Dangerous Product Alerts
Some of the featured dangerous drugs and products that Bernstein Liebhard’s attorneys and trained staff are investigating currently include:
ZOCOR NEWS: FDA Issues Safety Alert Recommending Limits on Zocor Dosage
On June 8, 2011, the U.S. Food and Drug Administration (“FDA”) issued a warning to physicians alerting them of potential side effects when prescribing high doses of Zocor (simvastatin). Manufactured by Merck & Co., Zocor is a synthetic statin used to lower cholesterol. An estimated 2.1 million Americans currently take Zocor. However, a recent study conducted by FDA medical experts revealed that patients who take more than 80 milligram doses of Zocor face an increased risk of muscle injury, rhabdomyolysis or myopathy.
Supreme Court Opines on Radiation Lawsuits Against Cell Phone Manufacturers
On May 31, 2011, the U.S. Supreme Court asked acting Solicitor General Neal Kumar Katyal to file a brief, communicating the federal government’s views on whether reviving a putative class action accusing many cell phone providers of failing to warn and protect users from purportedly dangerous and hazardous radio frequency emissions would preempt federal regulatory responsibilities.
On May 31, 2011, the World Health Organization (“WHO”) concluded that heavy cell phone use puts individuals at an increased risk for both glioma, a malignant form of brain cancer, and acoustic neuroma, a tumor of the nerve that runs from the ear to the brain. In response to these findings, WHO reclassified the radiation emitted from cell phones by placing them in category 2B, meaning that they are possibly carcinogenic to humans.
On March 21, 2011, an article in The New York Times reported that approximately 30 women who participated in a breast cancer study were infected with metal tungsten in their breast tissue and chest muscles after being treated with the Axxent FlexiShield Mini, a surgical device that was recalled last month.
On March 4, 2011, the U.S. Food and Drug Administration (“FDA”) issued a safety alert, warning women of child-bearing age that Topamax (topiramate) can increase the risk of babies born with cleft lip and cleft palate. Topamax is an anti-seizure medication commonly prescribed to epileptics or those suffering from severe migraines. It is manufactured by Johnson & Johnson. Topamax was first approved by the FDA for the treatment of epilepsy, however in 2004, the FDA extended its approval for the treatment of migraines. Additionally, the drug is used off-label to treat bipolar disorder. Between 2007 and 2010, an estimated 32.3 million prescriptions for Topamax or the generic topiramate had been issued.
Darvocet & Darvon Recalled by manufacturer On November 19, 2010, Xanodyne, the manufacturer of propoxyphene, which is more commonly known under the brand name Darvon/ Darvocet, agreed to issue a recall of all Darvon/ Darvocet drugs in the United States. This most recent FDA recall for Darvon/Darvocet was issued following a previous recall in February 2009. Darvon is a painkiller which was first introduced in 1957, and contains propoxyphene to relieve mild to moderate post-surgical pain.
FDA Will Rescind Approval of Menaflex Knee Implant – On October 14, 2010, the FDA acknowledged that the approval of an orthopedic device used in the knee was a mistake. The FDA is conceding that pressure from Congressional lawmakers influenced the approval of ReGen Biologic’s “Menaflex” knee implant device. The agency is taking steps to revoke the device’s approval, but will meet with ReGen officials to discuss what data would be required to prove the implant is safe and effective.
New Study Links Meridia to Increased Heart Risk – A September 1, 2010 study published in the New England Journal of Medicine (“NEJM”) suggests that Meridia, also known as sibutramine, raises the risk of heart attacks and strokes in patients who have a history of cardiovascular disease. Because of the serious risks associated with Meridia’s use, the editors of NEJM recommended that Meridia be removed from the market. On September 15, 2010, an FDA advisory panel will review the safety of Meridia and discuss arguments that it be taken off the market entirely.
J&J Recalls Hip Replacement Products – On August 26, 2010, Johnson & Johnson recalled two kinds of hip replacement implants manufactured by DePuy Orthopaedics, a division of J&J. DePuy announced the recall of the J&J hip replacement products because of high failure rates. Evidence suggests that about one in eight patients implanted with a J&J recalled hip replacement product needed a second replacement within five years. Revision surgery is necessary for those who have the J&J recalled hip replacement part because the artificial joints do not fit properly, which can cause pain and trouble walking.
Increasing Problems with Medtronic Insulin Pumps On March 2, 2010, the FDA announced a growing number of hardware and software problems with certain insulin pumps. The problem pumps included insulin pumps manufactured by Medtronic.
Yasmin/YAZ Linked to Increased Blood Clot Risk August 14, 2009- Researchers performed a large-scale study of the oral contraceptives Yasmin and Yaz found that the user risk of blood clots is significantly higher compared to users of other oral contraceptives (OCs), despite marketing from the makers of Yasmin/YAZ suggesting that their blood clot risks were no greater.
FDA Adds Black Box Warning to Reglan – February 26, 2009- The U.S. Food & Drug Administration (FDA) added a “Black Box Warning” to metoclopramide-containing drugs, including Reglan tablets, Reglan oral disintegrating tablets, metoclopramide oral solution, and Reglan injections. According to the FDA, “the chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”
FDA Panel Recommends Darvocet & Darvon Recall February 2009 – An advisory committee to the U.S. Food and Drug Administration (FDA) has recommended that the FDA recall Darvon, a popular painkiller also sold in combination with acetaminophen under the brand name Darvocet.
FDA Warning: Transvaginal Surgical Mesh May Cause Serious Complications January 22, 2009 – The Food and Drug Administration (FDA) issued a Public Health Notification warning consumers and health practitioners about serious complications associated with transvaginal placement of surgical mesh used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
Peanut Butter Corporation of America (“PCA”) Announces Nationwide Peanut Butter Recall January 13, 2009 – On January 13, 2009, the Peanut Butter Corporation of America (PCA) announced a nationwide recall of peanut butter produced in its Blakely, Georgia processing facility because of potential salmonella contamination. PCA is a peanut processing company and maker of peanut butter for bulk distribution to institutions, food service industries, and private label food companies.
Denture Adhesive Creams Linked to Dangerous Neurological Side Effects, Including Neuropathy January 12, 2009 – Fixodent, Poligrip, and other popular denture adhesive creams have recently been linked to serious neurological side effects. Among these dangerous side effects is a nerve disorder called neuropathy, a condition in which a person suffers from peripheral nerve damage.
FDA Requires Black Box Warning For Oral Sodium Phosphate (OSP) Products December 11, 2009 – The FDA has issued a nationwide warning of serious, life-threatening kidney injuries including acute phosphate nephropathy linked to prescription and over-the-counter laxatives including Visicol, OsmoPrep and Fleet Phospho-soda. Oral sodium phosphate (OSP) products are commonly used by patients preparing to undergo a colonoscopy (colon examination to detect precancerous growths) because OSP products cleanse the bowels.
Shoulder Pain Pumps Linked to Cartilage Disorder PAGCL November 3, 2008 – The use of shoulder pain pumps has been linked to post-arthroscopic glenohumeral chrondrolysis (PAGCL), a painful and permanent condition that results in the breakdown and deterioration of the cartilage in the shoulder.
American Diabetes Association Advises Against Using Avandia for Type 2 Diabetes – Due to safety concerns, both the American Diabetes Association (ADA) and the European Association for the Study of Diabetes have unanimously advised against using Avandia. Avandia, which is prescribed to treat type 2 diabetes, has recently been linked to several serious and life-threatening side effects.
FDA Warns Public about Serious Complications with Mesh Vaginal Slings October 31, 2008 – The United States Food and Drug Administration (FDA) issued a public health alert notifying healthcare professionals of serious complications associated with surgical mesh vaginal slings, including the Mentor OB Tape. Over the past three years, the FDA says it has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh slings.
Zimmer Durom Cup Hip Replacement Implant Recalled – Linked to Hip Implant Failure July 2008 – Zimmer Holdings, the largest producer of orthopedic devices in the U.S., suspended sales of an artificial hip replacement part, known as the “Durom Cup,” due to high implant failure rates. The high implant failure rates were caused by the Zimmer Durom Cup’s inability to bond with the host bone, causing the implanted hip replacement part to migrate.
FDA Orders Genenteck to Display Black Box Warning on Raptiva Label October 16, 2008 – The FDA notified healthcare professionals of extensive Raptiva labeling changes, including a Black Box Warning about the risks of life-threatening infections with Raptiva use. A Black Box Warning is the FDA’s strongest health warning, signifying that [read more]
Byetta Linked to Fatal Cases of Pancreatitis August 2008 – Six patients taking the type 2 diabetes drug Byetta are reported to have died after developing severe cases of pancreatitis, according to officials from Amylin Pharmaceuticals and Eli Lily & Company, the companies that co-market Byetta. [read more]
FDA Requires Antibiotic Cipro to Carry Boxed Warning Cautioning Consumers about Risk of Tendon Ruptures July 2008 – the FDA this month issued a health alert requiring Cipro’s manufacturer, and the makers of similar antibiotics called fluoroquinolones, to add a warning to the antibiotics’ prescribing information about the increased risk of [read more]
Accutane Linked to Birth Defects, Suicide and Gastrointestinal Problems Accutane is a popular medication used to treat severe acne cases. The FDA approved Accutane only for acne that cannot be treated by other medications. Accutane is widely used with more than one million prescriptions a year in eighty different countries.[read more]
Asbestos Exposure Linked to Fatal Diseases An estimated 1.3 million workers face significant workplace asbestos exposure. Workers in the construction, manufacturing, and insulation industries are at greatest risk for asbestos exposure. One study concluded that workers in the insulation industry are 92 times more likely to [read more]
Urgent Digitek Recall: Defective Pills Could Cause Fatal Overdose On April 25, 2008, a nationwide recall was issued for all strengths of Digitek, a prescription drug used to treat heart failure and abnormal heart rhythms. According to Actavis Totowa LLC,Digitek’s maker, a manufacturing defect may have caused double- [read more]
Osteoporosis Drugs Linked to Jaw Bone Death In recent years, bisphosphonates such as Fosamax have been tied to a medical condition called Osteonecrosis of the Jaw (ONJ), an extremely painful and disfiguring jaw bone disease that causes the jaw bone to decay and die, making it difficult to eat or even speak. Thus, while [read more]
FDA Orders Black Box Warning Added to MRI Contrast Agent, Gadolinium Label On May 23 2007, the FDA ordered all gadolinium contrast agent manufacturers to add a black box warning to Gadolinium’s label, stating that patients with kidney problems or renal failure are at risk of developing Nephrogenic Systemic [read more]
Baxter Recalls All Heparin Products On February 29, 2008, Baxter International, Heparin’s manufacturer, recalled all Heparin products after it received reports that linked Heparin to more than 400 life-threatening allergic reactions, including 21 deaths. The allergic reactions were reported by users of Baxter’s Heparin Sodium [read more]
Sanofi-Aventis Adds Black Box Warning to Ketek’s Label In February 2007, Sanofi-Aventis, Ketek’s manufacturer, added a black box warning to Ketek’s label. The warning states that Ketek users have an increased risk of severe liver damage. Additionally, it warned against Ketek use by patients suffering from prior muscle [read more]
Antibiotic Levaquin Linked to Tendon Rupture July 2008 — The FDA is notifying manufactures of fluroquinlolone antimicrobial drugs (Levaquin, Cipro and others) that they need to add a Boxed Warning to the product’s labeling that warns consumers of the increased risk of tendonitis and tendon rupture in patients who take these drugs. The FDA also asked drug companies to provide patients with a Medication Guide that [read more]
New Ortho Evra Black Box Warning: Birth Control Patch Can Kill According to a new black box warning on the Ortho Evra label, Ortho Evra exposes women to about 60% more estrogen than typical birth control pills. Taking estrogen has been linked to health problems like blood clots, strokes, and heart attacks, which can be [read more]
Over-the-Counter Children’s Medicine Can Cause Fatal Skin Condition Nine-year-old Kaitlyn Langstaff of Saratoga died 20 months after taking Children’s Motrin. Two months after taking the same drug, seven-year-old Sabrina Brierton Johnson of Los Angeles went blind. In addition, three-year-old Heather Rose Kiss of New Jersey died a [read more]
FDA Orders Bayer to Remove Trasylol from the Market In November 2007, the FDA ordered Bayer, Trasylol’s manufacturer, to remove Trasylol from the market after studies linked Trasylol to tens of thousands of deaths. A Bayer study looked at more than 78,000 patients from January 2003 to January 2006 and concluded that [read more]
FDA Recalls Dangerous Kugel Mesh Hernia Patches 3 Times Defects in the Kugel Mesh Hernia Patch, a prosthetic used to treat hernias, have caused a number of patients to develop serious side effects, ranging from bowel obstruction to blood infections. In fact, at least one man has died as a result of Kugel Mesh Hernia Patch complications, and hundreds more have been seriously injured. [read more]
JAMA Article Reports Findings of Dramatic Risk of Heart Attack, Stroke and Cardiovascular Death in Patients Who Take Spiriva September 24, 2008 – A new study conducted by researchers at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. and published in the Journal of the American Medical Assocation (JAMA), found that using either Spiriva or Atrovent, which are both inhaled [read more]