FDA
Potential Neurovascular Stent Claims Following Recent FDA Safety Alert
Parker Waichman LLP is investigating potential personal injury and defective medical device claims related to adverse events associated with the use of Neurovascular Stents for Stent-Assisted Coiling (SAC) for the treatment of unruptured brain aneurysms. The Food and Drug Administration (FDA) has received adverse event reports … [Read more...]
Is the FDA Removing Bad Food from Shelves Quickly Enough?
The United States Food and Drug Administration has the power to order companies to remove potentially dangerous food items from retailer shelves. However, according to a recent report from The New York Times, the FDA may be dragging its feet a bit—leaving consumers at risk for dangerous food-borne illnesses. Federal investigators … [Read more...]
FDA Likely To Clear Cloned Animals
Does The Cloned Animals Is Safe. After over six years of debating whether consuming meat and milk from cloned animals is safe, the Food and Drug Administration (FDA) is expected to announce that they are. Clones are genetically identical copies whose gene sequencing is not modified. While many consumer groups oppose it, the FDA … [Read more...]
FDA Medication Labeling Changes
FDA Mandate Medication Labeling Changes. Numerous drugs have been approved for use, but that does not necessarily mean that the medical community is aware of all medication side effects. In fact, changes are frequently made to a drug's warning label to reflect the most recent knowledge. For instance, the U.S. Food and Drug … [Read more...]
FDA Tried To Thwart Release Of Vioxx Data
Vioxx Data Of Heart Problems. A Food and Drug Administration researcher was pressured by agency officials who wanted to prevent him from publishing a study that linked painkiller Vioxx to a high rate of heart problems, congressional investigators said yesterday. For the past few months, FDA epidemiologist David Graham … [Read more...]
FDA Updates Plan for Office in China
FDA Updates In China. In March we reported that the US Food and Drug Administration (FDA) received approval from the US State Department to establish eight full-time, permanent positions at US diplomatic posts in the People's Republic of China, pending authorization from the Chinese government. This was one step in the FDA's plans … [Read more...]
FDA Head Asks Congress for More Funding
FDA Head Ask Congress For More Funding. Beleaguered Food and Drug Commissioner (FDA) Dr. Andrew C. von Eschenbach has finally written Congress saying the FDA needs an immediate $275 million to ensure the safety of imported foods, drugs, and medical devices. The May 5 request was sent to Senator Arlen … [Read more...]
FDA Issues Chinese Heparin Supplier Warning Letter After Unsuitable Conditions
FDA Issues Chinese Heparin Supplier Warning Letter. An inspection by U.S. regulators of the Chinese factory that supplied tainted heparin ingredients to Baxter International revealed significant deviations from U.S. Current Good Manufacturing Practice standards. As a result, the Food & Drug Administration (FDA) informed the … [Read more...]
FDA China Office Slated To Open In October
FDA China Office Slated to Open. A month from now, the US Food & Drug Administration (FDA) could have full-time personnel on the ground in China, provided the Chinese government gives final approval to the plan. The assignment of FDA personnel to China comes on the heels of several scandals involving defective drugs and … [Read more...]
How Dangerous is Tainted Painkillers
Unlike the e-coli-tainted spinach that sickened 200 people and caused three deaths this fall, this week’s metal-tainted acetaminophen outbreak appears to have harmed no one. Even so, the Perrigo Company, the world’s largest manufacturer of generic over-the-counter drugs, isn’t taking any chances. At a cost of a reported $2.9 … [Read more...]
FDA Joins Investigation of Infants’ Deaths
Investigation of Infants’ Deaths. While the Chicago Tribune (2/25/06) is reporting that “accidental overdoses of prescription cold medicines are suspected in the deaths of two Kane County infants in a 24-hour period this winter,” it appears that the problem is anything but isolated. The coroner for Kane County requested … [Read more...]
Defective Drug Under Scrutiny
Drug Under Scrutiny. A hyperactivity drug linked last year to deaths, strokes and heart attacks in dozens of patients is expected to face new scrutiny next week when a government advisory committee considers how to study the safety of such medications. A Food and Drug Administration advisory committee will meet Feb. 9 and 10 to … [Read more...]
FDA to probe ADHD drug safety
FDA Review ADHD Drug Safety. The US Food and Drug Administration is planning to review the cardiovascular risks of attention-deficit hyperactivity disorder treatments, and has asked an advisory panel to discuss the issue at a meeting on February 9-10. The move follows reports of sudden deaths, strokes, heart attacks and high blood … [Read more...]
Elderly May Be At Greater Risk from Older Antipsychotic Drugs
Older Antipsychotic Drugs. A federally funded study shows that conventional antipsychotic drugs may be as unsafe or worse for the elderly than the newer drugs that the FDA warned about earlier this year. In April, the FDA asked drug makers to add warning labels to their newer antipyschotics because studies showed that elderly … [Read more...]
FDA Animal Drug Ban
Animal Drug From Bayer Are Being Banned. After five years of debate about human health concerns, the FDA ruled Thursday that an antibiotic made by Bayer Animal Health in Shawnee cannot be used for treating poultry. Food and Drug Administration Commissioner Lester Crawford, a veterinarian, agreed with evidence that widespread use … [Read more...]
Massive Drug Recall of Able Laboratories
Able Laboratories Drugs Are Being Recalled. Although several millions of doses of numerous generic prescriptions drugs were unexpectedly pulled from the market in a massive drug recall over one month ago, neither the FDA nor the manufacturer have come forward with any information to explain the matter. On May 19, Able Laboratories … [Read more...]
Nesiritide Increased Risk of Mortality
The U.S. Food and Drug Administration (FDA) and Scios, Inc., have alerted healthcare professionals via letter of several published reports that suggest nesiritide (Natrecor) may have adverse effects on survival and kidney function compared with control agents such as nitroglycerin and diuretics, according to an alert sent from … [Read more...]
FDA Launches Site to Warn Patients
The U.S. Food and Drug Administration has begun issuing alerts to patients and doctors on its Web site about emerging drug-safety concerns, including dangers posed by drugs prescribed for unapproved purposes. The new site, called Drug Watch, marks a significant change in how the agency communicates risks to the public. In the … [Read more...]
Safety of Albumin Administration in Critically Ill Patients
Safety of Albumin Administration. The Food and Drug Administration (FDA) is issuing this notice in order to update an earlier correspondence and revise our previous advice regarding the safety of albumin administration in critically ill patients. This action is being taken following FDA’s review of recent studies on the safety … [Read more...]
RADAR Finds Drug Reactions
Fatal Drug Reactions. Researchers in Chicago reported Wednesday they have found a large number of previously unknown and often fatal reactions to 14 commonly prescribed drugs and to drug-coated cardiac stents. The report in the Journal of the American Medical Association is one of the results of an independent pharmaceutical … [Read more...]
Metoclopramide Can Cause Drug-Induced Movement Disorders
Metoclopramide Can Cause Drug-Induced Movement Disorders. Safety experts from the Foodand Drug Administration (FDA) and the Duke University School of Medicine, publishing in the November/December 2004 Journal of the American Pharmacists Association. caution that the use of the heartburn drug metoclopramide (REGLAN) is increasing … [Read more...]
FDA Orders Heart-Risk Info on Drugs
Heart-Risk Info On Drugs. The Food and Drug Administration is ordering that more information about the risk of death from a heart failure drug be added to the package insert for doctors. The expanded data on nesiritide, sold as Natrecor, includes findings from seven studies with pooled results suggesting the drug might increase … [Read more...]
FDA Safety Labeling Changes: Viramune, Copegus, Malarone
Safety Labeling Changes For Viramune, Copegus, Malarone. The U.S. Food and Drug Administration (FDA) approved in February revisions to safety labeling to notify healthcare professionals of the following changes: use of nevirapine tablets and oral suspension may cause serious hepatotoxicity and skin reactions, and intensive … [Read more...]
FDA Warns Of Antipsychotic, Antihistamine Drug Mixup
FDA Warns Of Antipsychotic Drug Mixup. The Food and Drug Administration is warning health- care professionals and consumers about prescribing and dispensing errors between two drugs with similar names. The errors have occurred between Zyprexa, an antipsychotic drug made by Eli Lilly & Co. (LLY) and Zyrtec, an … [Read more...]
How to Improve Drug Safety
Drug Safety In The United States. It has been a tough three years for the Food and Drug Administration, which until recently was credited with providing the United States with the safest drug supply in the world. In September, Merck withdrew Vioxx from the market after a study showed that the drug significantly increases the … [Read more...]
Probe Urged Of Allegations Against FDA
The chairman of the Senate Finance Committee yesterday called on the inspector general of the Department of Health and Human Services to investigate alleged attempts to discredit a Food and Drug Administration whistle-blower. Sen. Charles E. Grassley (R-Iowa) cited allegations that FDA managers attempted to discredit David J. … [Read more...]
FDA Important Labeling Changes for Mifepristone
New Safety Changes For Mifepristone. The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and … [Read more...]
FDA Puts Depression Drugs On Watch List
Depression Drugs Should Be Closely Monitored. The Food and Drug Administration warned yesterday that anyone taking 10 popular antidepressants should be closely monitored for signs of suicidal thoughts or behavior. The move comes after an unusual hearing last month in which parents pleaded with an FDA panel to recommend … [Read more...]
