This may be old news, but I complained via e-mail to the FDA recently about finasteride. In particular I posted the following questions to them:
- WHY IS PROPECIA STILL LEGAL???
- MERCK now claims it can cause irreversible erectile dystfunction. WHY DOESN’T THE FDA MAKE MERCK FIND A CAUSE OF THE ERECTILE DYSFUNCTION FROM PROPECIA SO THEY CAN HELP ALL THE PEOPLE THAT THIS FDA APPROVED DRUG HAS HURT?
- WHAT IS WRONG WITH YOU PEOPLE?
I have not replied back to their response yet, but thought I’d post it here.
**********RESPONSE TO COMPLAINT FROM FDA BELOW ***************
Thank you for your message to the Center for Drug Evaluation and Research (CDER), one of the seven centers within the Food and Drug Administration (FDA).
I was sorry to learn of the problems you continue to suffer after being prescribed Propecia. The FDA continues to evaluate both the attributability and incidence of the reported adverse events associated with Propecia. These reports are taken into account as part of the ongoing safety evaluation that occurs throughout the lifetime of all drug products. As you may be aware, any drug that has potential benefits also has potential risks, and it is often impossible to predict which individual may have a particular side effect.
The safety profile of a drug evolves over its lifetime on the market. Even after many years of use, new information that may impact the clinical use of a medical product can often be detected.
Medical product safety monitoring is an ongoing process accomplished through postmarketing surveillance, the collection of data about drugs once they are marketed and thus available to a larger population than those patients involved in clinical trials.
The MedWatch Adverse Events Reporting System (MedWatch) is an aspect of FDA’s ongoing surveillance of marketed drug products for adverse events. We view this reporting system as a source of signals showing trends of adverse events. Should a trend emerge from the spontaneous adverse events reports, the FDA will work with the sponsor of the product to address the problem. The solutions may include changes in the labeling information, enhanced warnings in the labeling, or communications to health care professionals. In the most serious cases or where other attempted solutions have not been effective, the sponsor may decide to remove the drug from the market or the FDA may request that the drug be withdrawn.
There may be instances in which the signals generated by the spontaneous reporting system may
not be of sufficient strength to warrant additional epidemiological investigation about a drug. This may be especially likely in cases where a drug is used chronically and there are many confounding factors. It is also quite possible that a particular drug may be associated with adverse events and still be a valuable part of a medical treatment program, depending on what it is used for and what other therapies are available to various types of patients. The decision to remove a drug from the market based on reported adverse events is done on a case-by-case basis. There is no standard protocol. The risk to patients is difficult to characterize fully using only post-marketing case reports. Further assessment using pharmacoepidemiological safety studies, registries, and surveys may be warranted when a signal is detected from any source. Because different products post different benefit-risk considerations, it is impossible to delineate a universal set of criteria for the studies. In general, all available safety data including studies from controlled clinical trials will be considered in the assessment of the benefit-risk balance of the product for the population of users as a whole and for identified at-risk patient populations before any type of regulatory action is taken that makes it necessary to withdrawal the drug from the market for safety reasons.
If you have not done so already, I would urge you to report the problems he experienced with Propecia to our MedWatch program. We now have a way to report directly to MedWatch via the Internet. You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (fda.gov/medwatch/index.html), and then click on Submit a Serious Medical Product Report Online" and then “Reporting by Health Professionals” or “Reporting by Consumers”. In addition, if you would like to report your adverse experience directly to the MedWatch Program, please call 1-800-FDA-1088. Alternatively, you can call our Office of Drug Information at 301-796-3400, and request that a MedWatch packet be sent to you.
The way that industry, consumer groups, and individuals can influence FDA to make a change in a regulation or to take other action is to submit a citizen petition. A petition requests the FDA Commissioner to establish, amend, or revoke a regulation or order, or to take or not to take any other form of administrative action, under the laws administered by FDA. Citizen petitions are placed in a public docket, allowing for public review and comment. CDER is then required by law to evaluate and respond to the petition.
Citizen petitions require careful preparation by the submitter. After review of the above information you still feel strongly that Propecia should be removed from the market or the FDA should demand action from Merck and think you wish to submit a citizen petition, please review the following publication “Making Your Voice Heard at FDA: How to Comment on Proposed Regulations and Submit Petitions” available on our Internet site at access.gpo.gov/nara/cfr/
Thank you again for making us aware of your situation.
Sincerely,
Division of Drug Information
D202D
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
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