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Recent Blog Posts
FDA Recommends Lower Dosage of Acetaminophen
Sometimes the most common drugs can be the most dangerous. In the second week of 2014, the Food and Drug Administration (FDA) issued a press release that recommended all “health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit.” Dosages of this amount or more have been found to contribute to liver damage, and when this dosage is coupled with other types of pain killing or serious drug treatments they are found to have serious side effects.
According to FDA Safety Information, “cases of severe liver injury with acetaminophen have occurred in patients who:
- took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
- took more than one acetaminophen-containing product at the same time; or
- drank alcohol while taking acetaminophen products.
The issue with overprescribing or over-taking acetaminophen isn't new. According to a New York Times review from 2011, an overdose of this common household drug is “one of the most common poisonings worldwide.” When taken in large doses, acetaminophen is deadly. In 2003, according to a different New York Times article, a group of 504 bottles of Dixon-brand acetaminophen were recalled because they had the incorrect dosage listed on the bottle. The FDA warned back then that overdoses can lead to “severe problems like liver toxicity and failure,” the Times reported.
FDA Issues HBOT Warning
The U.S. Food and Drug Administration (FDA) has issued a warning to consumers about hyperbaric oxygen therapy (HBOT) and how some companies may be using deceptive advertising to promote HBOT.
With HBOT, a person breathes pure oxygen in a pressurized chamber or room. The air pressure in the room is increased up to triple the amounts higher than normal, allowing the lungs to take in almost three times the amount of oxygen they would be able to take in under normal pressure. The oxygen flows in the blood throughout the body, which helps healing.
Some of the treatments the FDA has approved are decompression sickness (one of the dangers associated with scuba diving), bubbles in blood vessels, infections, and hard to heal wounds (a common side-effect of diabetes and radiation treatments), carbon monoxide poisoning and embolism treatments.
The FDA's issued their warning because they say there are internet sites that claim HBOT is a safe and effective treatment for a myriad of diseases and conditions that have not been approved by the agency. The agency is concerned that consumers who believe that these devises have been approved for other, unapproved conditions could be putting themselves at risk. Nayan Patel, a biomedical engineer in FDA's Anesthesiology Devices Branch, said, “Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies. In doing so, they may experience a lack of improvement and/or worsening of their existing condition(s).”
Johnson & Johnson Poised To Consider Settlement
The world's largest provider of products in the health care field is considering the benefits of settling a huge case regarding hip implant recalls. There are approximately 11,500 lawsuits pending around the country with regard to the defective medical devices, with numerous plaintiffs alleging serious medical conditions and side effects after their hip implants were installed.
The product manufacturer is considering settling all of the lawsuits with an offer of more than $300,000 per case. If it moves forward, this settlement would exceed $3 billion if the plaintiffs were to approve the terms. Previous discussions have yielded settlement offers of less than half this current amount.
In 2001, a manufacturer of a similar product, Sulzer, settled their cases for $1 billion. There are currently seven product-liability trials regarding J&J being held between September and January, which could certainly influence any settlement offers. The negotiations happening during this time are kept private.
Are Hip Implants Safe?
When it comes to medical devices that have been in the news, defective hip implants have been a constant player. Lawsuits surrounding hip implants have pointed out numerous weaknesses in the devices geared to help people, including complications requiring additional surgeries and even metal poisoning from implants that have broken down and released dangerous substances into the body.
A new lawsuit surged forth in July against Stryker, a company making hip implants that have been used across the country. This lawsuit was filed in Michigan by plaintiff Giniva Luque. The plaintiff alleges that she has had two different hip replacement surgeries, both involving Stryker hip replacement devices. Her hip implant surgeries happened in March, 2011, and September, 2012.
The patient, like many others who have raised concerns about the safety of hip implant devices, says that she experienced serious pain and discomfort in her body surrounding the area where the implants were added. Luque says she will have to schedule revision surgery for both hips to remove the faulty implants and put operable ones in instead.
Hip Replacement Recall
If you've had a hip replacement surgery in the last several years and you're experiencing pain or other complications, you may need to investigate hip product recalls. In January of 2013, the FDA issued a warning about faulty hip replacements for products using metal-on-metal in their design.
These products have been the focus of multiple recall efforts, starting in 2010 when 90,000 Johnson and Johnson Deputy Orthopedics products were realized to have early failure rates. Those particular products, of which 30 different varieties were made, had already found their way to hospitals and operation rooms around the world, affecting many people who had gone through hip replacement.
Metal on metal hip replacements can be dangerous if the metal products begin to corrode. Unfortunately, these particular models were corroding over the course of daily use, so patients were not to blame for any particular behavior that ignited the corrosion process. As the metals break down inside the body, metal poisoning can spread, damaging bones or soft tissue as it goes. Many people experience what's known as ARMD, or adverse reaction to metal debris. Each person can have a different reaction to the metal poisoning connected with ARMD, so patients concerned about this problem should set up an appointment with their regular doctor.
Two Defective Ventilator Products Recalled by FDA
A ventilator is a machine that assists people who are unable to breath by mechanically supplying oxygen and pulling out poisonous carbon dioxide. They can usually be found in intensive care units, emergency rooms, and when receiving healthcare at home. They can also be used during surgery for people who are under anesthesia, in case their heart is slowed too much. There are also manual units which are pumped during activities like CPR.
Given the uses of ventilators, the FDA has issued the highest class of recalls for two ventilator products. A Class I recall signifies that a medical product may cause serious injuries or death.
Ventlab, a corporation which manufactures ventilator products, had one of their manual units recalled by the FDA. The recall affects ventilators made during March and July of 2012. There is a defective valve which prevents patients from receiving oxygen, even though the bag inflates. Failures of this ventilator could lead to life-threatening situations including hypoxia, hypoventilation, and even death. This recall is on the heels of Ventlab issuing their own voluntary recall in July.
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