New and improved medications are being developed all the time. Some of these medications have the ability to help us lead longer and healthier lives. However, the long-term effects of some of these drugs may still be unknown when they are given to patients. Patients have to trust their doctors, pharmacists, and the drug companies to make sure these drugs are safe for users. Unfortunately for some patients, the medication side effects can cause serious injury or death.
Most patients don’t have the time, resources, or scientific background to help evaluate drug development and clinical trials. Instead, patients may be taking a chance when their doctor prescribes a new or unfamiliar drug to treat medical conditions. If you experience any side effects from a new drug or combination of medications, make sure you inform your doctor immediately.
If you suffered an injury because of unknown side effects of a medication or you were prescribed a dangerous combination of drugs, you may be able to file a claim for damages. In some cases, you can sue a pharmaceutical company for medication side effects that were not disclosed. For advice in your medical injury case, contact our office today online or by phone at 800-529-6162.
Medication Side Effects
Medications can be made from naturally occurring materials or from new compounds developed in a lab. Even natural substances made from plants or minerals, can impact the body in different ways, depending on the user, dosage, and combination with other foods or drugs. Drugs also impact different people in different ways. This makes it difficult to know what side effects a medication might have and how to reduce the risks of dangerous side effects.
Drug side effects can range from minor to fatal. For some patients, there are initial side effects as the body acclimates to the medication. Other patients can experience side effects intermittently. For some, the impact of the side effects may outweigh the benefits of the drugs and they may have to consult their doctor for a viable alternative. Minor side effects may include things like:
- Nausea
- Tiredness
- Headache
- Rash
Other side effects can be more serious and may represent a more serious health condition or reaction. This includes allergic reactions like swelling of the face, throat, or tongue. Other serious side effects that may require contacting your doctor immediately include:
- Difficulty breathing or swallowing
- Fever
- Yellowing of the skin or eyes
- Chest pain
- Fainting
- Loss of consciousness
- Blurred vision or loss of vision
- Confusion
- Seizures
- Loss of balance or coordination
- Problems with speech
Medication Warning Labels and Directions
Federal regulations require certain information to be conspicuously indicated on the drug label, including information like the drug name, manufacturer, and other information. The FDA regulates drug labeling, with most prescription medications including the following information:
- Indications and usage
- Dosage
- Timing and route of administration
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Expiration date
Most information about side effects should be included in sections about contraindications, warnings and precautions, adverse reactions, and drug interactions. Drugs with a boxed warning are to indicate drugs with more serious adverse reactions.
Contraindications and Drug Interactions
According to guidance by the FDA, a drug should be contraindicated in clinical situations for which the risk for use clearly outweighs any possible therapeutic benefit. This includes observed adverse reactions and anticipated advice reactions. Contraindications that involve drug interactions with serious outcomes should be described in contraindications and cross referenced in drug interactions.
Adverse Reactions
According to the FDA, adverse reactions should include serious adverse reactions, which include outcomes of:
- Death
- Life-threatening events
- Inpatient hospitalization or prolonged hospitalization
- Persistent or significant incapacity
- Congenital anomaly or birth defect
Warnings and precautions should also include clinically significant adverse reactions based on their indication and incidence. Anticipated adverse reactions or adverse reactions associated with unapproved uses may also be included in the warnings and precautions of the drug label.
Black Box Warnings
Boxed warnings are to be used for the medications where there is a greater risk of injury or harm to patients. According to the FDA, a boxed warning is ordinarily used in one of the following situations:
- There is an adverse reaction so serious in proportion to the potential benefit from the drug that it be considered in assessing the risks and benefits of using the drug; or
- There is a serious adverse reaction that can be prevented or reduced in frequency or severity by appropriate use of the drug; or
- FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.
Some of the most common drugs may still have boxed warnings for certain patients. According to a study in Pharmacy, one of the most commonly prescribed drugs in the U.S. is Zestril (lisinopril). Even lisinopril has a boxed warning for Fetal Toxicity:
- When pregnancy is detected, discontinue Zestril as soon as possible
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
If you have any questions about the medications you are taking and have concerns about side effects, adverse reactions, drug interactions, or contraindications, talk to your doctor.
Watching Out For Side Effects of New Medications or Drug Combinations
Whenever you begin taking a new drug, it is important to be aware of the warnings, adverse reactions, contraindications, and other side effects. Follow your doctor’s instructions and be aware of any side effects or concerns, and report them to your doctor. If your reactions are serious, they may be reported by your doctor to the FDA Safety Information and Adverse Event Reporting Program.
The FDA’s Adverse Reporting System (FAERS), is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events. This includes adverse events for drugs and other therapeutic biologic products.
Medical Advice About Side Effects
When you report side effects to your doctor, your doctor may want to evaluate your reaction in light of the benefits of the drugs. Your doctor can also advise you on the extent and severity of the side effects, and help you determine whether or not continuing the drug treatment is right for you or if other alternative treatment options are available. Most patients who have a concern over drug side effects continue following their doctor’s advice. However, what is a patient supposed to do when the doctor provides the wrong advice?
How Did Your Doctor Respond to Complaints About Side Effects?
Doctors are supposed to follow a certain standard of care. Under the standard of care, healthcare professionals are supposed to provide the same type and level of care that other reasonable healthcare professionals would provide under similar circumstances, based on the doctor’s specialty, training, and experience. Deviating from the standard of care which causes injury or harm to the patient may be considered medical malpractice.
If a doctor deviates from the standard of care, which causes an injury to the patient, and the patient suffers harm as a result, then the doctor may be liable for damages. Damages in a medical malpractice case can include medical bills, lost wages, pain and suffering, and any other losses associated with the injury.
Even if the pharmaceutical company was not at fault for your medical side effects, your doctor could be responsible because they failed to exercise the standard of care of a reasonable doctor. In some cases, the hospital, pharmacy, or other healthcare professionals could also be liable for your injuries caused by improper prescription drug administration.
Defective Drugs and Medical Injury Claims Against Pharmaceutical Companies
Drug companies may be liable for defective drugs or contaminated medications. Under product liability claims, drug manufacturers, suppliers, and distributors can be held liable for any injuries caused by their dangerous medications. In a drug defect claim, the injury victim can show there was a defective drug put out by the company or supplier, the defective drug was used as intended, and the injury victim suffered damage caused by the defective product. Drug defect cases may involve:
- Manufacturing defects
- Design defects
- Failure to warn defects
Medications are supposed to be produced in environments with strict quality control. However, manufacturing defects can change the way the drugs are supposed to be produced, leading to tainted drugs, potency problems, and improper storage practices. Some of the reasons the FDA may issue a recall for defective drugs may include:
- Unsterile packaging
- Potency lower than labeled
- Potency higher than labeled
- Contamination with bacteria or fungus
- Particulate matter
- Banned ingredients
- Tainted drug supplies
- Improper seal on the packaging
- Undisclosed ingredients
Dangerous Drug Recalls
Many drugs have been taken off the market or recalled because they presented an unnecessary danger to the public. This includes drugs that were found to have more dangerous side effects than previously disclosed, as well as defective drugs that had a manufacturing defect.
The Food and Drug Administration (FDA) is the federal government agency that monitors agricultural products, food, and drugs. Drug review and monitoring includes dietary supplements, prescription drugs, over-the-counter (OTC) drugs, and vaccines. If the FDA determines a drug is dangerous, the FDA can recall the drugs. However, most drugs end up going through a “voluntary” recall from the manufacturer.
When the drug company finds out about a problem with one of their medications or the FDA monitors adverse events, the company can propose a correction or product removal of the drug. Recall options for drug makers include:
- Recalling drugs
- Re-labeling drugs
- Notifying patients
- Monitoring patients
The FDA assigns a classification for the recall based on the danger of the drug. FDA recalls are classed as Class I, II, or II.
- Class I: There is a reasonable chance that a product will cause serious health problems or death.
- Class II: A product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
- Class III: Where a product is not likely to cause any health problem or injury.
After the Death of a Loved One From Fatal Side Effects
If you suffered an injury from dangerous drug side effects, you can take your case to court to recover damages from the pharmaceutical company. However, what if a loved one dies because of medication side effects? How can a family make sure justice is served when dangerous drug side effects are fatal?
If someone dies because of medical malpractice or defective drugs, a representative may be able to file a wrongful death claim. A wrongful death claim can help the family and beneficiaries recover compensation for the loss of a loved one. A wrongful death claim may also be the only way for the family of the deceased to make sure the drug companies are held responsible for their dangerous practices. Filing a wrongful death claim may also help other families avoid a similar fate for their loved ones.
Damages in a wrongful death claim can compensate the beneficiaries of the deceased. Damages may include any medical expenses for treatment after the injury until death, in addition to:
- Burial expenses
- Funeral
- Loss of financial support
- Loss of benefits
- Loss of services
Each state has a different time limit for filing a wrongful death claim. If you suspect a loved one died because of defective drugs or a medical error, contact medical error attorneys who understand how to handle these complex cases and can answer all your questions.
Were My Injuries Caused By a Medication Side Effect?
After suffering a medical injury, you deserve to be compensated for your financial losses, additional treatment, and any pain suffered as a result of malpractice. A medical malpractice attorney with experience handling medical injury cases can help you understand your options. If the injury was caused by a medical resident, the resident, supervising doctor, or hospital may be liable for damages. Talk to a malpractice attorney about who may be liable for your losses.
Talk to experienced trial attorneys who can review your case, get an expert’s review, and help you understand your legal options to file a claim after a medical malpractice injury. Contact Gilman & Bedigian online or at 800-529-6162 for a free consultation.