Adverse Drug Reaction
All prescription drugs produce some form of adverse drug reaction, (ADR). Most ADRs are mild, such as a mild stomach upset, and go away on their own. Some ADRs are serious, such as the blistering of the retina of the eye, and persist for months after withdrawal of the medication. A few ADRs cause death. All prescription drugs are tested for ADRs before they are put on the market; but the testing is limited.
Most new drugs are approved with an average of 1500 patient exposures and usually for only relative short periods of time. However, some drugs cause serious ADRs at very low frequencies and would require many more exposures to detect the reaction. To reliably detect the toxic effects of a drug with a 1 in 20,000 adverse drug reaction frequency, a new drug application database would have to include 100,000 patient exposures.
www.fda.gov/cder/drug/drugreactions at page 8
This limited pre-market testing means that the manufacturer probably does not know about the new product’s serious or even deadly drug reactions when the product is put on the market. These serious or even deadly drug reactions are not known until the first few million consumers try it out, the manufacturer gathers consumer complaints, and the manufacturer amends its product literature to disclose the risk of the infrequent but serious or deadly reactions. If this has happened to you, call us at (412) 391- 2515