New FDA Drug Apporvals

Beginning in this issue of Healthwatch, we will highlight some of the newest FDA-approved drugs that may be of interest to our readers. We hope you'll find this column helpful.

Celexa^tm - July 1998

Forest Laboratories' and Parke-Davis' Celexa^tm (citalopram HBr) has been approved for the treatment of depression.

A highly-selective serotonin re-uptake inhibitor (SSRI), Celexa^tm is the best-selling antidepressant in 13 countries, including eight in Europe, where other SSRIs are also available.

The antidepressant effects of Celexa^tm have been evaluated in several large, placebo-controlled trials, as well as a number of clinical studies comparing it with tricyclic antidepressants (TCAs) and other SSRIs. Results from these studies show that treatment with Celexa^tm consistently and significantly improves symptoms of depression, regardless of patient age, race, or gender. In addition, two six-month, double-blind, placebo-controlled studies have shown Celexa^tm is significantly more effective than placebo in preventing relapse of depression.

Effexor® - March 1999

Wyeth-Ayerst Laboratories' Effexor® XR (venlafaxine HCl) Extended-Release Capsules have been approved for the treatment of Generalized Anxiety Disorder (GAD). The drug is already indicated for the treatment of depression, and was first approved in 1993.

Effexor® XR is the first and only antidepressant proven effective in relieving GAD. Generalized Anxiety Disorder is one of the most prevalent anxiety disorders, estimated to affect approximately five percent of people; nearly two thirds of whom are women.

People with GAD experience excessive anxiety and worry about everyday routine life events. Other common symptoms include restlessness and feeling on edge, easily tired, having trouble concentrating, being irritable and experiencing muscle tension and sleep disturbance.

Celebrex^tm - February 1999

G.D. Searle & Co.'s and Pfizer Inc.'s Celebrex^tm (celecoxib) is now available in the United States to relieve the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA).

Celebrex^tm was designed using advanced molecular technology. In the body, there are two enzymes that are called COX-1 and COX-2. COX-1 helps regulate normal cell function in the stomach and blood. COX-2 plays a role in causing arthritis pain and inflammation. It is believed that Celebrex^tm works by primarily inhibiting COX-2 and, at therapeutic doses, does not inhibit COX-1.

Typical non-steroidal anti-inflammatory drugs (NSAIDs) inhibit both COX-1 and COX-2. Use of these medications may lead to stomach ulcers and other serious complications, such as gastrointestinal bleeding. In fact, a recent study estimates that these complications cause 107,000 hospitalizations and 16,500 deaths each year in the U.S.

Material taken from pslgroup.com/DOCGUIDE.HTM