Here is a response that I got back from the FDA if anyone is interested in reading typical government B.S. It's long and do apologize, but it's there rambling crap, not mine.
Dear Ms. Hackler,
Thank you for writing to the Division of Drug Information in the Center
for Drug Evaluation and Research (CDER).
We are very sorry to learn about your experience with this product.
Please let us provide you two points that will give a perspective
regarding the safety of drug products marketed in the U.S. They apply
to all drugs reviewed and approved by the FDA. The first is that all
drugs carry risks. Animal testing prior to administration of the drug
to humans attempts to define the most serious toxicities attributable to
the drug. Clinical testing of drug products prior to marketing further
attempts to define the risks to humans that may be associated with a
particular drug. This pre-approval testing is, for most products,
typically capable of revealing the most common adverse events likely to
occur with new drugs (perhaps down to a predicted occurrence rate of 1
to 4000). The seriousness of observed events and their predicted
frequency is judged against the benefits of the drug in the disease for
which it is intended. The benefits of a drug must outweigh its risks in
order for the drug to receive FDA marketing approval. If approved, the
labeling of the drug is written to describe, among other things, the
nature, seriousness, and frequency of the known adverse events that may
occur with its use, precautions to be taken to minimize certain events,
and warnings against the use of the drug in patients with certain
conditions. This information is intended to provide health care
practitioners with information for the safe use of the product. Even
though the label describes the known adverse events which may
potentially occur when a patient takes the product, it does not
guarantee that a patient won't experience an adverse event not described
in the labeling, such as a rare event not previously anticipated from
pre-approval testing.
The second point is that for a drug to remain on the market, the
benefits of the drug must continue to outweigh the risks identified in
post-marketing adverse event reports. Prior to approval, the number of
patients exposed to the drug in clinical testing is limited (a few
hundred to several thousand depending on a number of factors). After a
drug product enters the market, however, the number of patients in whom
it is used expands enormously. Widespread use may uncover rare events
that could not have been discovered from pre-market testing. After
approval of a new drug, the sponsor is required to provide us with
reports on the drug's adverse events. A large portion of adverse event
reports reach FDA through drug manufacturers. In addition, we also
monitor the safety of drug products through our MedWatch program. FDA
relies on the voluntary submission of MedWatch reports from health
professionals, as well as consumers, to report serious adverse reactions
to drug products. Post-marketing adverse event reports are continuously
received, reviewed, and analyzed for the frequency and seriousness of
reported events. Furthermore, the FDA is well aware that drug adverse
events are under-reported and takes this into account when analyzing
these data. What we do with the information from this ongoing
surveillance depends on an evaluation of the public health benefit of
the product compared to its evolving risk profile. The FDA considers
both the seriousness and the frequency of the reported events as well as
the estimated number of patients who benefit from the drug.
The occurrence of a rare event, even if it is a serious event, is not,
by itself, reason to take a drug off the market. Provided that the
public health benefit of the product outweighs its known risks, the FDA
would most likely allow the continued availability of the drug, often
with revised labeling to better describe the risk and provide warnings
to the prescriber. For example, we may ask the manufacturer to revise
the labeling to add information on adverse reactions not previously
listed, to add new warnings describing conditions under which the drug
should not be used, or to add new precautions advising doctors of
measures that should be taken to minimize risk. In the event of reports
of death or life-threatening injury, distribution of the product may be
restricted or removed from the market depending on the frequency of
reports, the seriousness of the disease or conditions for which the drug
provides a benefit, the availability of alternative therapy, and the
consequences of the disease left untreated. It is for this reason that
the post marketing MedWatch reports are so important.
In addition, the FDA believes that consumers should request complete
information about any drugs that they, or their family members are
taking so that they can make informed decisions regarding their medical
treatment and care. As discussed above, FDA is responsible for ensuring
that the benefits of these drug products outweigh their risks when used
as directed in the labeling. State licensing boards, both medical and
pharmacy, however, set the standards of practice for the professions in
prescribing and dispensing products that we have approved for marketing
to their patients.
As you may know, the FDA approves drug products both for prescription
use and self-medication (over-the-counter). The premise of prescription
drugs is that they require a "learned intermediary," such as a licensed
physician, to give guidance to the patient on the safe and proper use of
the medicines, and of any risks and precautions regarding the particular
drug in question. We have the responsibility to ensure that the
benefits of these drug products outweigh their risks when used as
directed in the labeling. However, the selection of specific drug
products or treatment regimens for particular patients are decisions to
be made between the patient and a physician who is familiar with the
individuals' current health status, past medical history and product
labeling, weighing the benefits over the risks.
The labeling, also called the "Professional Package Insert (PPI)," is
the most complete single source of information on the drug. The PPI is
a summary of the essential scientific and medical information that is
known about the drug and reflects the results obtained from clinical
trials of the drug. As mentioned above, this information is intended to
provide health care practitioners with information for the safe use of
the product. We have provided you a link to the labeling at
http://dailymed.nlm.... ... fm?id=5716Lastly, we urge you or your doctor to report your experience to the FDA
by submitting a MedWatch report electronically by going to the Internet
voluntary reporting form at
www.fda.gov/medwatch, click on "How to
Report," then "Reporting by Consumers/Health Professional." Also, you
may download and complete the form at the above link to be mailed to the
address stated on the form. Your report, along with others, is an
important element in our continued surveillance of the effects of this
product, and collectively will determine the content of its labeling or
the future of the product.
Thank you again for making us aware of your situation.
If you have further questions, please contact our Division of Drug
Information at 1-888-463-6332 or our direct line is at 301-796-3400.
Sincerely,
Division of Drug Information LL
Center for Drug Evaluation and Research
Food and Drug Administration
