted Tuesday that its cost-cutting would push its 2007 profits higher than it forecast in October.

Amgen, the world's largest biotech company, now expects 2007 earnings near $4.30 per share, Amgen chief executive Kevin Sharer said in a presentation at this year's JP Morgan Healthcare Conference in San Francisco.

Last January, before the U.S. Food and Drug Administration raised concerns about side effects of some anemia drugs, Amgen had forecast 2007 earnings between $4.30 per share and $4.50 per share.

In October, after sales fell in response to an FDA warning, Amgen predicted 2007 earnings per share between $4.13 and $4.23.

Analysts surveyed by Thomson Financial forecast, on average, an annual profit of $4.24 per share, excluding some one-time expenses.

Amgen shares jumped 94 cents, or 2.1 percent, to $46.33 Tuesday. The stock has fallen from its 52-week high of $76.95, reached last January.

The company's stock price fell as the FDA's concerns about drugs intended to treat anemia by stimulating production of red blood cells, as Amgen's Aranesp and Epogen do, cut into sales. The drugs are used to treat the blood disorder when it is caused by kidney-failure or chemotherapy.

In August, Amgen said it would cut between 12 percent and 14 percent of its work force because of the downturn.

The FDA issued a "black box" warning, its most serious, on erythropoiesis-stimulating agents, include Aranesp and Epogen, after research suggested high doses increased patients' risk of tumors and death.

The Centers for Medicare and Medicaid Services changed the reimbursement policy for Aranesp and drugs in the same class so doctors would be paid only for prescribing a low dose of the drugs.

Amgen could see its sales take a hit in 2008 if private insurers follow suit, according to some industry analysts.

Still, "the changes in Medicare reimbursement have not, to date, had an adverse effect on key drivers of Amgen sales, such as Aranesp," biotech analyst Jim Reddoch of Friedman, Billings, Ramsey & Co., Inc. wrote in a research note released Tuesday.

Sharer also said Amgen is on track to deliver cost savings in 2008 as a result of the restructuring and expects research and development costs to decline slightly as a percentage of sales.

Source:ap.google.com

Physicians say the well-nourished rank-and-file don't need extra Vitamin B12, but that hasn't dulled its luster among those who say it boosts energy

New York Yankees pitcher Roger Clemens is feeling the heat. A former trainer has said he injected the seven-time Cy Young winner with steroids and human growth hormone, but Clemens says the only injections he received were of vitamin B12 and lidocaine, an analgesic. Lidocaine is sometimes injected into joints to dull joint pain -- a potential problem for an aging athlete -- but B12 injections are more commonly used to treat pernicious anemia and address diet deficiencies in the elderly. Physicians generally believe that the well-nourished rank-and-file don't need it, but the vitamin hasn't lost its luster among those who say it boosts energy.

Vitamin B12 is an essential vitamin found primarily in animal foods. The body uses it in the formation of DNA and red blood cells, and it's necessary for the healthy functioning of the nervous system. For people who are deficient or at risk of deficiency, injections can be helpful. For a well-nourished pitcher hoping to improve his fastball, not so much.

"Some athletes believe that vitamin B12 injections will increase oxygen [supply to the muscles] and that that enhances performance," says Andrea Giancoli, a spokeswoman for the American Dietetic Assn. and consultant for the L.A. Unified School District on nutrition and policy. "But in the absence of a vitamin B12 deficiency, the studies don't support that."

Aside from a 1989 report in the International Journal for Vitamin and Nutrition Research, which found that a combination of B1 (thiamin), B6 (pyridoxine) and B12 (cyanocobalamin) improved fine motor skill in target shooting, the evidence is scant, writes Thomas Brenna, professor of human nutrition at Cornell University, in an e-mail.

And B12 injections are not going to give the average person an energy boost, says Dr. David Baron, chief of staff at Santa Monica-UCLA Medical Center and Orthopaedic Hospital.

"For my entire career, I have encountered patients who have requested B12 shots, and I've been explaining to them that they serve no useful purpose," Baron says. "Honestly, this is an argument that's been going on between Western scientific physicians and complementary and alternative healthcare providers for many, many years."

Some weight-loss programs even recommend B12 injections, says James Hill, director of the human nutrition center at the University of Colorado. "But there's no indication that they're doing any good," he says.

In fact, when the body is drenched with B12, the kidneys will filter out whatever isn't needed, says Dr. Michael Karp, an internist and assistant professor of clinical medicine at USC School of Medicine. The upside is that too much B12 probably won't hurt you, he says.

The basis for the belief that vitamin B12 shots can provide energy goes back decades, Baron says. "Before we knew how to manufacture B12 in an injectable form, people who were deficient for various reasons were quite ill," he says. Once physicians began giving B12 shots to this population, "people who were horribly chronically anemic from B12 deficiency just basically came to life," he says. "It was a miracle."

The average person needs 2.4 micrograms of B12 per day, and most people get sufficient amounts in their food, particularly given how many foods -- such as cereals, nondairy milk, meat substitutes and protein bars -- are now fortified with B12, Giancoli says.

Vitamin B12 has a somewhat tangled path to absorption. The vitamin needs an acidic environment in the stomach in order to be released from food. It then binds with a glyco-protein compound called intrinsic factor, which allows it to be absorbed through the small intestine. If the stomach doesn't have a sufficient hydrochloric acid or lacks intrinsic factor, absorption will be limited.

To be sure, a deficiency of B12 can have serious consequences -- including pernicious anemia and nerve damage. "The nerve damage can start with memory problems, declined cognitive function, tingling in the extremities and can progress," Giancoli says. "And the neurological changes may not be apparent in everyone. There may be very general symptoms, like fatigue, weakness, weight loss, constipation, loss of appetite."

People most at risk for B12 deficiency are patients with certain types of gastrointestinal disorders (such as Crohn's disease), vegans and the elderly. The elderly are at risk for a number of reasons, says Dr. Marie Bernard, a spokeswoman for the American Geriatrics Society.

"As you get older, you're more likely to have accumulated medical problems that might prevent you from absorbing B12 optimally," Bernard says. Those events would include surgery to remove part of the intestine, and use of certain medications, such as acid-suppressing drugs.

As for that other segment clamoring for injections -- the worried well who believe the shots boost energy -- B12 may also have a benefit of sorts: a nice little placebo effect.

"Quite frankly," Karp says, "I'll sometimes get a new patient who says that they're getting a monthly vitamin B12 injection and that it makes them feel better, so I'll continue to give it to them. If it makes them feel better, that's still something."

Source:www.latimes.com

Fresh concerns about Amgen's anemia drugs

Anemia drugs sold by Amgen Inc. took another hit Thursday when government regulators said two new studies indicated that the drugs may increase the risk of death in some patients.

Based on the studies, the Food and Drug Administration may further restrict the use of the drugs, which already carry the agency's strictest "black box" warning.

"This new information further underscores the safety concerns," said Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research. She said the agency "is reviewing these data and may take additional action."

In recent years, six studies have found that the drugs -- all manufactured by Amgen and marketed by Amgen as Aranesp and Epogen and by Johnson & Johnson as Procrit -- can lead to an increased risk of heart attack, stroke, heart failure and cancer tumor growth in some patients.

Amgen, based in Thousand Oaks, until recently enjoyed an unusually charmed life in the often treacherous biotech industry, with profit and a market value higher than many top-shelf pharmaceutical companies. A large share of the company's fortunes came from Aranesp and Epogen, which accounted for more than half of its net income.

Since the summer, Amgen's stock has fallen to a five-year low and has lost $17 billion in value. The company laid off 14% of its employees late last year.

Known as erythropoietin-stimulating agents or ESAs, the anemia drugs are bioengineered versions of a natural protein made in the kidney that stimulates bone marrow to produce more red blood cells. Cancer and dialysis patients use injectable ESAs to treat anemia and boost energy.

Fallout from the earlier studies' findings rankled patients and regulators. The FDA added the black box warning last year and the federal Medicare agency followed with limits on what dosages of anemia drugs it would reimburse, severely affecting the company's sales.

The results of the two most recent research studies appear to reinforce concern that some cancer patients die sooner when taking the drugs than those who don't.

The first involved 733 women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14% of the patients who received Aranesp to treat their anemia had died, compared with 9.8% who didn't receive the drug. Tumors also grew faster in patients receiving Aranesp.

Amgen informed FDA officials about the findings in late November and regulators have been reviewing the data since.

A separate trial by the National Cancer Institute's Gynecologic Oncology Group, the results of which Amgen disclosed to federal regulators in December, reviewed patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were administered either Procrit or blood transfusions as needed. After three years, 66% of patients who did not take Procrit were alive and free of cancer growth, compared with 58% given the drug.

The FDA previously said it would hold a meeting early this year to look at the safety of the drugs in cancer patients, but a date has not yet been set.

Roger M. Perlmutter, executive vice president of research and development at Amgen, said in a statement in December that "as new information, including additional study results, becomes available, Amgen will communicate the data and, where appropriate, work with the FDA to update our product labels."

Wall Street appeared to take Thursday's news in stride, perhaps because many of the risks facing the company had already been priced into the stock. Shares of Amgen fell 91 cents, or 2%, to $45.69.

Joel Sendek, senior biotechnology analyst at Lazard Capital Markets, said in a note to clients that "we continue to forecast revenue decline in 2008 and limited [stock price] growth to 2010."


Source:www.latimes.com

FDA Reports New Risks Posed by Anemia Drugs

Two new studies offer further evidence of the health risks posed by the anemia drugs known as erythropoiesis-stimulating agents (ESAs), U.S. officials announced Thursday.The studies showed that patients with breast or advanced cervical cancer who took the drugs as treatment for chemotherapy-induced anemia died sooner or had more rapid tumor growth than patients not on the drugs, U.S. Food and Drug Administration officials said in a prepared statement.

On Nov. 8, the FDA approved new "black box" warnings on labels of the three ESAs -- Aranesp, Epogen and Procrit. The warnings detailed the dangers to patients with cancer and patients with chronic kidney failure. Those dangers include heart attack, stroke, heart failure and cancer tumor growth and shortened survival, the FDA said.

The drugs had been touted as a treatment to lessen fatigue and improve quality of life among cancer, HIV and other patients with anemia, but the revised label said there was no evidence to back that claim. The label change was the fifth such change since Procrit was approved in 1989, FDA officials said.

Results of the two studies released Thursday were not among the six studies that led to the Nov. 8 label revision. Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who didn't get this therapy, the FDA said.

The FDA said it plans to discuss the new findings and re-examine the risks and benefits of ESAs for patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.

"This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications," Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, said in the statement.

"FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients."

According to the FDA statement:

* On Nov. 30, Amgen Inc., manufacturer of the three ESAs -- Aranesp, Epogen, and Procrit -- provided the FDA with information from the 733-patient PREPARE study of women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14 percent of the patients who received Aranesp to treat their anemia had died, compared to 9.8 percent who did not get the drug. Tumor growth was also faster in patients receiving Aranesp.
* On Dec. 4, Amgen informed the FDA of the results of a study by the National Cancer Institute's Gynecologic Oncology Group of patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were given either Procrit to maintain hemoglobin levels above 12 grams per deciliter of blood or blood transfusions as needed. After three years, 66 percent of the patients who did not take Procrit were alive and free of cancer growth, compared to 58 percent who had received the drug.

In announcing the label revision in November, Dr. John Jenkins, director of the FDA's Office of New Drugs, said, "We are emphasizing that ESAs should be used at the lowest dose necessary to avoid blood transfusions, since that is the only identifiable benefit for ESAs. Doctors should have discussions with their patients about whether to use ESAs at all."

The three drugs are synthetic versions of a protein made in the kidney that tells bone marrow to produce red blood cells. The drugs are manufactured by Amgen, of Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J., a subsidiary of Johnson & Johnson.

For cancer patients, November's revised warnings emphasized that the drugs can cause tumor growth and reduce survival among patients with advanced breast, head and neck, lymphoid and non-small cell lung tumors. This is especially true when the dose is designed to produce a hemoglobin level of 12 grams per deciliter of blood or more.

For hemoglobin levels less than 12 grams per deciliter, the label says there's no evidence to determine if the drugs cause any of these problems, the FDA said.

The revised label also made it clear that ESAs should be used in cancer patients only when their anemia is caused by chemotherapy and not from other causes. Also, ESAs should be stopped when the patient's chemotherapy has ended, the FDA said.

Source:health.usnews.com

Former Indonesian dictator is placed on a ventilator

Doctors placed Indonesia’s ailing former dictator Suharto on a ventilator yesterday in their struggle to save the life of the man who led a government accused of killing hundreds of thousands of people.

Suharto, 86, who was deposed amid mass protests and rioting in 1998, was taken to the hospital a week ago, suffering from a weakening heart and anemia.

Doctors said that his health had deteriorated yesterday as his blood pressure and hemoglobin levels dropped

Source:www.journalnow.com

Rapper's jail sentence put on hold as he deals with reported complications from sickle cell.

Rapper Prodigy, one half of the duo Mobb Deep, was rushed to the hospital Monday night (Jan. 7) from what sources say were complications from sickle cell anemia, reports Allhiphop.com.

The 33-year-old performer was scheduled to begin his three and a half year prison term the following day, but he was granted a 30-day stay due to the emergency room visit, the Web site reports.

Prodigy, born Albert Johnson, was arrested in New York in October 2006 along with his producer The Alchemist after police caught him driving the wrong way down a one way street. Upon searching his SUV, they found a .22 caliber handgun hidden in a console.

Source:www.eurweb.com

Women with Postpartum Anemia

As we head into 2008 it’s time to get your health in check. If you are low on energy or feel overly tired or weak—you could be suffering from iron deficiency anemia—especially if you are a new mom.

As many as one in five women will suffer from excessive blood loss during their reproductive years. This causes a condition called anemia, which can have debilitating physical and emotional effects. Of the approximately 4 million women who give birth each year, about 2 million become iron deficient, and more than 1 million will suffer from postpartum anemia

“Postpartum anemia not only affects maternal mood, thinking and behavior – but can also have adverse effects on the baby and has been shown to cause developmental delay, said Dr. Mary Jane Minkin, clinical professor of Obstetrics and Gynecology in the Department of Obstetrics and Gynecology at Yale University School of Medicine and author of A Women’s Guide to Sexual Health.

Infants of mothers who are anemic at 10 weeks postpartum have been shown to experience developmental delay; moreover, these early deficits in infants may not be reversible by subsequent successful treatment of the mother’s anemia.

Despite the high prevalence, iron deficiency anemia tends to go unrecognized and under-diagnosed because many women assume that it’s normal to feel tired, weak or irritable, particularly when you have a new baby. Women with postpartum anemia need more blood transfusions, longer hospital stays and more emergency department visits. Studies to date indicate current methods for quantifying blood loss during delivery often under-estimate the severity of blood loss in conditions associated with pregnancy and postpartum-related bleeding, such as postpartum hemorrhage. For these reasons, many women are at risk for developing postpartum anemia (sounds like something is missing here?) may not be adequately screened prior to discharge or during the postpartum period.

“The good news is that anemia is treatable once it is diagnosed,” said Dr. Minkin.

According to the Centers for Disease Control and Prevention, multiple births are on the rise so it’s even more important for women to get checked out. This is especially true for African-American and Hispanic women, who are at a greater risk for postpartum anemia.

Source:www.healthnewsdigest.com

Further Review of Anemia Drugs by the FDA

The United States Food and Drug Administration (FDA) has announced that it is reviewing new data regarding erythropoiesis-stimulating agents (ESAs). ESAs are drugs used to treat anemia. They include Procrit® (epoetin alfa), Epogen® (epoetin alfa), and Aranesp® (darbepoetin alfa).

Anemia is a common side effect of chemotherapy and cancer. It is characterized by low levels of circulating red blood cells, which are responsible for delivering oxygen to tissues throughout the body. Severe anemia often requires treatment with blood transfusions.

ESAs stimulate the body to produce more red blood cells. Use of ESAs to treat anemia caused by chemotherapy has been shown to decrease the need for blood transfusions.

ESAs are approved for the treatment of anemia in chronic kidney failure patients, in patients with cancer whose anemia is caused by chemotherapy, in patients with HIV whose anemia is caused by AZT (zidovudine), and to reduce the number of transfusions during and after major surgery (except heart surgery).

Serious adverse effects of ESAs have been reported in certain groups of patients, particularly patients who have used ESAs for indications other than for which they are approved. The FDA has recently received additional data from two clinical studies that add to a list of concerns regarding use of ESAs.

The two studies that the FDA is now reviewing include data from the PREPARE study. The first study included 733 patients with breast cancer who were treated with chemotherapy prior to undergoing surgery. A portion of patients received Aranesp, while others did not. At three years 14% of patients who had been treated with Aranesp had died compared with approximately 10% who had not received Aranesp.

The second study includes data conducted by the National Cancer Institute’s Gynecologic Oncology Group and includes patients who were being treated with chemotherapy and radiation therapy for advanced cervical cancer. Patients received either Procrit or blood transfusions for anemia. At three years 66% of patients who had not received Procrit were alive compared with 58% of patients who had not received Procrit. this does not make sense?

It is not clear whether the ESAs were actually associated with the reduction in survival in these patients.

The FDA states that they are currently “reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients.”

Patients who are undergoing chemotherapy may wish to speak with their healthcare provider regarding their individual risks and benefits of treatment with ESAs.

Source:professional.cancerconsultants.com

Anemia, Acute

Synonyms and related keywords: low hemoglobin, low hematocrit, anemic, reduced red cell mass, diminished oxygen-carrying capacity, hematologic abnormality, decreased or ineffective red cell production, increased red cell destruction, blood loss, acute anemia, congestive heart failure, CHF, hemolysis, hemorrhage, thalassemia, splenectomy
Background: Anemia refers to a hemoglobin or hematocrit level lower than the age-adjusted reference range for healthy children. In adolescents and adults, normal values vary according to sex. Racial differences apparently exist, with black children having lower normal values than white and Asian children of the same age and socioeconomic background. With a statistical threshold set at 2 standard deviations lower than the mean for the healthy population, 2.5% of the healthy population is classified as anemic. Physiologically, anemia is a condition in which reduced red cell mass leads to diminished oxygen-carrying capacity that does not optimally meet the metabolic demands of the body. These points must be considered when evaluating a child for possible anemia.

Anemia is not a specific disease entity but a condition caused by a variety of underlying pathologic processes. It may be acute or chronic. This article provides a general overview of anemia with an emphasis on the acute form. In addition, conditions are emphasized in which anemia is the only hematologic abnormality. The combination of anemia with leukopenia, neutropenia, and/or thrombocytopenia may suggest a more global failure of hematopoiesis caused by conditions such as aplastic anemia, Fanconi anemia, myelofibrosis, or leukemia; these diagnoses are considered in more detail in other eMedicine articles.

Pathophysiology: The main physiologic role of red blood cells (RBCs) is to deliver oxygen to the tissues. Certain physiologic adjustments can occur in an individual with anemia to compensate for the lack of oxygen delivery. These include (1) increased cardiac output; (2) shunting of blood to vital organs; (3) increased 2,3-diphosphoglycerate (DPG) in the RBCs, which causes reduced oxygen affinity, shifting the oxygen dissociation curve to the right and thereby enhancing oxygen release to the tissues; and (4) increased erythropoietin to stimulate RBC production.

The clinical effects of anemia depend on its duration and severity. When anemia is acute, the body does not have enough time to make the necessary physiologic adjustments, and the symptoms are more likely to be pronounced and dramatic. In contrast, when anemia develops gradually, the body is able to adjust, ameliorating the symptoms relative to the degree of the anemia.

The underlying pathologic processes that cause anemia can be categorized broadly as (1) decreased or ineffective red cell production, (2) increased red cell destruction, or (3) blood loss.

Frequency:

* In the US: Among all races, ages, and socioeconomic groups studied, an overall steady decline (from 7.8% in 1975 to 2.9% in 1985) in prevalence of anemia in the US pediatric population (aged 6 mo to 6 y) has been observed. Iron deficiency is the most common etiology.

* Internationally: In developing nations, the prevalence of anemia is extremely high. This is particularly true in preschool aged children, in whom the prevalence reached as high as 90% of the sample population studied. Although iron deficiency is identified as the major factor, the etiology is often multifactorial, including recurrent or chronic infections (bacteria, parasites), malnutrition, and reduced immunity.

In addition, the prevalence of certain hereditary forms of anemia (eg, thalassemia, sickle cell disease) varies with ethnicity and, thus, with geography. For instance, alpha-thalassemia, which may be the most common single gene disorder in the world, has a frequency of up to 68% in the Southwest Pacific, 20-30% in western Africa, and 5-10% in the Mediterranean region. Beta-thalassemia mutations have high gene frequencies in the Mediterranean, northern Africa, Southeast Asia, and India, but they have low frequencies in Great Britain, Iceland, and Japan.

Mortality/Morbidity: Mortality and morbidity rates vary according to the underlying pathologic process causing the anemia, the degree of severity, and the acuteness of the process. When a precipitous drop in the hemoglobin or hematocrit level occurs (eg, due to massive bleeding or acute hemolysis), the clinical presentation is typically dramatic and can be fatal if the person is not treated immediately. In addition to the signs and symptoms of anemia, patients can present with congestive heart failure (CHF) or hypovolemia.

Race: Acute anemia is universal, but the likely underlying etiologies are influenced by race. Inherited red cell disorders are predominant in certain racial populations, such as sickle cell disease in black persons, beta thalassemia in persons of Mediterranean ethnicity, and alpha thalassemia in Asians, African Americans, and others.

Sex: Sex predisposition to anemia varies according to the underlying etiology. For instance, certain hereditary X-linked red cell disorders (eg, G-6-PD deficiency) are observed in males. Anemia caused by blood loss can be observed in males with an X-linked bleeding disorder (eg, hemophilia). Females with the autosomally inherited von Willebrand disease may be anemic because of heavy blood loss during menstruation. Acquired hemolytic anemia related to autoimmune disorders such as systemic lupus erythematosus is observed more commonly in females because of their relative predisposition to autoimmune disease.

Age:

* The newborn period is one age group in which acute anemia most commonly occurs. Significant blood loss can occur from birth trauma or blood exchange from the baby's mother or the placenta. Isoimmune anemia can result from maternal antibodies crossing the placenta. Neonates have a shorter red cell life span and limited erythropoiesis that can aggravate any hemolytic process. Abnormalities of fetal hemoglobin may cause anemia that resolves with the normal shift to adult-type hemoglobins.

* Nutritional anemia is common in infancy because of the associated rapid growth (necessitating an increase in red blood cell mass) and dietary adjustments.

* With exposure to new infections in early childhood, the anemia of acute infection can be commonly observed. Rarely, severe autoimmune hemolytic anemia can be triggered by certain infections.

* Adolescence is characterized by rapid growth and vulnerability to nutritional anemia. In addition, blood loss with heavy menstruation can be observed in adolescent girls.


History: History of the individual with anemia must include data that demonstrate the acuteness and severity of the condition and suggest a cause of the anemia.

* Symptoms of anemia include pallor, fatigue, lethargy, dizziness, and anorexia.

* Jaundice and, occasionally, dark urine may be present with significant hemolysis.

* Failure to thrive indicates a long-standing condition. It may reflect the anemia itself or the underlying cause (eg, chronic renal failure).

* Patients with acute anemia are overtly symptomatic when the condition is severe, whereas those with chronic anemia may go undiagnosed because they are asymptomatic relative to the degree of anemia.

* Age is an important clue to the etiology of the anemia. For example, blood loss, isoimmunization, and congenital red cell disorders are common causes of anemia in newborns. Although observed in older infants, toddlers, and adolescent girls, iron deficiency anemia is unlikely in newborns or infants in whom iron stores from the mother are usually adequate and in prepubertal school-aged children in whom no rapid growth and expansion of blood volume occurs.

* Some hereditary X-linked disorders are observed mainly in males. A common example is acute hemolysis in G-6-PD deficiency.

* Knowing the racial background or ethnicity can help diagnose inherited abnormalities of hemoglobin production. Examples include the following:

o Thalassemias, hemoglobin S and C in the black population

o Beta thalassemia in individuals of Mediterranean descent

o Alpha thalassemia and hemoglobin E disease in Asian individuals

o Red cell enzyme defects (eg, G-6-PD deficiency) among individuals from the Mediterranean, Africa, and Southeast Asia

* Review dietary history, including milk intake in infants and toddlers and the sources of other nutrients (eg, iron, folate, vitamin B-12).

* Note details about sources of blood loss, recent infections, travel, drug exposures, chemicals (eg, lead), toxins, and oxidants.

* Inquire about symptoms of hypothyroidism (eg, cold intolerance, constipation, lethargy, poor growth).

* Inquire regarding a neonatal history of anemia, jaundice, phototherapy, transfusion, any other chronic medical illnesses/complaints, and medications.

* When reviewing the family history, include questions regarding anemia, jaundice, gallbladder surgery, splenomegaly or splenectomy, autoimmune diseases, or a bleeding disorder.

Physical:

* Check vital signs.

o Patients with acute and severe anemia appear in distress with tachycardia, tachypnea, and hypovolemia.

o Patients with chronic anemia typically are well compensated and only have tachycardia.

* To evaluate chronicity, plot growth parameters, which may affect the urgency of treatment.

* Note pallor, jaundice, edema, and signs of bleeding (eg, petechiae, bruising).

* Patients with significant anemia often have a systolic ejection murmur.

* Look for signs of CHF (eg, tachycardia, gallop rhythm, tachypnea, cardiomegaly, hepatomegaly).

* Splenomegaly can be found in many hemolytic anemias or may reflect infiltration in malignancy. In young patients with sickle cell disease, splenic sequestration can manifest with tender splenomegaly and an exacerbation of anemia. Passive congestion of the spleen may complicate CHF.

* Note any dysmorphic features and other congenital anomalies.

o Facial bony prominences (eg, frontal bossing) are signs of extramedullary hematopoiesis associated with chronic severe hemolytic anemias and thalassemias.

o Some congenital bone marrow failure syndromes (eg, Diamond-Blackfan anemia, Fanconi anemia) are associated with facial, limb, and other anomalies.

* Signs of hypothyroidism include low body temperature, failure to thrive, dry skin, and thinning of the hair.

Causes: Causes of anemia are either inherent in the RBCs or related to an external factor. As noted previously, these can be simplified into 3 main categories, although more than one mechanism may be involved in some anemias.

* Anemia caused by decreased red cell production (generally develops gradually and causes chronic anemia)

o Marrow failure

+ Diamond-Blackfan anemia (congenital pure red cell aplasia)

+ Transient erythroblastopenia of childhood

+ Aplastic crisis caused by Parvovirus B19 infection (in patients with an underlying chronic hemolytic anemia)

o Impaired erythropoietin production

+ Anemia of chronic disease in renal failure

+ Chronic inflammatory diseases

+ Hypothyroidism

+ Severe protein malnutrition

o Defect in red cell maturation

+ Nutritional anemia secondary to iron, folate, or vitamin B-12 deficiency

+ Congenital dyserythropoietic anemia

+ Sideroblastic anemias

+ Pure red cell aplasia/maturational arrest

* Anemia caused by increased red cell destruction (hemolysis)

o Extracellular causes

+ Mechanical injury (hemolytic-uremic syndrome, cardiac valvular defects)

+ Antibodies (autoimmune hemolytic anemia)

+ Infections, drugs, toxins

+ Thermal injury to red blood cells (with severe burns)

o Intracellular causes

+ Red cell membrane defects (eg, hereditary spherocytosis, elliptocytosis)

+ Enzyme defects (eg, G-6-PD deficiency, pyruvate kinase deficiency)

+ Hemoglobinopathies (sickle cell disease, unstable hemoglobinopathies)

+ Thalassemias

+ Porphyrias

+ Paroxysmal nocturnal hemoglobinuria

* Anemia caused by blood loss

o Obvious or occult site of blood loss: GI tract, intra-abdominal, pulmonary, intracranial (in neonates)

o Particular risk of massive hemorrhage (internal or external) for patients with bleeding disorders

source:www.emedicine.com

Feature articles on anemia

Anemia drug found to cause fatal heart attacks and strokes
(NewsTarget) This week the U.S. Food and Drug Administration (FDA) warned doctors not to excessively boost patients' red blood cell counts with anti-anemia drugs. This came after the publication of a clinical trial earlier in the week that found exceeding the FDA's dosing recommendations regarding anti...

Folic acid deficiencies are widespread; here's why nearly everyone needs more folate
Pregnant women plagued by cravings for pickles and ice cream must remember to include plenty of folic acid in their diets. Shown to reduce the risk of miscarriage and birth defects, folic acid – found primarily in leafy green vegetables – is an absolute necessity for any woman who is pregnant or is...

Concept-related articles:
cancer:

* The mineral selenium proves itself as powerful anti-cancer medicine
* New research shows vitamin D slashes risk of cancers by 77 percent; cancer industry refuses to support cancer prevention
* Mammograms cause breast cancer (and other cancer facts you probably never knew)
* Canadian Cancer Society announces national program to prevent cancer using vitamin D

iron deficiency:

* Hair Loss May Be linked to Iron Deficiency, Cleveland Clinic Experts Report (press release)

hospital:

* New Study Shows Need for a Major Overhaul of How United States Manages Chronic Illness (press release)

the FDA:

* The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower

nervous system:

* Non-surgical treatment of fibromyalgia - an interview with Dr. Paul Whitcomb

oxygen:

* Oxygen water performance claims may be full of hot air

AIDS:

* Mandatory AIDS testing proposal is public health lunacy

pregnant women:

* Antidepressant drugs found to cause birth complications

water:

* Healing with water: the work of "water cure" pioneer Dr. Batmanghelidj

source:www.newstarget.com

Affymax® Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide™ for the Treatment of Anemia

PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY) today announced that additional Phase 2 clinical trial results for Hematide™ were presented at the European Renal Association-EDTA Congress being held in Barcelona, Spain by Iain C. Macdougall, M.D., a Hematide investigator from Kings College, London. Dr. Macdougall’s poster included data in previously-treated dialysis patients and treatment naïve, non-dialysis patients which demonstrated that mean hemoglobin (Hgb) levels could be maintained and corrected, respectively, with once monthly Hematide.

Specifically, the data showed that in non-dialysis patients an initial range of doses from .025 mg/kg to .075 mg/kg of Hematide, in conjunction with dose adjustments, is adequate to increase Hgb in anemic patients with renal failure when administered monthly. In addition, intravenous and subcutaneous dosing appeared to result in a similar Hgb increase.

“These data support further investigation of the versatility and flexibility of once-per-month Hematide in terms of starting doses and route of administration,” said Robert Naso, Ph.D., executive vice president of Research and Development at Affymax. “These results demonstrate that a narrow target range of hemoglobin levels can be reached with different initial Hematide doses. We are pleased to have such thorough evaluation of the product as we prepare for pivotal Phase 3 clinical trials.”

At the time of the presentation, the data generated to date were from two multi-center, open-label studies that have enrolled a total of 304 patients. Safety data were based on the entire patient population, while pharmacodynamic data were based on 179 patients who had mostly completed six months of treatment at European and U.S. clinical sites. Of those, 89 treatment-naïve CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The mean Hgb level was 10.2 g/dL at study entry and was increased to >11 g/dL following an initial dose of Hematide. In the maintenance-conversion study, 90 patients previously treated with Epoetin alfa were switched to Hematide once every four weeks. The mean baseline Hgb level, which was 11.5 g/dL at baseline, was maintained within +/- 1.0 g/dL at the end of six months of treatment. Hematide was generally well tolerated and compatible with adverse events usually observed in patients with chronic kidney disease, with 6 percent of patients reporting adverse events possibly related to Hematide such as fatigue, rash and hypertension and 0.7 percent of patients reporting serious adverse events possibly related to Hematide (one transient ischemic attack in a patient with history of atrial fibrillation, and one moderate infusion reaction in a patient who responded to outpatient intervention).

About Hematide

Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor. The product is being developed for treatment of anemia in patients with chronic renal failure and cancer patients receiving chemotherapy.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company developing novel peptide-based drugs to improve the treatment of serious and often life-threatening conditions. Affymax’s lead product candidate, Hematide™, is currently in Phase 2 clinical trials for the treatment of anemia associated with chronic renal failure and cancer. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding the timing, design and results of the Company’s clinical trials and drug development program, the timing and likelihood of the commercialization of Hematide. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.
Contacts

source:home.businesswire.com

Affymax® Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide™ for the Treatment of Anemia

PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY) today announced that additional Phase 2 clinical trial results for Hematide™ were presented at the European Renal Association-EDTA Congress being held in Barcelona, Spain by Iain C. Macdougall, M.D., a Hematide investigator from Kings College, London. Dr. Macdougall’s poster included data in previously-treated dialysis patients and treatment naïve, non-dialysis patients which demonstrated that mean hemoglobin (Hgb) levels could be maintained and corrected, respectively, with once monthly Hematide.

Specifically, the data showed that in non-dialysis patients an initial range of doses from .025 mg/kg to .075 mg/kg of Hematide, in conjunction with dose adjustments, is adequate to increase Hgb in anemic patients with renal failure when administered monthly. In addition, intravenous and subcutaneous dosing appeared to result in a similar Hgb increase.

“These data support further investigation of the versatility and flexibility of once-per-month Hematide in terms of starting doses and route of administration,” said Robert Naso, Ph.D., executive vice president of Research and Development at Affymax. “These results demonstrate that a narrow target range of hemoglobin levels can be reached with different initial Hematide doses. We are pleased to have such thorough evaluation of the product as we prepare for pivotal Phase 3 clinical trials.”

At the time of the presentation, the data generated to date were from two multi-center, open-label studies that have enrolled a total of 304 patients. Safety data were based on the entire patient population, while pharmacodynamic data were based on 179 patients who had mostly completed six months of treatment at European and U.S. clinical sites. Of those, 89 treatment-naïve CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The mean Hgb level was 10.2 g/dL at study entry and was increased to >11 g/dL following an initial dose of Hematide. In the maintenance-conversion study, 90 patients previously treated with Epoetin alfa were switched to Hematide once every four weeks. The mean baseline Hgb level, which was 11.5 g/dL at baseline, was maintained within +/- 1.0 g/dL at the end of six months of treatment. Hematide was generally well tolerated and compatible with adverse events usually observed in patients with chronic kidney disease, with 6 percent of patients reporting adverse events possibly related to Hematide such as fatigue, rash and hypertension and 0.7 percent of patients reporting serious adverse events possibly related to Hematide (one transient ischemic attack in a patient with history of atrial fibrillation, and one moderate infusion reaction in a patient who responded to outpatient intervention).

About Hematide

Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor. The product is being developed for treatment of anemia in patients with chronic renal failure and cancer patients receiving chemotherapy.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company developing novel peptide-based drugs to improve the treatment of serious and often life-threatening conditions. Affymax’s lead product candidate, Hematide™, is currently in Phase 2 clinical trials for the treatment of anemia associated with chronic renal failure and cancer. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding the timing, design and results of the Company’s clinical trials and drug development program, the timing and likelihood of the commercialization of Hematide. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.
Contacts

source:home.businesswire.com