There has been an update on the Swedish TV piece – a new news article published August 10, 2009 with video segment:
YOUTUBE VERSION: youtube.com/watch?v=QIDM2N1M … r_embedded
SWEDISH TV VERSION: svtplay.se/v/1649128/rapport/har … verkningar
– Can someone who speaks Swedish please translate the video?
ACCOMPANYING NEWS STORY (SWEDISH) – svt.se/2.22620/1.1649111/haravfa … rt527895=0
GOOGLE TRANSLATED NEWS STORY TO ENGLISH:
translate.google.ca/translate?u= … n&ie=UTF-8
August 10, 2009
Hair loss medicine may cause permanent erection problems
Now note that hair loss drugs Propecia can lead to permanent erection problems. This despite the fact that manufacturer Merck Sharp & Dome, MSD, long denied it.
Propecia is a prescription drug, marketed as a unique solution to the problem of male hereditary hair loss. Manufacturers writes on its website that ninety per cent of those who use Propecia may be the hair back.
MSD warns nevertheless that Propecia can have some effect on potency, but less than two percent have suffered side effects, according to MSD, however, stopped when they left with Propecia.
One of those who received permanent disability is Nicholas O’Neill, who in a story for over two years ago testified about side effects. He told me that he was impressed by the product results. But, after a time, problems accumulate. Nicholas became depressed, had hormone changes, began to develop breasts and became impotent.
Although the information did not cease the side effects when Nicholas stopped taking Propecia.
On the Internet there are several forums where people have been using Propecia discussing the problems they are experiencing. After the story was made, several people heard of the SVT. A Swedish saying that he feels cheated of a large part of his life.
Hard to criticize
According to the manufacturer uses around half million men around the world propecia. In the U.S., where most users are concerned about many doctors of the risks of permanent side effects. However, it is difficult to get doctors to openly criticize a powerful pharmaceutical companies. An American doctor wrote in an email to SVT that it is too risky to do it publicly.
Ulrik Kvist, Chief of the Center for andrology and sexual medicine confirms the picture.
-“They can basically do whatever they want”, he says. Now Swedish researchers warn that the drug Propecia may also affect male fertility.
-The substance called finastirid affect sperm ability to fertilize and contribute to the development of normal embryos. At worst, children and grandchildren be affected by developmental disabilities, "says Ulrik Kvist.
After the SVT’s story, Läkemedelsverket began a review of Propecia, which led to MSD have to amend the text of the leaflet, so it is clear that the drug may cause lasting harm. In order to get the amendment, Läkemedelsverket first had to threaten MSD to suspend the authorization.
MSD has been invited to participate in the News, but declined this. The company writes, however, in a written comment that it has received reports that people who use Propecia suffered permanent impotence, after treatment but it is not possible to establish that it was caused by Propecia.
Here is Merck’s written response regarding Propecia.
Swedish original: svt.se/content/1/c8/01/64/91/11/propeciabrev.pdf
Statement by Merck Sharp & Dohme, current update in June 2008 of information to prescribers for PROPECIA
(finasteride, 1 mg) in the EU.
The following statement from Merck Sharp & Dohme (MSD), the updating of information for prescribers of PROPECIA (finasterid, 1mg) that occurred during June 2008.
After a thorough review of data from controlled clinical studies with PROPECIA and a careful evaluation of pharmacovigilance, of healthcare and the public, MSD remains entirely convinced of the good efficacy and safety profile for PROPECIA, a drug used by millions of men with male hair loss all over the world, since the approval of EU 1998. For MSD is the safety of our medicines and vaccines of the highest weight.
In June 2008 updated the information for prescribers of PROPECIA with respect to permanent erectile dysfunction after discontinuation of treatment with PROPECIA, which was based on reports received after the product approval. This update also related to patient information in leaflet and in patient FASS. The update was done in connection within the European Union (EU) standardized the process for renewal approval (2008).
In three 12-month placebo-controlled studies with PROPECIA, was drug-related sexual side effects of 3.8% in the finasteride-treated group of men compared with 2.1% in the placebo group. Approximately 1% of men in each treatment group completed the study because of these side effects.
Of these studies, which lasted for 5 years, reduced the incidence of these effects to 0.6% in the finasteride treated group men during the fifth year. Following the approval of PROPECIA has received reports of erectile dysfunction, which has been made after the end of treatment with PROPECIA.
A side effect has been reported after approval does not mean that you can establish that this was caused by PROPECIA. Generally, events after approval is caused by underlying disease, genetic variation, other concomitant medication or events that can occur spontaneously in a population.
After a careful examination of data from controlled clinical studies with PROPECIA and a careful evaluation of pharmacovigilance coming in after the drug approved, Merck is confident that these data support continued use of PROPECIA to appropriate patients with male hair loss.
Patients with male hair loss should speak with their doctor if they have questions regarding benefits and risks of PROPECIA. Information is also available in www.fass.se.
Patients should not stop treatment without first discussing this with his doctor.
PROPECIA (finasterid 1 mg, MSD) is indicated for the treatment of early stages of androgent hair loss in men. PROPECIA is contraindicated for use of women because of risks as they are or may potentially be pregnant. PROPECIA if given to a woman carrying a fetus of the male sex, inhibit development of fetal external genitalia. Broken or split tablets should not be handled by women who are or might become pregnant because of possible absorption of finasteride. PROPECIA tablets are film coated to prevent contact with the active ingredient during normal handling, provided they are not broken or crushed.
PROPECIA is contraindicated in patients with hypersensitivity to finasteride or to any of the excipients.