FDA asks Genentech to strengthen label warning for Xolair.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. announced Feb. 21 that it has requested Genentech add a boxed warning to the product label for Xolair (omalizumab) to emphasize that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis anaphylaxis (ăn'əfəlăk`sĭs), hypersensitive state that may develop after introduction of a foreign protein or other antigen into the body tissues. . Anaphylaxis may include trouble breathing, chest tightness, dizziness, fainting, itching itching or pruritus Stimulation of nerve endings in the skin, usually incited by histamine, that evokes a desire to scratch. It is often transient and easily relieved. Pathological itching with skin changes usually signals dermatologic disease. and hives hives (urticaria), rash consisting of blotches or localized swellings (wheals) of the skin, caused by an allergic reaction (see allergy). The swelling is caused by distention of the skin capillaries and escape of serum and white cells into the skin and tissues. , and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide a Medication Guide for patients to strengthen the existing warning for anaphylaxis. Xolair was approved in 2003 to treat adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen aer·o·al·ler·gen n. Any of various airborne substances, such as pollen or spores, that can cause an allergic response. (pollen, grass or dust) and whose symptoms are inadequately controlled with inhaled in·hale v. in·haled, in·hal·ing, in·hales v.tr. 1. To draw (air or smoke, for example) into the lungs by breathing; inspire. 2. steroids. In clinical trials, Xolair decreased the rate of asthma exacerbations, which were defined as a worsening of asthma that required treatment with systemic corticosteroids Corticosteroids, Systemic Definition Corticosteroids are a group of drugs which are chemically related to the hormones produced by the adrenal glands as a response to adrenocorticotropic hormone (ACTH), but excluding the sex hormones that are produced or a doubling of baseline inhaled corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and dose. Anaphylaxis was reported following administration of Xolair in clinical trials and was therefore, discussed in the initial product labeling. The cases were reported at a frequency of approximately one in a thousand patients (0.1%). Due to the nature of continued reports in the post-marketing experience, including their life-threatening potential, frequency and the possibility for the delayed onset of anaphylaxis, FDA has now requested that Genentech add the boxed warning and strengthen the existing warning. As the agency gains experience and collects data about a marketed product the determination may be made to strengthen the product label to ensure that consumers are aware of newly identified significant risks. The strengthened warning includes the possibility of a patient developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours after the dose is given. Health care providers should be prepared to manage life-threatening anaphylaxis following Xolair administration and observe patients for at least two hours after an injection. Following administration of Xolair, patients should also carry and know how to initiate emergency self-treatment for anaphylaxis. For further information and a copy of the health care professional sheet, go to hittp://www.fda.gov/cder/drug/infopage/omalizumab/default.htm. |
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