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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Tunica Albuginea who wrote (6147)	11/25/1998 9:52:00 AM
From: Tunica Albuginea	Read Replies (1) \| Respond to of 9523

Time to short PFE;did this AM @ $113 13/16. The bloom is off the rose. Now we got retinitis pigmantosa thrown in too( thousands of folks )alongt with all the other warnings. I guess BigKNY3 the FDA didn't read your posts on SI about high retinal safety,GG. 130 deaths and rising. Now all we need to do is what for the first multimillion dollar lawsuits to start coming on, perhaps also class action suits to come on board and we are in business. The usual allegations PFE put out an unsafe product because they didn't test it on all these folks( see article below ) which of course they should . More later.. TA ===================================== November 25, 1998 Pfizer and FDA Agree to New Warnings On Labels for Viagra After 130 Deaths By ROCHELLE SHARPE and ROBERT LANGRETH Staff Reporters of THE WALL STREET JOURNAL WASHINGTON -- Federal regulators and Pfizer Inc. agreed to a host of new warnings for Viagra and said that 130 men have died taking the impotence drug since it went on the market in April. The new labels will caution patients to use the popular blue pill with care if they have a history of heart disease, blood-pressure problems or certain eye disorders, the U.S. Food and Drug Administration and Pfizer said. The labels also will warn doctors against prescribing Viagra or other impotence treatments to men who shouldn't have sex because of heart disease or other cardiovascular problems. The new label also addresses the problem of prolonged, painful erections, called priapisms. It will explain that they rarely occur but will urge patients to seek prompt medical attention if their erections last longer than four hours. The FDA said that 70% of the men who died while using Viagra had one or more risk factors for cardiovascular disease. Sixteen of the men had taken nitrates, which the FDA and Pfizer had previously warned shouldn't be taken with the drug. "We consider the drug to be safe and effective," said Lisa Rarick, head of the FDA's division of reproductive and urologic products, noting that labeling updates frequently occur with new drugs. Overall, more than six million prescriptions have been written for Viagra. "We think these are common-sense guidelines" for using the drug, said Pfizer spokesman Andrew McCormick. Company officials said the new labeling essentially makes more explicit the existing warnings about using the drug. The company said it plans to continue its consumer advertising efforts and that it is too early to tell whether sales will be hurt. But some analysts see a key challenge for Viagra. Hemant Shah, a pharmaceutical industry analyst in New Jersey, said the new warnings "will make it very difficult" for Pfizer to increase sales through consumer advertising since the risks will probably have to be mentioned in advertisements. U.S. sales of Viagra surged shortly after the product was introduced, but declined sharply over the summer because of patient worries about side effects. Viagra sales for the third quarter were $141 million, down from more than $400 million in the second quarter. In the last several weeks, the volume of domestic prescriptions has remained essentially flat in the last several weeks, despite extensive consumer advertising. The new label warns that doctors should use caution prescribing the drug to the kinds of patients excluded from clinical trials, including men who suffered a heart attack, stroke, or life-threatening irregular heart rhythms within the previous six months, as well as patients with a history of cardiac failure or coronary artery disease. Patients with uncontrolled high-blood pressure and those with uncontrolled low-blood pressure also were excluded from clinical trials and should use the drug cautiously. The new label will also highlight a warning on the existing label about patients with retinitis pigmentosa, a degenerative disease of the retina. "Some men left out of clinical trials certainly aren't candidates for elective therapy," Ms. Rarick said. "We just want to make sure doctors aren't giving these patients elective therapy without a lot of thought." She said adverse-event reports had not shown "anything alarming" involving eye changes.