Recently in Product Recalls Category

May 13, 2013

FDA Launches Investigation Into Compounding Pharmacies In The Wake Of Deadly Fungal Meningitis Outbreak

Post #6 image. 2013-04-19.jpgA recent press release from the Food and Drug Administration left many consumers worried about the safety of their medications. The FDA revealed that over the course of the last few months, an investigation has uncovered possibly life-threatening safety issues at more than 30 compounding pharmacies across the country. The issues were discovered after the deadly fungal meningitis outbreak prompted closer scrutiny of the nation's specialized pharmacies.

An especially scary example of the problems present in the nation's compounding pharmacies was found in Florida where the FDA said it discovered medicine with floating black particles. At a different pharmacy, inspectors with the FDA discovered rust and mold in supposed "clean rooms." Dozens of facilities had problems with their sterilization procedures, including allowing workers into rooms with medicine despite having tears in their gloves. All these violations are serious and could be responsible for yet another deadly outbreak like the one started in Massachusetts.

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April 9, 2013

DePuy Metal Hip Implant Case Results in Millions in Damages

Post #7 image. 2013-03-18.jpgDuring the middle of March 2013 a jury in Los Angeles decided that a former prison guard from Montana, Loren Kransky, was entitled to $8.3 million in damages for harm caused by Johnson & Johnson's DePuy subsidiary's metal hip implant.

The jury found that the ASR XL implant caused metal poisoning and other health problems for Kransky and were severe enough to cause the man to undergo painful revision surgery to remove the defective device. The jury found that DePuy knowingly marketed a faulty device and owed the injured patient millions as a result. However, the jury did not find that the company had acted with malice. This is important because it prevented Kransky from colleting punitive damages.

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March 27, 2013

First Of Thousands Of Cases About Risks of Actos Goes To Trial

Post #8 image. 2013-03-18.jpgThe first of more than 3,000 cases filed against Takeda Pharmaceuticals over it's once popular diabetes drug, Actos, is now underway. A witness recently testified that the pharmaceutical giant put sales ahead of consumer safety and allowed marketing concerns to trump patient health worries.

The witness, Howard Greenberg, was a clinical pharmacologist who had experience in the industry and based his testimony off emails sent between Takeda executives. The emails discussed the company's possible response to a warning by regulators across Europe and the U.S. that warning labels might be applied to Actos that described the possible risks associated with the development of bladder cancer.

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December 3, 2012

FDA Reveals 13 Deaths Linked to 5-Hour Energy

Post #2 image. 2012-11-21.jpgAccording to a recent article by the New York Times, the Food and Drug Administration has launched an investigation after reports that the 5-Hour Energy product may be linked to some 13 deaths over the past several years.

The FDA confirmed that it has begun an investigation into the 13 deaths which all occurred within the last four years. The investigation is similar to the one involving Monster Energy Drink and the five deaths that were related to its use.

A report by the New York Times revealed that since 2009, 5-Hour Energy has been named in some 90 filings with the FDA including 30 that involved life-threatening incidents. These include incidents of heart attack, convulsions and, in one especially tragic case, a spontaneous abortion.

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November 27, 2012

Drug Recall At Second Massachusetts Company Related to Fungal Meningitis Outbreak

Post #2 image. 2012-11-14.jpgA company with the same founders as the specialty pharmacy linked to a deadly fungal meningitis outbreak is recalling all of its products after federal inspectors said it must improve its sterility testing process.

Officials with the FDA have said that a routine inspection turned up inadequate quality assurance related to Ameridose's sterile products. The FDA was quick to say that it has not discovered any infections linked to the recalled products from Ameridose. In a statement, Ameridose declared it issued the recall "out of an abundance of caution."

Ameridose makes several injectable drugs which can be used in anesthesia or to correct acid imbalances in the body during critical care. Ameridose agreed to shut down for inspection in October after contaminated steroids from the New England Compounding Center (NECC) were linked to a growing fungal meningitis outbreak.

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November 21, 2012

Study Reveals Dangers of Yaz/Yasmin Birth Control

Post #1 image. 2012-11-14.jpgIt appears to have been a week of bad news for the maker of the birth control drugs Yasmin and Yaz as Bayer AG announced in its most recent financial report that it had agreed to pay a combined $750 million thus far to settle thousands of claims regarding its birth control drugs causing blood clots.

Adding insult to injury, a new study has found increased risk of blood clots with the use of birth control pills such as Yaz and Yasmin. According to the most recent study published in the journal Contraception, women who take oral contraceptives containing the synthetic hormone drospirenone are more likely to suffer from potentially fatal blood-clotting complications compared to those who were taking another type birth control.

Researchers at the Kaiser Permanente Northern California Division of Research gathered data on 573,680 women between the ages of 10 and 55 between 2001 and 2007. The study looked at women who were new users of combined hormonal contraceptives (CHCs), and compared the rate of blood clot related events among women who did or did not take contraceptives containing drospirenone. Overall, the study found that women who took birth control pills containing drospirenone were 77% more likely to experience blood clot related conditions such as deep vein thrombosis and pulmonary embolism.

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November 8, 2012

Reports of Death Prompt FDA to Launch Investigation Into Monster Energy Drink

Post #4 image. 2012-10-29.jpgThe Food and Drug Administration recently announced that the agency launched an investigation concerning five deaths and one non-fatal heart attack linked to consumption of the Monster Energy Drink. The Monster Energy Drink is a heavily caffeinated soda that has grown in popularity in recent years among those eager for a boost, especially young people.

Reports indicate that several people suffered adverse reactions after consuming the drink which contains a whopping 240 milligrams of caffeine. To put that number into some perspective, one Monster Energy Drink contains about seven times the caffeine in a typical 12-ounce can of soda.

The FDA issued a statement saying that it was taking the reports of death seriously and will begin a thorough investigation to determine if any action should be taken. Although the FDA caps the amount of caffeine in soda at 0.02 percent, there is no such limit for energy drinks, something that may need to change in the future. Though a response from the regulatory agency is a good thing, the timing leaves something to be desired as reports first surfaced back in 2004. The agency says so far there's no proof that the drinks directly caused the deaths or injuries.

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November 5, 2012

Where do your drugs come from?

Post #3 image. 2012-10-29.jpgThe recent outbreak of fungal meningitis has many people asking questions about the safety of compounding pharmacies and the origins of many of the medicines we put into our systems everyday. Something that many may not realize is just how hard it can be to track down the source of the drugs that you take on a daily basis.

So far the Centers for Disease Control and Prevention has said that the fungal meningitis outbreak has made 344 people sick in 18 states and caused 25 deaths. The outbreak was linked to a batch of injectable steroids that have since been recalled by the New England Compounding Center, a compounding pharmacy in Massachusetts. The facility has announced that as many as 14,000 patients have been treated with the steroids and may be at risk.

Compounders have recently played an important role in the medical field given the increasing occurrence of drug shortages. The pharmacies have been able to step in and provide some much needed supplies when the big manufacturers are down. Compounders are also useful as cheaper alternatives to the big name brands.

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October 5, 2012

Stryker Announces A New Class I Recall

Post #2 image. 2012-09-28.jpgStryker, the major medical device manufacturer, issued a Class I recall of their Neptune Fluid Waste Removal Systems in early June of this year. The initial recall was issued after two patients were injured and was meant to alert hospitals and doctors that the waste removal systems should not be connected to passive drainage tubes. In one case, a patient's passive drainage tube had been connected to the Neptune 2 system and the patient died.

Just last week, the company announced that it would be expanding the recall to the Neptune 1 Silver, Neptune 2 Ultra and a high-powered Neptune 2 Ultra waste removal system. The reason is that none of the waste removal systems had proper prior approval by the U.S. Food and Drug Administration (FDA). As such, the devices should never have been marketed until their safety and effectiveness had been assured.

Stryker has taken action to stop all further distribution of the waste removal systems. According to Businessweek, the company had the following grave statements for patients: "Customers who do not have an alternative machine available should weigh the risks and benefits of the recalled Neptune devices" and should "request a certificate of medical necessity if they plan to continue using them."

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October 2, 2012

Study Reveals that Patients Often Not Informed When Prescriptions Given for "Off-Label" Use

Post #1 image. 2012-09-25.jpgA recently released study found that doctors commonly prescribe medications for off-label use, but almost never inform their patients of that critical fact. This behavior runs directly counter to regulations issued by the U.S. Food and Drug Administration (FDA) and represents a possible danger to patients across Mississippi.

All drugs that reach the market have gone through clinical trials in order to determine their efficacy and safety for their intended purpose. Once the FDA feels the medication has met all of its requirements, it then approves the label for the medication. The drug is then meant to be used for its intended purpose which is specified on the label.

The term "off-label" means using a medication to treat a problem that it was not originally intended for. It can also refer to the use or form of a dosage of the drug that has not been approved by the FDA. A 2006 study found that one in five prescriptions were for off-label use.

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September 3, 2012

Medical Device Recalls Hit Highest Level in Years

Post #1 image. 2012-08-29.jpgAccording a recent report, this past year has seen a massive number of medical device recalls. According to ExpertRecall, a company tasked with tracking food, drug and device recalls, a whopping 123 million such devices were recalled in the most recent quarter of the year, representing a nearly two-year high.

ExpertRecall pointed out that the number of device recalls is actually down slightly from the first quarter. However, the number of individual units affected by the recalls passed the 100 million mark for the first time since the third quarter of 2010. An analysis of FDA enforcement reports found that the second quarter of 2012 saw some 242 medical device recalls, a drop of 13% from the 277 recalls seen in the first quarter of this year. Though there was a drop, the most recent numbers still represent an increase of 4% from the same time last year.

The 123 million units recalled last quarter represent an astounding 50% increase on the 82 million units recalled in the first quarter of the year. Though the gap may seem larger, stepping back in time reveals an even bigger difference. In the second quarter of 2011, only 16 million devices were recalled, about 1/8 as many as last quarter.

Though good news was hard to find in the report, one indicator showed some promise. Less than 7% of the recalls announced last quarter were Class I, meaning that the device carried a risk of serious injury or death. Moreover, these serious recalls accounted for less than 1% of the total units recalled in the quarter, thus affecting only a small number of patients.

It wasn't just medical devices that saw millions of recalls last quarter, the group revealed that there were 69 pharmaceutical recalls in the second quarter of 2012. These 69 recalls amounted to a total of 12 million units of prescription drugs.

Companies affected by the recent recalls include Coviden PLC, which recently announced a voluntary recall of some DGPHP RFA high-power single use grounding pads. It also announced a voluntary global recall of some adult tracheostomy tubes.

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August 20, 2012

Yaz/Yasmin Lawsuit Payouts Continue to Rise

Post #1 image. 2012-08-14.jpgBayer AG, the maker of Yasmin birth-control pills, said that settlements related to U.S. lawsuits over its product have increased to more than $402 million. Bayer said it has resolved almost 1,900 cases in which it has been claimed that Yasmin and Yaz contraceptives caused blood clots that can lead to heart attacks and strokes. The company said that the payments have broken down to an average of about $212,000 per case.

Bayer also announced that it had more than doubled its financial reserve for future payments related to Yaz cases, setting aside an additional $610 million this quarter alone. The $610 million is to pay the company's costs beyond what insurance will cover for legal fees, including cases that haven't been settled yet. Even this huge figure may not be enough as drug-industry analysts have said that Bayer may end up paying out over $2 billion to resolve all the cases related to the birth-control problems.

Lawyers suing the company have brought forward FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. The lawyers have argued that Bayer marketed the contraceptives for unapproved uses and misled women about their risks.

The suits follow a decision in April of this year by the U.S. FDA to order Bayer along with other drug makers to include stronger blood-clot warnings on their contraceptive products. Pills like Yasmin, which contain a synthetic hormone known as drospirenone, will now come with warnings that say researchers have found the drugs can triple a woman's risk of blood clots.

Given the number of women taking Yasmin, which was the fourth most prescribed oral contraceptive in 2011, with 4.6% of the overall market, the suits have affected potentially millions of women. Bayer faced more than 12,000 lawsuits over the Yasmin line of contraceptives, including claims that they caused blood clots in some women and damaged gallbladders in others. Thus far, Bayer has agreed to settle 1,877 cases.

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August 13, 2012

Wright Medical Profemur System Presents All-Metal Hip Problems

Post #2 image. 2012-08-09.jpgA terrifying statistic for the many thousands of patients who have undergone hip replacement surgery appeared in a Bloomberg article published in June of this year. The article explained that the FDA reported some 16,800 adverse events related to metal-on-metal hip implants in the U.S. between 2000 and 2011.

Another company is under the spotlight as the quality and durability of their products are in question. The Wright Medical Profemur Total Hip System is a line of hip replacement implants designed and manufactured by Wright Medical Technology. Problems have been reported with the device along the same lines of other all-metal counterparts.

One lawsuit was filed by a Michigan man in late 2011 which says the patient's Wright Profemur hip replacement failed less than three years after implantation, leading to severe problems. Other similar lawsuits have been filed against the manufacturer, each alleging the design of the Wright Profemur Hip Replacement Implant is defective and prone to early failure. The fact that these hip implant systems may fail within a few years after surgery is bad because it results in additional hip revision surgery, a painful process that no patient should be subjected to a second time in such a short period.

Hip implants should last for at least 15 years, but data indicates that the Wright Profemur Hip Implant often fails within just a few years of implantation. For example, 2009 data from an implant registry run by the Australian Orthopaedic Association found that one component, the Wright Profemur Z femoral stem, shows an 11.2% failure rate at the three year interval. This means that approximately one out of every 9 people who received the Wright Profemur Z hip implant experienced severe problems within a few years after their hip replacement.

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August 10, 2012

Software Failures At Fault In Many Medical Device Recalls

Post #1 image. 2012-08-09.jpgThe Food and Drug Administration just released some surprising news that it found poor software quality is to blame for many of the recalls that have been seen in the medical device industry. The FDA's research revealed that such glitches were responsible for 24% of all such recalls.

Given this revelation, the FDA's Office of Science and Engineering Laboratories will now begin dedicating significantly more time testing software quality and security. The goal will be to help reduce the failure rate cited in the most recent annual report which was just recently released. The agency will increase its efforts to avoid injury or death thanks to poorly designed or written software.

In a statement, the FDA said that it is developing "techniques and laboratory expertise to assist our review staff in identifying potential vulnerabilities and evaluating risk mitigation measures." The procedures the agency will put into place are in line with those in other regulated industries and are intended to be rigorous. The statement continued saying, "Manufacturers are responsible for identifying risks and hazards associated with medical device software/firmware, including risks related to security, and are responsible for putting appropriate mitigations in place to address patient safety."

There are multiple potential problems associated with software issues in medical devices. The first is obviously the risk such a failure can pose to a patient's health and safety. The less obvious, but nonetheless important risk is to a patient's privacy. Such devices can store vast troves of sensitive personal medical data that if compromised could reveal far more than a patient would feel comfortable with. There are even some devices that are connected to networks and which could conceivably be vulnerable to hacking attacks.

It was just this past month that Google reported disabling a hacked website that existed to distribute software updates for an array of medical devices. Among the devices receiving updates from the website include AVEA ventilators.

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August 3, 2012

Lawsuits Involving Pradaxa Injuries Make Their Way To Court

Post #2 image. 2012-07-31.jpgA man from neighboring Tennessee has filed a lawsuit against Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Pradaxa. The drug company is being sued by the man who claims his father died as a result of side effects he experienced as a result of his use of the blood-thinning prescription drug.

According to the suit, Melvin Giles' father was prescribed the drug as a blood thinner. The medication typically is used to reduce the chance of blood clots developing and leading to a stroke in patients who are at risk for such issues. Giles' father was given the medication in February of 2011 and in June of that same year suffered severe internal bleeding and died as a result. His son claims that the bleeding he suffered was the result of his use of Pradaxa.

Giles claims that the drug maker either knew or should have known about the potential for the dug to cause such serious complications. The suit cites as proof the 932 incidents reported to the FDA between October 2010 and March 2011 related to side effects of the medication. Some 120 of these reports involved death from Pradaxa bleeding, and 500 were severe and life-threatening bleeding events related to the medication. These numbers have gone on to spike and according to a new report from the Institute for Safe Medicine Practices, the U.S. Food & Drug Administration received 3,781 adverse event reports associated with Pradaxa in 2011, more than were associated with any other drug the agency monitors.

Pradaxa also led in reports of deaths (541), hemorrhage (2,367), kidney failure (291) and stroke (644), according to ISMP's most recent report. Pradaxa was also a suspect in 15 reports of liver injury made to the FDA.

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