From the Pharmacy Graveyard: What Am I?: Part 1

Over the years, many new drugs have been approved, yet some notable ones have been withdrawn from the market, because of serious adverse events or complications.

Let’s play What Am I? I will tell you about a drug that was withdrawn from the market, and you can try to guess which ones I am describing. Answers follow, after the questions.

Because there are so many drugs that have been pulled from the market, this will be part 1 of a series.

1. In 2005, the FDA requested that Pfizer stop sales and marketing of this COX-2 inhibitor. There was a lack of adequate data regarding the cardiovascular safety of long-term use of this drug and an increased risk of adverse cardiovascular events observed in trials of in coronary artery bypass postsurgical patients that were related to chronic use. Additionally, the FDA received reports of serious and potentially life-threatening skin reactions causing some fatalities in patients who received therapy with this drug. These reactions were unpredictable and occurred in patients who used this drug both short and long term, patients who were allergic to sulfa, and patients who were not allergic to sulfa.¹ What am I?

2. Many years ago, this drug was a household staple that parents could buy over the counter and keep at home in case of poisoning. After decades of research, it was concluded that though this drug indeed caused vomiting, there was little research to show that people who took this medication after poisoning did any better than others. It was also unsafe for anyone who swallowed chemicals that cause burns on contact or medicines that can cause seizures very quickly. Often, people with eating disorders would rely on this medication to induce vomiting, and regular use of this drug was linked to possible heart problems and death. Sometimes, people vomiting after taking this drug could not keep down other drugs that they needed to treat their poisonings. In 2003, the American Academy of Pediatrics issued a statement telling people to throw out this drug and instead focus on poison prevention, as well as calling Poison Control at 1-800-222-1222 for ingestion of a poisonous substance.² What am I?

3. Another COX-2 inhibitor, this drug was voluntarily withdrawn from the market by Merck in 2004. It was used for arthritis, pain, and painful menstrual cycles. The FDA issued a public health advisory. The medication was linked to an increased risk in cardiovascular events, such as heart attack and strokes during chronic use. Data for the withdrawal were based on research from a study called the APPROVe trial, which was a trial testing this drug to see if it prevented recurrence of colyn polyps. The study was stopped early, because of an increased risk for serious cardiovascular events, observed after 18 months of continuous treatment with this drug compared with the placebo.³ What am I?

4. In 2000, Janssen Pharmaceutica said it would stop marketing this drug in the United States. This medication was approved only for severe nighttime heartburn experienced by adult patients with gastroesophageal reflux disease (GERD) who did not adequately respond to other therapies. As of December 1999, the use of this drug was associated with 341 reports of heart

rhythm abnormalities, including 80 reports of deaths, many because of underlying conditions.⁴ I spoke directly to Janssen, and though this drug is not available through pharmacies or wholesalers, doctors can request and obtain the drug through a limited access program. What am I?

5. In 2008, this quinolone antibiotic by Bristol-Myers Squibb was withdrawn from the market, in the form of injection, oral tablets, and suspension. The drug was approved for treatment of infections, because of susceptible strains of designated microorganisms in the following conditions: acute bacterial exacerbation of chronic bronchitis; acute sinusitis; acute, uncomplicated rectal infections in women; community-acquired pneumonia; complicated and uncomplicated urinary tract infections; pyelonephritis; uncomplicated cervical and urethral gonorrhea; and uncomplicated skin and skin structure infections. In May 2006, Public Citizen petitioned the FDA to immediately ban this drug, because of the risk of hyperglycemia or hypoglycemia. After reviewing the petition and studying the literature, the FDA concluded that this drug must be withdrawn from the market, because of effectiveness and safety.⁵ It is still marketed, only in eyedrop form, under the brand name Zymaxid, as well as a generic. What am I?

6. In 1998, the FDA requested the removal of this antihistamine and combination product of this drug, plus pseudoephedrine, made by Hoechst Marion Roussel Inc. This drug interacted with many others, such as clarithromycin, erythromycin, itraconazole, and ketoconazole. This drug was responsible for hundreds of deaths from arrhythmia resulting from these interactions. Patients with liver disease also reported arrhythmia from the drug, even when not taken with another one. The company released another antihistamine, fexofenadine, which is a metabolite of the original drug but did not cause sedation or have serious drug interactions.^6,7 What am I?

Answers:

1. Bextra (valdecoxib)

2. Ipecac syrup

3. Vioxx (rofecoxib)

4. Propulsid (cisapride)

5. Tequin (gatifloxacin)

6. Seldane (terfenadine)

Thank you, Bryan Piskadlo, RPh, for the inspiration for this game.

References

1. Bextra withdrawal from the market - HSS physicians reflect on options for patients in pain. hss.edu/conditions_bextra-withdrawal-hss-physicians-reflect-options.asp. Accessed March 29, 2018

2. Poison Control. Ipecac. poison.org/articles/ipecac. Accessed March 29, 2018

3. FDA. Vioxx (rofecoxib) questions and answers. fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106290.htm. Updated April 6, 2016. Accessed March 29, 2018.

4. MedicineNet.com. Propulsid to go off market - warning. medicinenet.com/script/main/art.asp?articlekey=12840. Accessed March 29, 2018

5. FDA. Determination that Tequin (gatifloxacin) was withdrawn from sale for reasons of safety and effectiveness. fda.gov/OHRMS/DOCKETS/98fr/cd07129-n.pdf. Published September 9, 2008. Accessed March 29, 2018

6. MedicineNet.com. Seldane removed from U.S. market over safety concerns.medicinenet.com/script/main/art.asp?articlekey=919. Published January 5, 1998. Accessed March 29, 2018.

7. Schwartz. J. FDA wants drug Seldane off market. The Washington Post. washingtonpost.com/archive/politics/1997/01/14/fda-wants-drug-seldane-off-market/8f7d42b9-2e91-42fd-9576-49882c60f600/?utm_term=.f4655a9fb3fb. Published January 14, 1997. Accessed March 29, 2018.