It seems as if all drugs have the potential side effects. Listening to an advertisement for a prescription drug, it can sound as if the effects of taking the drug are worse than the condition it is supposed to treat. It’s true that essentially all drugs can cause side effects, but this doesn’t mean that all people taking any drug will experience them. The results vary by individual and by drug.
Many people take medications and experience only mild side effects or symptoms that are bearable and worth the therapeutic benefits of the drugs. Too often, though, people suffer severely because of side effects. Sometimes the warning was clear, but sometimes a drug company fails in its responsibility to warn patients and doctors of just how bad side effects can be. These situations lead to a lot of lawsuits and sometimes even a recall of a medication.
Why Side Effects?
It isn’t just dangerous drugs and products side effects; even an over the counter medication can cause them. The reason is that it is very difficult to develop a drug that has a limited, specific action. When a medication works to treat a symptom or disease, the action it takes in the body affects other processes. For instance, an antibiotic kills bacterial cells causing an infection, but it may also kill the beneficial antibiotics living in your gut. This in turn can cause you to have stomach upset or diarrhea. Limiting the action of a drug to one very specific thing, without affecting others, is nearly impossible.
Mild and Common Side Effects
Luckily for most of us, side effects from most drugs tend to be mild and tolerable. With drugs taken over a longer time period, the body can even adjust and side effects that start out strong may become milder or even disappear entirely. When you get a new prescription, you can check the label or insert to find out what the most commonly reported side effects are.
When a drug company designs a new drug, it is required to test it rigorously, including clinical trials. During this latter stage of testing, the drug is given to real patients who report back on many factors, including side effects. The label for the final product includes a list of those most often reported. Some examples include nausea, sleepiness, diarrhea or constipation, headaches, and muscle pain.
The FDA’s Role
The U.S. Food and Drug Administration (FDA) has the job of approving all new medications. Drug companies must submit a New Drug Application, or NDA, for approval. The NDA must prove that a drug is safe and effective, and then that the side effects are not so severe or common that they outweigh the benefits of the medication.
Not all side effects emerge from an NDA and the clinical trials. The FDA continues to monitor drugs through a post-marketing surveillance program. Doctors and other healthcare professionals can input information about side effects. These reports of adverse events help the FDA determine if the drug company missed or intentionally left out information about side effects.
If the FDA does find that there is one or more particularly harmful side effects of a drug it has to decide to pull the drug or to include an extra warning. If it decides to keep the drug on the market the FDA may decide to include a black box warning on the label for the medication. This is reserved for side effects that are the most severe and life-threatening. An example of this is the warning that accompanies nearly all antidepressants. It warns that the medications can increase the risk that a child or young adult will experience suicidal thoughts and behaviors.
With some drugs the FDA may find that the side effect potential is too great, too severe, or puts too many people at risk for the medication to stay on the market. This happened with the painkiller Vioxx made by Merck. The company voluntarily removed Vioxx, but the FDA was in the process of making that decision when it did and would likely have come to the same conclusion. Designed to treat chronic pain, like that from arthritis, Vioxx was found to cause heart attack and stroke in too many patients.
Examples of Dangerous Drug and Product Side Effects
Many drugs remain on the market that have particularly dangerous or damaging side effects. For these, patients need to be aware of the risks, but may decide the benefits make it worthwhile. Sometimes these side effects are truly unusual as is the case with the antipsychotic Abilify. Made by Otsuka and Bristol-Myers Squibb, this drug seems to cause compulsive behaviors, particularly gambling, in some patients. Some have lost their entire life savings, even if they had never previously been gamblers.
Depakote is another example of a drug still on the market that can cause serious side effects. Depakote is an anticonvulsive drug made by Abbott and used largely to treat epilepsy. The FDA has placed a black box warning on Depakote because of the potential for birth defects. Women who used it during pregnancy have given birth to children with cleft palate, spina bifida, heart defects, and even autism. The FDA also classified Depakote as a class D for pregnancy.
When Side Effects Help
In rare cases, a side effect of a medication may actually be desirable. This was the case with Merck’s finasteride, a drug initially marketed as Proscar for the treatment of enlarged prostate. One side effect seen in clinical trials was hair growth. Merck then tested finasteride as a treatment for male pattern baldness and came up with the drug Propecia. It may also cause less desirable side effects like sexual dysfunction, but this was one case in which a side effect turned out to be a bonus for many men.
In most cases, drugs cause side effects that are mild to non-existent and many people use medications with more benefits than risks. For those unfortunate people, though, side effects can ruin lives. From cancer to excessive bleeding and birth defects, serious side effects wreak havoc on people’s lives. When patients know and understand the risks, they can make informed decisions along with their doctors.
However, when drug companies withhold information about side effects, people get hurt. This also leads to lawsuits because people feel that drug companies were not responsible about reporting on side effects. In some cases drug companies may even actively try to hide this important information. In these cases, patients tend to win settlement money through lawsuits that bring them a sense of justice, but also the money needed to recover from secondary conditions.