New Schizophrenia Drug Approved in the U.S.
U.S. Food and Drug Administration (FDA) has approved Invega (paliperidone) for treating schizophrenia. Invega is a first-in-class (new molecule drug), which this is the first drug of its kind in the therapeutic category. Invega is an active metabolite of a drug already available for treating schizophrenia, risperidone. Common side effects included the following: Restlessness, Extrapyramidal symptoms (movement disorders), Rapid heart beat, and Sleepiness.
You may have first read about this drug in clinical trials here on the Mental Health Source Page. According to the FDA, it approved Invega based on 3 placebo-controlled clinical trials conducted for 6 weeks in North America, Europe and Asia and involving 1665 adult patients / human subjects. Based on clinical trial results, recommended dose range of Invega is 3mg to 12 mg a day.
Invega is also an atypical antipsychotics that have an increased rate of death compared with placebo in elderly patients with dementia-related psychosis, as its official website and drug label is required to disclose:
IMPORTANT SAFETY INFORMATION FOR INVEGA™
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.
Since the drug’s clinical trials spanned 6 weeks, Invega has not been studied in controlled clinical studies longer than 6 weeks, which means patients taking this drug for more than 6 weeks (more than 1.5 months) should be periodically checked by a doctor.
You may learn more about Invega at its official website or visit the FDA website for the original approval press release.
Blog Carnival Edition for December 12, 2006
I want to thank everyone for your overwhelming response to this edition of our carnival. I personally visit each and every entry submission, and where warranted, comment on the entry. Thus unlike other carnivals where your entries simply get listed, you know your submissions are being read (at the very least, by me!). However, this also means my carnival posts tend to run long. We’ve received almost 20 entries in this edition! Unfortunately I had to eliminate entries that are not directly related to mental health, which is unrelated to the quality of the post.
This edition will be particularly lengthy. If you need to find a particular topic, you can hit the [Ctrl] + [F] keys to “find” the word you are looking for without scrolling down paragraphs of text. Read more
SSRI Suicide Risk Differs in Age of Patient
Wall Street Journal published on December 6, 2006 the article, “FDA: Antidepressants Lessen Risk of Suicidal Thoughts for Seniors”, stating that the FDA’s review of 372 clinical study data involving 11 antidepressants had shown that antidepressants may increase suicidal risk in adolescents, but this risk decreases in but that in older adults the risk declines.
Currently antidepressants carry a black box warning (reserved for life threatening risk) on the increased risk of suicidal thinking in children and teens who have taken antidepressants. This FDA review included at least 100,000 patients who have taken antidepressants across different age groups. In fact, the FDA suggested that in adults 65 years and older, antidepressants actually had a protective effect against suicide risk. This has to be welcome news to drug companies that manufacture antidepressants, although a new labeling change may not happen anytime soon.