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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: EyeDrMike who wrote (6956)	4/14/1998 8:11:00 AM
From: BigKNY3	Read Replies (1) \| Respond to of 23519

Eye: You asked for it , here it is.... the Adverse Reaction section of the Viagra package insert. Nina's "40%" comment concerning visual effects at high dosage levels is not supported by this approved labeling. Good investing! BigKNY3 __________________________________________________ ADVERSE REACTIONS VIAGRA was administered to over 3700 patients (aged 19-87 years) during clinical trials worldwide. Over 550 patients were treated for longer than one year. ÿÿIn placebo-controlled clinical studies, the discontinuation rate due to adverse events for VIAGRA (2.5%) was not significantly different from placebo (2.3%). The adverse events were generally transient and mild to moderate in nature. ÿÿIn trials of all designs, adverse events reported by patients receiving VIAGRA were generally similar. In fixed-dose studies, the incidence of some adverse events increased with dose. The nature of the adverse events in flexible-dose studies, which more closely reflect the recommended dosage regimen, was similar to that for fixed-dose studies. When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials the following adverse events were reported: TABLE 1. ADVERSE EVENTS REPORTED BY > 2% OF PATIENTS TREATED WITH VIAGRA AND MORE FREQUENT ON DRUG THAN PLACEBO IN PRN FLEXIBLE-DOSE PHASE II / III STUDIES Adverse EventPercentage of Patients Reporting Event ÿ.......................VIAGRA... N=734.... PLACEBO N=725 Headache .............16%..................... 4% Flushing ................10%................... 1% Dyspepsia............... 7%.......................2% Nasal Congestion.... 4%.........................2% Urinary Tract Infection.. 3%..................2% Abnormal Vision+......... 3%....................0% Diarrhea ....................3%......................1% Dizziness.................. 2%.......................1% Rash ........................2%.......................1% +Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision. Other adverse reactions occurred at a rate of >2%, but equally common on placebo: respiratory tract infection, back pain, flu syndrome, and arthralgia. ÿÿIn fixed-dose studies, dyspepsia (17%) and abnormal vision (11%) were more common at 100 mg than at lower doses. At doses above the recommended dose range, adverse events were similar to those detailed above but generally were reported more frequently. No cases of priapism were reported.