Have you or a loved one been harmed by a dangerous prescription drug or failed medical device? At Harrell & Harrell, P.A., our experienced injury attorneys and expert staff is always investigating dangerous drugs and defective medical products that have inadequate warning labels or are under recall from the manufacturer. Millions of Americans rely on pharmaceuticals and medical products to improve our quality of life, and most of these are safe and effective. When a pharmaceutical or medical device company does develop, market and sell a defective or dangerous products, we believe they should be held accountable for their actions.
FDA Recall, Warning or Action: The FDA notified healthcare professionals of a nationwide recall on three (3) lots of Propofol® because of particles embedded in the glass that are visible. If these particles were injected into a person, there is chance of injury requiring medical attention.
Propofol® (diprivan) is an intravenous sedative-hypnotic drug for use in inducing and maintaining sedation or anesthesia. Possible side effects or negative patient outcomes include:
NOTE: The use of Propofol® for both adult and pediatric ICU sedation has been associated with organ system failures and metabolic derangements called Propofol Infusion Syndrome which can cause death.
FDA Recall, Warning or Action: The FDA has taken actions to warn the public that new studies of birth control pills containing drospirenone show an increased risk of blood clots compared to patients taking other birth control pills.
Gianvi® (drospirenone andethinyle) prevent the release of an egg from an ovary as well as cause changes in the cervical and uterine lining making it difficult for sperm to reach the uterus. This makes it harder for a fertilized egg to attach to the uterus. Possible side effects or negative patient outcomes include:
NOTE: The FDA will continue to communicate any new safety information on Gianvi® as it becomes available.
FDA Recall, Warning or Action: The FDA has warned that the use of SSRIs and SNRIs has been linked to malignant neuroleptic syndrome. Patients with this syndrome experience malfunctions in the body’s autonomic nervous system. This syndrome is a rare and very dangerous condition that can result in death.
Effexor® (venlafaxine) is used to treat depression, generalized anxiety disorder, social anxiety disorder, and panic disorder. This drug is classified as in a group of medications known as selective serotonin and norepinephrine reuptake inhibitors. It helps maintain mental balance in the brain. Possible side effects or negative patient outcomes include:
NOTE: Long term use of Effexor® and other antidepressants has shown a greater increase in depression and thoughts of suicide in some patients.
FDA Recall, Warning or Action: The Federal Drug Administration requires that a “black box” warning be placed on the labeling of the prescription drug. This is the strongest warning issued by the agency.
Rituxan® (rituximab) works to prevent the growth and spread of cancerous cells. The injectable solution marks the cells which alerts the immune system to destroy them. Possible side effects or negative patient outcomes include:
NOTE: Rituxan® has been approved for the treatment of non-Hodgkin’s lymphoma and adult rheumatoid arthritis when used in conjunction with other medications.
FDA Recall, Warning or Action: Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy, including the prescription drug Zometa®.
Zometa® is used to treat high blood calcium levels (hypercalcemia) that may occur with certain forms of cancer. It works by slowing the breakdown of your bones by cancer to prevent bone fractures. Possible side effects and negative outcomes can include:
NOTE: Do not use Zometa® if you have severe kidney disease. Before receiving a Zometa injection, tell your doctor if you are already being treated with Reclast.
Pioglitazone is the active ingredient in a medication prescribed to treat Type 2 diabetes. The drug is used to lower blood sugar levels and help diabetics use insulin more efficiently. On 6/15/11, the FDA notified the manufacturer of their failure to warn of the increased risk of bladder cancer.
Dabigatran etexilate mesylate is an anticoagulant medication prescribed as a blood thinner for patients who are at a high risk for stroke or blood clots. In December of 2011, the FDA notified the manufacturer of their failure to warn of serious bleeding events and death related to use of the anticoagulant.
Stryker Rejuvenate is a modular, non-metal on metal hip implant used to increase mobility and relieve pain in patients suffering from degenerative joint conditions. Failed components can corrode leading to metallosis, premature device failure, elevated cobalt levels, pseudo-tumor formation, and osteolysis.
Birth control pills have been used for decades as an effective contraceptive as well as a treatment for premenstrual dysphoric disorder (PMDD). Each of these products contain ethinyl estradiol and progestin drospirenone. Litigations have brought against the manufacturer’s for a failure to warn women of increased risks due to blood clots, deep vein thrombosis, pulmonary embolism, stroke, cerebrovascular accidents, heart attack, gallbladder disease and cardiac death.
Several manufacturers (DePuy, Zimmer, Stryker, Wright Medical and others) of metal-on-metal joint implants used in joint reconstruction have been recalled for failure to warn doctors and patients of possible dangers to include: breakdown of metallic surfaces, abnormal wear or premature failure, and elevated chromium in the blood causing metallosis and pseudo-tumor formations.
These medications are prescribed to strengthen bones that are weakened due to osteoporosis, osteopenia, Paget’s disease, or bone metastases. Manufacturer’s have been notified of failure to warn of impairment of the ability to repair damage to bones leading to femur fractures, jaw osteonecrosis, and possible link to esophageal cancer.
We have built a stellar record of navigating the legal system on behalf of clients injured or killed by the negligent, careless or unreasonable actions of others. To learn more about any pharmaceutical or medical device that is currently being recalled or forced to provide additional warnings or instructions, click on the product listed in the menu on the right side of this page. If you or a loved one has been injured or died due to a dangerous drug or defective medical device, contact us at 904-251-1111 or 1-800-251-1111 for a free consultation to review your claim.
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