Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, January 31, 2020

Newest Erectile Dysfunction Drug Approved By FDA

It has been a decade since any new treatments have been added to the pharmaceutical offerings for treatment of erectile dysfunction, or ED. On April 27, 2012, the U.S. Food and Drug Administration issued a press release announcing that the agency had approved a new medication, Stendra, that is intended to aid in the treatment of ED.

Stendra(Avanafil), Can Help In Treating Erectile Dysfunction


Stendra, the trade name for avanafil, joins the ranks of Viagra, Levitra and Cialis as medications to aid in increasing blood flow to the penis. All four drugs are in the class called phosphodiesterase type 5 (PDE5) inhibitors.

The Role of Clinical Research Studies

As with any new drug seeking approval from the FDA, years of background testing first in laboratories and then in humans must be completed. The research conclusions must demonstrate both effectiveness of the drug and its safety.

A total of three double-blind, placebo-controlled clinical studies that included more than 1200 participants. Study participants were followed for a 12-week course of one of the three dosages available for avanafil or a placebo 30 minutes prior to sexual activity; a smaller subset was monitored for an additional forty weeks.

The FDA reports that study participants, who were asked every four weeks to complete a questionnaire on erectile function, vaginal penetration and sexual intercourse, showed a "statistically significant improvement" in all three areas with each of the available doses.

Side effects of Stendra reported in more than 2 percent of study participants included headache, facial flushing, back pain and nasal congestion. As with the other PDE5 inhibitors, there is the possibility of the rare occurance of an erection that lasts longer than four hours (priapism) that requires immediate medical attention.

Bottom Line

Precautions with Stendra are the same as with the other ED medications: men who take nitrate medications should not take this medication and severe side effects such as vision and hearing changes/loss may occur.

As the physician in the accompanying video explains, only you and your doctor can determine if this new medication is right for you.

New Faster-Acting Erectile Dysfunction Drug Approved

This article is informational only. It is not intended to take the place of or replace information from your health care provider. Always consult your health care provider for questions/concerns about your health.

Source: http://m.edtreatmentindia.com/

Sunday, August 18, 2019

Testosterone replacement therapies raise "Low T" and risk of heart attack

You may have seen the enticing drug advertisements on television advising men who suffer from low energy and low sexual interest to talk to their doctors about "Low T" or low testosterone. Since those ads have been on the air, testosterone replacement therapies have gone flying off the shelves. But now the FDA warns that these testosterone therapies increase the risk of stroke and heart attack. In March of 2015, the FDA required that all manufacturers of testosterone drugs add a warning to their labels. This warning is finally trickling down to small town newspapers, such as the Lompoc Record which ran an edited reprint of a Los Angeles Times article on April 23.

Heart Attacks From Testosterone Replacement

Check this Article: Penile Implant Surgery in India

As one might already know, few people get the box. Everyone who goes to the pharmacy gets a typical pharmacy container. The warnings will have to be added to the information handed to the customer, or by adding a sticker next to the label. This may not be an effective way of transmitting the information to those who are desperate for what they see to be the positive effects of raising their testosterone. Why care about the risk of heart attack when a man can take a pill and feel young again? "People are looking for the fountain of youth," said FDA advisory panel member Dr. Aaron Katz, a urologist in Mineola, N.Y.

The FDA currently has only approved testosterone therapy for men who suffer from disorders which cause hypogonadism. Those disorders might stem from the testicles, the loss of the testicles, or from an under-functioning pituitary gland. The FDA recommends that low testosterone ought to be confirmed with laboratory testing before prescribing the medications.

This warning ought to extend to women. Testosterone patches are often used in conjunction with assisted reproductive technologies like invitro fertilization. The running theory is that women who have trouble conceiving may have lower levels of androgens from under-functioning pituitary glands. However, this is often not confirmed with laboratory testing. Most insurance companies do not cover testosterone therapy for women in conjunction with any ART, so the out of pocket cost can be quite high.

Sylvia Jenkins*, who underwent IVF in hopes of expanding her family told Examiner.com, "My doctor said I needed testosterone patches as part of IVF. I looked at my blood tests later, and I didn't see a test for that." She continued, "I felt totally wired on those patches. In a way, I liked it, but in another way, it was really uncomfortable and expensive. And IVF didn't even work."

Testosterone Lawsuit

For men, there may be other ways they can ignite the fires of their younger years which don't involve supplementing their level of testosterone. The wisest route to feeling more energetic is to quit smoking, eat a healthy diet, get 8 hours of restorative sleep per night, and to exercise since the greatest health factors for erectile dysfunction are diabetes, heart disease, and hypertension. Special attention should be paid to strengthening the core muscles, which tend to weaken with age. The core muscles include the pelvic floor muscles which control bladder and rectal function. A healthy pelvic floor can also help men to have a better sex life and can help men with erectile dysfunction and painful sex.

Source: http://m.edtreatmentindia.com/