There are reportedly thousands of Zithromax lawsuits filed over complications, including the potentially fatal skin reactions Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Other alleged injuries include heart attack, stroke, eye injuries and other issues. In 2012, a putative lawsuit was filed alleging that Zithromax caused SJS in a child.
Zithromax (azithromycin) is a popular antibiotic commonly referred to Z-Pak or Zmax as a single dose. It is manufactured by Pfizer. This commonly used antibiotic can lead to Stevens-Johnson Syndrome (SJS), which is an allergic skin reaction that leads to severe blistering and inflammation of the mucous membranes. Patients with SJS sometimes feel as though their skin is being burned from the inside out. When these skin lesions affect more than 30 percent of the body, it is known as Toxic Epidermal Necrolysis (TEN). Not all sufferers survive, and those who do are sometimes left with permanent injuries, such as vision problems, difficulty eating and scarring.
Pfizer has been warned by the U.S. Food and Drug Administration (FDA) for failing to adequately warn about the risk of SJS in Zithromax brochures. In a letter dated June 19, 2012, the agency said that the brochure does not discuss the severity of the condition even though the warning label mentions SJS,. Pfizer did not explain that SJS can cause large areas to blister and peel, leading open sores and infection, nor do they explain that in TEN, large areas of the skin and detach from the body and lesions can develop in the mucous membranes. The FDA letter also warned that Pfizer failed to warn about the risk of heart problems associated with Zithromax.
The warning label on Zithromax reads: “Serious allergic reactions, including angioedema, anaphylaxis, Stevens Johnson Syndrome and Toxic Epidermal Necrolysis have been reported rarely in patients on azithromycin therapy using other formulations. Although rare, fatalities have been reported.” The warning label also says that in some patients, the symptoms of SJS or TEN can come back even though they stop taking the drug. However, the agency points out that this information is not included in the brochures.
In a just-released study of a daily glucosamine drink, researchers found that the supplement did nothing to prevent knee cartilage deterioration, minimize bone bruises, or help with knee pain.
The recent short-term study looked at the effects of glucosamine hydrochloride on 201 adults. The study was just published in the journal Arthritis & Rheumatology. Continue reading
Philips Healthcare subsidiary Respironics, Inc. has announced a worldwide recall of Respironics Trilogy Ventilators, models 100, 200, and 202.
The ventilators were recalled over concerns that they may fail to provide breathing support, MassDevice.com reports. During production testing, Respironics discovered a faulty component on the device’s power management board. According to the U.S. Food and Drug Administration (FDA), if this issue is not corrected, the ventilator may fail to deliver mechanical breaths and the alarm function indicating ventilatory failure may be reduced, resulting in serious adverse health consequences or death. To date, there have been no reports of death or serious injury related to this problem. Continue reading
Group Recommends Genetic Testing for Susceptibility Serious Skin Recations Associated with Carbamazepine
A Canadian drug safety group has recommended genetic testing for gene variants associated with the risk of developing Stevens-Johnson syndrome, a serious, possibly fatal, skin reaction in patients taking the drug carbamazepine.
The Canadian Pharmacogenomics Network for Drug Safety (CPNDS) has recommended testing for the alleles HLA-B*15-02 and HLA-A*31:01 that affect histocompatibility before patients begin taking the anti-seizure medication carbamazepine. The study was published online March 5 in Epilepsia. Continue reading
Transvaginal mesh lawsuits are on the rise and a continuing legal issue for Boston Scientific, Mass Device reports. In their most recent 10-k report, the company said that there is an ever-increasing interest in lawsuits over their pelvic mesh devices. As of late last month, there were at least 18,000 lawsuits, including 8 reported class actions, in the United States. There were 1,700 cases pending in one Minnesota state court alone. Pelvic mesh cases have also been filed in Canada, where there are over 10 lawsuits, including 3 class actions. Boston Scientific is accused of fraud, failure to warn and other offenses. Plaintiffs claim that the company was aware of the risks but made no effort to inform the public. Continue reading
A verdict of $3 million has been returned against Janssen Pharmaceuticals, Inc., a Johnson & Johnson unit, in a case alleging the company failed to warn about side effects associated with its epilepsy drug Topamax during pregnancy. The lawsuit was filed by the Wisconsin family of 5-year-old Payton Anderson, who was born with a cleft lip after her mother, Kelly, took Topamax to treat chronic migraines while she was pregnant. Philadelphia County Court of Common Pleas heard on Tuesday that Janssen allegedly didn’t update the label on Topamax to warn about recent research showing that it can increase the risk of cleft lips and cleft palates in newborns.
According to Law360, the lawsuit was first filed in December 2011. It is the third case of its kind filed in Philadelphia to go to trial, and court records show that more are on the way; over 130 additional lawsuits are pending as part of the a mass tort litigation. The previous two cases to go to trial returned verdicts in favor of the plaintiffs. A $4 million was returned in October and a family won $10 million after a verdict returned in their favor in December. A fourth Topamax lawsuit in Philadelphia went to trial late last month. Continue reading
Federal safety regulators have received hundreds of complaints over the past 11 years about General Motors (GM) vehicles that allegedly shut down when being driven, leading to potential dangerous and deadly outcomes.
A recent The New York Times investigation revealed that GM allegedly did not then conduct an investigation and has announced its vehicles are associated with 13 deaths and that it must recall 1.6 million cars worldwide. An analysis of the 260 consumer complaints made to the National Highway Traffic Safety Administration (NHTSA) indicated that, since February 2003, the NHTSA has received approximately two complaints monthly over possibly dangerous vehicle shutdowns, but responded that there was not enough evidence to conduct a safety investigation, the Times wrote. The last recorded complaint was filed last week. Continue reading
After a a capsule of a heart medication was discovered in a bottle of the antidepressant drug Effexor XR (venlafaxine), Pfizer Inc. has recalled two lots of Effexor and one lot of generic venlafaxine.
A 25-mg Tikosyn capsule was discovered in a bottle of Effexor XR, according to the drug maker’s press release, posted by the U.S. Food and Drug Administration (FDA). Tikosyn (dofetilide) is used to treat irregular heartbeat and if it is taken by a patient “where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, [it] could cause serious adverse health consequences that could be fatal.” Although Pfizer, to date, has not received any other such reports, the company has undertaken the recall as a precaution because the two drugs were packaged on the same line. Continue reading
Overuse of antibiotics has been a concern in recent years. The Centers for Disease Control and Prevention (CDC) says that in some hospitals, doctors are prescribing three as more antibiotics than in other institutions. The large discrepancy indicated that in many situations, the use of antibiotics can be reduced. The agency published a study online in Morbidity and Mortality Weekly Report showing that antibiotic prescribing can be improved by more than 30 percent. Continue reading
A state investigation has cited St. Benedict’s Senior Community for a patient death that occurred after three nurses failed to provide any type of emergency care. The nursing home, located in St. Cloud, Minnesota, is responsible for the death, the investigation found. A report from the Minnesota Department of Health found that this neglect happened even though the resident stated that resuscitation efforts should be made if he is in a life-threatening situation.
St. Benedict’s is run by CentraCare Health. Their central Minnesota network includes six hospitals, six nursing homes, senior housing in six communities and 17 clinics.
The resident died on June 29th, after feeling dizzy and becoming unresponsive. At first, staff detected a pulse and relocated him to his bed. When they checked his pulse again and found none, they did not perform CPR because a supervisory nurse said that “there was no witness to the resident’s last breath [and] too much time had gone by,” Both nurses who checked the pulse felt that CPR should have been performed, but instead they followed the order from the supervisory nurse. A physician for the case confirmed that CPR should have been performed. The resident died ten minutes after first feeling dizzy.
The two nurses who checked for a pulse were fired two days after the resident’s death. The supervisory nurse was retrained in policy and procedure.