Published in the January, 2013 edition of Expert Opinion on Drug Safety, an article by S. Gur and a team of researchers from Tulane University (New Orleans) titled “Effects of 5-alpha reductase inhibitors on erectile function, sexual desire and ejaculation.” provides important insight into the connection between finasteride (Propecia, Proscar, others) and adverse sexual side effects.

Finasteride belongs to a greater class of drugs known as 5-alpha reductase inhibitors (5ARI), and are “commonly utilized for the treatment of benign prostatic hyperplasia (BPH).”  An example of such a drug is Proscar, which uses finasteride at 5mg daily doses.

To gather data, the team performed “A PubMed search … of all articles from 1990 to present, which reported any sexual side effects with finasteride or dutasteride.”  After statistical analysis, the team showed that “Clinical trials with 5ARI report prevalence rates of de novo erectile dysfunction of 5 – 9%. Decreased circulating dihydrotestosterone (DHT) resulting from 5ARI use is associated with diminished sexual desire and/or orgasm. The presence of adverse sexual effects is associated with decreased self-esteem, quality of life and ability to maintain an intimate relationship. Inhibition of 5ARI additionally influences progesterone and deoxycorticosterone levels and may alter psychological functions, including increased depression, melancholy and loss of general well being.”

Accordingly, the team recommends that “Patients receiving therapy with 5ARI should be counseled as to potential sexual and psychological adverse effects”, and suggests that “Future clinical studies are needed to further investigate the sexual side effects associated with this class of drugs.”

Due to the fact that many people have used these drugs unaware of the risk for sexual side effects, a number of Propecia lawsuits and Proscar 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 experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2006, an article by F. Giuliano titled “Impact of medical treatments for benign prostatic hyperplasia on sexual function.” published in BJU International helps elucidate the link between finasteride (the active chemical in Propecia, Proscar, and other drugs) and adverse sexual side effects — Proscar is a finasteride-containing drug used commonly in the treatment of benign prostatic hyperplasia.

The article states “The 5alpha-reductase inhibitors, finasteride and dutasteride, are associated with a greater risk of erectile dysfunction (ED), ejaculatory dysfunction (EjD) and decreased libido than is placebo.”

While much of the piece is about other drugs, the author concludes “because treatment options for managing BPH have different effects on sexuality, the sexual dimension should be considered when assessing patients’ expectations and the choice of treatment.”

Because it took Merck & Co., Inc. so long to adequately update warning labels to include the risk for sexual side effects causing a number of men to use these drugs unaware of such risk, many Proscar and Propecia lawsuits are currently being filed against the company.

If you or a loved one used Proscar or Propecia 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 Propecia lawyers and Proscar 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

What is federal preemption? It’s an easier concept to grasp than you might think.

Think back to when you were a kid, and you asked your mom if you could go to a party. She clearly said, “no.” You then went to ask your dad if you could go to the party, and he clearly said, “yes.” Since you were always taught that both parents ruled your actions, you figured as long as you had one parent’s approval to go the party, that was good enough, and you couldn’t get in trouble for going.

Wrong. That night, as you started to leave the house, your parents stopped you, forbidding you to go to the party after all. Angrily, they explained that since your mom had already determined that you could not go to the party, your dad’s permission was null and void. In other words, your mom’s rule wiped out or “preempted” your dad’s rule. Although you didn’t know it then, that night, you got your first lesson in the basic concept of federal preemption.

Federal preemption is a doctrine based on the Supremacy Clause of the United States Constitution, which states that federal law takes precedence over state law.

When state law and federal law conflict, federal law wipes out or “preempts,” state law, due to the Supremacy Clause of the Constitution. U.S. Const. art. VI., § 2. Specifically, the Supremacy Clause states, “the Laws of the United States …shall be the supreme law of the land …anything in the … laws of any state to the contrary notwithstanding.”

So, if federal law requires you to do something, and state law requires you do the opposite, which one wins? Due to federal preemption, federal law wins. For example, if, hypothetically, federal law requires you to paint your fence blue, and state law forbids you from painting your fence blue, federal law wins due to the Supremacy Clause of the Constitution. The federal law preempts the state law, and you would therefore be required to paint your fence blue.

In many recent cases involving prescription drugs, we have seen tension between federal law and state tort law. See, e.g., PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). The general pattern among these recent cases is as follows: State law requires all drug manufacturers—whether it be a brand-name manufacturer or a generic drug manufacturer—to design medications safely, and to provide adequate warning labels on all of their medications. In turn, if a drug manufacturer fails to safely design a medication or fails to provide an adequate warning label, and someone in harmed as a result, that person can sue the manufacturer under state tort law.

By direct contrast, federal law only requires brand-name manufacturers to design medications safely, and to provide adequate warning labels on all of their medications. Under federal law, the generic drug’s design and warning label must be identical to that of the brand-name version of the drug, no matter how unsafe or inadequate.

Therefore, if you are harmed by a generic version of a brand-name drug, state law automatically permits you to sue the manufacturer of the generic version, while federal law automatically forbids you from suing the manufacturer. Which one wins? Due to federal preemption, federal law wins.

Most often, manufacturers successfully argue that they cannot be sued because federal law allowed them to sell the unsafe product and that preempts—and immunizes them from—the state laws that would hold them accountable. See http://publicjustice.net/blog/fighting-for-access-tp-justice-part-2#sthash.YBK8uZQ5.dpuf.

However, and fortunately, courts are finding creative ways around federal preemption, which allow plaintiffs to be compensated for their injuries. For examples, see our previous post entitled, Brand-Name Drug Manufacturer can be Liable for Harm Caused by its Generic Version.

Also, please check in soon for more upcoming articles on other specific, recent cases where courts have ruled in favor of plaintiffs despite federal preemption.

 

A 2011 article by M.S. Irwig and S. Kolukula, a pair of researchers from The George Washington University, titled “Persistent sexual side effects of finasteride for male pattern hair loss.” demonstrates that sexual side effects of finasteride use often do not subside when drug use is discontinued.  For clarity, finasteride is the active chemical in Propecia, a drug used for male pattern hair loss, and is manufactured by Merck & Co., Inc.

The team writes “Finasteride has been associated with reversible adverse sexual side effects in multiple randomized, controlled trials for the treatment of male pattern hair loss (MPHL). The Medicines and Healthcare Products Regulatory Agency of the United Kingdom and the Swedish Medical Products Agency have both updated their patient information leaflets to include a statement that ‘persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use.’”

To perform this study, Irwig and Kolukula “conducted standardized interviews with 71 otherwise healthy men aged 21-46 years who reported the new onset of sexual side effects associated with the temporal use of finasteride, in which the symptoms persisted for at least 3 months despite the discontinuation of finasteride.”

Results showed that “Subjects reported new-onset persistent sexual dysfunction associated with the use of finasteride: 94% developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean number of sexual episodes per month dropped and the total sexual dysfunction score increased for before and after finasteride use according to the Arizona Sexual Experience Scale (P<0.0001 for both). The mean duration of finasteride use was 28 months and the mean duration of persistent sexual side effects was 40 months from the time of finasteride cessation to the interview date.”

As such, the team concluded that “Physicians treating MPHL should discuss the potential risk of persistent sexual side effects associated with finasteride.”

Unfortunately, the manufacturer Propecia failed to update warning labels in light of the publication of research such as this, and warning labels were not updated until the FDA required it in April, 2012.  As a result, a number of Propecia lawsuits have been filed.

If you or a loved one used Propecia and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact out 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

 

In 2003, a study by H. Wessells et al., a team from The University of Washington in Seattle, titled “Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia.” provided an important early illustration of the connection between drugs containing finasteride (such as Propecia and Proscar) and sexual side-effects.

It is worth noting that Merck & Co., Inc. did not update warning labels for these drugs for another nine years, and only after such action was required by the United States Food and Drug Administration.  Because of this failure to warn, a number of Proscar lawsuits and Propecia lawsuits have been filed.  To be clear, Proscar is a drug that uses finasteride in 5mg doses in the treatment of benign prostatic hyperplasia, and Propecia is a drug that uses finasteride in 1mg daily doses in the treatment of male pattern hair loss.

This study “was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men, aged 45 to 78 years, with symptomatic benign prostatic hyperplasia, enlarged prostates, and no evidence of prostate cancer.”

Results showed that “During year 1 of the study, 15% of finasteride-treated patients and 7% of placebo-treated patients had sexual AEs that were considered drug related by the investigator”.  The team found that “Sexual AEs resolved while continuing therapy in 12% of finasteride patients and 19% of placebo patients” and “Only 4% of finasteride and 2% of placebo patients discontinued the study because of sexual AEs.”

If you or a loved one used Proscar or Propecia and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Propecia lawyers and Proscar lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

A 2008 article titled “5-alpha reductase inhibitors and erectile dysfunction: the connection.” by F. Erdemir et al. in Journal of Sexual Medicine provides important insight into the link between finasteride (the active chemical in hair loss drug Propecia and BPH drug Proscar) and adverse sexual side-effects.

The authors state “Benign prostatic hyperplasia (BPH) is a common problem affecting middle-aged and elderly men. First-line medical therapy includes alpha 1blockers and 5alpha-reductase inhibitors (5ARIs), such as finasteride and dutasteride. 5ARI use has been associated with adverse sexual outcomes, including erectile dysfunction (ED), ejaculatory dysfunction (EjD), and decreased libido.”

Searching “all publications concerning 5ARIs and sexual AEs” (that is, drugs like finasteride and sexual adverse effects), the team found that “Sexual AEs are reported in clinical trials at rates of 2.1% to 38%. The most common sexual AE is ED, followed by EjD and decreased libido.”

As such, Erdemir et al. (2008) concludes “The connection between 5ARIs and sexual dysfunction is apparent upon review of the literature” and states “Since the connection between 5ARIs and sexual AEs is established in the literature, future research should be directed toward deciphering the pathophysiologic mechanisms.”

Due to the fact that research such as this had been available for years and yet Merck & Co., Inc., the manufacturer of these drugs failed to update warning labels to include these risks until 2012 (at the direction of the FDA), a number of Proscar lawsuits and Propecia lawsuits have been filed against the company.

If you or a loved one used Proscar or Propecia and suffered adverse sexual 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, experience, and resources required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2013, an article titled “Change in Sexual Function in Men with Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia Associated with Long-Term Treatment with Doxazosin, Finasteride and Combined Therapy.” by C.W. Fwu et al. published in The Journal of Urology illustrates the connection between finasteride, the active chemical in Propecia, Proscar, and other drugs, and persistent sexual side effects.

The authors state “We examined the effects of doxazosin, finasteride and combined therapy in men with lower urinary tract symptoms associated with benign prostatic hyperplasia on sexual function, as assessed by the Brief Male Sexual Function Inventory during 4 years.”  In all, just under 2,800 men were studied.

After statistical analyses, the team found that “Men assigned to finasteride and combined therapy experienced overall statistically significant but slight worsening of ejaculatory function compared with men on placebo. Men assigned to combined therapy also experienced significant worsening in erectile function and sexual problem assessment.”

Concluding, the team states “This study significantly extends understanding of the effects of long-term treatment with these drugs on sexual function in men with lower urinary tract symptoms associated with benign prostatic hyperplasia” and notes “Treatment with finasteride or combined therapy was associated with worsening sexual function”.

Due to the fact that many men have used Proscar, Propecia, and other finasteride-containing drugs unaware of the likelihood for sexual side effects, a number of Proscar lawsuits and Propecia lawsuits have been filed.  Unfortunately, it took years after the publication of studies such as this before Merck (the manufacturer of these drugs) changed Warning Labels to include these risks, and only after the FDA required the company do so.

If you or a loved one used Propecia or Proscar and suffered sexual side-effects, contact our team of Proscar lawyers and Propecia lawyers at the information provided below.  We have the experience, resources, and skill required to win the compensation you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

According to the Federal Register (05/01/2014), “the Daily Journal of the United States Government,” the United States Food and Drug Administration has recently called to reclassify transvaginal mesh in the repair of pelvic organ prolapse, an ailment that affects about 50% of women, even if only to a small extent.

The Register states that the FDA “is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device.”

For clarity, the FDA medical device classification system is based on safety and likelihood to perform intended device function.  There are three classes in all:  Class I contains items such as dental floss, Class II contains items such as condoms, and Class III contains items such as replacement heart valves.  The proposal by the FDA to move vaginal mesh to a higher class indicates that the Agency finds vaginal mesh more dangerous than previously thought.

This makes sense: over the past several decades, a number of peer-reviewed scientific studies have illustrated the danger of vaginal mesh, particularly with respect to mesh failure rates, mesh erosion into tissue, and the need for secondary surgery after mesh implantation.

Because this research was published in widely-read journals, and vaginal mesh manufacturers failed to update warning labels or discontinue the product, a number of vaginal mesh lawsuits have been filed.  Furthermore, writes Matthew Perrone of The Washington Post, “In February, U.S. District Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded that [Johnson and Johnson] destroyed thousands of documents regarding development of its pelvic-mesh implants, but said there was no proof that it was done intentionally. The documents would have included reports on patient testing of the mesh implants and could have shown whether participants suffered serious complications.”

As it currently stands, there are more than 20,000 vaginal mesh lawsuits pending against Johnson and Johnson alone, one of many vaginal mesh manufacturers.

If you or a loved one used transvaginal mesh and suffered complications or required surgery, you too may be eligible to file a transvaginal mesh lawsuit and gain significant financial compensation.  For a free, no-obligation case consultation, contact our team of transvaginal mesh 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

Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have any questions about Transvaginal Mesh.

In early 2012, before the Propecia and Proscar Warning Labels were changed to include more information about sexaul side effects, a study published by Venkataram Mysore in Indian Dermatology Online Journal titled “Finasteride and sexual side effects” aimed to further clarify the relationship between finasteride (the active chemical in the the two aforementioned drugs) and long-term sexual side effects.

As such, the author states, “Finasteride, a 5-alpha reductase inhibitor, widely used in the medical management of male pattern hairloss, has been reported to cause sexual side effects. This article critically examines the evidence available and makes recommendations as to how a physician should counsel a patient while prescribing the drug.”

The author explains, “Pattern hair loss in males is androgenic in etiology. Antiandrogens such as finasteride are therefore useful in the management of the condition. Androgens, especially testosterone increases the libido. Any drug which interferes with the action of androgens is therefore assumed, by the lay person, to induce impotence.”

Continuing, it is noted “A number of studies have looked at the problem of side effects caused by finasteride.[6–11] These studies which are discussed below reveal that sexual adverse effects occur at the rates of 2.1% to 3.8%, erectile dysfunction (ED) being the commonest followed by ejaculatory dysfunction and loss of libido. These effects occurred early in the therapy and returned to normal on stopping or over a time on continuous use of the drug. The only causal relation between finasteride and sexual adverse effects is decreased ejaculatory volume because of predominant action of DHT on prostate.”

Due to the fact that a number of people have used Propecia and Proscar (Merck & Co., Inc.) without sufficient knowledge of the possibility of sexual side-effects, a number of Propecia lawsuits and Proscar lawsuits have been filed.  If you or a loved one used one of these drugs 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 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

A 2007 article by N. Mondaini et al. titled “Finasteride 5 mg and sexual side effects: how many of these are related to a nocebo phenomenon?” published in Journal of Sexual Medicine provides important insight into the connection between finasteride (the active chemical in the hair loss drug Propecia and the benign prostatic hyperplasia (BPH) drug Proscar) and long-term sexual side-effects.

The authors write “Sexual adverse experiences such as erectile dysfunction (ED), loss of libido, and ejaculation disorders have been consistent side effects of finasteride in a maximum percentage of 15% after 1 year of therapy.”

Studying 120 patients suffering from BPH who used finasteride for one year, half of whom were aware of sexual side effects and half of whom were not, the team found that “the incidence of ED, decreased libido, and ejaculation disorders were 9.6, 7.7, and 5.7% for group 1, and 30.9, 23.6, and 16.3% for group 2, respectively.”  While this study shows that the incidence of sexual side-effects may be impacted by patient expectation of those side-effects, the overall rate of adverse sexual side effects was high, and much higher than that reported in the Proscar warning label.

Due to the fact that many people have used finasteride unaware of the risk for adverse sexual side-effects, a number of Propecia lawsuits and Proscar lawsuits are currently being filed.  If you or a loved one used Propecia or Proscar and experienced adverse sexual side effects, you may be entitled to significant financial compensation for your injury.  For a free, no-obligation case consultation contact our team or Propecia lawyers and Proscar 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