The Ten Worst Drug Recalls In The History Of The FDA

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6) Troglitazone (Rezulin)

  • Maker: Warner-Lambert
  • Recalled: 2000 (after one year on the market)
  • Financial damage: Warner-Lambert grossed $2.1 billion in sales before recall

The Rezulin saga, originally aired by the Los Angeles Times, was an ugly view into the process by which Rezulin was eventually removed from the market, but only after the FDA seemingly delayed the process due to complaints by Rezulin’s manufacturer.  A FDA doctor who voiced concern over the drug was later removed from his position at the behest of Warner-Lambert, an action that delayed the recall process.  Rezulin, an anti-diabetic and anti-inflammatory drug,  was eventually found to be causally connected with hepatitis.

7) Able Laboratories Generic Prescription Drugs

  • Maker: Able Laboratories
  • Recalled: 2005
  • Financial Damage:  Able Laboratories had $103 million in annual sales before recall

On May 23, 2005, all of Able Laboratories’ products were removed from the market due to questions surrounding the quality of the manufacturing process.  Some drugs were found to be too potent; others not potent enough.  Moreover, four of its managers were found to have fraudulently distributed misbranded and adulterated drugs.  The recall put Able Labs out of business.

8) Terfenadine (Seldane)

  • Maker: Hoechst Marion Roussel (now Aventis)
  • Recalled: 1997 (after 13 years on the market)
  • Financial damage: Seldane was a big moneymaker for Hoechst Marion Roussel for such a long period (the year before it was pulled it sold $440 million worth of Terfenadine worldwide).  In addition to its legal expenses, the loss of market share alone to drugs such as Loratadine (Claritin) was steep.

Seldane was a popular antihistamine brought to market in 1985 to treat allergies without causing drowsiness.  The FDA sought a recall from the manufacturer after cases of cardiac arrhythmia (abnormal electrical activity in the heart) appeared in patients taking Seldane with other drugs.  The recall is notable mostly for its scale; more than 100 million patients worldwide used Terfenandine as of 1990.  Following Seldane’s recall, Hoechst was able to mitigate its damages to some degree by introducing Allegra, a drug very similar to Seldane but without its side effects.

Read More: Lululemon Furthers Path To A Monopoly.

9) Phenylpropanolamine (PPA)

  • Maker: No principal manufacturer, widely manufactured across the industry
  • Recalled: in 2000 (at least 60 years on the market)
  • Financial damage: untold millions, if not billions (one manufacture alone settled for $15 million)

PPA, a psychoactive drug that saw many uses over its long history, is unique because it was never formally approved by the FDA. For decades it was used for everything from dieting to cold medication to treatment of psychological disorders, existing in a kind of limbo where it was neither banned nor fully endorsed.  That is, until an analysis by Yale University in 2000 recognized its connection with cardiac events and stroke, particularly in women.  The study estimated that 1 woman may have a stroke due to phenylpropanolamine for every 107,000 to 3,268,000 women who use products containing phenylpropanolamine as an appetite suppressant within a three-day window. The FDA estimates that between 200 to 500 strokes per year would have been prevented if PPA was replaced with something that presented less risks.  More than 25,000 lawsuits have been filed against a variety of drug companies, and awards for damages across the pharmaceutical industry number in the hundreds of millions, if not billions.

10) Mibefradil (Posicor)

  • Maker: Roche
  • Recalled: 1998 (after one year on the market)
  • Financial damage: Analysts had projected $2.9 billion in sales within 4 years

In only one year on the market, Posicor was linked to 123 deaths.  Considered relatively safe when taken alone, Posicor became potentially deadly when combined with any of 25 different drugs.  The large number of deaths are troublesome considering that the drug was prescribed to no more than 200,000 people worldwide in the space of one year, a relatively small number.  Posicor is on this list for stimulating debate surrounding policies encouraging the FDA to hasten the approval of certain drugs. It is often cited as a strong example of what can go wrong when drugs are rushed to market.

Jack Campbell
with Ashley Allen and Douglas A. McIntyre