MedWatch is the U.S. Food and Drug Administration’s system for detecting safety-hazard signals for pharmaceutical products and medical devices. If a signal is detected, the FDA can issue safety alerts, or order product recalls, withdrawals or labeling changes to protect the public health.
Established in 1993, MedWatch collects reports of adverse reactions and quality problems, primarily with drugs. An adverse event is any undesirable experience associated with the use of a medical product, including persistent side effects.
PFS has been reported to occur in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).
Reported symptoms include loss of libido, erectile dysfunction, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, severely dry skin, tinnitus, and depression. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicides.
In April 2012, as a result, in part, of hundreds of PFS patients filing MedWatch reports, the FDA ordered drug manufacturer Merck to revise the labeling on Propecia to reflect mounting evidence that it can cause persistent sexual dysfunction. Of the 421 Propecia-related sexual dysfunction cases reviewed by the FDA in its probe, 14 percent lasted longer than three months after patients quit the drug.
“It’s critical that the FDA be informed of each and every finasteride user who has experienced long-term side effects from the medication,” said PFS Foundation CEO Dr. John Santmann. “If you haven’t already filed a MedWatch report, please do so as soon as possible.”
Voluntary reporting by patients and health care professionals is conducted via a one-page reporting form that can be accessed online at FDA.gov.
Reporting can also be conducted by phone at 800-FDA-1088, or by submitting FDA form 3500 via regular mail to: “MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.”
PFS patients are also encouraged to report their persistent side effects to RxISK.org, a global, independent pharmacovigilance organization whose database is used by patients, doctors and pharmacists to research prescription drugs and their side effects, ideally to identify problems early on in the life of a drug.
About the PFS Foundation
Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad. Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.
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Media Relations Manager
The Post-Finasteride Syndrome Foundation