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Seventeen federal Propecia sexual side effects lawsuits which were originally pending in six different districts have been consolidated into one multidistrict litigation (MDL) in the U.S. District Court, Eastern District of New York under Judge John Gleeson. The U.S. Judicial Panel on Multidistrict Litigation established the MDL on April 16, 2012.

Seperately from the MDL, 41 additional Propecia lawsuits were recently consolidated in the Superior Court of Middlesex Country under Judge Jessica R. Mayer.

New label warns that side effects may continue even after Propecia is discontinued

The lawsuits all allege sexual side effects such as Propecia erectile dysfunction and decreased libido. When Propecia (finasteride) was first approved and put on the market in 1992, the label noted that a small percentage of men who took the anti-baldness drug experienced sexual side effects, but assured men that these side effects disappeared when the drug was stopped.

But over time, numerous lawsuits were filed against Merck by men whose Propecia sexual side effects continued even after they stopped taking the drug. Recent studies have shown that these side effects can persist for years after men stop taking Propecia, and in some cases may even be permanent.

Categories: Propecia

Hair loss or baldness is a common problem these days. People suffering from these problems always try to overcome it, but it is hard to believe that the medicines prescribed for baldness may cause sexual problems. Here is a case of one drug called Finasteride. Its brand name is Propecia and Proscar. With the name of proscar it is used to treat benign prostate hypertrophy (BPH) and with the name of Propecia it is used to treat baldness.

Propecia was approved by US food and drug administration (FDA) in 1997 and Proscar was approved in 1992 by the same authority. Propecia is used widely by Americans for baldness and in some users it caused decreased libido and in some users it caused male infertility and poor semen quality.

When they stopped taking the drug the symptoms improved, but in some cases the symptoms remained for more than three months after stopping the medicine. Now you have to be cautious while taking treatment for baldness or prostate enlargement.

US food and drug administration reviewed 421 reports of sexual dysfunction from 1998 to 2011 reported to Propecia. FDA suggests that in case of Propecia 59 people reported sexual problems, while 131 cases of erectile dysfunction and 68 cases of decreased libido with Proscar were reported from 1992 to 2010. Condition lasted longer than three months after drug discontinuation.

FDA has announced label changes for both drugs, saying they could cause sexual side effects in men who take them.

Categories: Propecia

Prescribing labels for Merck & Co's drugs for baldness and enlarged prostate will add reports of sexual side effects that continued after use of the medicines was stopped, U.S. health regulators said.

Labels will be revised for Proscar, which treats symptoms of enlarged prostate, and hair-loss treatment Propecia, the Food and Drug Administration said. The active ingredient in both drugs is finasteride.

The Propecia label will now include notification of problems with libido, ejaculation and orgasms that continued after use of the drug was ended. Proscar's label will include notification of decreased libido.

The labels of both drugs will also include a description of reports of male infertility and poor semen quality that normalized or improved after use of the drugs was stopped.

In announcing the label changes, FDA cited events reported to the agency.

"The cases suggest a broader range of adverse effects than previously reported in patients taking these drugs," FDA said in a notification posted on its website. But it also said no clear causal links between finasteride and sexual adverse events had been established.

FDA said sexual side effects were included in the labels of both drugs when they were approved in the 1990s. But in subsequent clinical trials, the side effects were resolved in patients who stopped using the drugs as well as in most patients who continued therapy, the agency said.

Categories: Propecia

Evidence from a new study suggests that sexual side effects caused by Propecia (finasteride) persist long after discontinuation of the drug.

This evidence has sparked a number of lawsuits to be filed throughout the United States alleging that the manufacturers of Propecia failed to warn consumers of the risk of permanent sexual dysfunction such as erectile dysfunction and impotence.

Some men in a recent study experienced persistent sexual side effects — including continuing impotence, a diminished sex drive, depression, reduced ejaculation, and a smaller semen volume — for 5 to 10 years after they stopped taking finasteride, a drug commonly prescribed to treat male-pattern baldness, researchers say.

Other men were suicidal or had lost their jobs from the psychological and physiological fallout caused by the sexual side effects after taking Propecia.

Endocrinologist Dr. Michael Irwig of George Washington University told ABC News that the study will finally give proof that persisting sexual side effects exist after stopping Propecia. He says there is strong evidence suggesting finasteride interferes with hormones in the brain, which alter levels of neurotransmitters that affect mood and thinking.

Categories: Propecia

Health Canada is warning that two popular medications used to treat baldness and enlarged prostates may put men at an increased risk of a serious form of prostate cancer, known as high-grade prostate cancer.

The agency warned Monday that finasteride and dutasteride can increase the risk for high-grade prostate cancer, an aggressive type of prostate cancer that grows and spreads more quickly than low-grade cancers.

The warning comes after Health Canada reviewed two large international clinical trials that, ironically, were designed to provide evidence to support using finasteride and dutasteride to prevent prostate cancer.

Health Canada advised doctors and the public Monday that high-grade prostate cancer is rare, "and the increased risk seen with finasteride and dutasteride drugs is still considered very small."

Nevertheless, the agency said that new warnings about the risk are now being added to the labels for finasteride and dutasteride products.

Finasteride is available under the brand names Proscar (5 mg finasteride), Propecia (1 mg finasteride), and their generic equivalents, all of which contain "finasteride" in their name. Propecia is used for the treatment of male pattern hair loss while the higher-dose Proscar is used in the treatment of benign prostatic hyperplasia (BPH), or a non-cancerous enlarged prostate.

Dutasteride is available under the brand names Avodart and Jalyn (a combination drug product containing dutasteride and tamsulosin).

Categories: Propecia

Fears in France have been raised over the use of an anti-hair loss treatment, Propecia, which allegedly causes a drop in male libido and impotence. According to the French daily Le Parisien, the treatment, which was prescribed to 32,000 Frenchmen in 2010, can cause impotence months after use of the drug has stopped or in some cases permanently.

The manufacturers of Propecia, Merck, says these side-effects are made clear on the instructions which come with the treatment which state that users may experience side-effects such as loss of libido and impotence.

Propecia contains finasteride which blocks the male hormone testosterone believed to be responsible for hair loss in men.

Professor Dominique Maraninchi, head of the French agency for Health Product Safety, told the French news agency that in small doses the chances of these side-effects are slight.

“When it is used in small doses it slows down, without stopping altogether, hair loss,”he explained. “In small doses over a prolonged period of time loss of libido is around three per cent.”

Categories: Propecia

The U.S. Food and Drug Administration has confirmed it is conducting a new safety review of the hair growth drug Propecia. In response to written questions submitted by the Examiner, FDA spokesperson Sandy Walsh wrote in an email that, “The focus of the current review is the persistence of severe male sexual dysfunction after discontinuation of Propecia’s use. This review was prompted by routine drug safety surveillance.”

FDA’s safety investigation comes as a growing number of men say Propecia’s severe side effects have caused them to suffer persistent and permanent sexual dysfunction. While several European countries have required Propecia’s maker, drug-giant Merck & Co., to issue warnings regarding the drug’s irreversible side effects, this marks the first time the FDA has acknowledged it is reviewing the drug’s safety here.

Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. When prescribed in 5mg doses to treat enlarged prostate it is sold under the brand name Proscar. The FDA approved Propecia in 1997 and reports that Merck’s annual Propecia sales are over $400 million.

In her email to the Examiner, Ms. Walsh wrote that, “Routine safety surveillance includes a number of things, like regular monitoring of adverse event (MedWatch) reports (AERS), reviewing scientific literature and looking at data from post-market clinical trials.”

Ms. Walsh also noted, “Our AERS web site, FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.”

Last year, researchers from the George Washington University and Boston University medical schools published separate studies in the Journal of Sexual Medicine that reported Propecia’s persistent and permanent side effects. Those side effects include erectile dysfunction, impotence, greatly reduced libido,testicular pain, problems with orgasms and gynecomastia – an over-development of the male breast.

Categories: Propecia

The law firm of d’Oliveira & Associates, P.C. is currently informing men who have developed erectile dysfunction after using Propecia of their possible legal claims. d’Oliveira & Associates is working with some of the leading attorneys in the United States who are representing clients who have been injured by Propecia.

Propecia is a type of drug known as a 5-alpha reductase inhibitor (5-ARI). These types of drugs work by altering the hormone dihydrotestosterone (DHT). The change in the hormones reduces the occurrence of male pattern baldness, and also can be used to treat an enlarged prostate.

The scientific name for the drug is finasteride, and it is marketed for hair loss under the brand name Propecia, and for an enlarged prostate under the name Proscar. Both Proscar and Propecia are manufactured by Merck, but variations on finasteride are also available through generic manufacturers under the names Avodart and Jalyn.

Recent studies, including one published by Boston University researchers, suggest that the link between Propecia and erectile dysfunctions is greater than initially reported by Merck. In 2008, the drug company manufacturing Propecia and Proscar changed the drugs’ labels to include sexual side effects, including erectile dysfunction, decreased libido, and problems with ejaculation. However, the warnings did not inform consumers that the sexual side effects can last long after the drug is discontinued, and can even be permanent.

Categories: Propecia

Over a two-year period, finasteride increased hair growth in all four areas of the scalp affected by male pattern baldness and reduced hair loss in two or more of these areas, depending on patient age, according to research published online Feb. 13 in the Journal of the American Academy of Dermatology.

Elise A. Olsen, M.D., of the Duke University Medical Center in Durham, N.C., and colleagues conducted a randomized, double-blind, multicenter study involving men with vertex hair loss who were given finasteride (1 mg/d) or matching placebo for 24 months. Men were divided into two groups based on age (18 to 41 and 41 to 60 years). Standard global photographic assessment of the vertex, anterior/mid-scalp regions, and frontal and temporal hairlines were used to determine the efficacy of finasteride in the treatment of male pattern baldness.

Compared with placebo, the researchers found that finasteride resulted in statistically significant hair growth in all four scalp regions after 24 months of treatment. Furthermore, younger men treated with finasteride experienced less hair loss in all four regions, while older men had less hair loss in the vertex and anterior/mid-scalp regions. Drug-related sexual side effects were reported at a slightly higher rate with finasteride treatment compared with placebo in both age groups.

Categories: Propecia

Merck & Co. has agreed that all Propecia lawsuits filed in federal district courts throughout the United States by men who experienced sexual problems after using their hair-loss drug should be consolidated before one judge for pretrial proceedings.

Merck Prefers New Jersey

Merck has suggested that the U.S. Judicial Panel on Multidistrict Litigation should transfer all cases to the U.S. District Court for the District of New Jersey, where 41 of the 53 lawsuits over Propecia have already been filed.

Some plaintiffs proposed that the Propecia MDL be centralized in the U.S. District Court for the Eastern District of New York, or, in the alternative, in the U.S. District Court for the Western District of Washington.

Merck’s attorneys claim that moving the cases to the Eastern District of New York, or the Western District of Washington, would be inefficient because the courts lack familiarity with issues already addressed in a number of the cases.

Categories: Propecia

A man who took the male pattern baldness drug Propecia for four years claims it gave him "severe sexual dysfunction and cognitive impairment."

Jason McCord sued Merck & Co. in Federal Court.

Merck has been sued at least 15 times in the past two years for similar claims, according to the Courthouse News database.

McCord says he was 36 when he was prescribed Propecia, in 2006, and he took it for four years. He says the trade-off wasn't worth it.

"Male pattern hair loss affects 30 percent of men by the age of 30 years and 50 percent of men by the age of 50 years. Men who suffer from hair loss may be perceived as older and less physically and socially attractive," according to the complaint.

"Male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a hormone called dihydrotestosterone ('DHT').

"DHT is a substance in the body that can shrink hair follicles until a person no longer has hair on top of his head.

"Finasteride is a 5-alpha reductase inhibitor that decreases the conversion of testosterone to DHT, therefore, preventing hair loss.

Categories: Propecia

International Society of Hair Restoration Surgery Maintains Safety and Efficacy of Propecia (Finasteride 1mg) for Male Hair Loss Is Backed by Proven Scientific Data

The International Society of Hair Restoration Surgery (ISHRS) -- the world's leading medical authority on hair loss and hair restoration -- cautions that recent anecdotal reports of persistent sexual dysfunction by some men who have used finasteride 1mg (Propecia) to treat hair loss should not define the safety and effectiveness of this drug. Propecia is the only oral medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of hair loss in men.

From a scientific standpoint, the ISHRS reports that there are no evidence-based data substantiating the link between finasteride and persistent sexual side effects after discontinued use of the drug in numerous, double blinded, placebo controlled studies conducted evaluating the use of Propecia 1mg for hair loss.

"The health and well being of our patients is the utmost concern of the 900 physician members of the ISHRS -- whether prescribing medications like Propecia or performing hair restoration surgery," said ISHRS President Dr. Jennifer Martinick. "ISHRS members devote an average of 72% of their practices to medically and surgically treating hair loss, and collectively they have treated millions of men around the world suffering from hair loss with finasteride 1mg with virtually no side effects."

Since receiving FDA approval in December of 1997, 20.5 million and 6.7 million patient-years of exposure using Proscar (finasteride 5mg) and Propecia (finasteride 1mg) respectively are recorded with a low adverse event profile. The ISHRS believes that these are the most current and reliable data available until further studies are conducted.

Sexual dysfunction is a complex disorder, and Dr. Martinick noted that it often can be hard to pinpoint the exact cause -- particularly when multiple factors such as nicotine, alcohol, prescription medications, stress, anxiety, fatigue and depression can contribute to erectile dysfunction (ED).

Categories: Propecia

Before now, there has been no study of finasteride use exceeding 1 year in Japanese men with androgenetic alopecia (AGA) except the study subsequently conducted from the development phase.

Since the launch of finasteride, no study in a larger population had been reported. Ethnic variation of the onset age, progressive nature and degree of hair loss of androgenetic alopecia are known.

The therapeutic effect of oral finasteride (Propecia) was examined on androgenetic alopecia of Japanese men. The efficacy and safety of finasteride (1 mg tablet) was evaluated in Japanese men with AGA in the long term.

The study enrolled 3177 men given finasteride 1 mg/day from January 2006 to June 2009 at our clinic.

Efficacy was evaluated in 2561 men by the modified global photographic assessment; the photographs were assessed using the standardized 7-point rating scale.

Categories: Propecia

An unidentified man in Colorado has filed suit against the maker of Propecia, claiming the male baldness drug caused him to suffer erectile dysfunction and other sexual problems. The claim, brought in U.S. District Court for the District of Colorado, is just the latest Propecia lawsuit filed against Merck & Co. by men who say that the drug caused sexual issues.

Propecia (known generically as finasteride 1 mg) is part of a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. Other drugs in this class including Merck’s Proscar (finasteride 5 mg), and GlaxoSmithKline’s Avodart (dutasteride) and Jalyn (dutasteride and tamsulosin) are manufactured by GlaxoSmithKline.

While Propecia is used to treat male pattern baldness, other 5 ARIs are used to treat enlarged prostate. According to the U.S. Food & Drug Administration (FDA), almost 5 million men were prescribed one of these medications between 2002 and 2009.

Propecia and these other drugs work by preventing the conversion of androgen testosterone to DHT, a hormone critical to male sexual performance. Merck’s label for Propecia warns that side effects may include sexual dysfunction but says the side effects “resolve after discontinued use of the drug.” While the Propecia label in Europe was updated in 2008 to warn of “persistent” sexual side effects, no such update has occurred in the U.S.

In March, a group of researchers at Boston University published a study finding that in a small number of cases, erectile dysfunction linked to 5-ARIs may continue after the drugs have been discontinued.

Categories: Propecia

A recent study reports that Propecia may cause persistent sexual dysfunction in 5 to 23 percent of the men who take the pill.

The study, recently by GW University Professor of Medicine Michael S. Irwig and published in the Journal of Sexual Medicine, reveals that finasteride – an antiandrogen that treats hair loss and is found in popular male pattern baldness drug Propecia – can cause persistent sexual dysfunction, including low sexual desire, erectile dysfunction and problems with orgasms.

More than one million men take Propecia to treat male pattern baldness. The findings indicate that between 50,000 and 230,000 patients may be experiencing side effects.

Propecia side effects may also include an increased risk of developing an aggressive form of prostate cancer and breast cancer.

Categories: Propecia

Propecia (finasteride) is a drug that can reverse male pattern baldness. But it can also cause some unacceptable side effects that you or your partner may be experiencing. These include low sexual desire, the inability to get or keep an erection, problems with ejaculation or orgasm and decresed semen leading to fertility problems.

These side effects can be permanent- meaning that they do not go away after you stop taking the drug.

All drugs have side effects. Before a person starts treatment with a new drug, they should consider the potential side effects and decide for themselves if the benefit outweighs the risk .

The problem with Propecia is that Merck & Co., the drug company that sells Propecia, has stated in its literature that these side effects are rare and more importantly, that they will go away after stopping taking the drug.

Only recently (June 2011), did Merck add an updated warning to its USA labeling (European countries [Sweden, Italy, U.K.] have had the warning for sometime) that states “In general use the following have been reported…difficulty in achieving an erection that continued after stopping the medication.”

Categories: Propecia

A Washington man has filed a product liability lawsuit against Merck & Co. over sexual dysfunction side effects of Propecia, the popular male pattern baldness drug.

Paul Dawson, 26, filed a Propecia impotence lawsuit on August 18 in the U.S. District Court for the Western District of Washington, indicating that he has experienced a number of sexual problems after taking the hair-loss drug.

Merck faces a growing number of similar Propecia lawsuits filed by men who allege that the drug maker failed to adequately warn about the risk that the medication may lead to permanent and irreversible problems, such as impotence, erectile dysfunction, infertility and other sexual dysfunction.

According to Dawson’s Propecia suit, he began using the medication in February 2008 to reverse the effects of male pattern hair loss. In August 2008, the 26 year-old reported to his doctor that he was suffering from sexual dysfunction, inculding decreased libido, impotence, anxiety and depression.

Dawson alleges that he continues to suffer injuries from Propecia, such as erectile dysfunction, loss of sexual sensation, decreased semen output, testicular pain and emotional issues. He also alleges that he would not have used Propecia if he or his physician had been warned about the risk of these permanent problems.

In the United States, the warnings for Propecia indicate that the small number of men who experienced sexual side effects while taking the medication during clinical trials had the dysfunction resolve after stopping the medication. However, recent research and numerous post-marketing reports involving men like Dawson who have experienced continuing Propecia sexual dysfunction suggest that these statements are false and misleading.

In several European countries, Merck updated the Propecia warning label as early as 2008 to indicate that some men experienced persistent erectile dysfunction problems from Propecia. However, users and doctors in the United States still have not receive that warning.

Propecia (finasteride) is approved for the treatment of male pattern baldness. It is a low-dose version of Proscar, approved in 1992 for the treatment of benign prostatic hyperplasia.

Categories: Propecia

Simmons Browder Gianaris Angelides & Barnerd LLC is currently investigating claims that Propecia, a drug manufactured by Merck to treat baldness in men, can have debilitating sexual side effects.

Propecia, and its parent drug Proscar, are the trademark versions of finasteride, a synthetic antiandrogen that limits the production of enzymes believed to contribute to the cause of male pattern baldness and an enlarged prostate. Propecia treats baldness in men, while Proscar treats benign prostatic hyperplasia.

A new study conducted by George Washington University and published in the March issue of the Journal of Sexual Medicine found that taking finasteride can cause decreased arousal, erectile dysfunction, severe depression and other serious sexual side effects.

“Many of the men who take these drugs were unaware of the seriousness of these Propecia side effects because they were led to believe that any symptoms would cease once they discontinued taking Propecia,” said Trent Miracle, Simmons Firm Partner who is leading the investigation. “This is not necessarily the case for all users.”

Categories: Propecia

A popular drug used by men across the country to treat pattern baldness could come with an unwanted side effect: an increased risk of breast cancer.

Although the apparent risks are low, Health Canada issued a warning Thursday telling consumers the drug, finasteride, could be potentially dangerous. The drug, which comes in one-milligram and five-milligram formats, is used in the lower dose to treat baldness and the higher dose to treat non-cancerous enlarged prostate. Previous studies have raised flags about the five-milligram format, sold in Canada under the brand name Proscar, including an increased risk of prostate cancer.

Health Canada says a small number of breast-cancer cases have been reported worldwide among patients who took the drug in either dose. Previous research has found the drug can lead to prolonged sexual dysfunction, prompting men in Canada and the United States to sue drug maker Merck & Co. Inc.

The warning raises questions about whether men will stick with the medication, sold under the one-milligram format as Propecia, if they are using it for purely cosmetic reasons.

Many other drugs, procedures and treatments come with a serious risk of side effects or health problems, but there continues to be a market for them, highlighting the lengths some will go for the sake of appearances.

Categories: Propecia

The Oklahoma law firm of Atkins & Markoff and its firm members who serve clients as defective drugs attorneys have made the decision to offer people who have used the medication known as Propecia an opportunity to obtain a free and confidential legal consultation regarding their potential legal rights and options regarding possible side effects of permanent sexual dysfunction and impotence.

These free initial legal consultations are meant to provide information and guidance to those who have used Propecia and who feel that they have suffered from alleged Propecia side effects. Consumers who believe they may have been harmed in this manner are encouraged to contact the firm immediately to schedule this free initial consultation.

Propecia is a medication that's manufactured by Merck & Co. that is intended to be used to treat and to potentially reverse the progression of male pattern baldness, otherwise known as MPB. Propecia is available via prescription and is to be used only by men who are experiencing male pattern hair loss that is mild to moderate in nature. In addition, Propecia is supposed to be prescribed for men whose hair loss is occurring either on the vertex, which is the top of the head and/or on the anterior mid-scalp area, which is the middle-front of the head.

The official Propecia Web site warns against the potential for Propecia side effects to develop, specifically stating that a "small number of men had sexual side effects, with each occurring in less than 2% of men. These include less desire for sex, difficulty in achieving an erection, and a decrease in the amount of semen. These side effects went away in men who stopped taking Propecia because of them. In addition, these side effects decreased to 0.3% of men or less by the fifth year of treatment."

Categories: Hair Loss, Propecia