(PC:MEDLINEPLUS)
These kind of bans often spark debates about drug safety, regulatory practices, and the balance between risk and benefit in pharmaceutical approvals:
- Thalidomide:
“In the late 1950s and early 1960s, the use of thalidomide in 46 countries by women who were pregnant or who subsequently became pregnant resulted in the “biggest anthropogenic medical disaster ever,” with more than 10,000 children born with a range of severe deformities, such as phocomelia, as well as thousands of miscarriages.” says wikipedia.
- Fen-Phen:
The drug combination fenfluramine/phentermine, usually called fen-phen, was an anti-obesity treatment in the early 1990s that utilized two anorectics. Fenfluramine was marketed by American Home Products (later known as Wyeth) as Pondimin, but was shown to cause potentially fatal pulmonary hypertension and heart valve problems, which eventually led to its withdrawal in 1997 and legal damages of over $13 billion.Phentermine was not shown to have harmful effects on the body.
- Vioxx:
Shortly before the FDA approved Vioxx in 1999, drug maker Merck launched a study in which he hoped to prove that Vioxx was superior to older painkillers, because it caused fewer gastrointestinal problems. Instead, the study would eventually show Vioxx could be deadly, causing heart attacks and strokes.
Five years after Vioxx’s launch, Merck withdrew the drug from the market. By that time, Merck had sold billions of dollars of the drug worldwide.
- Ephedra
“Ephedra is a low evergreen shrub with small scaly leaves. It has a long history of medicinal use in China and India to treat colds, fever, headaches, coughing, wheezing, and other conditions.
The U.S. Food and Drug Administration (FDA) banned the sale of dietary supplements containing ephedrine alkaloids (stimulant compounds found in Ephedra sinica and some other plants) in the United States in 2004. Prior to the ban, ephedra was an ingredient in some dietary supplements promoted for weight loss, increased energy, and enhanced athletic performance.” Says NCCIH.
- Seldane:
The manufacturer of Seldane, one of the most popular allergy drugs ever sold, said Monday that it will voluntarily remove the product from the marketplace Feb. 1 in response to the Food and Drug Administration’s approval of the company’s safer alternative drug.
The decision will eliminate a drug with the potential to cause life-threatening heart problems when taken with certain other drugs and the safer and better alternative for this medicine was available.
- Propoxyphene
Propoxyphene was banned in 2010 because it was linked to a higher risk of developing serious and sometimes fatal heart rhythm abnormalities, even when taken at recommended doses. Many people who took propoxyphene eventually developed heart-related problems, it also included the problem of high tolerance meaning that some people had to take higher doses for it to have an effect which can lead to overdose.
- Rofecoxib (Vioxx)
Another name for Vioxx, its ban was controversial due to debates about the transparency of safety data and the timing of the recall.
- Duract
The drug, Duract, a painkiller manufactured by Wyeth-Ayerst Laboratories of St. Davids, Pa., has caused a dozen cases of serious liver failure since it went on the market last July; four patients died and eight required liver transplants. All the cases involved patients who took the drug for longer than the recommended 10 days. This was the second time the FDA Pulled a medicine out of the market in the same week.
- Bextra
On April 7, 2005, Pfizer withdrew Bextra from the U.S. market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. This was a result of recent attention to prescription NSAIDs, such as Merck’s Vioxx.
- Elidel
Pimecrolimus, used for eczema, faced restrictions due to concerns about a possible increased risk of skin cancer.