Accumulating risk of side effects for diet drugs Alli and Xenical
Public Citizen, a nonprofit consumer advocacy organization has filed a petition with the FDA on Thursday, citing that there have been 47 cases of acute pancreatitis and 73 cases of kidney stones along with some rare cases of liver failure in those patients who had taken the diet drugs.
Alli had been granted approval in 2007 as an over-the-counter drug. Xencial had been granted approval in 1999 and does require a prescription. Previously the FDA had banned two top market pills Fen-phen and ephedra due to the possibility of deadly side effects.
GlaxoSmithKline who manufactures the drug states that Alli is the most studied weight loss drug. This includes 100 clinical studies that consisted of more than 30,000 patients.
In May of 2010, the FDA had announced that it would require warnings on both diet drugs indicating liver injury possibility.
Currently, Canadian researchers an increase in kidney damage in patients taking the drug. Researchers looking through Canadian health data had discovered that 0.5 % of patients prescribed the drug were hospitalized for kidney problems in the year before treatment. That rate had gone up to 2% after patients had been on the drug for one year.
The drugs blocking around one-third of fat enzymes in which enter the body. The fat goes through the body to the gastrointestinal tract until it becomes expeld. Fat soluble vitamins which include A and B are also blocked.
The pamphlets that come with Alli note that this drug is only expected to lose five to ten pounds within six months. However, there are some adverse reactions that have been reported in Alli. These include leakages and oily discharges which could produce soiled underwear. The marketing materials did suggest to maintain meals under 15 grams of fat to avoid this issue.
Public Citizen is requesting the FDA due have these drugs removed from the market due to reappearing reports and studies of adverse events to the liver, kidneys and pancreas. These are serious side effects but it is important to note these affects have occurred in a small portion of the 40 million people who take these drugs.
Numerous experts due agree that these side effects are rare. However, it has not been made clear as to which patients taking these drugs may have severe side effects.
Monique Paulwell of Bosie Maryland had taken Alli and related her experience with Alli. She states she had taken Alli only four times when she began experiencing fatigue, appetite loss, constant headache and jaundice.
Ms. Paulwell had a full range of tests and was notified her liver had been attacked. Upon admittance to the hospital she was told she had 48 hours to live. She had needed a liver transplant to save her life.
In a statement released by the drug manufacture they wish to ensure that consumers and physicians understand the safety profile of Xenical and Alli. They are constantly observing the safety and do share all vital information with regulatory agencies.
According to Dr. Donald Hensrud, associate professor of nutrition and preventive medicine at the Mayo Clinic in Rochester, Minnesota, those people who are overweight are already at risk for liver disease. Therefore, it may not be the medication. It could be that people who would likely take these medications would already experience these effects. The data is not consistent.
Currently, it is not known if the FDA will accept this latest petition from Public Citizen's. Some experts feel that the market instead of the FDA will decide the drugs fate.
Keith Ayoob, a registered dietician and director of the nutrition clinic at the Rose R. Kennedy Center at theCollege of Medicine states that Alli is going to fade away on its own
Sales of these diet drugs have declined greatly in the last ten years. Alli sales in 2007 was $145 million and at mid 2010 was only at $84 million. These figures come from a report released from Public Citizen.
Some natural herbs that are noted to work the best for weight loss include:
Aloe cleans the digestive system to aide in weight loss.
Bee Pollen curbs appetite and increase metabolism.
Astragalus promotes absorption of nutrients and boosts energy.
Fennel decrease appetite and cleans fat and mucus from intestinal tract.
Green tea burns fat.
Plus there is always seeking the advice of a nutritionist who can inform you of what type of foods or health choices, aide you in devising a proper diet plan.