July, 19 2010
By: David Gutierrez
The HIV drug Videx (sold generically as didanosine) may cause fatal liver problems, the FDA has warned.
Since the drug’s initial approval, the agency has received 42 adverse event reports linking Videx and its delayed release version Videx EC to a rare liver disorder known as non-cirrotic portal hypertension. In four of these cases, patients died from liver failure or severe bleeding. Only three patients were able to fully recover from the condition, and all of those needed a liver transplant. Patients had been undergoing treatment with the drug for anywhere from months to years.
Although it has not yet been proven that the drugs caused the liver disorder, the FDA noted that there is definitely an association between the two.
In non-cirrotic portal hypertension, blood flow through a major vein in the liver becomes constricted, causing blood to back up into the esophagus. Veins in the throat can become so enlarged that they rupture, leading to serious and potentially fatal bleeding.
Although the FDA stated that the benefits for HIV patients still outweigh the risks, it warned that Videx patients should be closely monitored for any signs of portal hypertension. Furthermore, it noted that “the decision to use this drug … must be made on an individual basis between the treating physician and the patient.”
Videx was first approved in 1991, and the delayed release version was approved in 2000. The drug is a type of antiretroviral drug known as a nucleoside analogue, and slows the proliferation of HIV to prolong the onset of AIDS and extend the life of patients.
It has previously been linked to other forms of liver damage, especially in combination with other antiretroviral drugs including hydroxyurea and ribavirin.
According to a spokesperson for manufacturer Bristol-Myers Squib, worldwide sales of the drug amounted to $71 million in 2009.
November 16, 2009
By S. L. Baker
The appendix is a small, tube-like organ located in the lower right area of the abdomen and attached to the first part of the colon. Researchers have theorized this seemingly superfluous bit of our internal body is simply a remnant of the time when early humans ate a huge amount of plant matter. The appendix, the theory goes, once helped with fermentation and digestion of all that roughage ancient hominids consumed. But when it comes to modern-day humans, mainstream medicine says the appendix has no known function and is virtually useless. However, the latest research suggests it is this idea that should be thrown away — not the human appendix.
Sure, an appendix can sometimes become blocked and inflamed, a condition known as appendicitis. And if not treated, an appendix in this state can rupture and spread life-threatening infection into the body. So, following their belief the appendix is nothing but a potential liability, doctors are often willing and even enthusiastic about removing a perfectly healthy appendix.
A case in point: a study by University of Miami gynecologists and obstetricians, published in 2003 in the American Journal of Obstetrics and Gynecology concluded the removal of an appendix (a procedure dubbed an appendectomy) at the time of “benign gynecologic procedures does not increase postoperative complication rates or length of hospital stay.” So, based on the fact cutting out a healthy appendix didn’t result in longer hospital stays or more immediate post-surgery problems, the doctors recommended routinely including appendectomies in all abdominal hysterectomies in order to avoid any possibility of appendicitis in a woman’s lifetime.
But what if the appendix has remained in humans for thousands upon thousands of years for a reason? What if your appendix helps sustain health? What if it is better to keep all your original parts — including organs — when possible, and that includes your appendix? There’s growing evidence the appendix isn’t just a useless piece of tissue. And new research is showing it could, in fact, play an important role in keeping the gastrointestinal tract healthy and the immune system strong.
Recently, scientists have found evidence the appendix may play a role in helping the immune system by maintaining internal flora found in the human gut known as symbiotic bacteria. These bacteria live in symbiosis (meaning they maintain a close ecological relationship) with other organisms in the digestive tract. For example, symbiotic bacteria may work together to help break down fiber containing foods and they may also help produce vitamins.
In a study published October 22nd in the Journal of Evolutionary Biology, researchers from the University of Arizona College of Medicine and Arizona State University concluded that the appendix does have a purpose. It is a highly specialized organ that has been maintained in mammalian evolution for 80 million years or more. The reason? To harbor symbiotic bacteria essential for health. The scientists call the appendix a kind of “safe-house for symbiotic gut microbes” that probably evolved to preserve health-protecting internal flora during times of gastrointestinal infection. “This function is potentially a selective force for the evolution and maintenance of the appendix, and provides an impetus for reassessment of the evolution of the appendix,” the scientists stated.