

Source: http://www.familiesusa.org   


MedWatch is the USFDA's medical products reporting system. A serious adverse event is any undesirable experience associated with the use of a medical product in a patient that results in: death, threat to life, hospitalization (initial or prolonged), disability. congenital anomaly, and/or intervention to prevent permanent impairment or damage.

People who suspect they, or a family member, have had a serious reaction or problem with medical products, such as drugs or medical devices, can contact the FDA for additional questions about the medical product which caused the problem or to request hard-copy MedWatch reporting forms.  CALL THE FDA TOLL FREE AT: 888-INFO-FDA (463-6332); the MedWatch fax is 800-FDA-0178.  To report your adverse experience by telephone, or if you have a complaint about a medical product, call the FDA Office of Emergency Operations at 301-443-1240.

Forms can also be obtained and reported on line at:  http://www.fda.gov/medwatch/getforms.htm    Form 3500 is a voluntary reporting form for use by healthcare professionals and consumers and Form 3500a is a mandatory reporting form for use by RISK MANAGERS and other personnel within user-facilities such as hospitals, nursing homes, etc., who are legally required to report suspected medical device-related deaths and serious injuries.

NOTE: Adverse events and product problems that occur with vaccines should be reported to the joint FDA and Centers for Disease Control  and Prevention's Vaccine Adverse Event Reporting System (VAERS) at:  800-822-7967.

As a follow-on, this information is quite interesting:

Source: http://ivu.org/news/3-98/vivisection.html

A report of a survey of 500 doctors, published in the European and British Medical Journal, shows that nine out of ten doctors admit
that animal experiments are misleading, while other surveys of over 20,000 people show that eight out of ten potential patients would
want to see all animal experiments stopped immediately. However, although animal experiments stand in the way of true scientific and medical progress - as a cruel, useless and dangerous practice, causing untold suffering and millions of unnecessary deaths - the testing of drugs remains a profitable business, offering a perfect alibi for the marketing of new products regardless of the fact that the likely side effects (often ignored) can only be determined at the human trial stage.

Pharmaceutical companies such as Pfizer Inc. candidly admit that their profitable search for magic bullets can often turn out to be a
game of Russian roulette so far as their original expectations and the business potential of drugs are concerned. A case in point is
Viagra (blessed by the Science Committee of the Vatican as something that can improve family relations), the first pill against male
impotence marketed by Phizer.

Despite being initially designed five years ago for the treatment of cardiovascular problems caused by blocked arteries, Viagra or
sildenafil as it is generically known had a surprising and welcome side effect for Phizer's fortunes (at 40,000 daily $10 pill prescriptions in the USA) and, seemingly, for the potential users - some 30 million men with potency problems in the USA and 140 million worldwide, misled by powerful advertising techniques into ignoring the growing list of potentially serious side effects, including a number of deaths attributed to Viagra and currently under investigation.

Drugs obtained by the extrapolation of results from animals to humans through animal testing are totally unsatisfactory as anatomical and physiological differences from other species render the results - obtained without any proper scientific criteria - dangerously misleading: the serious side effects of drugs and iatrogenesis (doctor-induced disease) being responsible for up to one in six cases requiring hospitalisation and more than 100,000 deaths a year from adverse drug reactions in U.S. hospitals alone.