Before a newly developed drug can be sold commercially, it must first endure an exhaustive clinical trial process through which it is tested for safety, toxicity, side effects and efficacy. The final phase of any drug clinical trial revolves around Food and Drug Administration (FDA) approval, clearing it for distribution.
FDA approval does not void a drug manufacturer's liability for defects or severe side effects that are caused as a result of using their drugs. Drug manufacturers are required to take comprehensive measures to ensure that their products are safe. Failure to disclose any side effects, defects, or other such complications associated with their drugs is negligent and grounds for legal action. The purpose of the clinical trial process is to test the drug across a wide variety of populations so as to monitor sporadic issues affecting specific groups (gender, age, race, etc.)
Although the final phase of any drug clinical trial revolves around long-term studies designed to monitor the effects of continued use of the drug, latent effects can present themselves after FDA approval of the drug and after it has been widely distributed and used.
The following list of FDA approved drugs has recently garnered a great deal of attention resulting from harmful defects and side effects that have been affecting significant numbers of people.
COX-2 Inhibitors: a new class of non-steroidal, anti-inflammatory drugs that inhibit cyclooxygenase (COX-2), a naturally occurring enzyme that plays an integral role in inflammation. COX-2 inhibitors function without getting in the way of COX-1, a naturally occurring enzyme that plays an integral role in the protection of the stomach. The primary reason that COX-2 inhibitors were developed was to provide people with an anti-inflammatory drug that would not cause harm to the stomach; however, recent studies have indicated that COX-2 inhibitors are just as harmful to the stomach as older anti-inflammatory drugs like aspirin.
Ortho Evra: a type of birth control skin patch, Ortho Evra is a weekly hormonal contraceptive that is worn on the skin to prevent pregnancy. The Ortho Evra patch releases estrogen and a type of synthetic hormone called progestin into the bloodstream. The drug-induced hormonal release thickens cervical mucous, preventing sperm from penetrating into the uterus and fertilizing eggs. Ortho Evra patches introduce more estrogen into the body than standard birth control pills. This has been linked with a variety of complications, notably the formation of blood clots in the legs and lungs. The risk factor is increased in women who smoke or have a family history of blood disorders.
Paxil: also known by its generic name paroxetine, Paxil is the most widely used type of selective serotonin reuptake inhibitor (SSRI), a class of anti-depressant drugs. Paxil is commonly prescribed for the treatment of depression, anxiety disorder, obsessive-compulsive disorder (OCD) and panic disorder. Paxil treats depression and related disorders by correcting neurotransmitter imbalances. When a patient stops taking Paxil without supervision, it can lead to potentially dangerous consequences. Withdrawal symptoms can include extreme dizziness, and brain "zaps" (electro-shock like sensations). Studies have also correlated Paxil use with deepened depression and in extreme cases, suicide and suicidal tendencies.
If a drug manufacturer learns of a potential serious side effect caused by its drug, it has a responsibility to notify the physicians who prescribe the drugs in order to protect the safety of the patients. If a drug manufacturer does not provide the proper notifications and patients are harmed by its drug, the harmed patients may be entitled to compensation. The lawyers of Aylstock Witkin and Sasser are experts in handling cases of negligence by large drug companies. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. If you or a loved one has been harmed by a defective drug, contact us at 877 810 4808 for a case evaluation.
The attorneys of the Law Office of Justice Lawyers are personal injury lawyers in Pensacola who protect victims of auto accidents, personal injury, wrongful death, defective drugs, consumer fraud, insurance fraud, product defects and defective medical devices, such as Guidant and Medtronic Pacemakers, and potentially harmful drugs, such as Ortho Evra. When you think of the top personal injury lawyers or car accident lawyers in Pensacola, think of Justice Lawyers.