|Drug Recalls & Warnings|
|About Drug Recalls and Warnings|
Following receipt of numerous adverse reports regarding a drug, the manufacturer or the Food and Drug Administration (FDA) may issue a warning, or in more serious cases, a recall, to communicate the possible dangers to consumers. According to an analysis of FDA data, in 2008 there were 426 drug recalls, and in 2009, there were a staggering 1,742 drug recalls. From January to June of 2010, 296 drug recalls have already taken place, with more anticipated in the coming months.
Recalls may be issued in response to the discovery of a manufacturing defect, a design defect or a labeling defect.
Manufacturing defects account for the majority of recalls. Manufacturing defects typically occur when something goes wrong during the manufacturing process, such as when a batch of drugs produced at a facility deviates from their proper design specifications, or the drugs are adulterated or contaminated with other substances. Quality control concerns at a facility may also prompt a manufacturing defect recall. Manufacturing defects may also occur when the packaging itself is not manufactured according to approved specifications such as when a product is mislabeled – e.g. the wrong dosage is indicated on the packaging or the labeling omits important information or warnings. Typically, manufacturing defects affect only certain "lots" or batches of drugs. The affected or recalled lots are usually published on the FDA and/or manufatcurer's website.
In contrast, design defects do not involve a problem with the manufacturing process. Rather, a design defect exists when a product is manufactured according to its proper specifications, but does not perform as marketed or intended, or presents unreasonable risk of injury. A design defect typically occurs when studies, additional data, or adverse event reports indicate that a drug may unreasonably increase the risk of a serious side effect. In some cases, the drug's label or prescription information may be deemed defective if it fails to disclose risks, side-effects, study data, and other important information. Design defects may corrected by revising the label to include updated information. However, in more serious cases, a defectively designed drug may result in a complete, product-wide recall.
The FDA and manufacturer may agree to keep the product on the market but with stricter warnings and updated prescription information. The strictest warning the FDA can demand is a "black box" warning.
Given the frequency and volume of recent recalls, the FDA and pharmaceutical industry have both come under severe criticism for failing to do more to safeguard the public against potentially dangerous drugs. In response, two bills introduced this year (2010) have promised to impose stricter regulations on the pharmaceutical industry.
Notice: Not all drugs on this list have been recalled and you should never stop taking any of your prescribed medication without first consulting your physician.