The FDA has announced that warnings regarding long-lasting male sexual side effects will be added to the labels of Propecia and Proscar
New York, New York (PRWEB) April 13, 2012
Parker Waichman LLP is warning users of Proscar (finasteride 5 mg) and Propecia (finasteride 1 mg) that these drugs may cause long-lasting male sexual side effects, including libido disorders, ejaculation disorders, and orgasm disorders, even after use of the medications has ended. The U.S. Food & Drug Administration (FDA) announced last night that warnings regarding these possible sexual side effects would be added to the labels of Propecia and Proscar. [fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm?utm_source=fdaSearch&utm_medium=website&utm_term=finasteride&utm_content=1]
According to the FDA, Propecia and Proscar belong to a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. Propecia is approved to treat male pattern baldness, while Proscar is indicated for the treatment of enlarged prostate, and to reduce the risk of urinary retention or surgery related to an enlarged prostate. Both medications are manufactured by Merck & Co.
The Propecia label will now include notification of problems with libido, ejaculation and orgasms that continued after use of the drug was ended, the FDA said. Proscar's label will include notification of decreased libido that persisted after use was discontinued.
Both drugs will now include label information describing reports of male infertility and poor semen quality that normalized or improved after use of the drugs was stopped.
According to the FDA, it has reviewed 421 postmarketing reports of sexual dysfunction among Propecia users between 1998 and 2011, 59 of which reported that the side effects lasted for at least three months after they stopped taking the drug. The agency also said it reviewed 131 cases of erectile dysfunction and 68 cases of lowered libido reported by users of Proscar. The agency's review of clinical trials showed 3.8 percent of men taking Propecia reported one or more sexual side effects, compared with 2.1 percent of those who received a placebo.
Propecia sexual side effects lawsuits have been filed in jurisdictions throughout the country. In March, the Supreme Court of New Jersey ordered that all such lawsuits filed in New Jersey state courts be transferred to and centralized in New Jersey Superior Court, Law Division, Middlesex County and assigned to Judge Jessica R. Mayer. The U.S. Judicial Panel on Multidistrict Litigation also heard oral arguments last month regarding the proposed consolidation of all federally filed Propecia sexual side effects lawsuits.[judiciary.state.nj.us/notices/2012/n120322b.pdf; jpml.uscourts.gov/2012_March_Oral_Argument_Schedule_San_Diego.pdf]
Parker Waichman LLP is currently offering free legal consultations to victims of Proscar or Propecia sexual side effects. Please contact their office by visiting the Proscar and Propecia side effect pages at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Propecia and Proscar side effects lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Herb Waichman, Partner