Today's Vidyya contains three articles on safety, be it drug safety warnings or regarding medical device safety.
A warning has been added to the prescribing information for Serentil® to prominently advise clinicians that Serentil has been shown to prolong the QTc interval in a dose related manner, and drugs with this potential, including Serentil, have been associated with torsade de pointes-type arrhythmias and sudden death.
Serentil is now indicated only for schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs.
Rare cases of central nervous system disorders,
including demyelinating disorders such as multiple sclerosis, myelitis, and optic neuritis, have been reported in patients with rheumatoid arthritis who have received Enbrel therapy. Although the causal relationship to Enbrel therapy remains unclear, other tumor necrosis factor (TNF) antagonists administered to patients with multiple sclerosis have been associated with increases in disease activity.
Health professionals are being notified by the FDA of the potential for serious thermal injury and related complications associated with the use of microwave energy to treat benign prostatic hyperplasia (BPH). Although the use of microwave thermotherapy for the treatment of BPH has been demonstrated to be safe and effective, and more than 25,000 procedures have been performed, there are concerns about some unexpected procedure-related complications that have occurred.
In research news, scientists have sequenced the entire genome of a sexually transmitted bacterium, Ureaplasma urealyticum, that infects an estimated 60 percent to 80 percent of adults and, if passed on to newborn infants, can cause in them meningitis, pneumonia, and even death.
In other research news, inhaled corticosteroids are safe and effective for the long-term treatment of children with mild to moderate asthma, according to the "Childhood Asthma Management Program (CAMP)," a 5-year, 8-center study funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. The study appears in the October 12, 2000 New England Journal of Medicine (NEJM).
The articles in today's Vidyya are:
As always, we hope you enjoy the issue.