Generic Allegra

The onset of menopause signals more than just an end to a woman’s menstrual cycle.

The American College of Obstetricians and Gynecologists lists these changes that commonly affect women during menopause:

• Irregular periods, heavy bleeding or periods that stop.
• Hot flashes.
• Night sweats and difficulty sleeping.
• Vaginal dryness and reduced bladder control.
• Thinning, weakening bones.
• Moodiness, diminished memory and reduced concentration.

The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person’s mood, energy, and ability to function.

“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”

The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence.

Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.
Saphris is in a class of drugs called atypical antipsychotics. All atypical antipsychotics contain a boxed warning, the FDA’s strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis (a brain disorder that lessens the ability to remember, think, and reason). Saphris is not approved for these patients.

The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.

The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless (akathisia), decreased oral sensitivity (oral hypoesthesia) and drowsiness (somnolence).

The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia and weight increase.

Liver transplantation “holds increased risk” in adults who are very thin or very obese before surgery, research shows.

Patients undergoing liver transplantation who are underweight or very severely obese experience significantly higher rates of illness and death in comparison with patients in the middle weight categories, the researchers report in the journal Liver Transplantation.

Dr. Andre A. S. Dick, of the University of Washington Medical Center, Seattle, and colleagues investigated the impact of pre-transplant body weight on patient survival by reviewing data from the United Network for Organ Sharing on 71,446 liver transplants performed in adults from 1987 through 2007.

They found that subjects who were very thin were more likely to require a second surgery and to die from bleeding complications, compared with “control” patients in the middle weight range.

Transplant patients who were very severely obese had higher rates of death from infectious complications and cancer.

Being underweight and very severe obesity were “significant predictors of death,” Dick and colleagues note.

Moreover, patients at the extremes of body weight — both high and low — had costlier care; they used more intensive care unit services and had longer hospital stays, than patients in the middle weight categories.