The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.
Merck has updated the drug's labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior.
FDA said it asked the Whitehouse, N.J.-based company to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it has not established a "causal relationship" between Merck's drug and suicidal behavior. An agency spokeswoman said the review was prompted by three to four suicide reports it received since last October.
It could take up to nine months before agency scientists can draw any conclusions, FDA said in a posting to its Web site.
The agency recently began notifying the public earlier about possible safety issues. The policy change came after the FDA was criticized for acting too slowly on information about the risks of Merck's painkiller Vioxx and, GlaxoSmithKline plc's diabetes pill Avandia.
Merck officials stressed that the FDA's inquiry is based on reports, not clinical studies - which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.
"We have no indication that anything about the mechanism of Singulair is consistent with these events," said George Philip, director of research and product development. "But because suicide is a life-threatening event we thought it was important to provide this information in the product label."
Merck said it recently added reports of suicide to Singulair's label, which already listed suicidal thinking and behavior as reported side effects.
In clinical trials of asthma patients, the most common side effects were headache, flu, abdominal pain and cough.
With sales of $4.3 billion last year, Singulair is used by millions of patients in the U.S, according to Merck. First approved in 1998, it's part of a class of asthma and allergy drugs that includes AstraZeneca's Accolate and Critical Therapeutics's Zyflo.
FDA said it is also reviewing reports of side effects with those drugs. Their labeling does not contain language about suicide.
"Patients should not stop taking Singulair before talking to their doctor," FDA said in its statement, adding that doctors should monitor patients for suicidal behavior and mood changes.
- Verbal fluency (how well you speak, read, write, and understand)
- Creativity (how original, imaginative, and resourceful you are)
- Executive function (planning skills and problem solving skills
- Exams in math, physics, chemistry, or economics, or in any other test that requires not only recall of information but application of recalled knowledge to new situations and problem solving
- Oral presentations, debates
- Essay tests in literature, history, social sciences, art
- Multiple-choice tests that emphasize rote memorization
- Short answer tests that don't involve much problem solving; that is, plain recall
just read this
I didn't know that
I didn't know how the tradition of Spring Break started so I looked it up. Some friends and I went to Panama City a few weeks ago and had a great time.
From the end of World War II until the 1980s, Fort Lauderdale, Florida, was a notorious spring break destination in the United States. On March 19, 2006, the New York Times reported that Fort Lauderdale's reputation as a spring break destination for college students started when the Colgate University men's swimming team went to practice there over break in 1935.[1] Fort Lauderdale became even more popular due to the 1960 film Where the Boys Are, in which college girls met boys while on spring break there.
Common practices
Spring break's notorieties include increased drinking and sexuality. Residents of the Fort Lauderdale area became so upset at the damage done by vacationers, that the local government passed laws restricting parties in 1985. At the same time, the National Minimum Drinking Age Act was enacted in Florida (and most of the rest of the United States), raising the minimum drinking age to 21 and causing many underage college vacationers to travel outside the United States for spring break. By 1989, the number of college vacationers fell to 20,000, a far cry from the 350,000 who went to Fort Lauderdale four years prior.[2]
Spring break party goers responded by moving to the more permissive community of Daytona Beach area (over 200,000 students traveled there each spring at its peak), but after Daytona's local government undertook similar measures, the crowds of the mid-1990s and early 2000s had fallen to a point where "a few students still come, but officials don't even estimate their numbers." Panama City Beach, Florida remains a popular spring break destination due to its relatively close proximity to many Southern colleges and driving distances. The locals in Panama City Beach welcome Spring Breakers every year, and is a major factor in the city's economy.
South Padre Island, Texas has since limited the Spring Break following suit with Fort Lauderdale and Daytona Beach.
Popular destinations outside the United States include Cancun, Cabo San Lucas, Acapulco, Mazatlan, Puerto Vallarta, Jamaica, and the Bahamas. Tour agencies have not only cited the lower drinking ages in these places, but also the fact that the drinking ages are poorly enforced.
.
Best Way to a Killer Middle
Good news! You don't have to kill yourself with crunches to get a sleek stomach.
But it turns out that you do need to get your heart rate up. Aerobic exercise is key to banishing both the deep belly fat and the superficial doughy stuff that give you a pooch.
Going the Distance
How much aerobic exercise does it take to trim a tummy? In a recent study, overweight people who jogged, cycled, or hit the elliptical for about 3 hours a week had the best belly-busting outcome -- as long as they exercised at an up-tempo pace. Not ready to go that distance yet? Try walking briskly for just a couple of hours per week. That's enough to at least keep belly swelling in check.
It's All Good
It's almost a guarantee that people who do nothing as they age will be watching their waists grow along with their risks of diabetes and cardiovascular disease. So whether you do it a little or a lot, sweat is still a sweet way to manage your middle. In addition to up-tempo exercise, try these tips and tools for training your body and toning your stomach.
work
It was another long nite at work and there were a lot of older people that were having lots of problems with their insurance. I really hope that by the time I am a senior citizen, things will be easier, medically. I feel so sorry for the ones that get turned down and really need the medicine. And then you see the obvious 'dopers' get theirs free.
in need of sleep
What every college student should know about ‘The All-Nighter'
Can college students pull an ‘All-Nighter'-staying up the entire night to cram for a test-and have their brains function close to normal the next day? The majority, of course, think so ...
But several studies clearly show brain function takes a big hit after an all-nighter. Memory systems and frontal lobe function especially suffer.
Moderate Sleep Deprivation Produces Impairments in Cognitive and Motor Performance Equivalent to Legally Prescribed Levels of Alcohol Intoxication
According to the article, after 19+ hours without sleep, performance on cognitive tests reached levels equivalent to those associated with a BAC (blood alcohol concentration) of 0.1 percent. In the majority of states, a BAC of 0.08 percent is grounds for a DUI-an arrest for driving under the influence of alcohol! This means that if you pull an all-nighter, you don't have enough brain function to legally drive a car.
As mentioned above, memory systems and frontal lobe function markedly suffer after an all-nighter. The functions of memory systems are obvious, but what do the frontal lobes do? They are brain regions important for:
Frontal lobe function is therefore particularly important for:
Frontal lobe function is less important in these:
However, it is worth repeating that after an all-nighter, all types of memory recall will be impaired regardless of the type of test you take.
Page 13 of 15 • Prev 1 ... 10 11 12 13 14 15 Next


