6 Major Drug Recalls from the Past
Patients take a doctor's prescription, believing that their doctor knows best, and the vast majority of the time that is correct. So it can be quite a shock when a recall happens on well-known prescription drugs because of possible health issues. Zantac, a popular H2 receptor blcoker that treats extreme cases of heartburn or recurring acid reflux, was recently added to the list of products getting pulled off the shelf.
Unfortunately, Zantac and similar drugs that block the production of acid in the stomach are showing a connection to the development of stomach cancer. GlaxoSmithKline has officially recalled Zantac as a "precaution."
It’s always big news when popular drugs get pulled off the shelf. Here are six major recalls from the past worth noting:
Valsartan, Losartan and Irbesartan
It's technically three drugs, but all three are within the same family and serve the same function. Additionally, all three drugs were part of recalls for the same issue. These common blood pressure medications have had over 75 recalls in recent years because of impurities that could be cancer-causing.
Valsartan, Irbesartan and Losartan aren't directly linked to cancer. However, during the refining process, each has produced batches with impurities that have led to cancer and numerous recall incidents.
Accutane was widely prescribed to treat acne for roughly three decades. Then after thousands of lawsuits and millions paid out in verdicts, it was recalled. The recall cited several severe side effects.
With the use of Accutane, patients were at risk of experiencing inflammatory bowel disease as well as suicidal tendencies. Anyone using Accutane when pregnant was in danger of miscarriage, premature birth and children at greater risk for congenital disabilities. As a result, production of this popular drug ended entirely by Roche. Generic variations still produced today but the use of them has significantly diminished.
Over a four and a half year span, Vioxx resulted in nearly 28,000 cardiac deaths or heart attacks. Vioxx was used by over 20 million people and even had Olympic athletes featured in ads for the pain medication. The average rate of heart attacks works out to about 4 per every 1,000 people who used the drug.
The manufacturer, Merck, pulled the drug after identifying the substantially increased possibility of a stroke or heart attack.
Efalizumab or Raptiva was a psoriasis treatment that was eventually found to onset a brain infection called leukoencephalopathy. This brain infection is extremely rare but lethal. Essentially, leukoencephalopathy causes the white matter of the brain to become inflamed, resulting in damaged white matter and ultimately damage to the central nervous system.
In early 2009 the FDA announced a Public Health Advisory, which notified the healthcare community of these risks associated with Raptiva. The manufacturer then voluntarily removed the product from the market.
Darvocet and Darvon
The Darvocet recall received quite a bit of publicity when the common pain treatment was found to lead to many serious heart rhythm risks. Heart rhythm abnormalities, which were not only severe but frequently fatal, caused Xanodyne Pharmaceuticals to pull the brand name opioid medication. The FDA requested the generic producers of the drug, Darvon, to follow Xanodyne's example and remove their products as well.
At one point in time, Darvocet was among the most popular pain treatments in both Europe and the United States. Now it is completely banned throughout the U.S. and the U.K.
The direct competitor to Lipitor, Lipobay, treated high-cholesterol, and was meant to prevent heart disease. Bayer manufactured this drug through the late 1990s but ultimately pulled it in 2001.
Lipobay presented the risk of rhabdomyolysis, which causes muscle breakdown. Then the deteriorated muscle tissue clogs the kidneys leading to renal failure. After 52 deaths connected with Lipobay, the drug was removed from the global market.
Why Do Medication Recalls Happen?
In some cases, such as Lipobay, the medications become available through surrogate endpoints. With surrogate endpoints, the new drug uses the clinical data of similar drugs to receive approval without clinical trials. Recalls for these drugs usually happen because of unexpected differences that change the outcome of use for patients. In other cases, new medication does go through extensive testing, research, development, and refinement. Recalls are still possible even after successful clinical trials. Zantac's recall, for instance, is happening because of an impurity in manufacturing, whereas the drug itself is not the problem.