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Propecia Side Effects: Erectile Dysfunction & Decreased Libido

After just one year on the market, more than 400,000 men in the United States were filling prescriptions for Propecia to reverse their male pattern baldness. While the drug’s active ingredient, finasteride, effectively blocks the hormone responsible for this common genetic form of hair loss, numerous studies suggest that it can also have damaging effects on users’ sexual health.

Before Propecia was approved for use in the United States in 1997, manufacturer Merck & Co. released clinical trial data on the drug’s safety. One study revealed that 3.8 percent of men treated with Propecia reported one or more adverse sexual side effects, compared with 2 percent of those given a placebo.

The most commonly reported sexual side effects of Propecia include:

• Erectile dysfunction
• Ejaculation disorder
• Decreased libido

While both Merck and the Food and Drug Administration (FDA) assured patients that these complications would resolve once they stopped taking Propecia, later evidence would prove the contrary.

The preapproval trials were not especially reliable, as the information was drawn from a relatively small patient group treated for only six months to one year, and follow-up procedures were unclear. More recent investigations demonstrate that Propecia’s sexual side effects can persist even after cessation of use. In some cases, the complications are irreversible.

One case study describes a 24-year-old patient who started taking Propecia in 1999. Within one week, he experienced soreness in his testicles, a lack of sex drive and the inability to achieve an erection. He stopped taking the drug about a month later, and while some side effects disappeared, his sexual function never returned to normal. In a follow-up 11 years later, he still suffered from erectile dysfunction and loss of libido.

Although situations like this are rare, they can have a huge impact on quality of life for those affected. Starting in April 2012, claimants suffering persistent sexual dysfunction from Propecia use began filing lawsuits against Merck & Co. To better manage the growing caseload, the Propecia lawsuits were consolidated into a multidistrict litigation: MDL 2331. By January 2013, the MDL had grown to 139 lawsuits. More than 250 additional claims have been filed in New Jersey state courts.

Persistent Sexual Side Effects

One of the earliest indications that the sexual side effects of finasteride may continue even after patients stop using the drug came from a 2003 study funded by Merck. In the first year of treatment, 15 percent of men taking finasteride for an enlarged prostate (the drug’s other approved use) reported sexual side effects. Researchers stated that side effects later resolved in 50 percent of patients, but the other group with persistent sexual complications received no follow-up. The study concluded that the problems were most likely caused by factors unrelated to the drug.

The selected group of patients, young men between the ages of 21 and 46, took a survey that revealed a wide range of sexual side effects that arose after Propecia use, including issues with erectile function, arousal, sexual desire, orgasm and orgasm satisfaction. These side effects appeared slowly and gradually, and persisted for an average of 40 months after the end of treatment.

Upon following up with 51 of these patients one year later, Irwig discovered that 96 percent of the men were still suffering from the sexual dysfunctions they initially reported. None of the men reported sexual, psychiatric or medical complaints before taking finasteride.

By 2012, the FDA published results from its own investigation into the adverse effects of finasteride. Using data collected from 1998 to 2011, this study identified persistent sexual dysfunction of at least three months in 14 percent of the 421 evaluated cases. While the agency stated that a clear causal link between finasteride and sexual side effects had not been established, warnings of these complications were added to the drug’s prescribing information.

Erectile Dysfunction

Drawing on data from six Propecia clinical trials, one review of the drug’s adverse sexual side effects reported that approximately 6 to 8 percent of patients experienced erectile dysfunction. This side effect repeatedly appears in Propecia studies, including double-blind, randomized and placebo-controlled trials.

Symptoms of erectile dysfunction may be persistent, and include:

• Difficulty getting an erection
• Difficulty maintaining an erection
• Low sexual desire

In a large observational cohort study of 14,772 men taking finasteride, erectile dysfunction was the most frequently reported of all side effects; 143 patients (roughly 1 percent of those involved) withdrew from treatment as a direct result of erectile dysfunction. According to the American Urological Association (AUA), erectile problems affected 8 percent of men on finasteride and 4 percent of those taking a placebo.

These complications can likely be attributed to Propecia’s suppression of DHT, a hormone that plays an important role in erectile physiology. Numerous animal and human studies have confirmed that Propecia and other 5-alpha-reductase inhibitor drugs can have an adverse effect on erectile response.

While lowering the body’s levels of DHT may correct hair loss, problems arise because this sex hormone is important for maintaining the structural integrity of nerves, smooth muscle, connective tissue and signaling pathways in the penis.

Loss of Libido

Another Propecia side effect that may persist long after men stop taking the drug is a reduced interest in sex. The AUA clinical practice guideline states that 5 percent of men taking finasteride experience a loss of libido, compared with 3 percent of the men given a placebo.

In Irwig and Kolukula’s study of 71 patients who experienced Propecia sexual side effects, 94 percent of men experienced  a decline in libido. The average duration of all sexual side effects, measured from the time of drug cessation, was 40 months.

While a persistent reduction in libido only occurs in a small subset of patients, it can be devastating for those affected. The problem can threaten relationships and often has a severe emotional toll on men and their partners.

Ejaculatory Disorder

Evidence of ejaculatory dysfunction has been observed in 20 finasteride trials, as well as in trials for other 5-alpha-reductase inhibitors like dutasteride. In one study, finasteride and dutasteride led to a decrease in ejaculatory function in week 26 and week 52 of treatment, according to results of a sexual function inventory.

Propecia use has been associated with numerous ejaculatory disorders, including retrograde ejaculation, ejaculation failure and a decrease in semen volume. According to the AUA clinical practice guideline’s review of 5-alpha-reductase inhibitor trials, 4 percent of men taking finasteride experienced some ejaculatory disorder, compared with 1 percent of men taking a placebo.

Male Pattern Baldness

Male pattern baldness affects over half of men to some extent over the age of 50 and most men at some stage in their lives. Most affected men do not wish to have any treatment. If required, treatment can usually prevent further hair loss and often cause hair regrowth.

What is male pattern baldness?

Male pattern baldness is the common type of hair loss that develops in most men at some stage. The condition is sometimes called androgenetic alopecia. It usually takes 15-25 years to go bald. However, some men go bald in fewer than five years.

Typically, at first the hair begins to thin (recede) at the sides (temples). At the same time, the hair usually becomes thin on the top of the head. A bald patch gradually develops in the middle of the scalp. The receding sides and the bald patch on the top (the crown) gradually enlarge and join together, leaving a patch at the front. The patch at the front eventually thins as well.

A rim of hair is often left around the back and sides of the scalp. In some men, this rim of hair also thins and goes to leave a completely bald scalp.

Who gets male pattern baldness?

Nearly all men have some baldness by the time they are in their 60s. However, the age the hair loss starts is variable. About three in ten 30 year-olds and half of 50 year-olds are quite bald. Some women also develop a similar type of hair loss, mainly at the crown. Baldness in women is much more common after the menopause. About 13 in a 100 women have some baldness before the menopause, rising to 75 in a 100 over the age of 65.

What causes male pattern baldness?

Hair is made in hair follicles which are like tiny pouches just under the skin surface. A hair normally grows from each follicle for about three years. It is then shed and a new hair grows from the follicle. This cycle of hair growth, shedding and new growth goes on throughout life. The following is thought to occur in men as they gradually become bald:

• Affected hair follicles on the scalp gradually become smaller than normal.
• As the follicle shrinks, each new hair is thinner than the previous one.
• Before falling out, each new hair grows for much less time than the normal three years or so.
• Eventually, all that remains is a much smaller hair follicle and a thin stump of hair that does not grow out to the skin surface.

Male hormones are involved in causing these changes. The level of the main male hormone, testosterone, is normal in men with baldness. Hair follicles convert testosterone into another hormone called dihydrotestosterone. For reasons that are not clear, affected hair follicles become more sensitive to dihydrotestosterone, which causes the hair follicles to shrink. It is also not clear why different hair follicles are affected at different times to make the balding process gradual.

The condition is hereditary (genetic); the location of the gene was identified in 2008.

It is also not clear why only scalp hairs are affected and not other areas such as the beard or armpits.

Are there any complications from male pattern baldness?

Although male pattern baldness is a common and harmless condition, it can be linked to metabolic syndrome (the combination of obesity, diabetes, raised blood pressure and raised choleterol), resulting in an increased risk of heart disease. This link is most often seen in men who develop baldness at a relatively young age.

Women with male pattern baldness should be checked for causes of raised male hormone levels, such as polycystic ovary syndrome (a condition in which cysts develop in the ovaries).

What are the treatment options for male pattern baldness?

No treatment

To become gradually bald is a normal part of the ageing process for most men. No treatment is wanted or needed by most affected men. For some men, baldness can be distressing, particularly if it is excessive or occurs early in life. Treatment may then help.

Medication

Currently there are two medicines that help - finasteride (trade name Propecia®) and minoxidil (trade name Regaine®). Neither is available on the NHS, so you need to pay the full price for them.

Finasteride was launched in the UK in 2002, although it has been available in the USA since 1997. It works by blocking the conversion of testosterone to dihydrotestosterone. The hair follicles are then not affected by this hormone and can enlarge back to normal.

Some hair regrowth occurs in about 2 in 3 men who take a finasteride tablet each day. In about 1 in 3 men there is no hair regrowth but most do not have any further hair loss whilst taking finasteride. It has no effect in about 1 in 100 men. So, if you take finasteride, you have a good chance that hair will regrow, or at least stop any further hair loss.

Some points about finasteride include the following:

• It takes about four months for any effect to be noticed and up to 1-2 years for full hair growth.
• The balding process returns if treatment is stopped. Therefore, if successful, you need to carry on treatment to maintain the effect.
• Side-effects are uncommon. The most common is that about 2 in 100 treated men report loss of sex drive (libido).
• It does not work in women with male pattern baldness.
• You need a private prescription to get it from a pharmacy.

Minoxidil lotion is a rub-on treatment that you can buy at pharmacies without a prescription. It is not clear how it works. The higher-strength solution (5%) is for men only and is more effective than the 2% solution. The 5% strength is now also available as a foam.

There is debate as to how effective it is. Probably about half of men who use minoxidil delay further balding. About 15 in 100 users have good hair regrowth. There is continued hair loss in about a third of users. However, some reports claim much highersuccess rates. It seems that it is best used to prevent further hair loss but hair regrowth occurs in some users.

Some points about minoxidil include the following:

• It needs to be rubbed on the scalp every day.
• It usually takes four months or more for any effect to be noticed.
• Treatment needs to be continued indefinitely. Any new hair that does regrow falls out two months after treatment is stopped.
• It is quite expensive.
• It may work in some women who have male pattern baldness.
• Side-effects are uncommon - for example, skin irritation or a rash sometimes occurs.

Wigs

A wig is the traditional option for baldness.

Scalp surgery

Techniques such as hair transplantation, scalp flaps and other procedures have been used for a number of years. Success rates vary and an opinion from a doctor who is a specialist is needed if surgery is considered. It is expensive and not available on the NHS.