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food drug administration 11 articles

Dangerous Darvocet, Darvon may still be in consumers’ medicine cabinets

Many people who were prescribed the painkillers Darvon and Darvocet may still be taking them even though the Food and Drug Administration (FDA) has ruled them too dangerous to remain on the market. Last month, the FDA pulled all drugs containing the active ingredient propoxyphene, including Darvon and Darvocet as well as generic equivalents, because a review of data showed the drugs increased the risk of deadly abnormal heart rhythms. The drug is being removed from pharmacies and doctors were informed to stop prescribing the drug. Many pharmacies sent letters to patients who had recently filled prescriptions for Darvon and ... Read More

Red flags surrounded painkillers Darvocet and Darvon for years

When the Food and Drug Administration (FDA) announced last week that it was pulling the longtime prescription painkillers Darvocet and Darvon from the U.S. market because of concerns that the medications put users at greater risk for fatal heart problems, the drugs were already covered in red flags. Propoxyphene, the active ingredient in Darvon and Darvocet, was approved by the FDA for mild to moderate pain relief more than 50 years ago and generated about 23 million prescriptions a year. Concerns were first raised about the safety of the drugs in 1978, but little was done until in 2006, when ... Read More

Chilling new data links Darvocet, Darvon to fatal heart problems

Millions of people, in particular senior citizens, use the painkillers Darvon and Darvocet to help with minor aches and pains. But chilling new data from a clinical study suggesting the drugs could cause serious and sometimes fatal heart problems has spurred the Food and Drug Administration (FDA) to order the removal of the painkillers from the U.S. market. Darvon and Darvocet are brand names of the generic propoxyphene. Last year, the FDA ordered a black box warning be placed on the drugs stating that propoxyphene has been linked to fatal overdoses. Black box warnings are the most serious warnings the ... Read More

Poor FDA scrutiny of Medtronic Sprint Fidelis lead

The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it comes to defective implantable medical devices. That’s because the number of medical devices meant to be implanted in patients’ bodies is rapidly rising. Unfortunately, despite their rising numbers, as the case of the Sprint Fidelis Lead recall illustrates, the Food & Drug Administration (FDA) is doing a poor job of regulating implantable devices, and often ignores reports of device failures until someone dies. Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead ... Read More

Medtronic faces investigations over defective Sprint Fidelis Defibrillator lead

Medtronic, Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, is the now the subject of two separate investigations. A Senate panel wants information about Medtronic’s October Sprint Fidelis Defibrillator Lead recall, while a second investigation by the US Justice Department is looking into allegations that Medtronic made illegal payments to foreign physicians. Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s ... Read More

Medtronic asks Supreme Court to ban personal injury lawsuits

Medtronic, Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead and several other defective medical devices, will try to convince the US Supreme Court that people injured by dangerous medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration (FDA). If Medtronic is successful, the thousands of people injured by the company’s defective devices, as well as those hurt by faulty drugs and devices made by other manufacturers, would not be able to receive compensation for their injuries in state courts. The Medtronic Supreme Court case ... Read More

Gadolinium based MRI contrast agents put kidney patients at risk

Gadolinium based MRI contrast agents have been implicated in at least 1,000 cases of a debilitating disorder called Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD) around the world. This horrible disease causes a buildup of collagen in tissues, leading to a severe thickening and hardening of the skin. NSF/NSD can completely immobilize patients, and in severe cases it can lead to death. NSF/NSD is a rare disease that so far has affected only people with pre-existing kidney problems. The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000. NSF/NSD leads to excessive ... Read More

Avandia reviewer calls for changes in FDA drug approval process

The Avandia debacle has prompted a safety official from the Food & Drug Administration (FDA) to call for changes in the way diabetes medications are approved for use in the United States. The FDA official, who reviewed the original approval application for Avandia, told the Journal of Diabetes Care that the safety and effectiveness of experimental diabetes medications should be tested against existing drugs before they are approved. If such a testing protocol were to be adopted by the FDA, it would mark a significant departure from the way most medications are granted approval in the United States. Avandia has ... Read More

Defective Medtronic Sprint Fidelis lead fracture reports ignored by company

Medtronic Inc. knew that its Sprint Fidelis Defibrillator Leads were fracturing at higher-than-usual rates for months. Yet, the company appears to have dragged its feet in getting the defective Sprint Fidelis Lead off the market. Medtronic even went so far as to blame physicians for the problems, claiming that they weren’t implanting the defective Sprint Fidelis Lead properly. What’s even worse, the Food & Drug Administration (FDA), which never required the defective medical device to undergo clinical testing, was oblivious to the increasing reports of Sprint Fidelis Lead problems. Medtronic suspended sales of the Sprint Fidelis Leads in October, after ... Read More

Gadolinium contrast agents used off-label in MRAs pose even greater risk

Gadolinium based contrast agents used during MRIs, are known to be associated with the onset of Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD) in patients with pre-existing kidney disease. But the use of gadolinium in a procedure call Magnetic Resonance Angiography (MRA) could put these patients at an even greater risk of developing NSF/NSD, because these procedures often use far more gadolinium than a typical MRI. The use of gadolinium contrast agents in MRAs is a growing practice, even though the Food Drug Administration (FDA) never approved gadolinium for MRAs. An MRA is a variation of a traditional MRI that ... Read More