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Why did pharmaceuticals release hair loss drugs in tablet form

Why did pharmaceuticals release hair loss drugs in tablet form

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Why did pharmaceuticals release hair loss drugs in tablet form?

Why have Korean pharmaceutical companies released hair loss treatments in tablets instead of soft gelatine capsules?

Dong-A ST, JW Pharmaceutical, and Hyundai Pharm recently rolled out tablets of generic copies of GSK’s Avodart (dutasteride), a treatment for enlarged prostate and hair loss. Avodart and MSD’s Propecia (finasteride) are two major treatments for hair loss in the domestic market.

After Avodart’s substance patent expired in 2016, generic copies came out on the market in soft capsules, just like the original. However, local drugmakers recently changed the form to tablets.

Dong-A ST’s Dutavan Plus, JW Pharmaceutical’s Jdart, and Hyundai Pharm’s Damodar are all newly released tablets. The three companies said they chose the tablet form to make the treatment “patient-friendly,” officials said.

While soft gel capsules could be stuck in the mouth or esophagus, smaller and film-coated tablets make it easier to swallow. Also, the deformation of a soft gel capsule could affect the absorption of the drug, but tablets are free from such risk.

Tablets have advantages in the distribution process, too. While soft capsules could rupture and leak the medicine, tablets rarely rupture even in high temperature, officials said.

However, GSK emphasized that Avodart is different from other soft capsules.

“Dutasteride has a large molecular weight and very high lipophilicity. So it is almost insoluble in water. From the pharmaceutical point of view and considering the efficacy and safety of the drug, it is more common to develop dutasteride in soft gelatin capsules,” an official at GSK said.

Theoretically, it is possible to develop it in small-size tablets. But to do so, you have to use additives such as surfactants and certain solvents, he added.

Avodart used an excipient, guaranteed by the U.S. Food and Drug Administration as “generally recognized as safe,” in manufacturing Avodart, which was exceptional, the official said.

The GSK’s official also noted that dutasteride’s high lipophilicity raises the risk of drug absorption through the skin. “If the drug comes in a tablet, not in a soft capsule, touching dutasteride directly by hand could expose the powder of the drug to the patient, family or pregnant women. That could be a problem,” he said.

Why did pharmaceuticals release hair loss drugs in tablet form?

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Class-action lawsuit alleging link between hair-loss drugs and erectile dysfunction

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Quebec court authorizes class-action lawsuit alleging link between hair-loss drugs and erectile dysfunction

Quebec’s highest court has authorized a class-action suit on behalf of men who took medication for hair loss and then allegedly suffered various problems, including erectile dysfunction.

The defendants are Merck Canada Inc. and Merck Frosst Canada Ltd, which sold the Propecia and Proscar prescription drugs.

Propecia is used mainly to treat baldness, while Proscar is used primarily to treat enlargement of the prostate. Both contain the active ingredient finasteride.

The lawsuit covers Quebec men who were prescribed one of the two drugs before Nov. 18, 2011, and then allegedly developed problems that lasted even after they stopped using them.

The problems included erectile dysfunction, lower libido levels, ejaculation issues, shrinkage of the genitals and difficulty in having an orgasm.

It is alleged that doctors prescribed Proscar for hair loss.

A lower court nixed the idea of a lawsuit in 2016, but the appeals court ruled Quebec Superior Court imposed too much of a burden on lead plaintiff Camilo Baratto.

The three-judge appeals panel said the lower court, without having to at that stage of the proceedings, took a position on the scientific debate surrounding the medication and its effects.

The high court said the debate must take place, but not at the stage of the authorization.

Mr. Baratto says he started taking Proscar for his baldness in October 2008, by cutting the pills to bring the dose closer to that of Propecia.

He states he stopped the medication after one month because he was starting to have side-effects such as a drop in libido, erectile and ejaculation problems, anxiety and depression symptoms.

Mr. Baratto, who says he is still suffering today from some of the secondary effects, acknowledges the potential risks were mentioned on the container but not the fact that they could continue once he stopped taking the drug.

He alleges the two companies changed the wording in Switzerland in 2008 but failed to do so in Canada until November 2011.

Mr. Baratto is seeking at least $100,000 for all his alleged problems.

The amount for those who will join the action has yet to be determined, but $10,000 in punitive damages is being sought for each.

Lawyers at the firm of Trudel Johnston & Lesperance who launched the legal action said they are happy with the Quebec Court of Appeal’s decision on Thursday to authorize the lawsuit but they did not want to comment further.

In an e-mail on Friday, Merck Canada said it disagrees with the appeals courts’ judicial analysis but did not elaborate.

But the company said it intends to use “reliable and scientific medical information” to defend its position that the drugs are innocuous and efficient.

class-action lawsuit alleging link between hair-loss drugs and erectile dysfunction

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Kyocera to join hair regeneration research project

Kyocera to join hair regeneration research project

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Kyocera to join hair regeneration research project

Kyocera is teaming with the Riken research institute and bioventure Organ Technologies to conduct research on the use of regenerative medicine for treating hair loss.

The electronics and ceramics company said Tuesday that it will work with the partners to develop prototype equipment by March 2018. The trio aims to begin human clinical studies by 2020.

The treatment involves cutting off a small section of scalp and extracting two kinds of stem cells from hair follicles.
The extracted cells are processed and propagated to increase their number by 100- to 1,000-fold, making it possible to transplant a large number of hair follicles by cutting off only a small section of the scalp.

Hair transplants are a common treatment for baldness already, but the conventional method requires the excision of relatively large sections of scalp to obtain enough healthy hair follicles for transplant.

The new treatment uses the patient’s own cells, so the procedure would be no more dangerous than the commercial methods already established for use of regenerated skin and cartilage tissue.

If the research proceeds as planned, Kyoto-based Kyocera hopes to launch a business in 2020 acting as a contract manufacturer for medical institutions.

Kyocera’s planned business model is to receive scalp tissue from the clinic, process it over the course of around three weeks, and then return the propagated hair follicles back to the clinic.

The business will require high-precision technologies that can process and multiply the cultured cells, and that is where Kyocera’s expertise will come in handy.

The Japanese company has technologies for the processing of precision parts, has experience in the medical field with artificial joints, and is familiar with the kind of precision injection technologies used in inkjet printing.

It is estimated that a total of more than 18 million men and women suffer from alopecia in Japan alone. Technologies developed for regenerative hair treatment likely will pave the way for regenerative organ transplant treatments.

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MDL judge sends Propecia case back to state court

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MDL judge sends Propecia case back to state court

A federal judge overseeing multidistrict litigation over claims that Merck’s hair-loss drug Propecia causes sexual disorders has ruled that one man’s case can return to the California state court where it was originally filed.

In granting plaintiff Kyle Michelson’s remand motion on Thursday, U.S. District Judge Brian Cogan in the Eastern District of New York said the case did not belong in federal court because Michelson had asserted a viable malpractice claim against his local doctors that could proceed in tandem with his products-liability claim against New Jersey-based Merck

 

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Research indicates that Propecia is most effective in 9 out of 10 men who have mild to moderate hair loss and it can show positive results as early as three months after treatment has commenced.
Furthermore, it is shown to provide a 47% improvement in counts of anagen hair (hair in its growth phase) within 48 weeks.
Most men who take it stop losing their head of hair and some even see regrowth. So, using Propecia may help you to get the head of hair you want and it may boost your confidence during this process.
Propecia results
Propecia tablets 1mg are used to treat men with male pattern hair loss(androgenetic alopecia) by increasing hair growth and preventing further balding from all areas of the scalp, for example the front. Propecia1mg tablets can help invert balding in men with mild to moderate hair thinning but does not restore hair that has been lost for some time. It is not used to treat hair thinning in females.
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Propecia Problems Top Twitter

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Propecia Problems Top Twitter

Only men who live in a bubble would not know about Propecia risks by now.

”How many men who are considering taking a hair-loss medication are reading a medical journal?

Not only are there warnings on television, from commercials to the evening news, there were recently 4.4 million tweets involving @Merck and a Propecia victim.

Almost four years ago, JAMA (The Journal of the American Medical Association) reported that finasteride, the active ingredient in Propecia, had been linked to sexual dysfunction and infertility, and 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.

”How many men who are considering taking a hair-loss medication are reading a medical journal?

Chances are better that they have a Twitter or Facebook account.

And chances are their doctor doesn’t have time to read it either. Their doctor likely gets Propecia information from the Merck sales rep.

Men with receding hairlines who are considering whether to take the hair-loss drug likely know of Propecia risks from their doctor and from the warning label, which states that 1-2 percent of Propecia users may experience temporary sexual problems.

Enter social media.

It is encouraging that more social media channels are unbiased and reporting that the percentage of Propecia users is a lot higher.

And they are reporting that for many men, the sexual side effects are permanent. Propecia can also lead to suicide.

The Post-Finasteride Syndrome (PFS) Foundation writes about Daniel Stewart’s suicide on its website.

It claims that his death can be linked to the “5-alpha reductase type II enzyme inhibitor finasteride used in the production of Propecia which they argue causes devastating sexual, neurological, and physical side effects.” Naturally, Merck disputes its contention.

And the medical community is increasingly warning about Propecia.

Recently, Mensjournal.com quoted Dr. Nelson Novick, a clinical professor of dermatology at Mount Sinai School of Medicine in New York.

“My yardstick for treating any patient is, what would I do if this were my own son? Ten years ago I would have answered differently, but now I would not feel comfortable recommending Propecia to a young, sexually active man.”

With increasing bombardments from social media and other media channels, the medical community and lawsuits, Merck must be feeling somewhat pressured.

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More Propecia Complaints

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More Propecia Complaints

About 1,400 Propecia lawsuits against Merck had been filed by June of 2015, claiming persistent sexual side effects.

The drugmaker reported the amount of product liability lawsuits filed in the United States to the Securities and Exchange Commission in August.

About 1,700 plaintiffs (some partners joined the suits, claiming loss of consortium) claim they have experienced sexual dysfunction, and 60 plaintiffs claim the hair loss medication has caused or can cause prostate cancer, testicular cancer or male breast cancer.

Despite the number of lawsuits filed, countless articles about Propecia side effects reported by the media, and studies researched by experts and presented in reputable publications, Propecia is still being prescribed and mostly to men aged 20-30.

While hair loss is not quite a life-threatening condition, sexual dysfunction certainly diminishes quality of life. And for a healthy young man to suffer from possibly permanent sexual side effects, severe depression and thoughts of suicide can be life-threatening

The Journal of Sexual Medicine in 2011 published an article where researchers found 96 percent of 71 men in a Propecia study complained of sexual side effects that continued for three months, and 20 percent of men reported these same problems more than five years after discontinuing the drug.

The FDA was slow to warn the public about Propecia’s persistent sexual side effects. It took the agency until 2012 to say it would update Propecia labeling “to caution patients that persistent sexual side effects could result even after discontinuation.” It also warned the public that Propecia can lead to decreased quality of semen and fertility problems.

Edward (not his real name) was prescribed Propecia after the FDA announced the updated warning. “I had no idea that the possible cause of my erectile dysfunction was this medication,” he said in an e-mail. I also had depression and fatigue while I took Propecia.

When I researched the side effects, I couldn’t believe that mine was a classic case. Nearly every Propecia side effect was something I had experienced, from excessive weight gain in the midsection to loss of energy and loss of sexual drive, which led to depression.

I would like Merck to compensate me for my ailments and I want to be included in a class-action lawsuit.”

Jeff said that prior to taking Propecia he had a “normal” sex life. “I never suffered from any ED symptoms but about a year after taking the drug, I wasn’t able to perform like I used to,” he explained in an e-mail.

“I finally got up enough courage to talk to my doctor and he advised me to stop taking it right away, which I did. But my ED never went away and to this day, I still suffer from those problems. And my wife suffers.”

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Propecia and Drug-Induced Harm

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Propecia treatment for hair loss

Propecia and “Drug-Induced Harm”

DCA drug conspiracy theorist could posit that Merck is double-dipping. Say the Propecia manufacturer and the testosterone manufacturer are in cahoots together because Propecia victims are increasingly needing testosterone treatment due to Propecia side effects.

Oh wait, Merck makes both the hair loss drug and testosterone drugs. Cha-ching!

Merck makes Andriol, a popular testosterone therapy treatment for men with low testosterone levels.

Andriol sales may be on the rise as more Propecia victims are diagnosed with hypogonadism – meaning a total testosterone level of less than 300 ng/dl.

Trouble is, so many men are unaware that Propecia (Finasteride) can be the cause of low testosterone count.

Despite reports that Propecia side effects are not as temporary as Merck wants consumers and the health community to believe, it is still easy to get a prescription. Some dermatologists are still prescribing the hair loss drug, possibly because they don’t directly hear of sexual dysfunction problems from their patients.

It’s unfortunate that all dermatologists aren’t on the same page as Dr. Nelson Novick, a clinical professor of dermatology at Mount Sinai School of Medicine in New York, or that some kind of central registry is not in existence. Dr. Novick told Men’s Journal (Sept 2015) that he would not recommend Propecia to a young, sexually active man.

“I took Propecia in my late 20s for a few years,” says Steve (not his real name). “I didn’t see it helping my baldness so I stopped taking it. For the past five or so years I’ve had a complete lack of sexual desire, which led to a deep depression. I can’t keep an erection and have a loss of sensation in the penile area.

Consequently I’ve been unable to maintain intimate relationships with women due to my lack of interest in sexual activity.”

So why does the medical community rarely hear of persistent sexual problems, from low libido to erectile dysfunction from patients?

Steve says he eventually went to a psychiatrist to treat his depression, but he never connected sexual dysfunction with Propecia until seeing a TV commercial and then reading online about the proliferation of Propecia lawsuits.

“When I think about the number of times I got my prescription refilled, I feel duped. Merck knew that these Propecia side effects weren’t temporary but they didn’t warn anyone.”

Propecia users have been led to believe that sexual side effects will go away when they stop taking the drug, so when these symptoms persist, it is normal to think there is something else going on.

And many men are embarrassed to bring up sexual problems, even to their family doctor.

Thomas Moore, a researcher with the Institute for Safe Medication Practices, wrote in a JAMA Dermatology editorial (June 2015) that “Sexual impairment induced by antidepressant drugs was underestimated for decades for just this reason… the persistence of drug-induced harms is rarely measured.”

It’s like a vicious cycle: Propecia can cause sexual dysfunction and low testosterone levels, which can lead to depression.

Moore also said that “the extent to which finasteride [Propecia]-related sexual impairment can be persistent is not clearly reported in any of the standard sources.” That would include Merck’s clinical trials.

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Propecia Victim Candid about Sexual Side Effects

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Propecia packaging

Propecia Victim Candid about Sexual Side Effects

Peter (not his real name) stopped taking Propecia after researching the hair loss medication’s side effects. “I got really upset with the manufacturer because my sexual dysfunction got worse after I quit the medication rather than go away as Merck claims,” says Peter. “That’s when I filed a Propecia claim.”

Peter Googled Propecia and was shocked at the results. He found a blog where another Propecia user described his permanent sexual problems, so Peter figured it was time to stop. Now he worries that it is too late…

“Around 2000, my friend mentioned that my hair was thinning in the back, something I never realized,” Peter says. “He told me that Propecia is helping his hair loss problem, just ask a dermatologist.” So Peter did just that. The dermatologist said he was a good candidate and there were “pretty much no side effects.” But that was 15 years ago.

“Only a month after I started Propecia I felt different,” Peter says.

“My libido wasn’t as high as it used to be. Back then, I was in my mid-30s and had a great girlfriend. But I didn’t dwell on it; in fact, it was rather a relief not to think about sex 24/7.”

Peter started having erection issues. Again, he didn’t give it much thought, but decided to stop taking the medication in 2012. “One month after I quit Propecia, everything went downhill. Erections were difficult to maintain and my libido was almost non-existent,” Peter explains. “I could go for a few months without wanting sex. And when we did have intercourse, it would last 30-40 minutes rather than five or 10 minutes because I couldn’t feel much.

Peter’s GP gave him a prescription for Viagra but it didn’t work: Peter was experiencing psychological, not physical, problems. Next up, he has an appointment to see an endocrinologist for possible testosterone treatment. Peter’s testosterone levels are low – he blames Propecia.

“I was surprised that my doctor didn’t know about Propecia’s long-term side effects. I told her it was even banned in some countries – she had no idea,” says Peter.

“Neither did my girlfriend have any idea. We finally talked about my sexual problems and about this time I got severely depressed, thinking I might never again get an erection. We broke up shortly afterward. I wouldn’t recommend this drug to anyone, better to lose your hair.”

Peter filed a claim in Canada. Propecia lawsuits have also been filed in Canada, including two class actions – one in Ontario and another in British Columbia.

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Propecia Victims Like Zombies

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Propecia for hair loss

Propecia Victims “Like Zombies”

Anyone considering taking Propecia should be informed that the sexual side effects are often long term – possibly permanent.

And anyone prescribing the hair loss drug should know by now that Propecia sexual dysfunction is not a rare side effect.

If Dave (not his real name) was told that Propecia would put him at risk in any way, he would have taken his wife over vanity.

Instead, Dave is getting divorced from his bride of of just six months. “I don’t blame her. She deserves a happy and sexually fulfilling life and that won’t happen with me,” he says. Although Dave jokingly refers to himself as a zombie due to Propecia, he is far from joking about its long-term side effects.

Dave isn’t alone. This reporter has spoken with several Propecia victims who are suffering with Propecia impotence and other serious complications.

Most men took the medication for hair loss; others were prescribed finasteride to treat benign prostate enlargement (BPH).

In fact, a recent study published in Endocrine Reviews and Metabolic Disorders (August 2015) by researchers at Boston University School of Medicine reported that 25 percent of men currently taking Propecia for the treatment of BPH appear not to benefit from taking these medications!

Commenting on the study, The Post-Finasteride Syndrome Foundation said that “Those prescribed Propecia…for male pattern hair loss are also at risk for adverse events elicited by these drugs.”

Dave quit taking the hair loss medication earlier this year, hoping that the Propecia sexual dysfunction side effects were short term, but it’s been downhill ever since.

As well as facing divorce, Dave almost lost his job. He is suffering from depression and anxiety and financial troubles. “I’m sick to my stomach with worry. I’m not performing well at work and I’m sure I won’t be employed here much longer,” he adds.

Here is Dave’s story, in his words.

“About six years ago coworkers and my girlfriend at the time noticed my hair was thinning – it made me feel insecure and less confident. I started looking at hair restoration and found a place in Dallas that was offering a new procedure called neograft.

I was young and successful and could afford the procedure. Afterward I received a prescription for Propecia, but I was hesitant because I never take medications. However, the thought of losing my hair won over any hesitation.

“After taking Propecia I began a spiral into sickness, depression, anxiety, suicidal ideation and alcoholism. I was prescribed lexapro, celexa, cymbalta, and lorezapam over the course of the past six years; I am still on cymbalta and lorezapam.

I’ve spent thousands of dollars trying to understand what is wrong with me and why I’m suffering like this. I had my first panic attack after moving to Kansas City for a job promotion – I just wanted to give up everything.

After the panic attack I sought treatment again and was put back on antidepressants.

That was in January 2012. Fast-forward to January 2015 when I stumbled upon Post Finasteride Syndrome and it all made sense! Everything I was experiencing was related to Propecia. I’m not sexually active anymore as I’m not able to maintain an erection throughout intercourse. I should’ve known better when I first took Propecia and had pain in my testicles. I should have known Propecia’s promise [to restore hair] was too good to be true…

“Something must be done to find a cure for all of us suffering, and compensation must happen. Merck has robbed me and so many others of our humanity. Zombies don’t exist but Propecia victims are the next closest thing. I’m unable to feel emotions like I once did and incapable of the simplest human function known to man, reproduction.”

Yours Truly,
Zombie in Missouri

Dave adds that he tried to participate in the Propecia Baylor Studies but panicked before the test because it would involve an incision in his penis. He filed a claim with LawyersandSettlements hoping that he might be able to represent other men who have suffered but are too embarrassed to come forward. If you or someone you know has a story like Dave’s, a Propecia attorney might be able to help.

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Hair Loss and Growth Treatments and Products Market 2018

Statistics and Research Further Confirm Propecia Sexual Dysfunction

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Statistics and Research Further Confirm Propecia Sexual Dysfunction

Statistics from the UK and recent research from the US further indicate that Propecia is to blame for Propecia long-term side effects, namely sexual dysfunction. And it appears that men under 40 are most affected.

Propecia research

Propecia (finasteride) and Flomax (tamsulosin) are both used to treat lower urinary tract symptoms related to benign prostate hyperplasia (BPH).

propecia side effects

Men who used Propecia to treat BPH experienced worsening erectile dysfunction (ED) that did not resolve with continued treatment, concluded researchers from Boston University School of Medicine.

Their findings were published online in the journal Hormone Molecular Biology and Clinical Investigation (June 2015).

In the study, 470 men given Propecia also experienced reduced testosterone levels leading to hypogonadism (little to no production of sex hormones).

However, 230 men who used Flomax experienced none of these sexual dysfunction affects.

One of the study authors concluded that “Since sexual function is considered an integral part of overall health, it is important that physicians are aware of the adverse side effects of this class of drugs on human health in general and on sexual function in particular.

Our study emphasized that the effect on erectile function is a serious concern and needs to be considered more carefully.”

In another study earlier this year, researchers from George Washington University found that “There are a significant number of men under 40 who experience ED.

In the past, the vast majority of cases were thought to be psychogenic (psychological cause, not physical) in nature.” They found that “medications causing ED include antidepressants, NSAIDs and finasteride (Propecia), antiepileptics and neuroleptics.”

Hair loss statistics

Men who will have noticeable hair loss by age 35 – 40 %
Men who will have noticeable hair loss by age 60 – 65 %
Men who will have noticeable hair loss by age 80 – 70 %

Men who have had surgical hair restoration

Ages 30-39 – 30.4 %
Ages 40-49 – 26.3 %
Ages 50-59 – 15.4 %
60 + – 7.1 %

 Non-Surgical Patient Prescription Usage

Propecia – 27.5 %
Rogain Foam – 14.8 %

More than 1 million men in the US have been prescribed Propecia since it was first introduced in the 1980s as a treatment for enlarged prostate.

The FDA approved the drug to treat hair loss in 1997. But in June 2011, the agency required Merck to slap a new label on Propecia, warning that it may increase the risk of developing a serious type of prostate cancer.

And another label change in April 2012 included warnings about “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.”

However, the US labels were behind those of Sweden by at least four years. Swedish labels in 2008 warned of persistent erectile dysfunction after discontinuing use.

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