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Volume 1 Published - 14:00 UTC    08:00 EST    19-APR-2000      
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Back To Vidyya Pharmaceutical Industry News

U.S. FDA Grants Marketing Approval of Actonel(R) for Prevention and Treatment of Osteoporosis

Procter and Gamble and Aventis Pharmaceuticals announced on April 17 that the U.S. Food and Drug Administration (FDA) approved 5 mg Actonel(R) (risedronate sodium tablets) for the treatment and prevention of postmenopausal osteoporosis (PMO) and glucocorticoid-induced osteoporosis (GIO). Procter & Gamble, the inventor of Actonel, and Aventis Pharmaceuticals will market the drug collaboratively.

The approval of Actonel is important to health care providers for a number of reasons:

  • Actonel is the first osteoporosis therapy to consistently demonstrate a reduction in vertebral (spinal) fracture incidence in just one year of treatment.
  • Actonel significantly reduced the risk of new vertebral fractures by 65% in one year in postmenopausal women compared to a control group of women taking supplemental calcium and vitamin D.
  • Actonel was well-tolerated, even in patients with gastrointestinal (GI) diseases. The clinical trials for Actonel included patients with gastrointestinal (GI) disease-including ulcers, esophagitis, and heartburn-and those taking nonsteroidal anti-inflammatory drugs (NSAIDs), which often cause GI complaints. Almost 40% of patients in the trial had ongoing GI disease. Even among these patients, the incidence of GI side effects in Actonel treated patients was similar to that of patients taking placebo (sugar pill).
  • Actonel is also the first ever therapy approved for the prevention of glucocorticoid-induced osteoporosis (GIO) in men and women. This news is important for those men and women taking asthma medications and drugs such as prednisone for chronic diseases.

The efficacy of Actonel in patients with GIO was tested in two studies with men and women taking oral glucocorticoid steroids for diseases such as rheumatoid arthritis. Combined results from the studies demonstrated that treatment with Actonel for one year significantly reduced vertebral fractures by 70%. This is the first data of its kind and is important because approximately one in six patients initiating glucocorticoid therapy will suffer a vertebral fracture within one year, and up to 50% of patients on chronic glucocorticoid therapy will suffer a fracture. Actonel is the first therapy ever approved for the prevention of GIO.

"New understanding about osteoporosis suggests it progresses much faster than was originally thought, demonstrating the clear need for fast- acting therapies," said Robert Lindsay, MD, Ph.D., College of Physicians and Surgeons, Department of Medicine, Columbia University, New York, NY. "With Actonel, patients who act quickly to get diagnosed and treated can significantly reduce their risk of vertebral fractures within a short time period."

For more information on Actonel please visit the Actonel Web site at www.actonel.com

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TAXOL Injection Approved By Health Canada

A new adjuvant therapy for early stage breast cancer has just been approved by Health Canada. Taxol ® Injection will give thousands of Canadian women a new weapon in the ever-growing arsenal against breast cancer.

Breast Cancer is the second leading cause of cancer death in Canacda after lung cancer. Of the 19,000 Canadian women who will be diagnosied with breast cancer this year approximately 7,600 will be candidates for the new Taxol injection therapy.

The Canadian health organization's approval of Taxol was due partially to an American study of 3,000 women. In that study, women given doxorubicin plus cyclophasphamide with Taxol fared more favorably than their counterparts who received doxorubicin plus cyclophasphamide alone. The study results were heralded as the most significant advance in the treatment of breast cancer in the past 20 years.

Taxol is well tolerated by patients. It has been used to treat cancer in hundreds of thousands of patients around the world. The drug is currently indicated in the treatment of ovarian cancer, breast cancer and advanced non-small cell lung cancer. Common side effects are reduction in white blood cell count, hair loss, peripheral neuropathy and myalgia. The drug is produced by Bristol-Myers Squibb.

For more informaiton on Taxol ®, and other BMS products visit the Bristol-Myers Squibb Web site.

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The Dangers Of Ephedra

The Food and Drug Administration is raising concerns regarding the use of ephedra, a common ingredient found in herbal dietary supplements such as Metabolife.

According to recent adverse drug reaction reporting, there have been 273 reports of cardiac arrest or stroke in ephedra users since 1996. Among the most notable are a 38 year-old California businessman and a 20-year-old college student who died of cardiac arrest after ingesting the herbal supplement. To date there have been 800 reports of side effects and 44 reported deaths.

The FDA expressed interest in reducing the legal dose of the herb, but the dietary supplements industry opposed the proposed new rulsed. The FDA has backed-off from its desire to cut the legal dose but has proposed the use warning labels and plans public hearings on the subject in the summer of 2000.

Health professionals are asked to strongly caution patients wil heart disease, high blood pressure, thyroid disease, kidney disease, diabetes or a history of seizures against the use of the over-the-counter stimulant.

In response to the FDA, ephedra manufacturers have formed the Ephedra Education Council. The council concedes some risk involved with ephedra supplements and urge companies to voluntarily take up warning labels. The council contends that if ephedra were truly dangerous, FDA approved, over-the-counter, asthma medications containing ephedrine would cause similar problems and need regulation and warning labels.

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