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Vidyya, from the Sanskrit "vaidya," a practitioner who has come to understand the science of life.

Volume 1 Published - 14:00 UTC    08:00 EST    14-April-2000      
Issue 1 Next Update - 14:00 UTC 08:00 EST    15-April-2000      

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Back To Vidyya News From The FDA

Viagra May Soon Have A Rival: FDA Advisory Committee Recommends Approval Of Uprima ® For Treatment OF Erectile Dysfunction

Viagra will soon have a rival for the multi-billion dollar anti-impotence drug market. The Food and Drug Administration's Urology Subcommittee of the Advisory Committee for Reproductive Health Drugs recommended the approval of Uprima ® (apomorphine HCl tablets) for the treatment of impotence.

Uprima is a fast-acting sublingual tablet. If final approval is granted in July, the drug will be the first centrally acting impotence treatment available to patients. When absorbed under the tongue, Uprima works to stimulate production of the brain chemical dopamine, which then sends a signal for an erection. The drug's current rival, Viagra, works by restoring blood flow to the penis.

In clinical trials, the drug worked in as little as 10 minutes, with a median response time of 16-19 minutes. There were some notable side effects in the studies. Such side effects included fainting, nausea and adverse interactions with alcohol. The reported nausea was moderate to severe and occurred in 15% of the patients taking the drug. The drug's success rate has been placed at 44% to 56%. Approval is expected in July 2000.

For more information regarding Uprima, visit Abbot Laboratories.

bulletNews From The FDA


Janssen to Stop Marketing Cisapride In The US

Janssen Pharmaceutics Inc., of Titusville, NJ, has announced that is has decided to stop marketing cisapride (Propulsid) in the United States as of July 14, 2000. The effective date of the voluntary action is intended to provide adequate time for patients and physicians to make alternative treatment decisions.

Cisapride is a prescription drug treatment approved for severe nighttime heartburn experienced by adult patients with gastroesophageal reflux disease (GERD) that does not adequately respond to other therapies.

As of December 31, 1999, use of cisapride has been associated with 341 reports of heart rhythm abnormalities including 80 reported fatalities. Most of these adverse events occurred in patients who were taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride.

Patients who are currently prescribed cisapride are urged to promptly contact their health care providers to discuss alternative treatments.

Physicians who are treating patients with severely debilitation conditions for whom they believe the benefits of cisapride may still outweigh the risks are encouraged to contact Janssen at 1-800-JANSSEN. The company will continue to make the drug available to patients who meet specific clinical eligibility criteria for a limited-access protocol.

Since the drug's approval in 1993, Cisapride's labeling has been revised several times, most recently in January 2000, to inform health care professionals and patients about the drug's risks. Despite these risk management efforts, the firm decided in consultation with the FDA that continued general US prescription access to the drug poses unacceptable risks.

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St. John's Wort: Updated Drug Interactions And Contraindications

Adverse interactions have been reported between St John's wort (hypericum), an herbal product used to treat depression, and two drugs: indinavir, a protease inhibitor used to treat HIV and cyclosporine, a drug used to reduce the risk of organ transplant rejection.

According to researchers at the National Institutes of Health Clinical Center, when St. John's wort and the protease inhibitor indinavir are taken together, the levels of indinavir in the blood drop dramatically. A loss of therapeutic benefit results when the antiviral drug is metabolized too quickly. Participants in the study experienced a serum drop in indinavir from 49% to 99%.

St. John's wort is already contraindicated for patients taking monoamine oxidase inhibitors (MAOIs), warfarin and cyclosporins. Health professionals are warned to include protease inhibitors and nonnucleoside reverse transcriptase inhibitors to the list.

In press releases, the NIH stressed how vital it is for health professionals to understand how prescription drugs and herbal products interact. St. John's wort may have many other unsuspected adverse effects on the functions of drugs essential to the health of vulnerable patient populations.

bulletNews From The FDA



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Editor: Susan K. Boyer, RN
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