Most drugs have side effects, some of which are unpleasant. This is, unfortunately, a reality of using many types of medications. But consumers deserve the opportunity to make informed choices about medications and weigh the cost and consequences of potential side effects against the value the medication provides, especially when side effects can be life-threatening or -altering.
Pharmaceutical companies are required to do thorough and rigorous testing of products before they are approved by the Food and Drug Administration (FDA). They are also legally obligated to notify consumers, medical professionals, distributors, and sales representatives of any and all known side effects of the drugs they manufacture.
Sadly, it’s been proven that the system doesn’t always work, and unsafe medications are at times distributed to the general public.
Here are three such drugs that have caused dangerous side effects and the negligence that allowed for their distribution:
Propulsid is a drug that is no longer available in the U.S. It was used to treat gastric reflux (known to many as heartburn) by increasing muscle contractions of the lower esophagus and the lower esophagus sphincter using a prokinetic agent.
However, within two years of Propulsid becoming available for public use, 57 patients had developed serious heart problems, including cardiac arrhythmias.
Despite being made aware of these and increasingly more numerous cases, the manufacturer, Johnson & Johnson, failed to warn the public of potential complications from the medication—even after the FDA decided to deny pediatric approval for the drug (a ruling which the company continually sidestepped to push the medication on children).
It continued to be available for public use until 2000, when Johnson & Johnson executives removed the medication from the market.
After the drug was withdrawn, Johnson & Johnson agreed to pay up to $90 million to settle claims by some patients affected by the drug. In all, Propulsid killed at least 300 patients and injured over 16,000.
Zyprexa is an antipsychotic medication that affects chemicals in the brain. It is used to treat the symptoms of psychotic conditions such as schizophrenia and the symptoms of bipolar disorder (manic depression) in adults and children.
An alarming side effect of Zyprexa is the disruption of glucose metabolism in some patients, causing many to develop diabetes.
The manufacturers of the drug, Eli Lilly, knew about the dangerous side effects; but instead of warning doctors and patients, they continued to market the drug using deceptive methods.
Eli Lilly agreed to pay up to $500 million to settle 18,000 lawsuits from people who claimed they had developed diabetes or other diseases after taking Zyprexa, and in 2009, the company was fined $1.4 billion for its dishonest and illegal marketing methods.
Elmiron (Pentosan Polysulfate Sodium)
Elmiron is an oral prescription drug used to treat discomfort or bladder pain associated with interstitial cystitis (IC), which is a chronic condition that causes bladder pain and pressure.
One dangerous side effect, which was not included in any warnings, has been shown to cause vision loss and retinal damage. It is claimed that the long-term use of Elmiron can cause maculopathy, which affects the retina and can cause permanent blindness.
Making this case more devastating is the fact that Elmiron is currently the only FDA-approved drug to treat the painful symptoms of IC, leaving many patients either desperate for relief or risking literal blindness by continuing to take the drug.
This is a side effect that Elmiron’s manufacturer, Janssen Pharmaceuticals, should have known of and warned individuals about prior use. As such, this is a current example of a pharmaceutical litigation case, as there are currently many people who have filed an Elmiron lawsuit with Janssen Pharmaceuticals.
When a pharmaceutical manufacturing company fails to fully alert patients to the harmful side effects of a medication, especially when these effects are purposefully covered up or ignored, it needs to be held accountable.