Singulair Warning Issued by FDA
Amid mounting concern regarding reports of increasingly serious negative side effects, the Food and Drug Administration (FDA) issued a warning regarding the asthma drug Singulair. According to the FDA, there may be a connection between Singulair and suicidal thoughts and behaviors in patients. A study has been undertaken by the FDA to determine the extent of the connection.
Anti-Smoking Drug Chantix Gets Public Health Advisory
Following building concern on the connection between Pfizer's anti-smoking aide Chantix and erratic behavior in patients, the FDA has issued a public health advisory to caution Americans on the possible adverse side effects of Chantix. These side effects can include the further worsening of preexisting psychiatric illness or causing a recurrence of past psychiatric issues, as well as the incidence of depressive or suicidal behaviors where none have existed before.
Danger of Trasylol Featured on 60 Minutes
In a segment aimed at informing the public of a serious potential public health threat, the news program 60 Minutes recently illuminated the full breadth of danger posed by the blood clotting agent Trasylol. In the report, the news program illustrated not only the danger of Trasylol, but also how swifter action by the FDA might have saved American lives.
Brain Injuries Receive Increasing Attention as Signature Injury of Iraq War
As more and more American soldiers return from combat operations in the Iraq War, a disturbing trend is emerging among servicemen and women: a high prevalence of mild or even sever traumatic brain injury. Because of the high incidence of improvised explosive devices (commonly known as IEDs), large numbers of US soldiers are falling victim to concussive injuries and their sometimes debilitating after-effects. These after-effects can stretch on for months, even years, and may require more treatment than the military can provide. Also potentially dangerous are those brain injuries that go undiagnosed until after a soldier has been discharged, creating a position where compensation or treatment for the injury may be more difficult to get.
The Danger of Commercial Truck Accidents
With the number of commercial trucks on American highways continuing to increase every year, it is important for motorists to remember important safety guidelines when driving around or near large commercial trucks. In addition, it is important for motorists who may have been injured in accidents with commercial trucks to be aware of the laws and regulations concerning commercial trucking safety, as well as what legal options victims of such accidents may have.
Medtronic Defibrillator Lead Recalled By Manufacturer
Medical device maker Medtronic has announced it is voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because fractures in the leads have been detected in a number of patients. This voluntary recall came after Medtronic identified five patients whose deaths may have been related to a fractured Sprint Fidelis defibrillator lead. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product will be pulled from inventory and returned to the company, according to the Food and Drug Administration (FDA). While the FDA has not suggested or mandated the Sprint Fidelis lead be removed from the more than 268,000 patients who have had it implanted, those patients are encouraged to contact their physicians for further information.
Largest Crib Recall In History
Federal regulators recently recalled about 1 million cribs made by Simplicity Inc. because the drop rail on some of the nation's best-selling models can detach from the crib, creating a dangerous gap that has led to the deaths of at least three children.
Following a Chicago Tribune investigation to, the Consumer Product Safety Commission announced the recall of cribs sold under both the Simplicity and Graco name. It is the largest recall of full-size cribs since the agency was created in the 1970s.
FDA Halts Sale of Heart Surgery Drug Trasylol
After an extensive study indicated a link between Trasylol and an increased risk of death in patients, Bayer A.G. announced that it had agreed to withdraw the controversial heart surgery drug. The FDA has asked for a phased withdrawal of the drug, because of concerns that alternative medicines could run short.
Trasylol's withdrawal from the market comes after more than a year of speculation and investigation into the drug's safety, including revelations that Bayer may have failed in 2006 to disclose findings of a study that indicated risks associated with the drug.
Airbag Failures Lead to Recalls
Although airbags are one of the great automotive safety innovations of our time, sometimes defective airbags can fail when motorists might rely on them most to provide potentially life-saving protection during a collision. The U.S. National Highway Traffic Safety Administration is constantly monitoring the situation surrounding airbags and whether they are being held to strict quality standards. Even with this constant monitoring, safety hazards do occur where airbags fail and do not protect automobile passengers as they should.
Mesothelioma Symptoms Increasingly Important to Recognize
Between 1940 and 1979, it is estimated that 27.5 million people were occupationally exposed to asbestos in the United States. Add to this the number of individuals exposed due to the presence of asbestos in the home and the number may double. As a result, it is increasingly important that doctors and patients be able to recognize the symptoms of mesothelioma, a form of lung cancer that is nearly always associated with exposure to asbestos. What can make mesothelioma so dangerous is the fact that it is one of the most deadly forms of lung cancer, combined with the fact that it can be so often misdiagnosed as a less serious lung malady. Therefore, anyone who may have been exposed to asbestos in the past should be on the lookout for the warning signs of mesothelioma.
Diabetes Drug Avandia Linked to Heart Attack Risk
In details recently released from a study to be published in the New England Journal of Medicine, the diabetes drug Avandia has been linked with a 43 percent increased risk of heart attack. As a response to this new information, the federal Food and Drug Administration (FDA) released a new warning for Avandia, cautioning those patients with Type 2 diabetes who are taking the drug that they should contact their doctors to asses the risk posed by Avandia, although the FDA stopped short of recommending any Avandia recall.
Peter Pan Peanut Butter Linked To Salmonella
The federal Food and Drug Administration (FDA) has warned consumers not to eat Peter Pan and Great Value peanut butter following a nationwide salmonella outbreak. ConAgra, which manufactures the peanut butter, has issued a voluntary peanut butter recall and Peter Pan peanut butter is being pulled from store shelves across the nation. Infected patients have been hospitalized and immobilized by salmonella symptoms including nausea, fever and gastrointestinal ailments. The FDA is telling customers to immediately dispose of jars of Peter Pan peanut butter manufactured in 2006 and 2007.
FDA Issues Hernia Patch Recall for Composix Mesh Patch
The federal Food and Drug Administration (FDA) has issued an updated recall for Bard's Composix Kugel Mesh Hernia Patch, which has been linked to ruptured bowels and intestinal fistulae in some patients due to a design defect. The patch is used in ventral hernia repair and relies upon a "memory recoil ring" that fails to activate in some larger sizes of the patch. The hernia mesh recall will affect thousands of patients who had ventral hernia surgery in the last two to three years.
Is Your Child's Car Seat Safe?
A recent report by Consumer Reports on the safety of child safety seats has raised questions about these seats' performance in crash tests. Though the report has been disputed and partially recalled, Consumer Reports stands by its recommendation of an immediate recall for the Evenflo Discovery car seat.
Medtronic Loses Attempt to Dismiss Defibrillator Lawsuits
Medtronic, Inc. has lost its attempt to dismiss over 300 defibrillator lawsuits in a Minnesota court. This ruling gives the green light to plaintiffs, allowing them to proceed in seeking compensation for defective defibrillators.
FDA Orders Study of Drug-Eluting Stents
Claims that drug-eluting stents (also known as drug-coated stents) cause heightened risk of life-threatening blood clots have prompted the FDA to undertake a study of their safety. More than 6 million patients have had blood-eluting stents transplanted since 2002.
FDA Orders More Stringent Ketek Warnings
The FDA has ordered the manufacturer of Ketek (telithromycin), a popular antibiotic drug used to treat respiratory infections, to include more stringent side effects warnings on packaging after the drug was linked to liver damage, liver failure, and death. A Congressional investigation is underway to determine whether the FDA inappropriately approved the drug after a fraudulent clinical study in Ketek's trial phase.
Ortho-Evra Lawsuits Emerge Over Stroke Claims
Ortho-McNeil, the manufacturer of the popular Ortho-Evra birth control patch, is facing new lawsuits based on claims that patients experienced strokes and other heart problems while using the patch. The FDA previously warned that the patch exposes women to higher doses of estrogen than the birth control pill.
Assessing Serious Side Effects of Bextra
The FDA's 2005 recall of Pfizer's non-steroidal anti-inflammatory, Bextra, points to serious side effects shared by another COX-2 drug, Vioxx. The drug was linked to increased heart disease risk and even Stevens-Johnson syndrome in patients.
Growing Momentum in Fosamax Lawsuits
After years as Merck's second best-selling drug, Fosamax, an anti-osteoporosis drug known to increase bone density in patients, has come under fire for its connection with osteonecrosis (bone death) of the jaw. In March 2006, the FDA announced that dead jaw lead to death in some patients taking Fosamax.
