Propecia Risks, Side Effects and Legal Warnings

Propecia is a brand-name drug that is available as a generic called finasteride. Oral versions of Propecia and finasteride received U.S. Food & Drug Administration (FDA) approval, but some users have experienced side effects like depression, decreased libido and erectile dysfunction.

The FDA has also issued warnings about side effects associated with topical finasteride, including anxiety, brain fog, fatigue, insomnia and suicidal ideation.

Propecia lawsuits have been filed against the medication’s manufacturer, Merck. If you have experienced any of these complications after taking Propecia, consider getting legal help to understand your rights.

Propecia is prescribed to treat male-pattern hair loss, known as androgenetic alopecia. This is when the hair on the top of your head gets thinner, causing you to experience a receding hairline or baldness.

Propecia can also be used to treat benign prostatic hyperplasia. This condition causes an enlarged prostate that results in urinary symptoms like incomplete emptying, straining or urgency.

Propecia does have potential side effects, including sexual dysfunction, psychiatric disorders and pain.

According to the FDA’s Adverse Event Reporting System (FAERS), the most commonly reported Propecia side effects are erectile and sexual dysfunction, depression, anxiety and decreased libido. Patients have filed just over 6,200 side effect reports.

While adverse reactions to Propecia are rare, they can become serious. Over half of the total reported number of cases turned into severe cases.

Various forms of reproductive system disorders, including erectile and sexual dysfunction, make up roughly 50% of the reported effects. Additionally, almost 45% of the reports relate to having psychiatric disorders like increased anxiety or depression.

Although Propecia side effect reports have decreased annually since 2016, those who use Propecia should still promptly inform their doctor of any side effects.

Propecia and Erectile Dysfunction

Research over the past decade has pointed to finasteride as a potential instigator of erectile dysfunction.

One study published in the journal PeerJ found that 530 patients in a study of 11,909 participants developed erectile dysfunction after taking finasteride. The condition was temporary in most of those patients, but 167 of those patients developed persistent erectile dysfunction. This dysfunction took an average of three to four years to resolve after the patients stopped taking the drug.

Drugwatch spoke with a man from Florida who claims that taking Propecia devastated his life. As a result, he had resorted to using testosterone replacements, medications for erectile dysfunction like Viagra and Cialis. He even underwent a penile implant. He asked to be identified only as “DR.”

“Whenever people looked at me, they saw this successful, good-looking guy. But, it’s like I’ve got this secret,” he said. “I would love to be married and settled down, but I can’t enter a relationship and say, ‘Hey, you know what? I can’t have a consistent erection.’”

Another man from New York state, who asked to be identified simply as “G.M.,” initially took Propecia to address his hair loss. However, he experienced many adverse side effects, including mood problems and sexual disorders.

“I don’t know of anything that can change you so much,” G.M. told Drugwatch. “I don’t know any other pharmaceutical that basically castrates you.”

Depression and Suicidal Ideation

Evidence has linked Propecia to various mental health conditions, including depression, anxiety and even suicidal ideation.

A 2012 study interviewed patients who had discontinued taking finasteride at least three months before the study. Researchers found that 44% of participants had persistent suicidal thoughts despite discontinuing the drug. The study’s control group of individuals who did not take finasteride had a suicidal ideation rate of only 3%.

Differences regarding depressive symptoms were also significant. Approximately 10% of the control group expressed some form of depression, but that rate rose to 75% among participants on Propecia.

Organizations beyond the FDA have taken notice of the drug’s potential impacts on mental health. A press release issued by the United Kingdom’s Medicines and Healthcare products Regulatory Industries asked men currently taking finasteride to remain vigilant for any adverse effects on their mood.

If you are experiencing major depressive episodes or are contemplating taking your own life, call a mental health professional immediately.

Cancer Risks With Propecia

The label Merck puts on Propecia warns that taking the drug may increase your risk of developing high-grade prostate cancer, the deadliest form of this disease. However, there is mixed evidence for this.

While research from the National Cancer Institute has shown that taking finasteride can lower the likelihood of developing low-grade prostate cancer for men ages 55 and older, those same studies discovered a correlation between finasteride use and higher rates of high-grade prostate cancer.

But, because finasteride decreases prostate size, it is unclear if the drug directly caused these higher rates. It’s possible that the smaller size made it easier to detect pre-existing cancer during screenings.

In 2011, Merck also added male breast cancer to its list of potential adverse effects. The label instructs patients taking the medication to seek treatment if they experience breast lumps, pain or discharge.

Persistent Adverse Effects

Some Propecia side effects may cause persistent and irreversible symptoms that might continue after you stop taking the medication.

These side effects might be referred to as Post-Finasteride Syndrome (PFS). PFS can include ongoing mental, neurological, physical and sexual side effects.

No evidence-based treatments exist for post-finasteride syndrome. You may have few options for recovery if you are dealing with these long-term side effects.

As problems with Propecia came to light, the FDA required a series of label changes to the Propecia safety information. These included:

Propecia’s packaging now contains the information required in the 2012 revisions. However, the alert does not take the form of a black box warning, which is the most serious type of warning.

Patient advocacy group Post-Finasteride Syndrome Foundation has unsuccessfully petitioned the FDA to require stronger warnings.

Global Warnings and Label Changes

The FDA isn’t the only agency that wants drugmakers to alert customers about finasteride side effects. The European Medicines Agency requires a warning to patients taking one milligram finasteride tablets to seek medical advice if they experience problems with sexual function.

Additionally, Health Canada recommended that manufacturers update the labels of finasteride-containing products to inform users about the risk of serious muscle-related side effects.

People who used Propecia have taken legal action against Merck. Many claims were consolidated into federal multidistrict litigation (MDL).

An MDL allows similar cases to be grouped and heard before one judge. In the Propecia litigation, multiple plaintiffs who were harmed by the drug had their cases consolidated into a federal MDL in the Eastern District of New York.

Plaintiffs pursuing claims against Merck alleged that the company failed to warn them of the potential side effects, minimized the long-term adverse impacts, knowingly concealed risks of the dangers and inadequately labeled the drug.

While the original labels downplayed the risk, plaintiffs allege that internal communications show Merck was aware of the devastating effect the drug could have on men’s health many years before the risks were public knowledge.

As the MDL and the number of cases grew, Merck agreed to pay $4.3 million to settle most of the lawsuits. Settlement details were initially sealed, but a judge later ordered them unsealed. These documents showed that Merck was aware of suicidal behavior in men taking Propecia.

Currently, there’s no litigation that we know of for this side effect. However, it may still be possible to take legal action if you were harmed by Propecia. You can talk with a lawyer about your options.

While PFS is part of many plaintiff claims against Propecia, there is controversy about this syndrome.

Many people who used Propecia claimed to have experienced this condition, and the Post-Finasteride Syndrome Foundation argues that the syndrome has adversely impacted the lives of many men.

However, there is some dispute about whether PFS is real. Reasons for doubt include:

Controversy over the syndrome’s existence creates additional challenges for victims since Merck is less likely to make a fair settlement offer if it does not accept that the problem exists.

If you or someone you love took Propecia, watch for side effects like sexual dysfunction or cognitive changes. Talk to your doctor and stop taking the medication if you have concerning symptoms.

You should also report side effects to the FDA using its MedWatch program. This allows the FDA to collect data and take appropriate action if there is a pattern of problems with a particular drug.

FDA warnings and alerts help keep the public safe. Reporting health issues caused by Propecia or other drugs could protect others from experiencing dangerous side effects.

If you suffered injuries due to Propecia, you can contact an attorney to better understand your rights. Get your free case review today with Drugwatch and see if you qualify for compensation.