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Medicine gone wrong: a timeline of major drug recalls

November 26, 2013

BY: Justin Boyle

Pharmaceutical companies tend to do reasonably well at controlling their products for potentially harmful side effects and drug interactions before bringing them to market. And the FDA, along with physicians and pharmacists, act as a second defense to ensure medications are safe for the public. The system isn't full proof however. Sometimes an under-researched formula or a bad batch of pills makes it out of the lab and it's necessary to pull the product off the shelves. Unfortunately, this often only occurs after a considerable number of people have been harmed or killed. Here's a look back at seven major drug recalls throughout history and the regrettable events that led to them.

  • Thalidomide (1961) was prescribed to pregnant women across the world as a remedy for anxiety and morning sickness, until doctors began to notice that developmental abnormalities were beginning to show up in the children of women who took it. Even though the period of thalidomide vulnerability in a fetus is only 13 days long, the tragic nature of the drug's side effects and its international distribution combined to create a climate of urgency for drug safety reform. Interestingly, even though the thalidomide scare contributed to the establishment of strict FDA regulations regarding pharmaceutical safety, the agency approved it for use in 2012 as a treatment for leprosy and multiple myeloma.
  • Diethylstilbestrol (1975), or DES, was originally prescribed as a preventative measure against miscarriage and premature delivery. When a rare form of cancer began to show up in the daughters of women who had taken DES, the FDA began to warn doctors against prescribing the drug to pregnant women. Manufacturers continued to suggest other conditions for which DES could be recommended -- some doctors even prescribed it to pre-pubescent girls as a guard against "excess height" -- until all doses larger than the 5-milligram amount prescribed to treat breast and prostate cancer were forcibly withdrawn from the market.
  • Tylenol (1982) was subject to a different sort of drug recall when six deaths in the Chicago area were found to be linked to Tylenol capsules adulterated with potassium cyanide. Manufacturer Johnson & Johnson initiated a series of measures shortly after the link was established, including a region-wide product recall, which The New York Times names as the first voluntary recall procedure in U.S. history. The company also offered to replace purchased capsules with tablets, which are much harder to alter, and developed new tamper-proof packaging for future distributions of the drug.
  • Fen-Phen (1997) was a popular appetite suppressant diet pill in the early nineties. Its constituent compounds -- fenfluramine and phentermine, hence the name -- had each been in use for decades before a 1992 study showed that the two could be combined to reduce their respective side effects. The lower doses of each component drug led to some doctors prescribing Fen-Phen for periods of greater than one year, for which neither single drug had been approved. Heart disease and pulmonary hypertension began to become associated with Fen-Phen, and all forms of fenfluramine were removed from the market amid a flurry of lawsuits. Phentermine, which had been in use since 1957, remains available in its standalone form.
  • Posicor (1998), a remedy for hypertension and chest pain, was linked to 123 deaths in its single year of availability. The drug itself was recognized as safe, but it had a tendency to produce dangerously low heart rates in patients who combined it with any of more than two dozen other medications. What's potentially more shocking about the Posicor saga is the assertion by the Los Angeles Times that an even greater incidence of death was experienced by subjects in studies conducted prior to the drug's approval by the FDA. Posicor is frequently cited as a textbook example of the dangers of rushing a drug to market.
  • Vioxx (2004) was a non-steroidal anti-inflammatory drug (NSAID) and painkiller that selectively targeted the source of pain and inflammation, an enzyme called COX-2. That selectivity made the drug less likely to produce the gastrointestinal side effects associated with other NSAIDs, but it was revealed to cause heart attacks, stroke and death in patients who took it for even short periods of time. Allegations that representatives of manufacturer Merck colluded with federal regulators to prevent the health risk information from being distributed added another layer of scandal to the drug's recall.
  • Tylenol (2010) was back in the news in January 2010 after Johnson & Johnson analysts suspected that batches of the medicine may have been contaminated with a strain of bacteria that can cause infections in people with weakened immune systems. In June of the same year, a moldy or musty smell in some batches of Tylenol and other Johnson & Johnson drugs triggered a second recall.

These aren't the only drug recalls and they likely won't be the last. But with a tighter focus on pharmaceutical safety from all involved, the list of major recall incidents hopefully won't get much longer.

Sources

"Thalidomide," Encyclopedia Britannica, http://www.britannica.com/EBchecked/topic/589836/thalidomide

"DES Diethylstilbestrol," Journal of a DES Daughter, http://diethylstilbestrol.co.uk/

"Diethylstilbestrol," MakeHumans.com, http://www.makehumans.com/htmx/diethylstilbestrol.php#cite_ref-10

"The Ten Worst Drug Recalls in the History of the FDA," 24/7 Wall St., December 10, 2010, http://247wallst.com/investing/2010/12/10/the-ten-worst-drug-recalls-in-the-history-of-the-fda/2/

"Tylenol made a hero of Johnson & Johnson : The recall that started them all," Judith Rehak, The New York Times, March 23, 2002, http://www.nytimes.com/2002/03/23/your-money/23iht-mjj_ed3_.html

"Fen-Phen: Rise and Fall of a Diet Drug," Rosanne Bachman, Facworld.com, 2010, https://www.facworld.com/facworld.nsf/doc/7casphen-fen

"Posicor," Resource4thePeople.com, http://www.resource4thepeople.com/recalleddrugs/posicor.html

"POSICOR: 143 Sudden Deaths Did Not Stop Approval," David Willman, The Los Angeles Times, December 20, 2000, http://www.latimes.com/news/nationworld/nation/la-122001posicor,0,1685821.story#axzz2krjsvYvG

"Vioxx," DrugWatch, September 20, 2013, http://www.drugwatch.com/vioxx/

"Biggest Drug Recalls of the Past Decade: Tylenol," iVillage, February 28, 2012, http://www.ivillage.com/biggest-drug-recalls-past-decade/4-b-156084#156087