An ongoing clinical trial of the asthma drug Xolair suggests that patients taking the medication may have an increased risk of blood clots, heart failure, stroke, cardiac arrhythmias and heart enlargement when compared to patients not treated with the asthma drug, the Food and Drug Administration said Thursday. The agency announced it was assessing the significance of the preliminary findings to determine if further regulatory actions are necessary to protect patients.
Omalizumab, marketed as Xolair, is approved as a treatment for adults and children older than 12 who suffer from moderate to severe asthma complicated by seasonal allergies. The concern over possible side effects has arisen out of a trial comparing 5,000 Xolair users and 2,500 asthmatics not taking Xolair over a five-year period. Xolair was approved by the FDA in 2003, and last year, brought its maker, Genentech, $517 million in revenues.
The FDA said that "interim data" provided by Genentech from that trial "suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events" among users of Xolair. The agency's announcement emphasized that no causal link between the drug and the adverse events has been established, and advised patients prescribed the drug not to discontinue its use at this time.
The FDA's announcement is termed an "early communication."
Unless the FDA calls a halt to the safety trial, it is expected to continue, with final results expected in 2012. The FDA in 2007 required Xolair's maker to include a "black box warning" -- the agency's highest level of consumer alert -- warning patients that Xolair may cause potentially fatal anaphylactic reactions.
Flomax is a name known by many, if not most, men suffering with an enlarged prostate gland. How could it not be?
It's one of the nation's most-prescribed drugs with a hefty marketing budget behind it. But Consumer Reports says it might not be the best choice for many patients, just the more expensive choice.
In an analysis of 60 studies of drugs that treat enlarged prostate, the much cheaper doxazosin came out on top. Using that drug instead of Flomax, Consumer Reports says, could save patients about $3,000 a year.
Getting a prescription filled doesn't do much good if you don't know how or when to take the drug.
A new study from Northwestern University suggests how un-illuminating many pharmacy-counter exchanges might be for those who speak only Spanish. Researchers there surveyed pharmacies in Texas and Colorado (which have had, for some time, large Latino populations) and Georgia and North Carolina (which have burgeoning Latino populations).
Of 764 pharmacies, only 43.3% could solidly offer instructions in Spanish, 21.7% offered some translation services and 34.9% offered no such services.
The Northwestern news release. The journal abstract, in the June issue of the journal Medical Care. Y Manual Merck de información médica para el hogar.
The abstract concludes: "The majority of pharmacies surveyed offered limited or no translation services. Lack of translation services is not isolated to rural areas or locations with a marginal Latino population. Spanish-speaking patients encounter barriers to acquiring instructions that support the safe and effective use of medications."
— Tami Dennis
Photo: Taking prescription drugs, such as the antidepressant Effexor, requires guidance.
Most people give their fingerprints little thought, simply assuming they're at the tips of their hands where they belong. And if they're undergoing treatment for head and neck cancer, like a recent traveler to the United States, they have considerably more important things to worry about anyway.
But that fingerprint assumption can make for a travel nightmare.
A cancer patient from Singapore who was attempting to visit relatives in the United States was held up for four hours in customs because officials couldn't detect his fingerprints. His chemotherapy drug, capecitabine, had caused them to disappear.
The traveler, known as Mr. S., finally got through, but he was advised to carry a doctor's note next time. One would imagine he figured that out sometime in the first hour.
His oncologist went beyond writing a single note, issuing a heads up to pretty much everyone about the possibility of fingerprint loss. His travel warning, in the form of a letter to the editor, was published online Tuesday in Annals of Oncology.
It concludes, in referring to patients taking the drug capecitabine: "These patients should prepare adequately before traveling to avert the inconvenience that Mr S was put through."
The letter also points out that others may benefit from long-term use of the drug. And, if so, more people could encounter trouble when traveling.
Here's some background:
Capecitabine (brand name Xeloda) is a common chemotherapy drug. Sometimes, it causes a reaction called hand-foot syndrome, especially when taken long term, leaving the palms and soles tender and red and making them swell and peel. (More on capecitabine from Rxlist.)
Other drugs can cause the condition as well, says Cancer.net, including cytarabine, floxuridine, fluorouracil, idarubin and liposomal doxorubicin.
Here's what Chemocare.com advises for managing the condition. Reducing friction and heat exposure is crucial. Those conditions, on top of the drug-caused effects on the capillaries, do not improve your chances of hassle-free traveling.
-- Tami Dennis
Photo: Don't make the airport travel experience more difficult than it needs to be. Carry a note from your doctor if you lack fingerprints.
Acid-suppressing drugs are routinely given to about half of all hospital patients. And while the drugs, specifically the ones known as proton pump inhibitors (Prilosec, Prevacid and Nexium among others), may cut down on the likelihood of gastric reflux and gastrointestinal bleeding or ulcers, they don't seem to do much for pneumonia risk.
A new study published today in the Journal of the American Medical Assn. finds that acid-suppressing drugs, most notably those proton pump inhibitors, are linked to an increased chance of hospital-acquired pneumonia.
This connection isn't exactly a bolt out of the blue. Other research has shown a link between such drugs and pneumonia as well.
But it does add impetus to the need to reexamine the routine administering of the medications.
And here's the abstract, or short version, of the new study.
The larger report concludes: "This study found that acid-suppressive medication use was associated with 30% increased odds of hospital-acquired pneumonia, and this result was significant for proton-pump inhibitor use.... Further scrutiny is warranted regarding inpatient prescribing practices of these medications."
Taking Viagra, Levitra or Cialis improves erectile function. That much we now know. Again.
What we still don't know is which medication works best.
At the request of the American College of Physicians, the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services, set out to assess the impotence drugs' effectiveness and their risk of side effects. Doctors apparently like to have as clear a picture as possible before prescribing the drugs to patients.
The report, released today, distills evidence from 126 randomized controlled trials of the drugs technically known as oral phosphodiesterase type 5 inhibitors. But only four trials compared sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis) against each other, making cut-and-dried conclusions difficult.
Researchers have a pretty good idea of the drugs' benefits. And of their risks -- most common are headaches, flushing, dyspepsia (indigestion -- here's an explainer from MedicineNet) and rhinitis (inflammation of the nose's inner lining -- and another explainer). They just can't tell doctors which one should be prescribed.
But the report does offer one-place-shopping for information on dose-response effect of the individual drugs (higher doses tended to get better results), plus less-conclusive assessments of injections, suppositories, topical treatments, hormones and drugs prescribed off-label. The researchers also tried to evaluate the usefulness of routine blood tests in identifying (and thus, treating) hormonal disorders. The limited amount of data made this problematic.
For most men, and their doctors, the report largely means: If you're looking for a thorough comparative summary of the data on these drugs, now you have one.
Of note, the big three drugs tended to work fairly well across the board. That is, they helped men regardless of the cause of erectile dysfunction. (Here's a primer on causes, courtesy of the Urology Channel.)
And men tended to prefer tadalafil (Cialis) over its cousins, partly because the drug's effects last longer.
The researchers wrote: "There is still insufficient information regarding the effectiveness and safety related to the use of different treatment modalities in various clinical subgroups of patients (e.g. diabetes, cardiovascular disease). Furthermore, there is insufficient data with regard to long-term adverse effects of oral ED medications that have been used by millions of users for over a decade."
Translation: We need more data, especially about how the drugs might affect men with diabetes and heart disease. And long-term data -- we definitely need more of that.
-- Tami Dennis
Photo: Viagra has been often discussed, but not often compared -- clinically speaking -- to its cousins Levitra and Cialis.
She writes: "In recent years Adderall and Ritalin, another stimulant, have been adopted as cognitive enhancers: drugs that high-functioning, overcommitted people take to become higher-functioning and more overcommitted."
She tells her story in some part through a recent Harvard graduate named Alex. He makes a compelling case for what can be accomplished with a little help.
Photo: Ritalin -- the little helper for people with attention deficit hyperactivity disorder and overworked, over-stressed students -- is going mainstream.
The birth-control shot, a popular contraceptive choice among teenagers, causes significant weight gain and an increase in body fat, according to a study published in the current issue of the American Journal of Obstetrics & Gynecology.
The shot is comprised of the drug depot medroxyprogesterone acetate, or DMPA, which is administered once every three months to halt ovulation. The contraceptive, also known by the brand name Depo-Provera, is used by about 2 million American women, including 400,000 teenagers. Its advantages are the infrequent administration along with the fact that it's inexpensive and has a low failure rate.
But the study, by Dr. Abbey Berenson and her colleagues at the University of Texas Medical Branch, found that women who used the contraceptive gained an average of 11 pounds and increased their body fat by 3.4% over three years. After the women switched to a non-hormonal contraceptive they began to slowly lose the weight and fat they gained. But women who switched to oral contraceptives after the shots gained an average of four more pounds over the next two years. The study included 703 women. Overall, the DMPA users were more than twice as likely as women using non-hormonal birth control to become obese over the next three years. The researchers are now conducting follow-up studies to determine which subset of women is most likely to gain weight on DMPA. Preliminary data from this study show that about 25% of women on the medication experience significant and potentially dangerous body composition changes.
Berenson says researchers aren't sure why DMPA seems to cause weight gain. No connections were found between the drug and caloric intake, fat consumption or amount of exercise. But, she said: "Women and their doctors should factor in this new data when choosing the most appropriate birth control method. One concern is DMPA's link to increased abdominal fat, a known component of metabolic syndrome, which increases the risk of cardiovascular disease, stroke and diabetes."
The birth-control shot is a staple of many public health clinics that serve low-income and teenage women. Though preventing unintended pregnancy is a worthy objective, public health officials also might want to ponder whether the potential advantages of this contraceptive outweigh its potential contribution to the nation's growing obesity rate and the many diseases linked to obesity.
The FDA has ordered a wide range of antidepressants to carry new warnings of an unusual but potentially deadly side effect seen most often in the first few weeks of treatment or when a patient increases dosages. The labels of two classes of new-generation medications for depression -- selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) must now notify patients that malignant neuroleptic syndrome has been linked to the use of these drugs.
Among the drug companies ordered to revise their labels to alert patients of the danger were those making Celexa, Cymbalta, Effexor, Lexapro, Paxil, Pexeva, Pristiq, Prozac, Venlafaxine and Zoloft. The orders were dated Feb. 4, but disseminated this morning in a public notice of FDA actions.
In malignant neuroleptic syndrome, patients experience muscle rigidity, extreme variations in body temperature and wild fluctuations of heart rate and blood pressure -- all signs of malfunction in the body's autonomic nervous system, which regulates involuntary body functions. Malignant neuroleptic syndrome has been associated with older antipsychotic medication such as haloperidol, lithium salts and risperidone. But the widespread use of SSRI and SNRI antidepressants has made this syndrome a more common and visible affliction.
With one in 10 Americans taking prescription antidepressants, medicines such as Zoloft, Prozac and Effexor are currently the most commonly prescribed class of drugs in the United States, just ahead of high-blood pressure medicine, according to the Centers for Disease Control. And SSRIs and SNRIs have become by far the most common types of antidepressant dispensed by pharmacies, driving a tripling of prescriptions since 1988.
Malignant neuroleptic syndrome is a rare but extremely dangerous condition that results in death in, by some estimates, 10% to 20% of cases. Until recently, it was so uncommon it was unlikely to be recognized in many emergency departments. But the widespread use of SSRIs and SNRI antidepressants had made this bizarre syndrome a more common affliction seen in emergency departments.
A Food and Drug Administration spokeswoman said this afternoon that she had not been notified of the labeling change and was unaware of what led to it. Watch this space.
Generic drugs for the treatment of heart disease are as effective as their brand-name counterparts, according to a study published today in the Journal of the American Medical Assn.
The study was aimed at addressing the common perception that generic versions of such drugs as beta-blockers, diuretics, calcium-channel blockers, antiplatelet agents, statins, ACE inhibitors and alpha-blockers are somehow different than brand-name drugs. Generic drugs are often much cheaper and insurers sometimes pay only for generic brands. Researchers at Harvard Medical School and Brigham and Women's Hospital examined 47 studies on the effectiveness of various cardiovascular medications. The majority of the studies found generic and brand-name drugs are equivalent. The researchers also looked at editorials and opinion pieces on the issue of brand-name-versus-generic and found more than half expressed a negative view of the interchangeability of the drugs.
Why would doctors prescribe expensive brand-name drugs when the evidence doesn't warrant it? One possibility, the authors of the paper say, is that financial relationships with brand-name pharmaceutical companies influence their opinions and prescribing practices.
Tami Dennis, who takes the word "skeptic" to previously uncharted territory, is the Times' Health and Science editor. She's adamant that pitches promoting awareness days, weeks or months are, by their nature, non-stories. And, because she's an adult, she refuses to use words like "veggies," "tummy" and "yummy."
Rosie Mestel, deputy Health and Science editor, studied genetics before abandoning flies, fungi and DNA for health/medical writing. Her hero is the biologist Ernst Haeckel, whose jellyfish paintings inspired snazzy chandeliers. Her favorite toast-spread is Marmite, a British delicacy made of yeast extract. Her least-favorite word is "millenniums."
Melissa Healy is a staff writer for the Health section reporting from Washington D.C. Healy's a veteran of The Times' National staff, having covered the Pentagon, Congress, poverty and social welfare, the environment, and the White House before shifting to Health in 2003. She writes frequently about mental health and human behavior, about federal health policy, prescription medication and ethics in medicine. More wonk than wellness freak, Healy chooses to believe in the health benefits of coffee and wine, and considers water a better work-out medium than beverage.
Karen Kaplan covers genetics, stem cells and cloning. She and colleague Thomas H. Maugh II comprise about 25% of the unofficial MIT-Alumni-in-Journalism Club, and she is proud to have taken more math (5) than English (0) courses in college. Her contributions to Booster Shots will, she hopes, appear more frequently than postings to her mommy blog.
Thomas H. Maugh II has been a science and medical writer at the Times for 23 years. Before that, he was on the staff of the journal Science for 13 years.
He has bachelor's degrees in English and chemistry from MIT and a doctorate in chemistry from UC Santa Barbara.
After a brief stint as a sports writer, Shari Roan turned to health journalism and has covered the topic for The Times for 18 years. She is the author of three books and the mother of two daughters, both teenagers who refer to her as a "health freak." She likes to jog, watch baseball and is very happy that dark chocolate contains some health benefit.
Jeannine Stein writes about fitness, sports medicine and obesity for the Health section. She’s a gym rat from way back and never met an elliptical trainer she didn’t like. Well, maybe one or two. She tempers exercise with a steady diet of reality television because she believes it’s all about balance.
Generic drugs for the treatment of heart disease are as effective as their brand-name counterparts, according to a study published today in the 