September 07, 2005 - FDA -

CDER informed about the latest revision of labeling information for Xenical (oral pills for treating obesity), which was approved on September 02, 2005 after considering and evaluating the additional information on the side effects and adverse reaction of Xenical treatment.

The previous versions of Xenical labels contained information on the gastrointestinal symptoms, such as oily spotting, flatus with discharge, fecal urgency, oily or increased defecation as the major adverse reaction to treating obesity with Xenical.

Now the Adverse Reactions section is supplemented with data, concerning other clinical studies and post-marketing surveillance, revealing new possible side effects of Xenical treatment. They mostly concerns increased level of sensitivity or hypersensitivity, resulting in such unpleasant conditions as pruritus (itching), urticaria or nettle rush and bronchospasm.

Besides, the new Xenical label regards decreased level of prothrombin when Xenical treatment is combined with anticoagulants as well as cases of hepatitis, though the relationship between Xenical and hepatitis is not yet proved. All the cases with the above said side effects are mentioned as the “rare cases” without reporting the actual number of patients, experienced such adverse effects.

In general the Xenical label has been revised for six times after the initial approval by FDA in 1999.

The full text of new Xenical label is available at the following address: www.fda.gov/cder/foi/label/2005/020766s021lbl.pdf

What is what? Xenical is the oral pill for treating the obesity in people. This drug is manufactured by Hoffman-LaRoche Inc. and has been approved by FDA in April 1999. Xenical helps people with obesity to loose their weight. The reason for obesity is mainly in the food, containing too much fat or calories. All these calories after digestion in stomach stay in human body, causing the gaining of weight. Xenical works to block the fat from being digested, thus it does not stay in the organism. Xenical can block up to 30% of all fat, coming into the organism with food, thus it is recommended to combine Xenical treatment with low calorie diet.

Center for Drug Evaluation and Research (CDER) is the branch institution of Food and Drug Administration (FDA), dealing with the approving procedure for all new drugs and medications for American market as well as permanent control for quality of approved medicines and their compliance to the state regulatory acts.

Nick

---

External resources
http://www.fda.gov

(C) ePillz.com, All rights reserved.
This material may not be published, broadcast, rewritten, or redistributed in any form.

Your Feedback for This Article

Nickname: Input code the below: