The biggest issue with the Flibanserin is that you can't drink alcohol on it. And they did the study with men in order to see what would be the effect of drinking a couple of beers and taking this drug. They found that the blood pressure drops significantly. I mean, it was, actually, pretty astonishing. Systolic blood pressure dropped after these men drank two large beers. The systolic pressure drop was between 20 and 54 millimeters of mercury, and the diastolic drop was between 24 and 46 millimeters of mercury. So, the systolic set the top number, and the diastolic sat the bottom number. The kind of the goal is less than 120 over 80. So, you can think of a blood pressure drop someone with normal blood pressure that would be a 40% blood pressure drop. You definitely feel that, and patients can pass out. They can feel faintly, and they can, actually, faint. They can feel dizzy.
There is a black box warning on the drug, basically saying not to drink, and patients cannot drink on it. I believe, when patients start taking the drugs, they have to sign an agreement that they won't drink alcohol on it, which is hard for people. And, you know, patients might sign that agreement and really not want to drink alcohol, and then they could be at a party or something, or they might be getting wined and dined, and then they're slipping up, and they're drinking and falling back in their chair. So, it's a huge issue with the drug, it's a major caveat, it's why there is a risk, mitigation strategy that the FDA approved. So, it's a complicated drug.
Other side effect is dizziness. It can make you tired. So, placebo group had 2.9% of patients, who felt tired, and that increased to 11%. So, a lot of people can feel tired on the drug, and they can feel dizzy. That can be related to blood pressure dropping, nauseous, fatigue, not being able to sleep, and dry mouth.
The drug by itself can cause the drop of blood pressure, dizziness, feeling fainting. The main side effects with the drug are blood pressure drops.