ISHRS
The position of the ISHRS on Finasteride
Since 1998, Finasteride (Propecia) has been used by millions of men to treat androgenic alopecia successfully and with a relatively low rate of side effects. Recently, various articles in the press and medical literature have described a number of young patients with androgenic alopecia who have claimed that effects persist after the use and posterior suspension of Finasteride. The International Society of Hair Restoration Surgery has established a working group to evaluate the the controversy surrounding “Adverse effects of Finasteride” published and to inform and update the doctors who form the society about the use of said drug. Until a public survey demonstrates that the difficulty of having an erection during a long time after suspending the use of Finasteride in a minimum number of patients is confirmed, then the incidence of this problem is currently unknown.This rare side effect is included in the Merck prospectus in the USA; and in the Medical Products Agency of Sweden. On the 11th of April, 2012, the FDA (US Food and Drug Administration) announced changes in the instructions for using Propecia (Finasteride 1 mg) and Proscar (Finasteride 5 mg) expanding the list of side effects to include the sexual type reported to the FDA as some side effects had persisted after suspension of the medicine (note: erectile dysfunction after discontinuing Finasteride was added as a side effect in 2011). The new instructions for use include the following changes: A review in the instructions for Propecia that includes disorders in the libido, ejaculation and orgasms that could continue after having stopped taking the medicine. A review of Proscar that includes a reduction in the libido which may continue after having stopped taking the medicine. A review for both Propecia and Proscar that includes the possibility of poor semen quality, which returns to normal or improves after suspending medication. Despite there being no established cause for linking Finasteride (Propecia or Proscar) to the appearance of sexual side effects, the cases which do appear suggest a wider range of side effects than those currently registered in patients who are under treatment. The information about these side effects can be important to certain patients. Therefore, doctors and patients need to be alerted and informed about these effects during the risk / benefit discussion held when deciding on the best options for treatment. (Excerpt from the FDA site): http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.html The persistence of sexual side effects appears rarely and it should be determined if the appearance of these cases represents a true cause-effect relationship or if they are simply coincidence and related to other factors such as general sexual dysfunction and/or the placebo effect. There is no medical or psychological data available of previous patients to exclude other possible effects. Until now the interaction between the brain, 5- alpha-reductase and hormones in sexual dysfunction are only speculative and are poorly understood. Clearly this is a complicated issue which is placed with other medical disciplines such as Endocrinology, Urology and Psychiatry. It is necessary to perform more investigations to establish the real number of incidents of sexual side effects, determine if there is a real cause between the medication and the persistent effects and, if so, determine who is at risk. We look forward to participating in multidisciplinary debates to better understand and evaluate this issue. Millions of patients have benefitted from the use of Finasteride with very little or no side effects. It is important that the medical community verifies anecdotal reports and if necessary perform new studies to be able to offer patients more precise information so they can make a more educated and correct decision about using the medication. The working group of the ISHRS, Controversies on the Side Effects of Finasteride, are in the process of gathering information and forming a multidisciplinary panel to direct these issues and keep the ISHRS members informed of the side effects post-marketing.
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