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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (448)	7/1/1998 9:46:00 PM
From: Anthony Wong	Read Replies (3) \| Respond to of 1722

U.S. consumer group attacks Viagra labeling Wednesday July 1 8:11 PM EDT By Maggie Fox, Health and Science Correspondent WASHINGTON (Reuters) - A consumer group attacked the U.S. government's labeling requirements for the best-selling anti-impotence drug Viagra Wednesday, saying that warning labels leave out important information. More than a million men have been given prescriptions for the drug since it hit the market in April, and about 30 deaths have been reported among men who take it. The deaths have not been linked directly to Viagra. The Food and Drug Administration (FDA) stresses that it thinks Viagra is safe when taken as directed. There are clear labels on the drug saying it must not be taken by men on drugs containing nitrates -- such as the heart medication nitroglycerin. It can cause a fatal drug interaction. In addition, Pfizer Inc, which makes the drug, has issued a broad warning to the public and health workers. But Public Citizen, a group founded by consumer rights campaigner Ralph Nader, said labeling requirements do not go far enough. "There are several extremely troubling safety problems in the FDA's review of sildenafil," the group said in a statement. Sildenafil is Viagra's generic name. It said men with certain medical conditions were kept out of large clinical trials used to determine if the drug was safe. These conditions include very high or very low blood pressure, bleeding ulcers, or the need to take blood-thinning drugs including aspirin. "Thus, people whom investigators correctly thought might be at higher risk for adverse effects of sildenafil, were usually excluded from the pre-approval experiments using the drug but people with such diseases are not excluded from using the drug now that it is on the market," the group said in a letter to acting FDA director Dr. Michael Friedman. They said the FDA and Pfizer were engaging in a giant experiment involving men. But Dr, Murray Lumpkin of the FDA said the warnings were clear, and tests cannot be run to see how Viagra interacts with every other drug on the market. "For example, one of the things ... is the concern for people with certain cardiac problems being excluded," he said in a telephone interview. "People already knew that sexual activity has a certain cardiovascular risk and so there was no reason to re-test that in the clinical trial." He said it was up to the doctor to decide with each individual patient whether he should take Viagra. Drugs shown to have a certain toxic reaction, such as the nitrates, have been clearly contraindicated on labels, he said. Contraindication means the two drugs should never be prescribed together. Lumpkin defended the practice of excluding certain patients from clinical trials. "You do put in the exclusion so that you give the best chance possible to find out if the drug is going to cause a problem ...," he said. "If the patient has a lot of serious underlying disease you don't know if it was a disease or the drug (causing any side-effect)." Lumpkin said labels make clear that there are certain conditions that were not tested with Viagra, including bleeding ulcers and an eye condition known as retinitis pigmentosa. That gives the doctor a warning to prescribe the drug with care in patients with such conditions. "You cannot study a drug in each and every patient group but you have to warn about what you do know and what you don't know," he said. Companies are required to report serious and unexpected adverse events to the FDA within 15 days. Companies also have to do quarterly reports on new drugs, and the FDA has not seen any reports yet that makes it doubt Viagra's safety. dailynews.yahoo.com