Men, if you or a loved one are among those who continue to experience the long term (more than 3 months from discontinuing the drug) sexual dysfunctional side effects from the use of fenasteride in the form of (Propecia, Proscar), you may have a claim for damages against the manufacturer. Call the Lord & Faris Law Firm and we will assist you in your claim at 612-333-LORD (5673) or 1-800-257-LORD (5673).
FINASTERIDE (PROSCAR, PROPECIA) SIDE EFFECTS
Propecia (1mg), which was approved by the FDA in 1997, is used to treat male pattern baldness. Proscar (5mg), which was approved by the FDA in 1992, is used to treat benign prostatic hyperplasia (enlarged prostate). Both Propecia and Proscar, which is manufactured by Merck, share the same active ingredient, finasteride. In order to maintain hair growth results, finasteride needs to be taken on a consistent, ongoing basis. In many cases physicians prescribe Proscar for the treatment of male pattern hair loss instead of Propecia, because it consists of 5 mg instead of 1 mg and they have advised patients to split the pills into quarters for use which is less expensive for the patient. It works for about 6- 12 months after discontinuing the drug and then ceases to be effective. Long term use is promoted for continued success.
POTENTIAL SIDE EFFECTS:
FDA Propecia clinical trials and various clinical studies of finasterid for male pattern hair loss, have shown that a percentage of men have experienced negative sexual side effects as a result of taking the drug, even for a short period of time. The most severe negative side effects include
ADDITIONAL POTENTIAL SIDE EFFECTS:
In addition, prescribing information warns against possible physical changes to the body, including breast tenderness or enlargement (gynecomastia); hypersensitivity (allergic) reactions including rash, pruritis (itching) and urticaria (hives); swelling of the lips and face; testicular pain; ejaculation disorder; impotence; and male breast cancer.
Anecdotally, some men have also reported various other psychiatric, neurological and neurocognitive side effects from Propecia, including depression (now listed by the manufacturer as a possible side effect), sexual anhedonia, sexual anesthesia, anxiety, bipolar mood disorder, suicidal ideation, cognitive dysfunction (memory loss or difficulty with intellectual processing), slurring of speech, social withdrawal, lethargy/fatigue and listlessness.
MERCK WARNING LABEL FOR PREGNANT WOMEN AND CHILDREN:
Women who are or may potentially be pregnant must not use PROPECIA and should not handle crushed or broken PROPECIA tablets because the active ingredient may cause abnormalities of a male baby’s sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
FOR MANY MEN THESE SIDE EFFECTS ARE LONG TERM OR PERMANENT:
Many men who have experienced the side effects while on the medication, once they stopped the medication have returned to normal in accordance with representations made in the official prescribing information. However, many of these men’s endocrine systems failed, and their side effects increased in severity. Many continue to have unresolved and persistent sexual, neurological, and physical side effects from the finasteride use – which have been known to go on indefinitely. Some men have reported using finasteride for as little as 2 weeks when sexual side effects began to develop and never went away.
(From Wikipedia.org) In 1974, Julianne Imperato-McGinley of Cornell Medical College in New York attended a conference on birth defects. She reported on a group of hermaphroditic children in the Caribbean that appeared sexually ambiguous at birth. These children were initially raised as girls but grew external genitalia and other male features after the onset of puberty. Her research group found that these children shared a genetic mutation that caused a deficiency of the 5-alpha reductase enzyme. A deficiency of this enzyme suppresses level of the male-hormone dihydrotestosterone, causing alteration of the children’s sexual development. Upon maturation, these individuals were shown to have small prostates and a lack of male pattern baldness.
In 1975, copies of Imperato-McGinley’s presentation were seen by P. Roy Vagelos, who was then serving as Merck’s basic-research chief. He was intrigued by the notion that decreased levels of dihydrotestosterone led to the development of a small prostate. Dr. Vagelos then sought to create a drug that would be able to reproduce the small prostate found in the pseudo-hermaphroditic children in older men who were plagued by enlarged prostates.
HOW FINESTERIDE (PROPECIA/PROSCAR) WORKS
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 contributes to shortening the growth phase of the hair and to thinning of the hair.
Finasteride blocks the function of an enzyme called 5-alpha reductase. This enzyme normally converts testosterone to dihydrotestosterone(DHT), which is a more potent hormone that acts at the prostate and the hair follicles to reduce or eliminate hair growth. DHT is a significant hormone that is critical for the proper mental, physical, sexual and fertility functioning of men. The occurrence of these symptoms in the setting of being on, or even after stopping the medicine, presents a compelling neuroendocrine problem. Not all men suffer from the exact same side effects.
MERCK’S USA/CANADA LABEL DOES NOT WARN OF PERMANENT SIDE EFFECTS:
Merck states in their product label that the adverse reactions disappeared once the drug was discontinued which is not the case.
3 EUROPEAN COUNTRIES NOW REQUIRE WARNING OF PERMANENCY:
Numerous reports have been made of persistent sexual dysfunction and “Brain Fog” once the drug was discontinued. In August of 2009, the Swedish Medical Products Agency concluded that Propecia can lead to permanent erectile dysfunction despite the fact that Merck denies it. Sweden, Italy, and the United Kingdom now require warning labels which describe the possible lingering effects.
NO-STUDY: MERCK: To date, Merck has not done any long term studies on the use of finesteride
STUDY: 2011 International Society for Sexual Medicine – published March 18, 2011.
Methods: Conducted standardized interviews with 71 otherwise healthy men aged 21-46 years who reported the new onset of sexual side effects associated with the the temporal use of finasteride, in which symptoms persisted for at least 3 months despite the discontinuation of finasteride.
Results: Subjects reported new-onset persistent sexual dysfunction associated with the use of finasteride: 94% developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean number of sexual episodes per month dropped and the total sexual dysfunction score increased for before and after finasteride use according to the Arizona Sexual Experience Scale (P<0.0001 for both). The mean finasteride use was 28 months and the mean duration of persistent sexual side effects was 40 months from the time of finasteride cessation to the interview date. Study limitations include a post hoc approach, selection bias, recall bias for before finasteride data, and no serum hormone levels.
Conclusion: Physicians treating MPHL should discuss the potential risk of persistent sexual side effects associated with finasteride.
STUDY: JOURNAL FOR SEXUAL MEDICINE 2011;8:872-884
Methods: Examined data reported in various clinical studies from the available literature concerning the side effects of finasteride and dutasteride/Avodart (same drug but sold by GlaxoSmithKline).
Results: Prolonged adverse effects on sexual function such as erectile dysfunction and diminished libido are reported by a subset of men, raising the possibility of a causal relationship.
Conclusion: We suggest discussion with patients on the potential sexual side effects of finasteride before commencing therapy. Alternative therapies may be considered in the discussion, especially when treating androgenetic alopecia.
If you have experienced one of the side effects discussed above, call Lord & Faris pharmaceutical drug injury attorneys at 1-866-250-1786 or 612-333-LORD.
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