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The Food and Drug Administration is requiring stronger safety warnings for a popular treatment to prevent pregnant women from prematurely giving birth.
Women should not be given injections of the drug terbutaline for more than three days "because of the potential for serious maternal heart problems and death," the FDA said Thursday. It is now requiring a boxed warning â€” the FDA's most serious type of warning â€” be added to the drug's label.
The FDA also warned doctors against prescribing a pill form of the drug for "any treatment of preterm labor" because it has not been shown to be effective and carries similar risks.
The FDA has approved terbutaline only to treat specific respiratory conditions, but doctors have widely prescribed the drug as a treatment for preterm labor. Once a drug has been approved by the FDA, doctors can prescribe the drug for any use they deem appropriate.
Many women receive it continuously for weeks through a terbutaline pump. Its use is strongly supported by some advocates for women carrying twins and triplets, who are at higher risk of giving birth prematurely.
"It would be alarming to me to see it become unavailable," said Janet Bleyl, president and founder of the Triplet Connection, a national support group for parents of multiples. "It has made a life-or-death difference for many, many of our families."
Last Updated (Tuesday, 22 February 2011 12:44)
Multaq may cause severe liver injury. Manufactured by Sanofi-Aventis, Multaq (dronedarone) was approved in July 2009 to treat abnormal heart rythyms. According to the FDA, Sanofi-Aventis was able to release Multaq only if it provided a Risk Evaluation and Mitigation Strategy (REMS). The REMS ensures the FDA that the benefits of a drug or biological product outweigh its risks. In the second quarter of 2010, the FDA placed Multaq on a list of medications that raised potential safety concerns, along with 13 other drugs.
On January 14, 2011, the FDA issued a warning after reports that two female patients suffered acute liver failure following their use of Multaq. Doctors were able to connect their liver damage with Multaq, and also found a great deal of cellular death in the liver.
Last Updated (Friday, 14 January 2011 16:57)
The FDA called upon the pharmaceutical companies to stop making propoxyphene following a clinical trial in which electrocardiograms showed that the drug altered the heart's electrical activity, potentially causing serious or life-threatening arrhythmias.
An arrhythmia is a problem with the rate or rhythm of the heartbeat. During an arrhythmia, the heart can beat too fast, too slow, or with an irregular rhythm. A heartbeat that is too fast is called tachycardia. A heartbeat that is too slow is called bradycardia. Although arrhythmias are harmless, some can be serious or even life threatening. When the heart rate is too fast, too slow, or irregular, the heart may not be able to pump enough blood to the body. The lack of blood caused by an arrhythmia can damage the brain, heart, and other organs, and in the most serious cases, may result in death.
The FDA estimates that the drug has been used by 10 million people in 2009. Propoxyphene was withdrawn from Britain in 2005 and European Union markets in June of 2009 after regulators concluded the risks outweighed pain-relieving benefits.
The safety of the drug has been the subject of controversy for decades. The consumer watchdog group, Public Citizen, petitioned the agency in 1978, and again in 2006, to pull the drug from the market. Public Citizen contends that 1,000 to 2,000 Americans have died from the drug since the U.K. ban, based in part upon data from the state of Florida that found 395 deaths from 2005 to 2009 associated with propoxyphene.
Darvon (generic: propoxyphene) is an opioid used to treat mild to moderate pain. It is manufactured by Xanodyne Pharmaceuticals Inc. The drug is also used in various generic forms.Â The most popular formulation, which contains the painkiller acetaminophen, is known as Darvocet.
The FDA advises patients who experience an abnormal heart rate or heart rhythm, dizziness, lightheadedness, heart palpitations or fainting to contact a doctor immediately.
PaxilÂ®, aÂ SSRI (Selective Serotonin Reuptake Inhibitors) antidepressant, been linked to serious and possibly fatal side effects. PaxilÂ® (paroxetine hydrochloride), also known as Seroxat in Europe, is manufactured by GlaxoSmithKline. It is a prescription drug prescribed for depression, panic disorders, social behavior disorders, and obsessive-compulsive disorder.Â The product liability lawsuits allege that Glaxo executives withheld critical safety and serious side effects information from the FDA despite requirements to disclose the evidence. Glaxo has reported nearly $1 billion in annual Paxil drug sales. Medical Studies in 2005 found that PaxilÂ® is directly related to infant heart defects, although this critical birth defect information was not disclosed to consumers.Â Â
Tylenol 8 Hour Caplets Recalled
On October 18, 2010, McNeil Consumer Healthcare/Johnson & Johnson initiated their sixth recall of 2010, recalling one lot of Tylenol 8 Hour caplets, due to numerous complaints of a musty or moldy odor, which is causing consumers to suffer from cases of nausea, vomiting, and diarrhea.
According to the FDA, consumers who have purchased Tylenol 8 Hour Caplets from lot # BCM155 should stop using the product immediately.
Many women who want to avoid pregnancy seek forms of contraception that will be conducive to their lifestyle. When traditional methods aren't working, women turn to birth-control pills. While there are many birth control pills available in today's market, women need to be properly informed of the risks associated with taking these drugs. Yaz, also known as Yasmin, contains a new type of hormone, known as drospirenone which raises potassium levels. Studies have linked high levels of potassium to life-threatening health problems such as heart attack, heart arrhythmias, deep vein thrombosis, blood clots, stroke, and heart attacks. Women who are obese or diabetic are at the greatest risk for these increased health problems.
The makers of Propofol have been ordered to pay over $500 million in fines and damages. It is alleged that the companies made the vials larger than necessary to eliminate costs and increase profit. Approximately 100 patients were infected, and 20,000 patients were notified about their possible exposure. In addition 73 lots of Propofol and 85 lots of Liposyn that were distributed between July 2009 and October 2009 were recalled by the Food and Drug Administration (FDA) due to contamination by particulates which could impede blood flow, causing stroke, kidney failure, and heart attack.
Written by Drug Recall Writer
Anybody who watches television, surfs the Internet or flips through a magazine is very familiar with advertising for pharmaceutical drugs picturing attractive, healthy and active people. Prescription and over the counter drugs are used by millions of consumers for various ailments, diseases and medical conditions. For most, prescription drugs can provide great benefit or relief. A consequence of the development of many drugs and the marketing to millions of consumers, are serious side effects or other undesired results. In extreme cases, the U.S. Food & Drug Administration (FDA) or manufacturer may recall or withdraw a drug.
Over the past few years, the safety of more than a dozen popular prescription drugs has been examined. In some cases, certain drugs have been recalled following reports of serious injury or death.
The recent recall of numerous popular drugs has resulted in heightened scrutiny of certain blockbuster drugs with hearings before Congress in which at least one FDA researcher suggests that the FDA may be incapable of protecting consumers from unsafe drugs and that several other popular drugs currently on the market may also present unacceptable patient risk. According to a survey by the Department of Health & Human Services Office of Inspector General, about two-thirds of Food & Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold.
DrugRecalls.com is a consumer resource from product liability lawyers engaged in assisting consumers suffering side effects from pharmaceutical drugs.
Not all drugs referenced on this website have been subject to recall or warning. Patients should never stop taking their medicine without first consulting with their physician.
Written by Drug Recall Lawyer
Drug Recall lawyer Dana Taschner is one of the most respected trial lawyers in the United States. After representing numerous individuals in pharmaceutical cases throughout the United States, and upon the arrival of the Internet as a communication tool in the 1990s, Dana founded Drug Recalls to provide helpful news and legal information about significant drug recalls impacting millions of consumers.
Dana has been involved in many of the most significant and serious Food and Drug Administration (FDA) or manufacturer drug recalls in history, including: Silicone Gel Breast Implants (FDA ban in 1992), Norplant (birth control implant recall), Fen-Phen (diet drugs recalled in September 1997), Rezulin (diabetes drug recalled in March 2000), Sulzer (hip device recalled in 2000), Baycol (cholesterol drug recalled in August 2001), Zyprexa (schizophrenia drug warning of 2004), Ortho Evra (birth control patch recalled in 2004) Avandia (diabetes drug recalled in July 2007), Paxil (SSRI Black Box Warning 2004), and Depuy Recall (hip device recalled in August 2010). Dana represented thousands of consumers adversely affected by these products after serious side effects or deaths were reported in connection to these pharmaceuticals. Dana has filed the first legal claim in the Courts of the United States following FDA or manufacturer recall in certain national recall cases.
For twenty consecutive years Dana has been awarded the highest national AV-rating (preeminent) for his legal ability and ethics based on reviews by judges and lawyers. Dana was awarded the American Bar Association's Sole Practitioner of the Year from a field of 400,000 lawyers, and the United States Senate honored Dana with a Senate Tribute, stating, "Taschner has achieved national recognitionâ€¦ Taschner truly brings honor to his profession." The Senate Majority Leader read into the Congressional Record, "Mr. Taschner's devotion to fighting oppression earned him the American Bar Association's Lawyer of the Year award."