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The black box…will this label prevent you from trying the drug?

By December 3, 2020November 2nd, 2021No Comments6 min read

Would a black box warning prevent you from trying a new drug? What if it was approved for female sexual dysfunction and could help you get your libido back?

Female sexual dysfunction affects a great number of women. Since hormones heavily impact a woman’s sexual desire, women of various ages may experience a lack of sexual interest at some time throughout their lives. Some may also find intercourse painful or have trouble achieving orgasm. While there are natural remedies to help you in getting your mojo back, the female version of Viagra had given a vast number of women high hopes. Unfortunately, the black box warning is hindering some from trying the drug altogether.

Addyi is the first and only FDA approved non-hormonal drug used to help patients with low sexual desire. Known as the female Viagra, the little pink is no miracle worker. As a matter of fact, the FDA issued a mandated black box warning for the medication as it could be associated with fainting or a drop in blood pressure when used in tandem with alcohol. Special testing would have to be passed by individuals prescribing and dispensing Addyi such as pharmacists and doctors. Women would also be encouraged to sign a consent form prior to taking the pill. This would acknowledge they are aware of the side effects and risks associated with the drug.

The little pink pill was supposed to be instrumental in treating hypoactive sexual desire disorder. What the study proved was that women experienced only one more monthly episode of intimacy after taking Addyi. Viagra can be taken on demand, unlike Addyi which is taken on a daily basis. The cost for Viagra is just pennies compared to the expense of Addyi for women.

With all of the advertising and attention it’s received, women don’t seem to be flocking to their doctors for the little pink pill. Addyi was rejected by the FDA twice as it didn’t reach the desired outcome. Finally approved on the third submission with a vote of 18 to 6, it still doesn’t seem to be making its mark the main reason is the marketing efforts by the company has been put on hold. The marketing for the pill is expected to increase this fall.

Over 25 percent of premenopausal women and over 50 percent of postmenopausal women have a low sex drive. Addyi was specifically approved by the FDA to help boost their libido. But there were red flags from the start. In addition to the side effects such as fainting, nausea, dizziness, constipation, dry mouth, anxiety and abdominal pain, studies showed the satisfying encounters at only once per month. While the manufacturers thoughts the female version of Viagra was going to be the greatest sensation since the birth control pill, it was turning out to be a costly dud. It’s even more dangerous when taken with alcohol as it can cause fainting and dangerously low blood pressure levels resulting in loss of conciousness. If you have a liver condition or you take other medications, you may be at an even greater risk as some common medication used in Gynecology will decrease the metabolism of this medication resulting in higher levels of the drug staying around and thus exceleration of the side effects.

While women may be desperate for a cure to improve their low libido, it shouldn’t come with such risks such as fainting. Having shared this information with my other patients in search of their comments, I received an underwhelming response after they learned of the dangerous side effects. Unless the manufacturers begin to listen to women, Addyi won’t be the saving grace that they thought it to be. I believe drug companies really need to pay attention to the special needs women have before developing a medication versus developing a medication that sounds a little promising or the “answer to women’s prayers and expecting them to flock to it. Unfortunately since there are no other medications geared for the treatment of hypoactive sexual dysfunction there will be an influx of patients wanting to try it.

Men have different needs than women when it comes to their sexuality and erectile dysfunction. While medications such as Viagra can assist the blood flow that helps to correct erectile dysfunction, there are a lot of other components that go into helping a woman achieve the right mood for sexual intercourse besides medicine. Hormones, less stress, happiness and good body image can all prove beneficial. How you feel about your partner is another important factor to sexual satisfaction. Women need more, and I don’t believe that one particular drug therapy can handle the job.

Bioidentical hormones, vaginal rejuvenation using laser technology, testosterone pellets and the “O” shot are all products that I have available in my office to help you get your mojo back. You’re also guaranteed not to lose consciousness.

Addyi is designed to reduce brain serotonin activity. Serotonin is believed to inhibit sexual function. A lot of medications on the market today being used to treat depression are in a class called SSRI’s and created to boost serotonin levels. In if you are on a SSRI it’s one of the contraindications to using Addyi.

Important facts you need to know about Addyi:

1. Does Addyi Really work? Addyi does work for some women. Based on clinical trials, 45 to 60 percent of women showed improvements.

2. How does Addyi work? The full mechanics of action is unknown. However, it helps lower brain serotonin which can lower a person’s sexual response.

3. Is Addyi a hormone? No. Addyi is a psychotropic that assists the brain to become sexually aroused by lowering serotonin neurotransmitters.

4. How safe is Addyi? The jury is still out on the safety of Addyi. Although some may say they found minimal improvements, the positive outcomes are few and far between. The reported side effects of high blood pressure and fainting when taken with alcohol has been worrisome. If your doctor prescribes Addyi, make sure you’re being monitored closely.

5. How long does Addyi take to work? Users may see results in four weeks. This means that you have to take the drug daily for four week. You could possibly see maximum results after 3 months of use.
6. How long should Addyi be taken before you decide it’s just not working for you? If you haven’t found any noticeable improvements after taking Addyi daily for 8 weeks, then the medication is not working for you. You should discontinue use at this time. You should also schedule an appointment with your doctor to help find another more viable resolution.

7. Will Addyi improve my ability to orgasm? Addyi is made to help change the chemistry of your brain and sexual libido. The medication will not make it any easier for a woman to achieve orgasm. It also won’t make sex more enjoyable. If this is what you need then consider the “OShot.”

8. Does Addyi cause hypersexuality? Addyi is not a “love” drug that will have you yearning for sex constantly.

9. Will Addyi cause me to gain weight? This question was looked into during clinical trials. Patients taking Addyi did not experience any weight gain. In some instances, patients noted some tendencies to shed pounds.

10. Is it worth giving Addyi a try? Only you and your doctor can answer that question. Your doctor should first assess your overall health and wellness. If you are healthy, you can find the right treatment plan that will best suit your needs.

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