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| 'Female viagra': FDA panel backs Flibanserin with safety restriction | |
| (about 9 hours later) | |
| Government health experts are backing an experimental drug intended to boost the female sex drive, but stress that it must carry safety restrictions to manage side effects including fatigue, low blood pressure and fainting. | Government health experts are backing an experimental drug intended to boost the female sex drive, but stress that it must carry safety restrictions to manage side effects including fatigue, low blood pressure and fainting. |
| The Food and Drug Administration panel voted 18-6 in favor of approving Sprout Pharmaceutical’s daily pill flibanserin, on the condition that its manufacturer develops a plan to limit safety risks. | The Food and Drug Administration panel voted 18-6 in favor of approving Sprout Pharmaceutical’s daily pill flibanserin, on the condition that its manufacturer develops a plan to limit safety risks. |
| The positive recommendation is a major victory for a drug sometimes hailed as “female Viagra”, but which has been plagued by for years by concerns about its lackluster effectiveness and safety issues. The FDA has twice rejected the drug since 2010. | The positive recommendation is a major victory for a drug sometimes hailed as “female Viagra”, but which has been plagued by for years by concerns about its lackluster effectiveness and safety issues. The FDA has twice rejected the drug since 2010. |
| The vote was preceded by testimony from women urged the agency to approve the drug and told about their fears of never being able to have sex again. | The vote was preceded by testimony from women urged the agency to approve the drug and told about their fears of never being able to have sex again. |
| A coalition of women’s groups and the drug’s manufacturer advocated for approval of the pill, Flibanserin. Other women’s health advocates advised that the agency remain cautious. | A coalition of women’s groups and the drug’s manufacturer advocated for approval of the pill, Flibanserin. Other women’s health advocates advised that the agency remain cautious. |
| “I should be able to determine if Flibanserin is worth the benefit of treatment,” said Amanda Parrish, one of more than 11,000 women who participated in a clinical trial of the pill. | “I should be able to determine if Flibanserin is worth the benefit of treatment,” said Amanda Parrish, one of more than 11,000 women who participated in a clinical trial of the pill. |
| Parrish said she began experiencing low libido during her second marriage and therefore decided to participate in the clinical trial. | Parrish said she began experiencing low libido during her second marriage and therefore decided to participate in the clinical trial. |
| “What a relationship-saving eight months that was,” she said. | “What a relationship-saving eight months that was,” she said. |
| Flibanserin does not work in the same way as Viagra, which increases blood flow, a simple biological function. Flibanserin, which was first studied as an antidepressant, changes brain chemistry. | Flibanserin does not work in the same way as Viagra, which increases blood flow, a simple biological function. Flibanserin, which was first studied as an antidepressant, changes brain chemistry. |
| For that and other reasons, a coalition led by the National Women’s Health Network opposes approval of the drug. | For that and other reasons, a coalition led by the National Women’s Health Network opposes approval of the drug. |
| “The problem with Flibanserin is not gender bias at the FDA but the drug itself,” the group said in a letter to the FDA. | “The problem with Flibanserin is not gender bias at the FDA but the drug itself,” the group said in a letter to the FDA. |
| In 2010, Flibanserin was rejected unanimously by an FDA panel, which said its benefits did not outweigh its risks, which can include low blood pressure and fainting spells. | In 2010, Flibanserin was rejected unanimously by an FDA panel, which said its benefits did not outweigh its risks, which can include low blood pressure and fainting spells. |
| Sprout pharmaceutical company picked up the drug in 2011 after it was dropped by its initial developer, Boehringer Ingelheim. They submitted it to the FDA again, and in October 2013 it was rejected again. | Sprout pharmaceutical company picked up the drug in 2011 after it was dropped by its initial developer, Boehringer Ingelheim. They submitted it to the FDA again, and in October 2013 it was rejected again. |
| “The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment,” the FDA said in its latest review. | “The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment,” the FDA said in its latest review. |
| In March, 11 members of Congress wrote to the FDA in support of a new review of the drug. | In March, 11 members of Congress wrote to the FDA in support of a new review of the drug. |
| A coalition of women’s groups, as well as Sprout, started a campaign called Even the Score, which believes there is a disparity in how sexual dysfunction drugs are made available. | A coalition of women’s groups, as well as Sprout, started a campaign called Even the Score, which believes there is a disparity in how sexual dysfunction drugs are made available. |
| Last year, Anita Clayton, interim chair of the Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia wrote in support of the drug for the Huffington Post and said that the FDA need to “overcome the problem of institutionalized sexism”. Susan Wood, a former FDA assistant commissioner for women’s health, said that accusing the agency of sexism “is wildly off the mark.” | Last year, Anita Clayton, interim chair of the Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia wrote in support of the drug for the Huffington Post and said that the FDA need to “overcome the problem of institutionalized sexism”. Susan Wood, a former FDA assistant commissioner for women’s health, said that accusing the agency of sexism “is wildly off the mark.” |
| She resigned in 2005 when the government refused to make Plan B available over the counter and is now an associate professor at George Washington University. | She resigned in 2005 when the government refused to make Plan B available over the counter and is now an associate professor at George Washington University. |
| “FDA’s responsibility is a broad public health one and it is to weigh the risks and benefits against each other for any particular product,” said Wood. “And I don’t think they are doing it any differently here than they do any other product.” | “FDA’s responsibility is a broad public health one and it is to weigh the risks and benefits against each other for any particular product,” said Wood. “And I don’t think they are doing it any differently here than they do any other product.” |
| The Associated Press contributed to this report | The Associated Press contributed to this report |