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FDA and Merck remain silent on Propecia safety while AdverseEvents speaks out

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Posted On 06.30.11 by in Propecia Archives

Since the Examiner first broke the story on March 2 that the FDA was investigating Propecia’s safety, Merck & Co., the drug’s maker, has maintained silence while others are speaking out on the drug’s negative effects on male sexuality.
Earlier today, AdverseEvents, Inc., the leading resource for information on drug side effects, released a report identifying FDA approved medications that are most associated with causing brain-related side effects.
By a wide margin, the top drug linked to inhibition of libido side effects was Propecia and the second was Proscar. Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. (When prescribed in 5mg doses to treat enlarged prostate it is sold under the brand name Proscar). The report was released in recognition of Brain Awareness Week which is March 12-18.
AdverseEvents used RxFilter(TM), its proprietary data aggregation and refinement process, to gather data from the FDA Adverse Event Reporting System (AERS) database. The Company found over 50,000 individual adverse event case reports linked to common brain-related side effect categories: memory loss, inhibition of libido, and compulsive behaviors.
P. Murali Doraiswamy, M.D., a professor and leading neuropsychiatric drug safety researcher at Duke University Medical Center, commented, “This is a very timely and insightful report. While the warning signals in this report don’t necessarily prove a causal relationship, they are often the first sign of such a link. Therefore, it is critical for consumers and prescribers to be aware of such potentially adverse effects. Some of these side effects, such as loss of libido or amnesia, can have a devastating impact on a person’s quality of life.”
Brian Overstreet, president of AdverseEvents said, “The AERS database is a significant repository of important and potentially life-saving information. And while the data does have limitations, the ability to easily and quickly mine this plethora of data using our proprietary RxFilter(TM) provides a significant step forward to a better understanding of real-world side-effect risks, the enabling of more accurate safety signaling, and the propelling of further clinical evaluation of potential problems.”
AdverseEvents used the Proportional Reporting Ratio and the Reporting Odds Ratio calculations to determine the top drugs in each side-effect category. Both are common methods of disproportionality analysis and signal detection used with AERS data. Case reports from 1/1/04 – 9/30/2011 were studied and drugs with limited case reports were excluded from the final list.
Top Three Drugs Linked To Inhibition of Libido:
Suspect Drug       PRR             ROR
PROPECIA          167.29       200.10
PROSCAR            84.01          91.69
AVODART           44.03           45.96
AdverseEvents, Inc. (www.adverseevents.com) is the first service provider to deliver accurate, real-time information on adverse drug events reported to the FDA. AEI utilizes a unique data sourcing method called RxFilter(TM), a proprietary 17-step data refinement process that standardizes and normalizes the data from the FDA’s Adverse Event Reporting System (AERS) into a user-friendly, fully-searchable database of all FDA approved medications. With AEI, the healthcare industry is able to quantify the benefit-risk assessments of FDA approved drugs to fully understand the scope of safety issues, based on accurate rates of side effects from such medications.
As previously reported, the FDA urges anyone affected by Propecia to “formally document your case via the MedWatch reporting system. The information you provide will be added to FDA’s post-marketing safety database and reviewed by the post marketing safety staff.
“You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/Safety/MedWatch/default.htm), click on ‘Reporting Serious Problems to FDA’, then ‘Reporting by Consumers’.”
Dr. Tatiana Oussova is responsible for conducting the agency’s Propecia safety review and under FDA policy she may read but not respond to the emails that are addressed to her. Her email address is: Tatiana.oussova@fda.hhs.gov
Dr. Kavita Dada is responsible for interacting with the public regarding the FDA’s ongoing Propecia safety review. Those persons who have been affected by Propecia may either email or call Dr. Dada by phone. It is Dr. Dada’s job to interact with the general public. Her phone number is 301-796-3105 and her email is Kavita.Dada@fda.hhs.gov
The Examiner will continue to report on this unfolding story and will publish updates when answers are received from the FDA or Merck on where Propecia consumers can find the latest information on the drug’s safety.

 



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