Actos®
The FDA has approved updated drug labels for Actos, usually prescribed to treat Type 2 diabetes. The new label states that the use of the drug for more than one year may be associated with an increased risk of bladder cancer. Actos, manufactured by Takeda, has been under FDA review since September 2010. In June 2011, the FDA issued a warning for Actos, while at the same time, drug regulators in France and Germany suspended use of the drug. Doctors in France and Germany were advised to stop prescribing Actos. We are currently investigating claims involving Actos use and bladder cancer. If you, or someone you know is suffering from bladder cancer after taking Actos please contact The Braswell Firm today. Time to file a claim is limited.
Antidepressants
SSRI-antidepressants such as Celexa, Lexapro, Luvox, Paxil, Prozac and Zoloft are prescribed to treat depression. Studies over the last several years have shown an increased risk of heart birth defects in children born to mothers who took SSRI-antidepressants in the first trimester. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart does not completely developed.
We are currently investigating claims of birth defects involving children whose mother was taking an SSRI during pregnancy. If you, or someone you know gave birth to a child with a heart defect after taking an anti-depressant while pregnant please contact The Braswell Firm today. Time to file a claim is limited.
DePuy Hip Replacements
Johnson & Johnson, in conjunction with its DePuy Orthopaedics subsidiary, announced at the end of August 2010 that it is recalling parts used for hip replacements. At issue is the high rate of repeat surgeries needed by people who have received the parts. An estimated 93,000 people will be affected by Johnson & Johnson’s latest product recall. Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Patients who reported problems in the first five years and had revision surgery reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently. Additionally, metal debris spreading in the hip area has been reported due to the metal on metal friction involved from the metal components moving together.
We would like to review any cases involving individuals who have had a DePuy hip device implanted and all individuals unsure of the type of hip device implanted if the person has had revision surgery, or the person is experiencing hip pain, hip swelling or difficulty walking.
If you, or someone you know has had a hip replacement and now suffers from any of the above symptoms or has had revision surgery please contact The Braswell Firm today. Time to file a claim is limited.
Fosamax®
Fosamax® (alendronate sodium), manufactured by Merck, is in a class of drugs called bisphosphonates. Fosamax® is commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Recently the Journal of Oral and Maxillofacial Surgeons reported a link between bisphosphonates and a serious bone disease called Osteonecrosis of the Jaw (ONJ). Osteonecrosis is a disfiguring and disabling condition of the jaw bone that causes infection and rotting of the jaw bone. Typical presentation of Osteonecrosis is pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone. Symptoms may occur spontaneously, or at the site of previous tooth extraction. Recently, Fosamax has been linked to low-energy femur fractures in people taking Fosamax for three or more years.
Femur Fracture Criteria: Documented use of Fosamax® for three years or longer with diagnosed low energy femur fractures.
Gardasil®
Gardasil, manufactured by Merck Sharp & Dohme Co., is aggressively marketed as a vaccine that prevents cervical cancer. In fact, it is a vaccine to prevent four types of the sexually transmitted disease, HPV (human papillomavirus). Gardasil is said to protect against four types of HPV, two of which are associated with cervical cancer. These two types of HPV are present in only 3.2% of the cases. At this time, Gardasil has not been proven to prevent cervical cancer. Scientific data indicates that the vaccine may not last longer than 5 years, if that long. The drug is indicated for young women and men from the age of 9 years old up to 26 years old, though the vaccine is primarily given to girls. The Vaccine Adverse Event Reporting System has over 21,000 reports of adverse events related to the administration of this vaccine including more than 90 deaths. Serious adverse events include multiple sclerosis, blindness, Guillain-Barré Syndrome, lupus, rheumatoid arthritis, paralysis, blood clots and death. The vaccine is recommended to most young girls in their early teens. Parents should proceed with caution before allowing their daughters (and sons) to be vaccinated. We are currently investigating cases with documented use of Gardasil and a diagnosis of multiple sclerosis, Guillain-Barré Syndrome, blindness, lupus, paralysis, rheumatoid arthritis and death.
Hormone Therapy
For years, women have taken Hormone Therapy (HT) to reduce the symptoms of menopause. Studies now show that HT medications such as Prempro and Premarin can increase the risk of breast cancer, ovarian cancer, stroke and heart disease. We are currently investigating potential claims against the manufacturers of HT medications.
If you, or someone you know is suffering from breast cancer, ovarian cancer, heart disease or stroke after taking Hormone Therapy drugs please contact The Braswell Firm today. Time to file a claim is limited.
Paxil®
Paxil® (paroxetine) is an anti-depressant manufactured by GlaxoSmithKline. Recently Public Health Advisories have been issued for Paxil® regarding an increased risk of heart birth defects, persistent pulmonary hypertension (PPHN), omphalocele (an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel) or craniosynostosis (connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull) in children born to mothers exposed to Paxil®.
Criteria: Children born with birth defects to a mother who has documented use of Paxil® during pregnancy.
Pain Pumps
Pain pumps are portable and often disposable pain management devices which continuously administer local anesthetic through a catheter to a surgical wound site for several days following surgery to decrease post-operative pain and assist in earlier rehabilitation. A “Y-connector” accessory is sometimes available so that the pain pump can be used on multiple wound sites. Examples of pain pump manufacturers include Stryker, I-Flow, CME McKinley, Breg, Medical Flow Systems, Baxter and Sgarlato Labs. Recently, the use of pain pumps to administer medication directly into the glenohumeral joint space following shoulder surgery has been linked to a severe condition called Postarthroscopic Glenohumeral Chondrolysis (“Chondrolysis”), in which the cartilage of the humeral head and the glenoid space of the shoulder process has been destroyed and lost. The destruction of the shoulder cartilage can be attributed to the application of anesthetic medication directly into the joint space via the pain pump catheter. In 2003, it appears that some pain pump manufacturers may have increased the anesthetic dosing capacity of their pain pumps, which may have hastened the onset of Chondrolysis in some patients.
Chondrolysis symptoms usually present between six weeks and six months following surgery and include increased shoulder pain and stiffness, loss of cartilage, decreased range of motion, loss of shoulder joint space, crepitus in the shoulder and loss of strength. Patients suffering from Chondrolysis are usually unable to complete their post-surgical physical therapy due to pain.
Whatever the patient’s condition was prior to his or her shoulder surgery, the post-operative diagnosis of Chondrolysis is typically much worse. Ultimately, complete shoulder replacement surgery (acromioarthroplasty) could become necessary in order to eliminate the painful and debilitating symptoms of Chondrolysis.
Stevens- Johnson Syndrome
Stevens-Johnson syndrome is an immune complex hypersensitivity reaction that can be caused from an infection or immune response to drugs. It is a severe expression of a simple rash known as erythema multiforme. SJS is also known as erythema multiforme major. It affects all ages and genders including pediatric populations. The most severe form of SJS is toxic epidermal necrolysis (TENS). SJS occurs twice as often in men as in women. Most cases of SJS appear in children and young adults under age 30. Females with SJS are twice as likely as males to develop TENS, and have an even higher chance if taking a category of drugs known as NSAIDs, nonsteroidal anti-inflammatory drugs.
If you, or someone you know is suffering from Steven-Johnson Syndrome please contact The Braswell Firm today. Time to file a claim is limited.
Transvaginal Mesh
The FDA has issued an updated safety communication warning doctors, health care professionals and patients that the placement of surgical mesh through the vagina to treat pelvic organ prolapse may present greater risk for the patient than other options. This is also called transvaginal mesh. According to the FDA, reported complications from using the mesh include the mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, organ perforation and urinary problems. Some cases required additional surgery or hospitalization for treatment or to remove the mesh.
If you, or someone you know has suffered pain or any of the above problems after having the cervical mesh implanted please contact The Braswell Firm today. Time to file a claim is limited.
Yaz, Yasmin, Ocella or Beyaz
Yaz is a combination birth control pill containing drospirenone and ethinyl estradiol. It is marketed not only as a contraceptive pill, but as a proven treatment for premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms. Yaz is also marketed as an effective treatment for moderate acne. However, studies indicate that Yaz poses a particular heath hazard because one of its two primary ingredients, drospirenone, is a diuretic, which can cause an increase in potassium levels in the blood and lead to hyperkalemia, which causes heart rhythm disturbances that can cause blood clots leading to sudden cardiac death or pulmonary embolism or strokes. Diuretics can also cause significant problems with the gallbladder, leading to gallbladder removal.
Criteria: Documented use of Yaz with a diagnosis of heart attack, stroke, pulmonary embolism, DVT, or gallbladder removal.
If you, or someone you know has suffered a heart attack, stroke, pulmonary embolism, DVT or gallbladder removal after taking Yaz, Yasmin, Ocella or Beyaz, please contact The Braswell Firm today. Time to file a claim is limited.