Drug Recalls

Drug Liability

Over The Counter Drugs
Prescription Drugs

The amount of time necessary to move a new medication from the research lab to the marketplace is a subject of great debate. Drug makers argue the U.S. Food and Drug Administration is too cautious, making the organization inefficient and subsequently driving up drug costs. Consumer advocates say the opposite; that the FDA review process is inadequate and that industry pressure and limited resources have allowed dangerous drugs to enter the market. In the early 1990s, as the world became increasingly aware of the threat from AIDS, there was great political pressure to bring AIDS and HIV-related medications to market quickly. Congress ordered the FDA to work with the pharmaceutical industry to accomplish this goal.

As a result, the FDA began giving "fast-track approval" to certain new drugs. Drugs on fast-track went through the approval process in half the normal time - one year instead of two. And where only four percent of the new medications submitted for FDA approval in 1988 eventually found their way to a pharmacist's shelf, by the end of the 1990's the agency was approving fully 80 percent of such new applications. It was no surprise then that numerous patients began developing an array of life threatening illnesses from drugs that were approved on the fast track. Between 1998-2001, the FDA recalled 10 drugs, and the American public began to wonder whether the agency cared more about boosting big drug makers' profits than it did consumer safety. Media reports that the pharmaceutical industry paid for more than half of the FDA's costs for reviewing new drugs made the situation worse. Critics also questioned whether the fast-track system allowed enough time to thoroughly test the drugs BEFORE they went to market, and whether American consumers had become "guinea pigs." Now under new leadership, the FDA is backtracking and drug approvals have declined to the lowest rate in a decade. Whereas in 1997 the FDA approved 120 new medicines, by 2002 the number had dropped to only 54. The agency cites increased testing of drug-to-drug interactions and greater scrutiny of each new application. Additionally, many medications submitted are variations of drugs that are already on the market, rather than completely new drugs. It's too early to tell if the slowdown in FDA approvals has translated into safer drugs. Regardless of the FDA's standards, it's always a good idea to talk with your doctor about any medications he or she prescribes for you. Make sure you have an answer to any questions or doubts that you might have and if necessary, do some research on you own via the Internet or even by reviewing medical journals. By now, consumers have heard the names Fen-Phen and Baycol and many know regulators recalled both drugs after finding they can have serious, sometimes deadly side effects. But most of us would likely be shocked to discover that each year, authorities recall an average of 15 drugs because of similar life-threatening problems. It's important then to understand what a drug recall entails, how often one occurs and where you can find the most up-to-date recall information. Both the U.S. Food and Drug Administration and drug manufacturers have the ability to initiate a recall. There are three levels of product recall. The most serious of these, known as a Class I recall, occurs when there is a reasonable probability that the use of or exposure to the recalled product will result in serious adverse health consequences or death. The Fen-Phen and Baycol recalls were both of the Class I variety. A Class II recall occurs when the use of or exposure to the recalled product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. For example, the maker of Nasonex allergy dispensers temporarily recalled the drug because it came out in a spray instead of a thin mist, delivering too much medication per dose. In the U.S., there are about 250 Class II recalls annually. A Class III recall occurs when the use of or exposure to the recalled product is not likely to cause adverse health consequences. For example, Aventis Pharmaceuticals recalled two lots of the antihistamine Allegra because the labels indicated that the boxes contained capsules when they actually contained tablets. Annually, there's an average of 125 Class III recalls in the U.S. To find the latest information on drug recalls, you could go to the FDA's website, Class I recalls appear on the site's homepage. The remainder of recalls is buried deeper in the site. An easier option for consumers is safetyalert.com. This site takes its information directly from FDA reports, but makes it easier for the average consumer to read and understand. As with any aspect of your health, it's critical that you be a vigilant, active participant. Educate yourself about the risks of any drugs you are prescribed and keep up with the status of those drugs.

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