When Accidents Happen: Adverse Reactions and Drug Injuries
A drug injury can occur any time during your use of a medication and not just when the drug is first administered. Possible causes of drug injuries include giving a medication to the wrong patient, giving the wrong medication to the right patient, giving the medication at the wrong time, giving the medication in the wrong dose, and delivering the drug by the wrong route of administration (for example the drug was injected versus given orally, or vice-versa). In short, a lot of things can go wrong.
In addition to a medical error (to learn more, see our HelpCenter on Medical Malpractice), the drug itself may cause injury due to an adverse reaction or unwanted side effect. Some reactions can be relatively minor (things like drowsiness or an upset stomach) but other reactions can be much more severe, causing serious injury and sometimes death. The American College of Allergy, Asthma, and Immunology reports that adverse drug reactions account for an estimated 106,000 deaths each year in the United States, alone.
Can Be Difficult to Determine
One of the difficulties with drug injuries, in general, is that the injury either remains hidden for a long period of time (a slow-growing cancer or slowly-evolving liver damage, for example) or the injury is obvious but looks like an another condition and is difficult to trace back to the medication that caused it in the first place (for example a heart attack, which is obvious may be caused by a drug that was taken months before).
Too many times victims of drug injury first become aware of a possibility of a dangerous medication when they see a news report in the paper or on TV or the internet. They see a story about a drug they are taking producing harmful side-effects and recognize some of the same symptoms and for the first time are able to piece-together the fact that their drug and their injury are possibly linked.
For the most part, it will be up to you to watch for signs that your prescription or over-the-counter medication (including herbal and nutritional supplements) is affecting you in a negative way.
Recognizing an Adverse Reaction
Recognize – The best way to recognize adverse reactions is to know precisely how your medication works and what symptoms it might typically produce. Does your medication normally make you feel light-headed? Does it cause you to have a dry mouth? What are the typical side effects that you experience each time you are on your medication? Knowing these signs will help you recognize typical side effects and will help distinguish an adverse reaction to the medication. Typical side effects of a medication aren’t necessarily adverse reactions, but it is important to take heed of any side effects because they might be meaningful in determining adverse reactions in the long run.
Research – The best way to find out more about possible or expected reactions is from your doctor when they offer a new prescription or a new drug therapy is introduced. The pharmacist who fills your prescription is also knowledge and a good resource for learning more. Finally, it’s a good practice to do some basic online research for yourself whenever you begin a new drug.
Report – Even the simplest side effects can mean something, so it is important that you bring up all the side effects in your follow-up appointment with your doctor after being on the drug for a period of time. Many drug reactions start out as very minor adverse reactions to the drug, but result in major injury down the road. It is important to discuss any minor reactions you are having on a drug therapy with your physician so that the appropriate steps can be taken.
In order to be best prepared to present an accurate report of your reaction, take note of the following important circumstances and information:
- When did you last take the medication?
- When did you first notice symptoms of a reaction?
- What are those symptoms and how long have they lasted?
- What other medications are you taking (including over-the-counter and supplements)?
- What is your dosage and how long have you been on the medication?
Remember, if you experience an unusual or painful reaction to any medication, do not wait until your next doctor’s visit, contact your pharmacist, doctor, or emergency medical services immediately.
FDA MedWatch Program for Public Safety
MedWatch is the U.S. Food and Drug Administration’s adverse events reporting system for defective drugs and defective medical devices. The FDA is tasked with ensuring the safety of all marketed medical products, and MedWatch, the FDA Safety and Adverse Event Reporting Program, serves the public in this capacity.
Health care officials and the public can take advantage of the MedWatch program to submit information about adverse drug reactions. MedWatch has an online form (form 3500) along with directions for reporting adverse drug experiences to the FDA. The MedWatch program keeps abreast of any safety-related drug labeling changes and allows consumers to access a database of the adverse events reported on the drugs they’re prescribed.
There’s also an email subscriber MedWatch ‘E-list’ that consumers can subscribe to for information on defective drugs and defective medical devices. The FDA MedWatch e-list delivers daily up-to-the-minute medical information on unsafe medical products and defective drugs. To subscribe to the e-list, go to the MedWatch LISTSERV subscribe page, where instructions for subscribing await.
It is terribly important that you use the MedWatch system to report an adverse effect whenever you experience an adverse effect of a drug or medical device. In fact, very few adverse events are actually reported to the FDA. It is estimated that less than 1% of all adverse events get reported to the FDA, but these adverse events serve as a basis for intense study to evaluate whether a drug is safe or not.
MedWatch allows doctors and consumers to report to the FDA serious reactions and problems associated with drugs or medical devices that they use or prescribe. These are loosely defined as potential and actual product use errors and product quality problems associated with the use of FDA-regulated drugs and medical devices, tissue, special nutritional products, and cosmetics.
An adverse event comprises any undesirable experience associated with an FDA-regulated drug or medical device. The adverse event rises to the threshold of a serious event to be reported to the FDA when the patient’s outcome from the event is death or life-threatening, if the patient requires hospitalization, if the event results in disability, if the event results in congenital anomaly, or if the adverse event requires medical intervention to prevent permanent impairment or damage to the patient.
Read the next article: What Happens Now: Drug Injury and the Legal Process