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Addyi Manufacturer Announces Changes | SexHealthMatters.org

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Addyi Manufacturer Announces ChangesThe manufacturer of Addyi (flibanserin), an oral drug used to treat general, acquired hypoactive sexual desire disorder (HSDD) in premenopausal women, has announced some changes for prescribers.

Affecting about 1 in 10 women, HSDD refers to a loss of sex drive accompanied by distress that can’t be easily explained by specific causes, like a health condition or drug side effect. HSDD is acquired if it happens after a period of healthy sex drive. It is considered general if it happens all the time, not just in certain sexual situations or with specific partners.

Addyi is a pill that balances the levels of three brain neurotransmitters: serotonin, dopamine, and norepinephrine. It is typically taken at bedtime.

The drug was approved by the FDA in the spring of 2015.

Alcohol Use

One of the labeling changes concerns alcohol use with Addyi.

When the drug was first approved, the FDA required Sprout Pharmaceuticals, the company that produces Addyi, to include a boxed warning (the strictest required by the FDA) that instructed women to avoid drinking any alcohol while taking Addyi.

At that time, “the FDA reviewed data that included several concerning cases of severe hypotension (low blood pressure) and syncope (passing out) when Addyi and alcohol were taken together,” the agency reported in an April 2019 press release.

Since the approval, subsequent post-marketing studies have shown that while there are still concerns about drinking alcohol and using Addyi, women can do so if they are careful and as long as the timing isn’t too close. The FDA still requires a boxed warning, but the language has been updated.

The current instructions are as follows, according to the Addyi website:

If a woman has had one or two alcoholic drinks, she should wait at least two hours before taking Addyi at bedtime.

If she has had three or more alcoholic drinks in one evening, she should skip her bedtime dose of Addyi.

If she has taken her regular dose of Addyi, she should not drink any alcohol until the next day.

Sprout Pharmaceuticals defines “1 standard alcoholic drink” as one 12-ounce regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits or shot.

Taking Addyi and drinking alcohol too close together could lead to severe low blood pressure and fainting.

REMS Certification

Before October 2019, clinicians who prescribed Addyi were required to have Risk Evaluation and Mitigation Strategy (REMS) certification through the FDA. REMS is a drug safety program for medications with safety concerns. Now, prescribers are no longer required to have REMS certification for Addyi.

More Information

Some of the more common side effects of Addyi are dizziness, drowsiness, nausea, fatigue, insomnia, and dry mouth.

A woman’s doctor can best advise on whether Addyi is an appropriate choice for her.

Resources

Addyi.com

“Important Safety Information”

https://addyi.com/faq/

International Society for Sexual Medicine

“FDA Modifies Boxed Warning for Addyi”

(April 22, 2019)

https://www.issm.info/news/sex-health-headlines/fda-modifies-boxed-warning-for-addyi/

Sprout Pharmaceuticals

Correspondence dated October 16, 2019 concerning changes for Addyi.

U.S. Food and Drug Administration (FDA)

“FDA orders important safety labeling changes for Addyi”

(Press release. April 11, 2019)

https://www.fda.gov/news-events/press-announcements/fda-orders-important-safety-labeling-changes-addyi

“Risk Evaluation and Mitigation Strategies | REMS”

(Content current as of August 8, 2019)

https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

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Men's Sex

Birth Control Pills for Men are Possible, Studies Suggest

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Birth Control Pills for Men are Possible, Studies SuggestBirth control pills may eventually be available for men, scientists say.

A final product may still be years in the making, but researchers have deemed the medications safe and tolerable for healthy men.

The results of one study were presented at the annual meeting of the Endocrine Society in March 2019.

The drug, 11-beta-MNTDC, may reduce the production of sperm without decreasing a man’s libido. The drug behaves like testosterone, the hormone that drives sexual desire and gives men some of their masculine characteristics. But it does not trigger sperm production in the testes.

Forty healthy men participated in the 28-day study. Each day, 14 men took 200 mg of the 11-beta-MNTDC drug, and 16 men took 400 mg. The remaining 10 men took a placebo pill.

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Men's Sex

Peyronie’s Disease: More Men Receiving CCH Injections

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Peyronie’s Disease: More Men Receiving CCH Injections Nowadays, more men with Peyronie’s disease are being treated with injections of collagenase clostridium histolyticum (CCH) than surgery, according to recent research.

Peyronie’s disease is characterized by plaques of hardened scar tissue that form on the penis, just below the skin’s surface. The plaques make the penis lose some of its flexibility. As a result, the penis starts to bend. Sometimes, the curve is so severe that intercourse is difficult. Men with Peyronie’s disease may also experience pain and erectile dysfunction (ED).

Surgery to correct the curve is a common treatment. CCH injections, which are targeted directly at the plaques, were approved in 2014.

The study findings are based on insurance claims data for 36,156 men who were first diagnosed with Peyronie’s disease between 2011 and 2017. Diagnosis rates did not change much during that period.

In 2014, the treatment rate with either CCH or surgery was 9.8%, but the rate rose to 15.5% by 2017, reflecting an increase in men undergoing CCH injections. After CCH injections were approved, their use as a first-line treatment increased an average of 1.6% per year.

The ratio of CCH to surgery as a first-line treatment increased from 1:1 in 2014 to about 2:1 by 2017.

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Men's Sex

Low Testosterone Common in Germ Cell Tumor Survivors

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Low Testosterone Common in Germ Cell Tumor SurvivorsIn a recent study of germ cell tumor survivors, roughly half had hypogonadism – low testosterone – regardless of whether they were treated with surgery alone or surgery with platinum-based chemotherapy, scientists report in the journal Supportive Care in Cancer.

However, patients who had chemotherapy added to their surgical treatment were more likely to have male aging symptoms.

Germ cells are reproductive cells: egg cells in females and sperm cells in males. Tumors form when these cells grow and accumulate in an abnormal way. Some germ cell tumors are cancerous. When they are, they usually develop into ovarian cancer or testicular cancer.

The study included 199 germ cell tumor survivors between the ages of 18 and 50. Each participant completed a quality of life questionnaire at the start of the study and again three and six months later.

About 48% of the entire group had low testosterone. (For this study, hypogonadism was diagnosed if a man’s testosterone levels were below 300 ng/dL.)

Next, the researchers looked at testosterone levels based on type of treatment. Among patients who had had both surgery and chemotherapy, the low testosterone rate was 51%. For those who had surgery alone, the rate was 45%.

Patients who had low testosterone levels were more likely to have reported fatigue, poor sleep quality, and worse general health at the start of the study.

When the scientists compared quality of life assessment scores for the two groups, they found no statistically significant differences. However, those who had had both surgery and chemotherapy “exhibited more symptoms related to male aging.”

Resources

Mayo Clinic

“Germ cell tumors”

(May 25, 2019)

https://www.mayoclinic.org/diseases-conditions/germ-cell-tumors/symptoms-causes/syc-20352493

Oncology Learning Network

Porcelli, Hina

“Surgery With or Without Chemo Yields Low Testosterone in GCT Survivors”

https://www.oncnet.com/news/surgery-or-without-chemo-yields-low-testosterone-gct-survivors

Ovarian Cancer Research Alliance

“Chemotherapy”

https://ocrahope.org/patients/about-ovarian-cancer/treatment/chemotherapy/

Supportive Care in Cancer

Khanal, N., et al.

“The effects of hypogonadism on quality of life in survivors of germ cell tumors treated with surgery alone versus surgery plus platinum-based chemotherapy”

(Abstract. Published: November 9, 2019)

https://link.springer.com/article/10.1007/s00520-019-05117-0

WebMD

“What Are Germ Cell Tumors?”

(Reviewed: October 12, 2019)

https://www.webmd.com/cancer/germ-cell-tumors#1

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