Update on Withdrawals of Dangerous Drugs in the U.S.

In October 2010, the FDA finally banned the diet drug sibutramine (MERIDIA) because of safety reasons, including increased heart attacks and strokes.

As a result of this action, we are updating our list of drugs approved after 1992 that were eventually removed from the market for safety reasons. The FDA has now withdrawn 20 drugs, all of which were approved in 1993 or later. (Three of these drugs were withdrawn and later allowed back on the market with much more restricted use.)

We chose 1993 as a starting point because Congress first enacted the Prescription Drug User Fee Act (PDUFA) the previous year and its effects had clearly begun to be seen by the beginning of 1993. This law changed the drug-regulation landscape in the U.S. by requiring the FDA to collect fees from pharmaceutical manufacturers to review their new drug applications. Thus the drug industry, rather than the American public, became an important customer of the FDA. We have long been concerned that the enactment of this law — and the drug industry pressure accompanying this funding — has lowered safety standards for approval and has kept demonstrably dangerous drugs on the market for far too long.

Table 1 lists 11 of the drugs that we warned Worst Pills, Best Pills News subscribers not to use before the drugs were banned. Our readers were warned an average of 3.3 years before the drugs came off the market.

We warned readers of the dangers of the NSAID bromfenac (DURACT) 203 days before it was banned. This NSAID was on the market for less than a year (342 days).

Table 2 lists the generic and brand names of all 20 of the withdrawn drugs, as well as the dates the drugs were approved and removed from the market. The last column shows the number of years each drug was on the market before it was withdrawn — an average of 4.1 years for the 20 drugs.

Of the 20 drugs, two were antibiotics: grepafloxacin (RAXAR) and gatifloxacin (TEQUIN); three were nonsteroidal anti-inflammatory drugs (NSAIDS): bromfenac (DURACT), rofecoxib (VIOXX) and valdecoxib (BEXTRA); two drugs were for weight loss: sibutramine and dexfenfluramine (REDUX); and one was for type-2 diabetes: troglitazone (REZULIN). Another diabetes drug, rosiglitazone (AVANDIA) recently has had some restrictions on its use but unlike in Europe, where it was completely banned, it is still being used in the U.S.

What You Can Do

You should keep reading Worst Pills, Best Pills News or WorstPills.org. They are your independent second opinion for drug safety.

Also, you should remember the Seven-Year Rule. You should not use a new drug until at least seven years after it is approved, unless it is one of those exceedingly rare drugs that offers a documented benefit over existing therapeutic options.

Consumers may report serious adverse events with drugs to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail, fax or phone.

• Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

Table 1. Time between Worst Pills, Best Pills News Warning and Market Withdrawal

Table 2. Twenty Drugs Approved After 1992 and Later Withdrawn From the Market for Safety Reasons (Starting With the Most Recently Withdrawn: Sibutramine)