The Ten Worst Drug Recalls In the History of the FDA

December 13, 2010

The Ten Worst Drug Recalls In The History Of The FDA

Posted: December 10, 2010 at 5:02 am

This year's recall of certain types of Tylenol and Motrin by &

(NYSE: JNJ), which began in January, brought back memories of the 1982 Tylenol

recall. It affected as many as 21 million packages which were in circulation at

the time. & 's reaction set the bar for other companies. It did

not spare any expense to protect the public from what turned out to be a tiny

number of tainted products.

Recalls are commonplace now. And, they are not just for drugs. Recent incidents

include children's beds and toys with high lead content. However, it is still

the huge recalls of prescription drugs that garner the most headlines because

they often harm the largest numbers of people. These recalls can also cost large

pharmaceutical companies billions of dollars.

Many dangerous drugs have slipped past the FDA and found their way into the

marketplace. When the agency approves a dangerous drug, there can be a number of

consequences, often times tragic. Once news of a tragedy reaches the public,

pressure mounts for FDA policy to change, as happened after the Thalidomide

controversy in the 1960s.

Prior to 1962, there was no mechanism in the US to approve drugs before they

went to market. Although the 1906 Food and Drugs Act required drugs to be

accurately and honestly labeled, that was largely the extent of the oversight.

In 1961, it was determined that Thalidomide caused horrifying birth defects. It

is estimated that between 10,000 to 20,000 people were affected in what is

considered to be among the worst medical disasters in history. Thalidomide

prompted Congress to act, and the Kefauver- Drug Amendments were passed in

1962, granting oversight of drugs to the FDA and compelling manufacturers to

prove that their drugs are safe for public consumption.

Each of the drugs or group of drugs on this list drew a strong reaction from the

public. In some cases, such as DES and PPA, what is shocking is how long the

drugs were on the market before their devastating side effects were

acknowledged. In others, the amount of money the drug company paid in

settlements was so huge it drew public attention and ire. Still others were

surprising because of the fraudulent manner in which they reached the market.

This is a list of the worst drug recalls since the FDA became responsible for

approving drugs in 1962.

Information for this article about litigation was obtained from the US

Department of Justice and from LexisNexis. Facts about the history of each

recall and statistics citing numbers of injuries or deaths were obtained from

the archives of The New York Times, The Los Angeles Times, The Washington Post

and USA Today.

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