USFDA Drug Safety : FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death

FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems. Health care professionals should not change the way they prescribe these drugs at this time.

The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.

For more information, please visit: Antiplatelet

News: Triangle pharmaceutical company: 'Female Viagra' performs well in clinical tests...

When the USFDA denied approval of Flibanserin last year, officials told Sprout Pharmaceuticals they wanted to see additional work on the drug that is designed to help treat female sexual dysfunction.
That work has continued in the form of clinical tests, and the Raleigh-based company will resubmit its request for approval in December with promising new results.

In recent tests, women on average doubled the number of satisfying sexual events and reported a 50 percent increase in sexual desire.
Amanda Parrish, a working mother of four, said she loved what the drug did for her. She said she felt a difference in less than a week.
"In the middle of the day, I could text Ben (her husband) for no apparent reason and start talking to him, and I would get that little flutter. I don't mean in my heart flutter," she said. "I would start getting aroused at noon, which that had never happened to me."
Sex therapist Laure Watson says renewed interest alone could do wonders for many relationships.
"Sex is something that binds us together. Literally oxytocin is released, and that's a bonding chemical," Watson said. "Without that, part of us that soothes and motivates us to forgive each other is gone.
Parrish agreed, saying her relationship with her husband improved.
"My relationship with my kids got better, I was not as irritable as I had been. I had the best sales year I've ever had in my career," she said.
If approved, Sprout's little pink pill will be the first on the market to treat female sexual dysfunction. Forty-three percent of women suffer from some kind of sexual dysfunction, and about 10 percent of those women suffer from hypo-active sexual desire disorder, or a lack of desire.
"It's a huge problem," Watson said of female sexual dysfunction. "Women don't have naturally occurring libido where they want it."
Flibanserin, which is non-hormonal, works on chemicals in the brain that impact sexual desire. Sprout officials said it could be on the market by the middle of 2015 if it gets a thumbs-up from the FDA.
About 15 percent of the women tested dropped out of clinical trials because of the drug's side effects, which include fatigue, nausea and dizziness.
Parrish, who said she didn't suffer any problems with side effects, said she'd buy the drug.
"In a heartbeat. I'm waiting for it to be approved. I would be the first one at the door," she said.
Capitol Broadcasting, parent company of WRAL, is an investor in Sprout Pharmaceuticals.

USFDA: CDRH Industry: Announcing Final Guidance and FDA Webinar on Evaluation of Sex-Specific Data in Medical Device Clinical Studies

Today the Food and Drug Administration (FDA) posted a final guidance document, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” in combination with the FDASIA Section 907 Action Plan. The FDA’s final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents. The action plan focuses on three over-arching priorities: Data Quality, Subgroup Participation, and Data Transparency. 

Certain medical products may elicit different responses in women than men and these variables may affect the safe and effective use of medical devices. The FDA’s final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents.

The final guidance provides recommendations to medical device industry and FDA staff on:

• Enrollment: Recommended methods for designing and conducting clinical studies to encourage enrollment of both sexes.
• Analysis: Recommended methods for analysis of demographic data.
• Reporting: Recommended approaches for reporting of demographic data for device studies in the labeling and other public documents for approved or cleared devices.
• Decision frameworks for sex-specific study design, and for considering sex-specific data when analyzing and interpreting overall study outcomes, including when additional data may be needed.

On August 25, 2014 the FDA will hold a webinar to explain the guidance and to provide an opportunity to ask questions.  Registration is not necessary.

Webinar Details:

Date: August 25, 2014

Time: 3:00 PM – 4:30 PM, Eastern Time
To ensure you are connected, log-in at 2:45 PM.

To hear the presentation and ask questions:  

Dial: 1-888-282-0359; passcode: 7984204

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join/
Conference number: PW8306676 
Passcode: 798204
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm

Please Note: the slide presentation will also be available at this site on the morning of the webinar.

If you have any questions regarding this guidance, please contact one of the following at FDA/CDRH:

• Jismi Johnson (Biomedical Engineer, ODE), jismi.johnson@fda.hhs.gov
• Lilly Yue (Deputy Director, OSB/Division of Biostatics), lilly.yue@fda.hhs.gov
• Nilsa Loyo-Berrios (Deputy Director, OSB/Division of Epidemiology), nilsa.loyo-berrios@fda.hhs.gov
• Robert Becker (Chief Medical Officer, OIR), robertl.becker@fda.hhs.gov)
• Katie O’Callaghan (Senior Health Science Advisor, OCD), kathryn.ocallaghan@fda.hhs.gov
• The Division of Industry and Consumer Education (DICE) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov

Food and Drug Administration
Center for Devices and Radiological Health