Pharmaceutical companies make billions of dollars each year from prescription drugs. Johnson & Johnson, the world’s largest pharmaceutical manufacturer, made $65 billion in pharmaceutical sales during 2011. In the same year, the U.S. set a new record with 4 billion prescriptions. While prescription drugs can cure medical conditions and save lives, they can also cause harm. Defective drugs are known to cause severe adverse effects and death.
Prescription Drugs and the FDA
The Food and Drug Administration (FDA) has strict policies, guidelines, and standards for ensuring consumer safety with regulated drugs. However, these processes can be slow-moving. It may take several years before people are fully aware of a drug’s dangerous side effects. Removing a defective drug from the market can take even longer.
As a result, many defective drugs make it into the hands of unknowing consumers. Thousands of people may be harmed or killed before action is taken against manufacturers. Patients must consider all potential side effects of a new prescription drug, even if the manufacturer claims the effect is rare.
The FDA reacts to adverse drug reports in several ways, including:
- Writing reports
- Assembling meetings
- Conducting reviews
- Demanding additional trials
- Writing letters to doctors
- Adding warnings to drug labels
- Requiring that patients enroll in special drug programs
Drug Company Misconduct
The FDA requires that clinical studies are conducted on new drugs before they can be approved and released to the public. While some defective drugs have unforeseen side effects, pharmaceutical companies can also contribute to safety problems. There are reported cases of pharmaceutical drug companies interfering with or concealing the true results of their clinical trials.
Drug companies can skew clinical trial results by:
- Studying adverse effects for an inadequately short amount of time
- Hiding or failing to inform the FDA of negative result information
- Studying only a small group of users as opposed to a larger, more diverse group
Types of Defective Drugs
Type 2 Diabetes Drugs
Diabetes drugs have been linked with cardiovascular problems such as heart attacks and heart failure. Pharmaceutical companies have paid billions of dollars to settle thousands of lawsuits relating to diabetes drugs. Defective diabetes drugs include Actos and Avandia.
Antidepressants including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have been used to treat depression and similar conditions for decades. However, antidepressants have been linked to serious side effects such as suicide, birth defects, and withdrawal once treatment is complete.
Problematic antidepressants include:
Birth Control Pills
Birth control pills can cause life-threatening side effects such as blood clots, stoke, and death. Yaz, Yasmin, and Ocella are linked to a significant increased risk of developing blood clots. Specific conditions include pulmonary embolisms and deep vein thrombosis.
Prescription acne medications can be extremely effective for severe cases of acne. However, drugs like Accutane can cause serious side effects such as suicidal thoughts and tendencies, Crohn’s disease, and birth defects when taken during pregnancy.
Heart Disease and Stroke Drugs
Defective blood thinners like Pradaxa can lead to fatal complications such as liver failure, heart attack, and uncontrolled bleeding. Crestor is used to treat and prevent stroke, heart attacks, and heart disease. Crestor can cause type 2 diabetes and rhabdomyolosis, which can lead to kidney failure and death. Patients who use cholesterol drugs like Zocor can also develop rhabdomyolosis and other serious muscle injury.
Reports indicate that some osteoporosis drugs like Fosamax may actually cause increased bone fractures. Fosamax can also cause osteonecrosis of the jaw, also known as Dead Jaw Syndrome. Osteonecrosis of the jaw causes the death and eventual collapse of the jawbone.
Known widely as a Z-Pak, Zithromax is a powerful antibiotic used to treat several types of bacterial infection in adults and children. However, the FDA released warnings indicating that Zithromax can cause deadly heart problems, especially for those with preexisting heart conditions.
Drugs like GranuFlo and NaturaLyte are used in dialysis treatments to treat chronic kidney disease and renal failure. However, when used incorrectly, these drugs can cause deadly side effects. GranuFlo and NaturaLyte are associated with severe conditions such as metabolic alkalosis and cardiac arrest.
Epileptic and Antipsychotic Drugs
Depakote for mood and seizure disorders can cause severe birth defects when taken during pregnancy. It can also lead to conditions that cause liver failure and pancreatitis. Topamax also treats epilepsy, and has been known to cause metabolic acidosis and oral birth defects such as cleft palate. Antipsychotic drug Risperdal leads to decreased white blood cells and neuroleptic malignant syndrome, which requires immediate intensive care.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.