Despite the fact that clear causal links between finasteride (Propecia) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.
(PRWEB) April 17, 2012
The Consumer Justice Foundation, a for-profit corporation whose team of professional consumer advocates provide free online educational and informational resources to consumers that relate to the potential dangers of using certain prescription medications, hereby alert the public of an FDA order that was issued regarding Propecia side effects. The FDA has ordered the manufacturer of Propecia to add language to the drug’s labels that specifically warn users of the potential for developing sexual side effects.
Specifically, the FDA has ordered Merck, the manufacturer of Propecia, to add Propecia side effects warning language that alerts users of this medication to the possibility of developing sexual side effects that include libido disorders, ejaculation disorders, and orgasm disorders. These Propecia side effects can arise even months after someone discontinues use of the drug. In addition, the labels will contain a new description of reported cases of male infertility and poor semen quality that improved after patients stopped taking the drug.
“Despite the fact that clear causal links between finasteride (Propecia) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs," the FDA said in a statement. "Therefore, prescribers and patients need to be aware of them, as part of a discussion of risk and benefits of finasteride when determining the best treatment options.”
The FDA reported receiving 421 incidents of the development of sexual problems in men who were using or who had used Propecia in the past through the agency’s Adverse Events Reporting System. 59 men experienced problems including erectile dysfunction, poor libido, difficulty ejaculating and orgasm disorders that lasted for at least three months after stopping the drug.
Propecia is a medication that’s prescribed for male pattern baldness, and it was originally approved for use in the United States by the FDA in 1997. Only men are allowed to use Propecia, and the active ingredient in the medication, known as finasteride, is also the active ingredient in another Merck medication that’s known as Proscar, which is used to treat prostate problems.
About the Consumer Justice Foundation
The Consumer Justice Foundation, whose Web site can be found at http://www.consumerjusticefoundation.com, is a for-profit organization that serves two purposes for consumers: (1) to provide educational information regarding the policies and procedures of large corporations and how they affect the average consumer; and (2) to provide news updates and resources that continue to update consumers regarding developments taken by corporations that include pharmaceutical drug companies, auto manufacturers and insurance companies so that consumers who have been harmed can use these informational resources to connect to an experienced professional who can help them. The team at the Consumer Justice Foundation is staffed by experienced and passionate consumer advocates whose mission is to raise the awareness of issues that could pose a risk of harm to those who may not otherwise be aware of the dangers they face.