MATEC-Missouri

Isentress (raltegravir) package insert updated Originally sent by the FDA on 11-2-11. Updates to the Isentress (raltegravir) package insert were approved on November 2, 2011 to include a new subsection in the Warnings and Precautions section and update the postmaketing experience section. Specifically, the following subsection was added to section 5 Warnings and Precautions:... 5.1 Severe Skin and Hypersensitivity Reactions Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction. In Section 6 Adverse Reactions, subsection 6.2 Postmarketing Experience, cerebellar ataxia and drug rash with eosinophilia and systemic symptoms was added. The Patient Counseling Information section and the patient labeling was also revised to incorporate these changes The following paragraph was added at the beginning of the Patient Counseling Information section: Patients should be informed that severe and potentially life-threatening rash has been reported. Patients should be advised to immediately contact their healthcare provider if they develop rash. Instruct patients to immediately stop taking ISENTRESS and other suspect agents, and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of a more serious reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis or severe hypersensitivity: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes, lips, mouth, breathing difficulty, and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on the right side below the ribs). Patients should understand that if severe rash occurs, they will be closely monitored, laboratory tests will be ordered and appropriate therapy will be initiated.

New Recomendations!!The Pediatrician's Role in Preventing HIV Infection. Pediatricians can play a key role in preventing and identifying human immunodeficiency virus (HIV) infection by promoting risk-reduction counseling and offering routine testing to adolescent and young adult patients, according to a new AAP policy statement, appearing in the November 2011 Pediatrics (published online Oct. 31). Despite great progress in treatment and continued efforts to screen targeted po...pulations, more than 1 million Americans were living with HIV in 2006, including 55,320 adolescents and young adults. Approximately 20 percent of Americans with HIV are unaware of their infection (for HIV infected youth, 48 percent are unaware of their infection). The AAP statement, "Adolescents and HIV Infection: The Pediatrician's Role in Promoting Routine Testing," recommends that pediatricians offer routine HIV screening. In communities where the prevalence of HIV in the patient population is more than 0.1 percent, screening should take place in pediatric offices for all adolescents, beginning at ages 16 to 18. In low-risk areas, screening is recommended for sexually active adolescents and those with other HIV risk factors, such as substance abuse. Pediatricians should provide an environment of tolerance and facilitate open discussions regarding sexual risk and sexual orientation. In addition, physicians should know and recognize the symptoms of HIV, understand state laws regarding testing of youth, and routinely assess patient sexual and substance use behaviors. Adolescents tested for other STIs should be tested for HIV at the same visit. Testing in emergency rooms and urgent care settings in high-risk areas can reach youth who do not receive regular preventative services. This statement promotes the goal of making discussions of sexual risk and HIV testing a routine part of adolescent health care. To view full text click here. Click here to read a related article: "Should all teenagers be tested for HIV?" in Yahoo News.

Did you know that the Midwest Aids Training and Education Center has been educating healthcare proffessionals for 23 years?