Since the early 1990s, scientists and medical researchers have found that finasteride use is linked to sexual dysfunction in the form of erectile dysfunction, loss of libido, ejaculation disorder, and other ailments.  This chemical is the active chemical in the hair loss drug Propecia (finasteride 1mg) and the benign prostatic hyperplasia (BPH) drug, Proscar (finasteride 5mg).

A 2001 article by C. Schulman in Prostate Cancer and Prostatic Diseases titled “Impact of treatment of BPH on sexuality.” states “The 5alpha-reductase inhibitor, finasteride, can result in ED in 5-9% of patients and ejaculation disorders in 0.8-2.0%.”  This rate of erectile dysfunction is significantly higher than that reported by Merck & Co., Inc., the manufacturer of Proscar.  Schulman asserts “In addition to information on the efficacy of a particular therapy, patients should be informed of side effects, in particular those relating to sexual function, in order that they can make informed treatment decisions.”  I couldn’t agree more.

An article titled “Finasteride in the treatment of clinical benign prostatic hyperplasia: a systematic review of randomised trials.” published by JE Edwards and RA Moore of the Pain Research and Nuffield Department of Anaesthetics at The University of Oxford in BMC Urology in 2002 also studied the connection between sexual dysfunction and Proscar.  The authors write “Significantly more sexual dysfunction, impotence, ejaculation disorder and decreased libido occurred with finasteride at 12 months; the NNH for any sexual dysfunction at 12 months was 14” in a study that reviewed nearly 9,000 finasteride and 6,000 control patient files from other studies.  An “NNH” of 14 means that in the first year of study, one of every 14 patients using Proscar will suffer sexual dysfunction (who wouldn’t if the drug was not used).

In 2000, an article titled “Medical therapy for benign prostatic hyperplasia: a review of the literature.” appearing in the July edition of European Urology makes a brief albeit important reference to the link between sexual dysfunction and Proscar.  Studying a variety of treatments for BPH, the research team remarks (led by GM Clifford), “They are, however, both associated with an increased risk of sexual dysfunction,” referencing finasteride (Proscar) and tamsulosin (Flomax).

All of these papers were published more than ten years before the manufacturer sufficiently updated warning labels.  Due to the fact that Merck & Co., Inc. failed to adequately warn users of the risk for sexual side effects, a number of Proscar lawsuits have been filed.  If you or a loved one used Proscar and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Here is an excerpt from a 2013 article appearing in Journal of Sexual Medicine titled “Neuroactive steroid levels are modified in cerebrospinal fluid and plasma of post-finasteride patients showing persistent sexual side effects and anxious/depressive symptomatology.”:

“Observations performed in a subset of subjects treated with finasteride (an inhibitor of the enzyme 5α-reductase) for male pattern hair loss seem to indicate that sexual dysfunction as well as anxious/depressive symptomatology may occur at the end of the treatment and continue after discontinuation.”

Finasteride is the active ingredient in the hair loss drug Propecia (Merck & Co., Inc.), and has been associated with sexual side effects that continue long after the drug is discontinued.  Now, we see that such long-term sexual dysfunction may play a role in the development of two psychiatric ailments, anxiety and depression.

The authors of the above-referenced paper, led by R.C. Melcangi state “A possible hypothesis to explain depression symptoms after finasteride treatment might be impairment in the levels of neuroactive steroids”, and as such, this was the focus of their study.

While it was found that the “Severity and frequency of the anxious/depressive symptoms were quite variable; overall, all the subjects had a fairly complex and constant neuropsychiatric pattern” of those symptoms.  And, “assessment of neuroactive steroid levels in patients showed some interindividual differences. However, the most important finding was the comparison of their neuroactive steroid levels with those of healthy controls. Indeed, decreased levels of tetrahydroprogesterone, isopregnanolone and dihydrotestosterone and increased levels of testosterone and 17β-estradiol were reported in cerebrospinal fluid of postfinasteride patients. Moreover, decreased levels of dihydroprogesterone and increased levels of 5α-androstane-3α,17β-diol and 17β-estradiol were observed in plasma.”

Essentially, the hypothesis of the team was not falsified, and their explanation of how Propecia patients suffer anxiety and depression in the face of long-term sexual dysfunction is plausible.  While this is very important, what may be more important is that individuals using Propecia be aware of these sexual side-effects and the risk for depression prior to taking the drug by way of clear and sufficient warning labels.

Since Merck & Co., Inc. failed time and again to provide such labels, a number of Propecia lawsuits are currently being filed.  If you or a loved one used Propecia and suffered sexual side effects, you may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Propecia lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

In the September 2012 edition of Journal of Clinical Psychiatry, medical researcher MS Irwig published a study titled “Depressive symptoms and suicidal thoughts among former users of finasteride with persistent sexual side effects.”, illustrating one dimension of the truly devastating effects of Propecia (finasteride 1mg, for hair loss) and Proscar (finasteride 5mg, for benign prostatic hyperplasia).

Irwrig writes “Finasteride, a commonly prescribed medication for male pattern hair loss, has recently been associated with persistent sexual side effects. In addition, depression has recently been added to the product labeling of Propecia (finasteride 1 mg). Finasteride reduces the levels of several neuroactive steroids linked to sexual function and depression. This study assesses depressive symptoms and suicidal thoughts in former users of finasteride who developed persistent sexual side effects despite the discontinuation of finasteride.”

Studying a relatively small sample of Propecia users with persistent sexual side effects, Irwig found that depression symptoms were more than seven times as common among men who had used Propecia, compared to controls (who had hair loss but never used the drug and denied history of any current or past psychiatric symptoms).  Suicidal thoughts were more than 14 times more prevalent among ex-Propecia users compared to those controls.

Due to the fact that Merck & Co., Inc. , the manufacturer of Propecia, failed time and again to adequately warn users of the risk for persistent sexual side effects, a number of Propecia lawsuits have been filed.  If you or someone you know used Propecia and suffered sexual side effects, you may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Propecia lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

An article published in the April, 2014 edition of Journal of Sexual Medicine by M. Gacci et al. titled “Impact of Medical Treatments for Male Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia on Ejaculatory Function: A Systematic Review and Meta-Analysis.” provides additional support for finasteride’s link to sexual dysfunction.  Finasteride is the active chemical in Proscar (finasteride 5mg, for benign prostatic hyperplasia – BPH), Propecia (finasteride 1mg, for hair loss), and other drugs, and is in the class of 5alpha-reductase inhibitors (5ARIs).

The authors studied 23 previously-conducted studies and found that ejaculation disorder “was significantly more common with 5ARIs as compared with placebo (OR:2.73; P < 0.0001)”, meaning that use of 5ARIs made one nearly three times as likely to suffer ejaulation disorder compared with placebo users.

It was also found that “Both Finasteride (OR 2.70; P < 0.0001) and Dutasteride (OR 2.81; P = 0.0002) were associated with significantly higher risk of EjD than placebo”, meaning that finasteride itself, not simply that class of drugs, was associated with a dramatically-increased risk for ejaculation disorder (2.7 times the risk).

Because the manufacturers of Proscar and Propecia (Merck & Co., Inc.) have failed to adequately warn users of the risk for such sexual side effects, a number of Proscar lawsuits and Propecia lawsuits have been filed.  If you or a loved one used Proscar or Propecia and suffered ejaculation disorder or another sexual side effect, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar lawyers and Propecia lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2005, an article titled “Sexual dysfunction and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).” appearing in the medical journal European Urology, provided further evidence of scholarly knowledge of the link between finasteride and sexual dysfunction long before warning labels for the drug were updated.

Finasteride is the active chemical in a number of drugs, including Propecia (a hair loss drug, finasteride 1mg) and Proscar (a benign prostatic hyperplasia (BPH) drug, finasteride 5mg) both manufactured by Merck & Co., Inc.

This research team, led by R.C. Rosen, states that “Effective medical therapies for [lower urinary tract symptoms (LUTS)] associated with BPH include alpha(1)-adrenergic receptor antagonists (i.e., alfuzosin, doxazosin, tamsulosin, and terazosin) and 5alpha-reductase inhibitors (i.e., finasteride and dutasteride). The side effects of these medications, including sexual dysfunction, are important distinguishing features. The successful management of patients with LUTS associated with BPH should include assessments of sexual function and monitoring of medication-related sexual side effects. For men with LUTS and sexual dysfunction, an appropriate integrated management approach, based on each patient’s symptoms and outcome objectives, is warranted.” (emphasis added)

Because Proscar warning labels were not updated until years later, and many men used Proscar unaware of the risk for sexual side effects, a number of men have chosen to file Proscar lawsuits.  If you or a loved one used Proscar and suffered sexual side effects, you too may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452-5529

justinian@dangerousdrugs.us

An article published in a 2005 edition of Comprehensive Therapy titled “Noninvasive management of lower urinary tract symptoms and sexual dysfunction associated with benign prostatic hyperplasia in the primary care setting.” makes an important note of the connection between finasteride and sexual side effects.  Finasteride is the active chemical in Proscar, a drug commonly used to treat benign prostatic hyperplasia (BPH), a drug in the larger class of 5alpha-reductase inhibitors.

The author states “Most men who live to middle age and beyond will ultimately develop lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), and many will also experience sexual dysfunction.”  And, the author states “5alpha-reductase inhibition is not recommended for men without demonstrable prostatic enlargement, may be associated with a long delay between treatment initiation and LUTS improvement, and is clearly associated with sexual side effects, including decreased libido, ejaculatory dysfunction, and erectile dysfunction.” (emphasis added)

Due to the fact that Merck & Co., Inc. failed time and again to adequately warn users of Proscar of the risk for sexual dysfunction, a number of Proscar lawsuits have been filed.  If you or a loved one used Proscar and suffered adverse sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our Proscar lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Finasteride is a chemical in a larger class called 5alpha-reductase inhibitors, and is the active chemical in the hair loss drug Propecia (finasteride 1mg), and the benign prostatic hyperplasia drug Proscar (finasteride 5mg).  Recently, a number of scientific studies have demonstrated that finasteride use is linked to adverse sexual effects including erectile dysfunction, ejaculation disorder, loss of libido, and others.

It is important to note that nearly all of the studies linking Proscar and Propecia with sexual side effects are double-blind, placebo-controlled studies – that is, studies in which comparable patients are given either placebo or finasteride and effects are monitored.  This is important because male pattern hair loss and BPH are common among aging men, who also have a greater tendency to exhibit the above-described sexual side effects. (Most BPH drug users are older men, who are more likely to have ED, for example.)  That being said, finasteride has been shown to cause long-term sexual side effects in healthy young and old men alike.

Though the finasteride warning label was not updated to include information in the risk for long-term side effects for years to come, a 2008 study made note of just that link.  In “Five-alpha-reductase Inhibitors for prostate cancer prevention.” by T.J. Wilt et al., it is stated that “Impaired sexual or erectile function or endocrine effects were more common with finasteride than placebo”, though it is not stated how much more common sexual side effects were, for the main aim of the study was elsewhere.

Due to the fact that many men have used finasteride in the form of Proscar or Propecia and suffered sexual side effects unaware of that possibility, a number of Proscar lawsuits and Propecia lawsuits have been filed.  If you or a loved one used Propecia or Proscar and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar lawyers and Propecia lawyers at the information provided below.  We have the compassion, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

 

A 2010 article published in Archives of Dermatology by JM Mella et al. titled “Efficacy and safety of finasteride therapy for androgenetic alopecia: a systematic review.” further demonstrates that finasteride use is linked to sexual side effects.  Finasteride is the active chemical in Alopecia, the BPH drug Proscar, the hair loss drug Propecia, among others.

Aiming to “determine the efficacy and safety of finasteride therapy for patients with androgenetic alopecia,” the researchers,” “MEDLINE, EMBASE, CINAHL, Cochrane Registers, and LILACS were searched for randomized controlled trials reported in any language that evaluated the efficacy and safety of finasteride therapy in comparison to treatment with placebo in adults with androgenetic alopecia.”  That is, the team studied other previously-conducted studies.

In all, “Twelve studies fulfilled the eligibility criteria (3927 male patients)” and Mella et al. (2010) found that Propecia (finasteride 1mg) was effective at re-growing scalp hair in a number of metrics, but that men receiving Propecia were more than twice as likely as placebo patients to suffer erectile dysfunction.  As such, the team concluded that “evidence suggests that daily use of oral finasteride increases hair count and improves patient and investigator assessment of hair appearance, while increasing the risk of sexual dysfunction.”

Due to the fact that a number of men have used Propecia unaware of the risk of sexual side effects, a number of Propecia lawsuits have been filed against the manufacturer, Merck & Co., Inc.  If you or a loved one used Propecia and suffered erectile dysfunction or another sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Propecia lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

An article published in the May, 2012 edition of Journal of the American Medical Association titled “Prostate, Baldness Drugs Linked to Sexual Dysfunction” provides important insight into the link that Proscar (finasteride 5mg, used to treat BPH) and Propecia (finasteride 1mg, used to treat male pattern hair loss) have with a range of adverse sexual effects.

The article states that “In 2011, the drug labels had been updated to note the possibility that users may experience erectile dysfunction even after they stop taking these drugs. However, the new labeling indicates that a number of other sexual adverse events may also be associated with use of these medications.”

Citing 421 cases of adverse sexual side effects in patients taking Propecia (1998-2011) and 131 among Proscar users in the same period,  the FDA remains hesitant to speak of any biologically causal relationship.  That being said, a number of reports have been published since the 1990’s linking sexual side effects to the use of finasteride, and correlative as those studies may be, a growing pile of such research without question says something.

Due to the fact it took so long for the manufacturer of these two drugs (Merck & Co., Inc.) so long to update the Propecia and Proscar warning labels, a number of Proscar lawsuits and Propecia lawsuits have been filed.  If you or a loved one used finasteride and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar lawyers and Propecia lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Here is an excerpt from the FDA’s frequently-asked questions page for required the Proscar and Propecia Warning Label Update:

Questions and Answers: Finasteride Label Changes

“On April 11, 2012, the U.S. Food and Drug Administration (FDA) announced changes to the professional labels for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) to expand the list of sexual adverse events reported to FDA as some of these events have been reported to continue after the drug is no longer being used (note that erectile dysfunction after stopping use of these drugs was added as a known event in 2011). The new label changes include:

  • A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.

  • A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.

  • A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.  Information about these adverse events may be important to individual patients.  Therefore, prescribers and patients need to be aware of them, as part of a discussion of risk and benefits of finasteride when determining the best treatment options.

Below are some additional questions and answers on this announcement and action.

Q1. What are Proscar and Propecia?

A1. Proscar and Propecia both contain the active ingredient finasteride and belong to a class of prescription medicines called 5 alpha-reductase inhibitors.

Proscar (finasteride 5 mg) was approved by FDA in 1992 and is indicated for the treatment of bothersome symptoms in men with benign prostatic hyperplasia (also referred to as BPH or an enlarged prostate). Proscar is also approved to reduce the risk of urinary retention or the need for surgery related to BPH.

Propecia (finasteride 1 mg) was approved by FDA in 1997 for use in males only and is indicated for the treatment of male pattern hair loss.

Q2. Are any similar side effects already listed in the labels of Proscar and Propecia?

A2. Yes. Sexual side effects were reported by patients during clinical trials, and this information was included in the Proscar and Propecia’s labels at the time of approval in 1992 and 1997, respectively. In controlled clinical trials, these side effects resolved in patients who stopped finasteride, as well as in most patients who continued therapy. In 2011, both Proscar and Propecia’s labels were revised to include erectile dysfunction that continued after drug discontinuation.

Q3. What studies and/or reports did FDA review to determine this information should be included in the label?

 

A3. For Propecia, FDA reviewed 421 postmarketing reports of sexual dysfunction submitted to the Agency’s Adverse Events Reporting System (AERS) database between 1998 and 2011.  Of these, 59 cases reported sexual dysfunction that lasted for at least three months following discontinuation of Propecia, and included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders.

For Proscar, FDA reviewed 131 cases of erectile dysfunction and 68 cases of decreased libido associated with the use of finasteride 5 mg submitted to the drug sponsor’s worldwide safety database between 1992 and 2010.  Where information was available, these reported events of erectile dysfunction and decreased libido lasted for at least several weeks after drug discontinuation.

Regarding semen quality, 251 cases associated with Propecia use were identified from the sponsor’s safety database.  Of these cases, 13 contained enough information for FDA to evaluate.  FDA reviewed 29 cases associated with Proscar use, of which only 3 cases involved men with benign prostatic hypertrophy.  There was limited information available on these cases to assess the effect of finasteride on semen quality.

FDA also requested additional information from the drug sponsor to assess the reports. No new clinical studies were reviewed to evaluate these adverse events. FDA is not aware of any additional controlled clinical studies conducted to evaluate these adverse events or to determine their cause or duration.

Q4. Why are the label changes for Proscar and Propecia different?

A4. The labels reflect the differences in the population of men using Propecia and Proscar, which have different indications of use. Postmarketing cases of sexual dysfunction that continued after patients stopped using Propecia occurred in a younger population of men compared to cases reported with Proscar. Older men who reported sexual adverse events with Proscar, in general, also had concurrent medical conditions and were treated with medications that may affect sexual function.

Q5. Do all men experience sexual adverse events when using Propecia or Proscar?

A5. No. Only a small percentage of men using these drugs have experienced a sexual adverse event. The frequency of sexual adverse events is best obtained from controlled clinical trials. Analysis of these controlled clinical trials showed that during treatment with Propecia, 36 (3.8%) of 945 men had reported one or more adverse sexual experiences as compared to 20 (2.1%) of 934 men who did not receive Propecia (received placebo).

Sexual adverse events associated with Proscar use were identified in two clinical trials. This information is included in the Proscar label.  In one trial, these events were reported more frequently during the first year of treatment with Proscar as compared to men who received placebo.  In years 2-4 of the trial, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

Q6. Has FDA notified healthcare professionals about the risk of sexual adverse events associated with finasteride use?

A6. FDA has notified healthcare professionals who would normally prescribe finasteride products—dermatologists, family practice professionals, internists and urologists—about FDA’s review of postmarketing reports and the label changes. This communication informs prescribers that FDA has not established a cause and effect relationship between finasteride and the sexual adverse events that continued after stopping drug use.

Q7. I am currently taking Propecia or Proscar. What should I do?

A7. If you have questions or concerns, you should consult your health care provider to discuss the risks and benefits of the medication as they specifically apply to you. Do not stop taking your medication without first consulting with your health care provider.

FDA believes that finasteride remains a safe and effective drug for its approved indications. Healthcare professionals and patients should consider this new label information when deciding the best treatment option.

Q8. How do I report an adverse event to the FDA?

A8. Patients and healthcare professionals should report adverse events experienced with Proscar or Propecia to the FDA MedWatch program. You can reach MedWatch at 1-800-332-1088, report online at MedWatch Online, or submit your report using regular mail and postage-paid FDA Form 3500.”

Propecia Lawsuit / Proscar Lawsuit

Because many men used these drugs unaware of the true risk for sexual side effects, many Proscar lawsuits and Propecia lawsuits have been filed.  If you or a loved one used one of these drugs and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar lawyers and Propecia lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us