Day: 11/16/2012

Fact or fiction? What’s the truth about breast cancer risk?

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Experts at Dana-Farber explain the myths and misconceptions

From the food we eat to the products we use, there are a lot of misconceptions about what may increase the risk of developing breast cancer. There are known factors, like genetics, that are well documented. But what about lifestyle issues like having a nightly cocktail or using deodorant?

So, what is fact and what is fiction? Wendy Chen, MD, MPH, a breast cancer expert at Dana-Farber Cancer Institute in Boston says an overabundance of information can be confusing, and it often is incorrect to some degree. She tackles some of the more common questions about breast cancer risks, explains the studies behind the answers, and provides risk-lowering tips.

1. Soy may increase the risk of breast cancer returning.

False. Chen, who was part of a study that looked at over 9,500 American and Chinese breast cancer survivors who ate soy every day, says that eating soy may be linked to a lower risk of recurrence of breast cancer. “Many of my patients ask about eating soy and soy foods after being treated for breast cancer,” says Chen. “But the research shows that soy is not harmful.” The study showed that women who ate at least 10 mg of soy isoflavones per day had a 25 percent reduction in their recurrence risk, as well as a minor reduction in all-cause and breast cancer-specific mortality. “This study should be comforting to women who enjoy soy in their diet and don’t want to eliminate it after a breast cancer diagnosis. However, it’s important to note that it is still too early to say that eating extra soy adds any benefits,” says Chen.

2. Alcohol consumption can increase the risk of breast cancer.

True. Dana-Farber researchers found that women who consume one alcoholic drink a day may increase their risk for breast cancer. “Women need to consider the possible effects of alcohol on breast cancer risk when weighing the risks and benefits of alcohol consumption,” says Chen, who was the lead author of the study. “Our findings indicate that in some women, even modest levels of alcohol consumption may elevate their risk of breast cancer.” Chen and her colleagues analyzed data from over 105,000 women in the Nurses’ Health Study. Those who consumed three to six glasses of wine a week were 15 percent more likely to receive a diagnosis of breast cancer. Those who drank fewer than three drinks a week had no increased risk. “It’s important to emphasize that an occasional cocktail or glass of wine is fine,” says Chen. “It’s not just what people do in the short term but how much they regularly drink over a long period of time.”

3. Fertility treatments increase a woman’s risk of breast cancer.

False. According to a recent study from the National Institutes of Health, ovulation-inducing fertility treatments like Clomid and follicle stimulating hormone (FSH) do not significantly increase a woman’s risk of developing breast cancer. The research did, however, reveal differences in cancer risk after infertility treatment based on whether or not the patient became pregnant after treatment. “We get asked this question all the time,” says Chen. “As of now, I would say this particular study is reassuring for women. It found that women who took fertility drugs, but did not get pregnant, had a slightly lower risk of developing breast cancer compared to women who stayed pregnant for at least 10 weeks.” In those cases the women only had a slightly elevated risk that was still not higher than the general population. However, Chen emphasizes that larger studies are still needed.

4. Wearing deodorant can increase the risk of breast cancer.

False. According to the National Cancer Institute, there is no conclusive research linking underarm deodorants to breast cancer. Some research suggests that aluminum-based compounds, which are often used in antiperspirants, may be absorbed by the skin and cause estrogen-like (hormonal) effects which may contribute to the development of breast cancer. Other studies have shown no connection, The National Cancer Institute believes additional research may be needed. “I agree with the National Cancer Institute that more research is needed on this topic,” says Chen. “This question comes up quite often and while there is no clear connection, this is very much an individual choice.”

5. The bigger the baby the bigger the risk of getting breast cancer.

Possibly true. “This is a tough one because the research is still evolving,” says Chen. But the latest research shows that women who have larger babies have more than twice the risk of developing breast cancer than mothers who give birth to smaller infants. Researchers say that having a heavier baby may create a hormonal environment in pregnancy that could lead to the future development of breast cancer. They found that during pregnancy in women who have heavier babies, the ratio of estrogen to anti-estrogen is unusually high. The greater the level of estrogen, the higher the risk of breast cancer. However, Chen emphasizes, “women who have larger babies should not panic. There is definitely a need for further research.” She says it’s important that women focus on maintaining a healthy diet and weight level, before, during, and after pregnancy.

The best way to reduce breast cancer risk

“It’s important that women talk with their caregivers, their primary care doctor, their oncologist and their nurse practitioner,” says Chen. “They will be able to offer the best advice based on a woman’s individual needs. But in general, the best way for a woman to lower her risk of breast cancer is to get enough exercise, eat a well-balanced diet, maintain a healthy weight, drink alcohol in moderation, get a yearly mammogram if she is 40 or older, know her body and see her doctor if there are any noticeable changes.”

Source: Dana-Farber cancer institute.

 

 

Targeting cancers’ ‘addiction’ to cell-cycle proteins shuts down tumors in mice.

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In what they say is a promising and highly selective treatment strategy, scientists at Dana-Farber Cancer Institute have safely shut down breast cancer and a form of leukemia in mice by targeting abnormal proteins to which the cancers are “addicted,” according to a new study.

Even though the investigators genetically silenced the proteins or blocked them with a drug in normal as well as cancerous tissues, the animals remained healthy, they report in the Oct. 16 issue of the journal Cancer Cell.

The experiments targeted two related proteins, cyclin D1 and cyclin D3, that control cells’ growth cycle. Many types of cancer have abnormal amounts of the proteins, spurring the cells to grow too rapidly and form tumors. Peter Sicinski, MD, PhD, the paper’s senior author, said that the new results show that the cancers’ addiction to these proteins is an Achilles’ heel that can be safely targeted with an inhibitor drug that halts cancer growth or causes cancer cells to die.

Based on the results, the Dana-Farber scientists are planning a clinical trial, using an experimental cyclin-inhibiting drug called PD0332991 that has already been tested in a form of lymphoma.

“It was impressive to find that you could target a single cyclin protein and completely clear the leukemia and the mouse remained healthy,” said Yoon Jong Choi, PhD, the study’s lead author. “We’re excited because we think this approach is very promising” as a potential treatment for some cancer types, she added.

Some of the experimental mice had been engineered to develop a type of breast cancer driven by the ErbB2 oncogene. Others were modified to develop a type of T-cell acute lymphoblastic leukemia (T-ALL) that is driven by an abnormal pathway known as Notch1. In one experiment, human T-ALL cells were infused into mice that then developed the disease.

Blocking cyclin D1 in the mice drove the breast cancer cells into a kind of permanent retirement called senescence, an irreversible halt to their growth cycle. Inhibiting cyclin D3 in the T-ALL leukemia mice caused the cancer cells to self-destruct — a programmed death process called apoptosis.

In addition to these tests with mouse cancers, the scientists found that the cyclin-D-inhibiting drug had similar effects on human blood cancer cells in the laboratory.

Cyclin proteins act as “checkpoint” guards to control cell’s cycle of rest, growth and division. The D-cyclins determine when a cell begins making DNA in preparation for dividing to form new cells. In many types of cancer, an excess of cyclins allows cells to grow too fast and form tumors. Abnormal cyclins D1, D2 and D3 are found in breast, lung, endometrial, pancreatic, and testicular cancers and in multiple myeloma and other blood cancers.

In a key report in Nature in 2001, Sicinski showed that mice engineered to lack cyclin D1 were resistant to developing breast cancer. It wasn’t known for many years, however, whether knocking out cyclin D1 could halt an established cancer, or if breast cancer needed the protein long-term.

Also unknown was whether normal cells could get along without cyclin D1: If not, treating cancer by targeting the protein might be too dangerous.

To test these questions, Choi and her Dana-Farber colleagues developed a strain of mice with cyclin D proteins that could be inactivated at any time by treating the mice with the drug tamoxifen.

“By generating these ‘conditional’ knockout mice, we could address these questions for the first time,” said Choi. The effect was global, affecting all the body cells, not just those that were cancerous. When the cyclin D proteins were turned off using this technique, the addicted cancer cells shut down while normal cells were unaffected.

The authors say the results show that blocking cyclin D “represents a highly selective anticancer strategy that specifically targets cancer cells without significantly affecting normal tissues.”

Other authors of the report include Xiaoyu Li, MD, PhD, a co-first author, and Harald von Boehmer, MD, PhD, of Dana-Farber, and Andrew L. Kung, MD, PhD, formerly at Dana-Farber and now at Columbia University.

Source: Dana-Farber cancer institute.

 

 

Dana-Farber compounds or creates medication tailored for individual patients.

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News of unclean facilities and lax safety standards at the New England Compounding Center in Framingham has cast a public spotlight on compounding — a critical, but not widely known, sector of the pharmaceutical industry. To learn more about compounding, its role in cancer treatment, and its use at Dana-Farber, DFCI Online spoke recently with Sylvia Bartel, RPh, MHP, the Institute’s vice president of Pharmacy Services.

 

What is pharmaceutical compounding?

It’s the preparation of sterile products used to treat patients intravenously. Such medications could be chemotherapy agents, antiemetics (which prevent nausea and vomiting), support medications, or vaccines.

Does Dana-Farber’s pharmacy do compounding?

Yes. The dose of chemotherapy a patient receives is based on his or her height, weight, and individual health circumstances. Because those factors vary from patient to patient and visit to visit, we prepare patient-specific doses on-site.

What are the main types of medications compounded here?

In general, they’re chemotherapy agents and biotherapies (drugs that stimulate the body’s immune system defenses) that treat a patient’s cancer. We also prepare antiemetics, as well as intravenous fluid solutions that could contain potassium or magnesium to prevent the depletion of these nutrients in patients receiving chemotherapy.

Does Dana-Farber use products from the New England Compounding Center?

The only products we’ve purchased from the New England Compounding Center are two topical solutions (agents applied to tissue) used in gynecologic procedures.

What is done to ensure the safety of products compounded here?

We have numerous safeguards to ensure the proper preparation of sterile products. We train and monitor our staff in correct preparation techniques. We routinely test staff members’ sterile technique and the work environment for microbial growth. We’ve implemented a series of quality-control checks and report regularly to the Institute’s Infection Control Committee.

What specific safety precautions are in place?

We follow USP 797, a set of regulations developed by the United States Pharmacopeial Convention, a scientific organization that sets standards for the purity of medicines. The standards govern the preparation of sterile products in “clean rooms” where dust and foreign matter is kept below certain levels. Products are prepared within biological safety cabinets within the clean rooms. Before entering a clean room, the staff washes their hands and put on special clothing, much like that used in an operating room. Clean rooms undergo specific cleaning procedures on a daily, weekly, and monthly basis, and we routinely test surfaces from to ensure there is no microbial growth.

Watch the video on youtube.URL: http://www.youtube.com/watch?feature=player_embedded&v=Z-O8NUPwywo

Source: Dana-Farber cancer institute.

Recurrent Erythema Migrans Represents New Lyme Infection.

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In a study involving 17 patients with recurrent erythema migrans, the implicated strains of Borrelia burgdorferi differed between the first and second episodes.

Lyme disease — infection with the tickborne spirochete Borrelia burgdorferi — is becoming more common, and its geographic zone is enlarging. The infection has protean manifestations and has been blamed for chronic symptoms of arthritis and fatigue. The most common initial symptom is erythema migrans (EM), a target-like lesion. Some patients, despite appropriate antibiotic treatment, experience recurrent EM. Distinguishing reinfection from relapse in these individuals can be difficult, and the issue remains controversial.

To explore this matter, researchers compared B. burgdorferi isolates from the skin or blood of adults with recurrent EM (17 patients, 22 paired consecutive episodes). All patients were treated with standard courses of antibiotics during each episode, with subsequent resolution of lesions.

Molecular typing of the isolated strains of B. burgdorferi, including analysis of the gene governing an outer-surface protein, revealed that in all of the paired EM episodes, the two episodes were associated with different strains. All repeat episodes were due to reinfection rather than relapse.

Comment: As noted by an editorialist, this study adds to the evidence that in antibiotic-treated patients, recurrent EM is caused by reinfection rather than by relapse of the original infection. The findings offer no real surprises: EM generally appears days to weeks after the offending tick bite. However, many patients with proven Lyme disease never experience (or notice) EM, and this study does not resolve the question of relapse or new infection in individuals with recurrent systemic symptoms.

Source: Journal Watch Infectious Diseases

 

 

 

 

Adjuvant Radiotherapy for High-Risk Prostate Cancer.

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At median follow-up of 10.6 years, postoperative radiotherapy improved biochemical progression-free survival, but not clinical disease progression.

The goal of adjuvant radiotherapy after radical prostatectomy is to sterilize the prostatic bed and, in selected settings, regional nodes to decrease the potential for local recurrence and, ultimately, reduce the systemic spread of the disease and improve survival. Recent randomized trials have shown that in patients with T3 disease or positive surgical margins, postoperative radiotherapy to the surgical bed improves local control and biochemical (prostate-specific antigen) progression-free survival (PFS).

One of these trials, by the Southwest Oncology Group (SWOG), demonstrated that adjuvant radiotherapy versus observation significantly reduced risk for distant metastases and improved overall survival (J Urol 2009; 181:956). However, another one, by the European Organisation for Research and Treatment of Cancer (EORTC) did not show such an overall survival benefit. The EORTC study reported results after a median 5-year follow-up of 1005 patients (age, 75) with pathologic stage PT2-3,N0 and at least one of the following risk factors: positive surgical margins, capsular perforation, or seminal vesicle invasion (Lancet 2005; 366:572).

Now, after a median 10.6 years of follow-up, the EORTC investigators report that patients who received adjuvant radiotherapy versus observation continued to achieve improved biochemical PFS (the primary end point) with similar severe late toxicity. Patients who received radiotherapy also achieved improved local–regional control and were less likely to receive subsequent hormonal treatment. However, no intergroup differences were observed in either overall survival or distant metastases, and the initial observation of a significant improvement in clinical disease progression was not maintained. Patients with pT3 disease and positive surgical margins achieved the greatest benefit from adjuvant radiotherapy.

Comment: The discordant findings of the EORTC and SWOG studies on overall survival continue to be the subject of debate, and the larger clinical issue regarding the role of immediate adjuvant radiotherapy versus salvage radiotherapy was not addressed, though it is the subject of ongoing clinical trials. As noted by editorialists, the EORTC trial showed that adjuvant radiotherapy resulted in acceptable long-term morbidity and quality of life as well as reduced the use of subsequent androgen deprivation therapy (ADT) by half, although the timing and clinical setting in which ADT is administered remains controversial.

Source: Journal Watch Oncology and Hematology

 

Once-Yearly Zoledronic Acid for Men with Osteoporosis.

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This drug lowered the incidence of radiographic, but not clinical, vertebral fractures.

In a 2007 study, once-yearly infusions of the bisphosphonate drug zoledronic acid (Reclast, Aclasta) lowered the incidence of fractures in postmenopausal women (JW Gen Med May 2 2007). Now, in another industry-sponsored randomized trial, 1199 men (age range, 50–85) at high risk for fractures received zoledronic acid (5-mg dose, given intravenously at baseline and at 12 months) or placebo. The study was open to men with osteoporosis defined by bone-density testing and to men with osteopenia plus one to three mild-to-moderate vertebral fractures identified by lateral spine radiographs.

At 2 years, the proportion of men with new radiographic vertebral fractures was significantly lower in the zoledronic acid group than in the placebo group (1.6% vs. 4.9%). A small difference in incidence of symptomatic vertebral or nonvertebral fractures (1.0% vs. 1.8%) did not reach significance. About 20% to 25% of zoledronic acid recipients developed fever, myalgia, or arthralgia (compared with about 5%–10% of placebo recipients), but the duration of these adverse effects was not reported. No cases of jaw osteonecrosis or atypical femoral fractures were noted, but myocardial infarction occurred in nine zoledronic acid recipients and in two placebo recipients (P=0.03).

Comment: A once-yearly infusion of zoledronic acid significantly lowered the incidence of radiographic vertebral fractures, but not clinical fractures, in this 2-year study in men. Infusions of this drug are known to cause transient flu-like symptoms; however, the small excess of myocardial infarctions was unexpected and is of some concern. In the trial in women that was cited above, zoledronic acid recipients experienced a higher incidence of serious atrial fibrillation (but not myocardial infarctions).

Source: Journal Watch General Medicine

 

If Possible, STEMI Patients Should Go Straight to a Cath Lab.

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Within a system designed to reduce time to reperfusion, mortality was lower in patients transported directly to a PCI-capable center than in those transferred from a non–PCI-capable center.

In the city of Ottawa, emergency medical system providers trained in electrocardiogram interpretation can triage patients with ST-segment-elevation myocardial infarction (STEMI) directly to a center with percutaneous coronary intervention (PCI) capability. In a registry study, investigators compared outcomes in 822 patients transported directly to a PCI-capable hospital with those in 567 patients transported initially to a non–PCI-capable hospital, then transferred for primary PCI.

The median door-to-balloon time was significantly shorter in patients transported directly for PCI (66 minutes) than in those transferred for PCI (117 minutes). At 180 days, all-cause mortality was lower in directly transported patients than in those first taken to a non–PCI-capable hospital (5.0% vs. 11.5%; P<0.001). After multivariable adjustment, direct transfer was associated with about a 50% reduction in mortality risk (odds ratio, 0.52; P=0.01).

Comment: This study strengthens evidence that standardized geographic protocols designed to reduce time to reperfusion for ST-segment-elevation myocardial infarction reduce mortality. The importance of prehospital STEMI diagnosis and systems for rapid transport and treatment are now reflected in guideline recommendations (JW Cardiol Jan 6 2010), and implementation of these practices should be a public-health priority.

Source: Journal Watch Cardiology

Poor Physical Performance Associated with Dementia, Again.

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The “oldest old” are more likely to have dementia if they have physical impairments.

Poor physical performance and impaired cognition have been associated with each other in both cross-sectional and prospective analyses. This study adds support for the connection, focusing on a specific population aged 90 and older. The 629 participants (mean age, 94; 73% women; 74% with more than a high school education) in the main analysis were part of a cohort-based study of aging. Between 2003 and 2009, participants underwent assessment of physical performance, including objective measures of walking speed, ability to arise from the seated position, balance, and grip strength.

Dementia was diagnosed in 162 participants (25.8%) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria using neurological evaluation, a cognitive screening test (Mini-Mental State Exam), and functional rating scales (Clinical Dementia Rating Scale and Functional Activities Questionnaire). Poor performance on each of the physical tasks was independently associated with an approximate doubling in the odds of all-cause dementia diagnosis. Secondary analyses that included 218 additional cohort members with partial physical performance datasets did not significantly affect the results.

Comment: Although these results are unique because of the age demographic of the participants, as the authors point out, the generalizability of the results may be challenged by the homogeneity of the study population of highly educated, Caucasian women aged 90 and older. Moreover, as with all cross-sectional studies, one cannot determine causation from these findings.

Source: Journal Watch Neurology

 

 

Novartis drug Exjade® recommended by CHMP for EU approval to treat patients with non-transfusion-dependent thalassemia syndromes .

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  • Exjade would be the first oral treatment approved specifically for patients with non-transfusion-dependent thalassemia (NTDT) syndromes 

 

  • Clinical data show Exjade significantly decreases iron burden in NTDT patients compared to placebo, with similar overall adverse event rate[1] 

 

  • NTDT patients accumulate excess iron, increasing their risk of complications, including liver fibrosis, cirrhosis, blood clots and bone and vascular disease[2]

 

 Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Exjade® (deferasirox) for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndromes. Exjade would be the first oral treatment in the European Union (EU) specifically indicated for the treatment of iron overload in patients with these types of thalassemia.

 

Results from the first prospective placebo-controlled study of iron chelation in NTDT patients, THALASSA, showed a significant dose-dependent decrease in iron burden compared to placebo[1]. In this pivotal study, Exjade was well tolerated, with an overall adverse event rate similar to the placebo arm[1].

 

Thalassemia refers to a diverse group of genetic disorders that affect red blood cell production, causing anemia. Unlike patients with other types of thalassemia, those with NTDT syndromes can live without regular transfusions, a significant cause of iron overload. However, even without transfusions, NTDT patients still accumulate excess iron through intestinal absorption, leading to debilitating health complications like liver fibrosis and cirrhosis, blood clots, bone disease, pulmonary hypertension and vascular and endocrine diseases[2],[3].

 

“Patients with NTDT have suffered the effects of iron overload without accurate diagnosis, clear treatment guidelines or specifically approved oral therapies,” said Hervé Hoppenot, President, Novartis Oncology. “The CHMP recommendation is an important step toward improving the outcomes of patients with this type of thalassemia.”

 

According to published studies, at least three quarters of a million people worldwide have NTDT syndromes, although as understanding of the disease increases, it is probable the number will grow[4],[5],[6]. Because NTDT patients are not symptomatic at birth, when most thalassemias are diagnosed, they are often underdiagnosed and undertreated[7]. Many complications associated with iron overload begin to appear as early as age 10 and become increasingly common as patients reach their 20s or 30s[8]. Most NTDT patients are of South and Southeast Asian, Mediterranean or Middle Eastern origin, with immigration broadening the global prevalence[7],[9].

 

The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 27 EU member states plus Iceland and Norway. Exjade has been approved to treat chronic iron overload in patients with NTDT in Canada and several other countries; further regulatory submissions are ongoing.

 

About Exjade

Exjade is an oral iron chelation therapy indicated for the treatment of chronic iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) in patients with beta thalassemia aged 6 years and older). It is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: patients with beta thalassemia major with iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) aged 2 to 5 years; patients with beta thalassemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older; and patients with other anemias aged 2 years and older[10].

 

It is approved in more than 100 countries including the US, Switzerland, Japan and countries comprising the EU. The approved indication may vary depending upon the individual country.

 

Exjade important safety information

Exjade is contraindicated in patients with an estimated creatinine clearance <60 mL/min, with hypersensitivity to the active substance or any of the excipients, or in combination with other iron chelator therapies. Exjade is not recommended in patients with severe hepatic impairment.

 

There have been postmarketing reports of acute renal failure, hepatic failure and cytopenias. Renal failure requiring temporary or permanent dialysis, renal tubulopathy and interstitial nephritis have been reported. Upper gastrointestinal ulceration and hemorrhage, sometimes fatal, have been reported. Caution should be used in elderly patients due to a higher frequency of adverse reactions. Exjade is not recommended in patients with a short life expectancy (e.g., high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events.

 

Skin rashes, serious hypersensitivity reactions, decreased hearing and lens opacities have been reported. The most common adverse reactions are nausea, vomiting, diarrhea, abdominal pain, rash, non-progressive increases in serum creatinine, increased transaminases, abdominal distension, constipation, dyspepsia, proteinuria and headache.

Please visit www.exjade.com for more information.

References

[1] Taher A, Porter J, Viprakasit V, et al. Deferasirox significantly reduces iron overload in non-transfusion-dependent thalassemia: 1-year results from a prospective, randomized, double-blind, placebo-controlled study. Blood. 2012. Published online before print May 15, 2012.

 

[2] Musallam KM, Cappellini MD, Wood JC, et al. Iron overload in non-transfusion-dependent thalassemia: a clinical perspective. Blood Reviews. 2012:26S:S16-S19.

 

[3] Musallam KM, Cappellini MD, Wood JC, Motta I, Graziadei G, Tamin H, Taher AT. Elevated liver iron concentration is a marker of increased morbidity in patients with ß thalassemia intermedia. Haematologica. 2011 Nov;96(11):1605-12.

 

[4] Vichinsky E. Hemoglobin E syndromes. Hematology Am Soc Hematol Educ Program. 2007;79-83.

 

[5] Weatherall DJ. The definition and epidemiology of non-transfusion-dependent thalassemia. Blood Reviews. 2012:26S:S3-S6.

 

[6] Vichinsky EP. Changing patterns of thalassemia worldwide. Ann NY Acad Sci. 2005;1054:18-24.

 

[7] Thalassaemia International Federation. The Thalassaemia International Federation’s (TIF) New Focus: Addressing the Management of Non-Transfusion-Dependent Thalassaemias (NTDT). Position Paper 5.2. March 20, 2012. Accessed at: http://www.thalassaemia.org.cy/pdf/NTDT_Position_Paper_Final.pdf.

 

[8] Taher AT. Age-related complications in treatment-naïve patients with thalassemia intermedia. Brit J Haematol. 2010;150:486-489.

 

[9] Taher A, Cappellini MD, Musallam KM. Recent advances and treatment challenges in patients with non-transfusion-dependent thalassemia. Blood. 2012;26S:S1-2.

 

[10] EMC. Summary of product characteristics: EXJADE 125 mg, 250mg, 500mg dispersible tablets. Last updated January 13, 2012. Accessed at: http://www.medicines.org.uk/emc/medicine/18805.

 

Source: Novartis newsletter.

 

 

FDA Investigating Reports of Deaths Tied to 5-Hour Energy Drink .

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The FDA is investigating 13 reports of deaths after people consumed 5-Hour Energy drink, the New York Times reports.

In the past 4 years, the agency has received 90 incident reports that cite 5-Hour Energy. Over 30 of these filings mentioned serious or life-threatening problems, such as myocardial infarctions, convulsions, and one spontaneous abortion. An FDA official told the Times that some of the reports may not contain enough information to determine whether the supplement played a role in the adverse event.

The drink, which comes as a 2-oz “shot,” contains about 215 mg of caffeine, according to Consumer Reports. Eight ounces of coffee may contain about half that amount, depending on the preparation method.

Recently, the FDA also acknowledged that it had received five fatality reports involving Monster Energy drink.

Source: New York Times