Contents page 1 — It was just bald page 2 — Make A pattern process On a page to read
Needs to adhere to a drug manufacturer when its product gets severe side effects? So far, the answer was, at least in Germany: no. Not a single judgment has been here spoken of, according to the a pharmaceutical company, a patient would have to pay compensation. That could change now.
It is a pioneering process for the rights of patients, had on the Thursday before the Berlin district court, a young, slender man appeared, who asked to remain anonymous. He believes, under the dire effects of a hair growth agent with the active ingredient finasteride to suffer, and has filed a claim against the manufacturer.
one year Ago, the TIME had reported about the side effects of the drug, which is marketed in Germany under the name Propecia Finapil and Finasterid-ratiopharm. The Concerned, in Germany there are around 1,000, to suffer permanently under a bunch of symptoms occurring after discontinuation of the drug. Erection problems, loss of Libido, sleep disturbance and muscle pain, and a cold, deaf, and a shrunken Penis, concentration problems and depression to thoughts of suicide. The Affected call this bundle of symptoms Post-finasteride syndrome.
hundreds of thousands sold
Also with the plaintiff, the TIME had spoken at length. He is a formerly life-loving young man whose Libido was so great that he arranged himself in the lunch break to have Sex. Today, he can feel no pleasure and no enjoyment of life. It took some time before he came to the fact that his enigmatic stature symptoms with the ingestion of a Hair product to do. Prior to that, he had to leave in search of a cause, even the water in his apartment to test.
On this first day of the trial was the question of when the defendant Pharmaceutical company derma Pharm what are the side effects knew. The hair growth tonic is prescribed since 1999 in Germany, and every year, hundreds of thousands of copies sold. Derma Pharm it distributes since 2009.
In the databases of the American and European drug authorities, as well as the world health organization lists a number of side effects which are not reported by Doctors or patients themselves after taking finasteride, but for a long time in the instruction leaflet. Alone between 1998 and 2013, the us food and drug administration has documented a total of 15,500 side effects, of ongoing sexual disorders and muscle atrophy, breast growth, and cognitive impairments to thoughts of suicide. Today, the databases lists more than 150 cases of people killed after taking the drug. But only in the past year, the competent Federal Institute for drugs and medical devices (BfArM) sent a so-called Red-Hand-letter to Doctors, so they warn their patients that sexual dysfunction after Discontinuation of the drug can permanently exist and that it can lead to mood changes to suicidal thoughts.
when knew the manufacturer of the side effects?
The plaintiff’s attorney, medical lawyer Joerg Heynemann, called derma Pharm now, his correspondence with the BfArM. Too often he had experienced in other procedures, he says in court, as in such a correspondence clearly could be that the pharmaceutical companies knew early on about side effects know, which were only incorporated much later in the leaflet. Derma Pharm would not like to disclose the correspondence.
“The Post-finasteride syndrome, there is not,” cried the lawyer of the pharmaceutical manufacturer by the small hall in state court. “The Hair has to be withdrawn from the market”, said lawyer heyne man. Even if the Post-finasteride syndrome would affect only a very small part of the consumers, it would not be justifiable to take the risk of such a significant and forever lasting symptoms due to a receding hairline. “The Benefit was disproportionate to the risk,” says Heyneman.