FDA Alerts Blog

PRT4445 Shows Promise as Antidote for Xarelto

July 15th, 2014

Although there is currently no approved reversal agent for the anticoagulant drug Xarelto, Janssen Pharmaceuticals, in collaboration with Portola and Bayer, is evaluating the safety of PRT4445, a potential antidote for Factor Xa inhibitors like Xarelto, which prolong the time it takes the blood to clot, sometimes leading to serious or fatal bleeding. The goal of the study is to determine the dose of PRT4445 that will be able to reverse the anticoagulant activity of Xarelto in case of an uncontrolled bleeding or other emergency situations.

Xarelto was approved by the U.S. Food and Drug Administration in 2011 as a potentially safer alternative to Warfarin, as Xarelto does not require regular blood monitoring or frequent doctor follow up. Xarelto was originally prescribed to prevent stroke or blood clots in patients suffering from atrial fibrillation and to reduce the risk of blood clots in patients undergoing knee or hip replacement surgery. Approval was expanded in 2012 to allow the drug to be used as a treatment for deep vein thrombosis or pulmonary embolism, but since that time, the FDA has received reports of dangerous blood clots caused by uncontrollable bleeding associated with use of Xarelto.

Although Xarelto is considered relatively safe, effective, and easy to use for both patients and physicians, there is no antidote, as opposed to the reliable warfarin (Coumadin), whose major bleeding rate is approximately 3 percent per year. Warfarin has been the most widely used in the U.S. for more than 50 years, and vitamin K is used 10 to 25 percent of the time to reverse its anticoagulant effects within four to six hours, although emergency situations require blood products such as plasma, prothrombin complex factor, or recombinant factor Vlla.

According to MedPage Today, approximately six million people in the U.S. are on outpatient anticoagulants, and in 2013 200,000 people, or one in 30, were admitted to the hospital due to bleeding complications, including 65,000 who are taking one of the new oral anticoagulants, which include Pradaxa, Xarelto, and Eliquis.

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Update: Xarelto Exceeds Pradaxa in Reported Adverse Events

July 14th, 2014

According to a July 9, 2014 report in the Digital Journal, the anticoagulant drug Xarelto has now surpassed Pradaxa in the number of reported adverse events, including serious bleeding events.

The Institute for Safe Medication Practices’ (ISMP) Quarter Watch publication reported that in 2013, the U.S. Food and Drug Administration received 680 serious adverse event reports from patients who alleged to have suffered adverse events while taking Xarelto, while 528 such events were reported by those taking Pradaxa.

Xarelto is manufactured by Bayer and marketed by Janssen Pharmaceuticals in the U.S., and was approved by the FDA in July 2011 for treatment to reduce the risk of blood clots in patients who undergo hip or knee replacement surgery. In November 2011, the FDA approved Xarelto for use in patients with atrial fibrillation to reduce their risk of stroke, and in 2012, Xarlto’s use was expanded again to include the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

High Risk Treatment Option

Anticoagulant drugs are considered a high-risk treatment and cause bleeding in approximately 15 percent of those with atrial fibrillation. Nearly one million prescriptions for Xarelto have been dispensed per quarter in the U.S., and by the end of 2013, outnumbered those written for Pradaxa by nearly two to one. The ease of using Xarelto and Pradaxa have made them popular alternatives to warfarin.

According to ISMP, marketing Xarelto for ease of use, rather than providing tools to reduce bleeding risk, is a critical mistake and recommends that the FDA reconsider its decision to prohibit a lower dose of dabigatran that is recommended for older patients in almost all other advanced countries, and establish a therapeutic range so that plasma level tests can identify patients with excessive or less than desirable effects.

If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Xarelto we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight to make things right.

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Bayer Facing Lawsuits over Xarelto; Drug Linked to Uncontrolled Bleeding

July 11th, 2014

Xarelto, Bayer’s blood thinner formulated to prevent blood clots and lower the risk of stroke, may also cause uncontrolled bleeding that can lead to hospitalization and even death.

Xarelto is an anticoagulant developed by Bayer and Johnson & Johnson’s New Jersey-based unit, Janssen Pharmaceuticals. Unlike other anticoagulants that require doctors to prescribe specific doses for each individual patient, Xarelto is prescribed in one uniform daily dose for those who suffer from atrial fibrillation (AF), a condition that affects about three million Americans and causes blood to pool in a storage chamber of the heart, where it can clot and travel to the brain.

FDA Approval

The U.S. Food and Drug Administration (FDA) approved Xarelto in July 2011 to reduce the risk of blood clots, deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with a history of knee or hip replacement surgery. In November 2011, the FDA expanded the approval for Xarelto to include using it to reduce the risk of stroke in people with AF. Then in 2012, the FDA approved Xarelto for the general treatment and recurring risk of DVT and PE.

Side Effects 

Xarelto is known to cause some severe side effects, including:

  • Uncontrolled bleeding resulting in death
  • Abdominal bleeding
  • Rectal bleeding
  • Brain hemorrhage
  • Abnormal liver function
  • Reduced platelet levels

Xarelto has no known antidote for uncontrolled bleeding, and the drug’s manufacturers have yet to release information for doctors on how to treat the condition. Doctors have been encouraged to recommend that patients with liver or kidney problems, those who are pregnant, breastfeeding, or planning to breastfeed should not take Xarelto.

In Germany, the number of side effects from Xarelto appears to be increasing. In the first eight months of 2013, German regulators received 968 records of side effects, including 72 deaths, and many physicians are hesitant to continue to prescribe the drug.

Lawsuits 

According to Reuters, Bayer is now facing its first lawsuits in the U.S. over Xarelto, one of the company’s top five medications in terms of sales last year. The suits allege that there should have been a warning communicated about the risks of uncontrolled bleeding associated with Xarelto, and that marketing induced doctors to prescribe the drug even though there were less dangerous and less expensive alternatives available, according to court documents.

If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Xarelto we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight for the maximum compensation for your injuries.

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Johnson & Johnson Ignores Risk of Talc And Fails to Issue Warnings On Ovarian Cancer

July 10th, 2014

Despite a clear association established by numerous studies that show talc (a/k/a “Talcum Powder”) can cause ovarian cancer in women when used on the genitals, Johnson & Johnson continues to fail to warn women of the risks of using Johnson Baby Powder and Shower-to-Shower Body Powder.

Johnson & Johnson first developed Baby Powder in 1893, promoting it as a means of absorbing unwanted moisture and odors in babies and women. Over the next century, Johnson’s Baby Powder grew into a top selling product and is now commonly found in every home.

The Link Between Talc and Ovarian Cancer

A long history of independent research has established a strong link between ovarian cancer and talc, yet Johnson & Johnson continues to sell the product as safe without warning women of the risks.

  • A 1961 study found that carbon particles similar to talc can translocate from the exterior of women’s genitals to women’s ovaries.
  • Another study done in 1968 determined that 19 percent of talc was fibrous content similar to asbestos that could cause unsuspecting health problems.
  • In 1971, researchers found talc particles deeply embedded in ovarian and cervical tumors of women with cancer, and determined that women without cancer had less chance of having such particles in their bodies.
  • Due to the fibrous content present in talc, researchers recommended in 1976 that regulatory standards be created for talc use, and the possible health risks be evaluated.
  • In 1982, Harvard researchers found that genital talc use increased the risk of ovarian cancer in women by 92 percent. The Harvard study was followed by 21 different studies worldwide, almost all finding a connection between talc and ovarian cancer, but Johnson & Johnson and other talc powder manufacturers called the findings inconclusive.

A recent study funded by the National Cancer Institute and the National Institutes of Health found a 36-41 percent increase in ovarian cancer related to the use of talc. The study advised women to immediately stop using the product.

Several studies have reported a positive association between perineal use of talcum powder among adult women and ovarian cancer risk…

Conclusion:

Our results suggest that perineal talcum powder use increases the risk of endometrial cancer, particularly among postmenopausal women.

For these reasons and many others, the Talcum Powder lawyers at Childers, Schlueter & Smith continue to review and investigate Talc cases in patients diagnosed with Ovarian Cancer.  If you have questions about a potential claim or just need more information, please contact our office right now to see how we can help.

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Should I Talk To Broadspire About My Stryker Hip Replacement Claim?

July 9th, 2014

Stryker Medical has elected to use the company Broadspire Services to help manage claims and recalls of the defective Rejuvenate and ABG II hip systems. Broadspire representatives are allegedly approaching Stryker hip lawsuit clients and offering lower forms of compensation to them, including an immediate sum of money in exchange for an agreement not to sue the company and a release to forever waive all their legal rights no matter what the future may hold. Broadspire is hoping to save the company millions of dollars at the expense of affected consumers and patients.

Stryker is one of several manufacturers of the implants that were recalled by the FDA in July 2012. The recall was initiated due to potential risks with the hip replacement systems, including fretting and/or corrosion at the modular-neck junction of the system. The Stryker system reportedly had a high early failure rate that resulted in the need for patients to undergo revision surgeries to replace the devices more often than with other hip replacement systems. For more information on the Stryker Hip Implant Recall-See our previous post on the “Top 10 Things All Stryker Hip Implant Patients Need To Know

FDA Approval

Stryker received approval from the FDA to sell the Rejuvenate system in the U.S. in 2008, and the ABG II system was approved for sale in 2009. Both were approved through the FDA’s controversial 510(K) medical device (“short-cut”) approval process, which allows manufacturers to market and sell medical devices without any pre-market testing or clinical trials, provided the manufacturer can prove that the device is substantially similar to a device already on the market. As a result, rather than testing artificial hips before they were marketed and sold, Stryker only conducted post-market surveillance.

Complications

Known complications associated with the Rejuvenate and ABG II systems include:

  • Blood toxicity from metal debris
  • Misalignment and loosening of system components
  • Intensified pain
  • Pseudo tumors
  • Metallosis
  • Tissue and bone necrosis

The treatment required to correct these complications is often a very complicated revision surgery in which the entire femoral system is removed and replaced with another larger metal stem. Because the stem is inserted down the center of the femur bone, removal is difficult and often results in fractures to the femur, which then has to be repaired with more metal hardware. The recovery process is often long and complicated, with a high potential for permanent loss of hip function and mobility.

The Stryker hip implant lawyers at Childers, Schlueter & Smith continue to review and investigate new Rejuvenate and ABG II hip implants on a daily basis.  If you have received a call from a Broadspire representative and have questions about your potential claim call us for a free initial evaluation and review.

 

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Xarelto Linked to Dangerous Side Effects

July 8th, 2014

Since the drug Xarelto (Rivaroxaban) was approved by the U.S. Food and Drug Administration to treat atrial fibrillation, a condition that causes blood to pool in the storage chamber of the heart where it can clot and travel to the brain, there have been over 2,100 reports made to the FDA regarding adverse side effects involving the drug, with over 1,800 listing Xarelto as the primary culprit.

xarelto What is Xarelto?

Xarelto is an anticoagulant drug that was first approved by the FDA in 2011. It is co-marketed by Bayer and Johnson and Johnson, and belongs to a class of anticoagulants, or blood thinners, called direct factor Xa inhibitors. Xarelto has three main uses:xarelto 2

  • To reduce the risk of blot clots and stroke in patients with atrial fibrillation
  • To treat deep vein thrombosis and pulmonary embolism
  • To reduce the risk of blood clots in patients undergoing knee or hip replacement surgery

About 130,000 U.S. prescriptions were written for Xarelto in the first three months of 2012, despite concerns that the drug does not have a known antidote for a bleeding emergency and not all patients taking it have undergone testing ahead of time to ensure good kidney function.

Side Effects of Xarelto

Despite its uses, Xarelto has been linked to some serious and life-threatening side effects, including:

  • Uncontrolled bleeding events
  • Pulmonary embolism
  • Deep vein thrombosis
  • Gastrointestinal hemorrhage
  • Hemoglobin decrease
  • Cerebrovascular accidents
  • Hematoma
  • Edema peripheral
  • Dyspnea

Concerns About Xarelto

Physicians have also expressed concern that the use of Xarelto, which does not require regular blood monitoring or frequent doctor follow-up, might raise the risk of serious and uncontrolled bleeding events, stroke, and blood clots, particularly in patients who suffer from poor kidney function.

Early in 2014, an FDA panel rejected wider use of Xarelto, voting for the third time against recommending approval of the drug for use in the 90 days after an acute coronary syndrome (ACS). The panel remained unconvinced that the risk-benefit balance for the drug was favorable in the 90 days after an ACS.

If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Xarelto we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight for the maximum compensation for your injuries.

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FDA Requests Broader Warning for Blood Clots On Testosterone Products

July 1st, 2014

On June 20, 2014 the U.S. Food and Drug Administration made a statement that all testosterone products on the market need to include a general warning about the risk of blood clots in veins on their warning labels.

Although testosterone products already carry a warning about the risk of clots related to polycythemia, a condition that sometimes happens with testosterone treatment. Polycythemia is an abnormal increase in the number of red blood cells that can lead to blood clots. Testosterone products are also the focus of an FDA investigation into the risk of stroke, heart attack, and death in men taking such medications.

In its latest report, the FDA said that after receiving reports of blood clots in the veins unrelated to polycythemia in patients taking testosterone products, it decided to require a more general warning on the labeling. Blood clots in the veins include deep vein thrombosis, or DVT clots typically found in the legs, and pulmonary embolism, a potentially deadly event that occurs when a clot breaks away and travels to the lungs. The FDA also advised doctors to consider whether the benefits of testosterone treatment outweigh the potential risks.

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are approved for use in men who lack or have low levels of testosterone (low-T) in combination with an associated medical condition. These medical conditions include failure of the testicles to produce testosterone because of genetic problems or chemotherapy. Approved formulations include topical gel, transdermal patches, buccal system, and injection.

Symptoms of low-T include:

  • Loss of libido
  • Decreased muscle mass
  • Fatigue

Products affected by the FDA request include AbbVie Inc’s AndroGel, Endo International Plc’s Aveed and Trimel Pharmaceuticals Corp’s Natesto. AndroGel, a testosterone gel applied to the shoulder and upper arm, and Axiron, a solution applied to the underarm, are two of the most commonly prescribed and heavily marketed testosterone products. For example, sources say that AbbVie spent $80 million on marketing AndroGel in 2012 alone.

If you or a loved one has suffered cardiac complications or blood clot injuries as a result of taking testosterone therapy, consult with one of our Georgia Testosterone Supplement Lawyers to explore your legal rights. Our attorneys are committed to holding these drug manufacturers accountable. Contact us today for a free consultation.

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Boston Scientific Mesh Implant Lawsuits Moving Forward

June 17th, 2014

More than 50,000 federal product liability lawsuits have been filed by women who were injured by transvaginal mesh products implanted to repair pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). Over 5,000 of those cases have been filed against Boston Scientific specifically. According to court documents, the first bellwether trial involving eleven Boston Scientific mesh implant cases will begin on October 14, 2014.

Boston Scientific has been manufacturing transvaginal mesh products since 1996, when the company introduced ProtoGen, the first vaginal sling. After hundreds of adverse reports, Boston Scientific recalled the device in 1999 and settled hundreds of lawsuits for an undisclosed sum in 2003.

Despite the issues with ProtoGen, Boston Scientific has continued to produce, market, and sell similar polypropolene mesh devices that the U.S. FDA now says may be equally as dangerous as ProtoGen. Boston Scientific has sold transvaginal mesh products under the following names:

  • Advantage Transvaginal Mid-Urethral Sling System
  • Uphold Vaginal Support System
  • Prefyx Mid U Mesh Sling System
  • Prefyx PPS System
  • Prefyx PPS System
  • Obtryx Transobturator Mid-Urethral Sling System
  • Polyform Synthetic Mesh
  • Pinnacle

According to the FDA, once the mesh has been inserted, many patients experience mesh erosion or extrusion as the tissue begins to form through the porous mesh material, causing extreme pain and infection. By 2010, the FDA estimated that it had received more than 4,000 adverse event reports regarding transvaginal mesh implants, such as:

  • Infection
  • Pelvic pain
  • Pain during sexual intercourse
  • Organ perforation
  • Urinary problems
  • Vaginal bleeding
  • Neuro-muscular problems
  • Vaginal scarring and/or shrinkage

Because of the risk of serious injury, consumer advocates as well as legal and medical experts are advocating that transvaginal mesh products be recalled and banned. Many also demand new legislation to prevent injury to more women in the future from these defective mesh implants.

Contact the experienced medical device lawyers of Childers, Schlueter & Smith, LLC for a free initial consultation. We will listen to your story and explain your legal rights to help you choose the best course of action for your claim.

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Hi-Tech Ordered to pay over $40M for Deceptive Diet Supplement Advertising

June 15th, 2014

On May 14, 2014 a Georgia federal court handed out contempt sanctions, ordering Hi-Tech Pharmaceuticals and three of its directors to pay more than $40 million to consumers for violating a 2008 court order relating to the advertising and labeling of Hi-Tech’s diet supplements. The court also demanded an immediate recall of four of the company’s products dietary supplements – Fastin, Lipodrene, Benzedrine, and Stimerex-ES – that featured deceptive labeling with false claims regarding the products’ effectiveness.

Procedural History

In 2008, the court enjoined the defendants from advertising the weight-loss products without substantiated, competent and reliable scientific evidence, but in 2011, the company began running print advertisements in national magazines and through its website with claims that violated the 2008 injunction. The advertising was not removed from the company website until January 2014, approximately five months after the court had found the defendants in contempt.

In 2009, Hi-Tech Pharmaceuticals CEO Jared Wheat and several other executives spent 18 months in federal prison for violating an FDA request barring him from marketing or selling more than a dozen different supplements. It was in prison that Wheat implemented Hi-Tech’s national marketing campaign that was featured in USA Today, Cosmopolitan, Women’s Day, Redbook, and The National Enquirer, among others.

Dangerous Side Effects

Besides questionable effectiveness regarding weight loss, the supplements in question can also lead a number of potentially serious side effects:

  • Fastin – highly addictive and can lead to physical and psychological dependence
  • Lipodrene – may cause nausea, dehydration, constipation, sleep complications, and cardiovascular issues
  • Benzedrine – a stimulant with characteristics similar to amphetamine
  • Stimerex-ES – raises heart rate and blood pressure

Wheat and Senior Vice President Sean Smith will face jail time if they fail to comply with the court’s order, and to date they still have not fully paid the $15.8 million in regulatory fines they were ordered to pay in 2008. The judge also permanently banned Wheat from continuing to rely on unsubstantiated representations to sell expensive supplements. The contempt actions came at the urging of the Federal Trade Commission, the U.S. Food and Drug Administration, and Georgia federal prosecutors.

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Testosterone Lawsuits Consolidated in Illinois Federal Court

June 13th, 2014

By order of a panel of federal judges, all product liability lawsuits filed in district courts nationwide involving injuries associated with testosterone replacement therapy (TRT) will now to be centralized before one judge in the Northern District of Illinois as part of a multidistrict litigation (MDL).

45 Lawsuits Affected So Far

The ruling impacts a minimum of 45 lawsuits filed against the makers of AndroDerm, AndroGel, Axiron, Depo-Testosterone, Foresta, and Testim. Any future cases involving any testosterone cream, gel, injection, or other prescribed treatment will also be transferred to the MDL.

The rationale behind centralizing the litigation appears to be the fact that all the low T drug lawsuits involve common allegations that the medications caused users to suffer heart attacks, strokes, blood clots, and other cardiovascular injuries. The MDL will also reduce the risk of duplicative discovery, avoid conflicting rulings, and be more convenient for the parties, witnesses, and the courts.

AndroGel Main Culprit

Most of the complaints brought so far involve problems associated with the use of AndroGel, the most widely used testosterone treatment. AndroGel has been used by millions of U.S. men since it was approved by the FDA in 2000, but new studies warn that that the medication may significantly increase the risk of heart attack, stroke, cardiovascular injury, and death.

Although AndroGel is approved only for the treatment of certified low testosterone levels, a study has shown that 43 percent of those given the drug didn’t even have low testosterone levels. Instead, the drug’s manufacturer, AbbVie, is alleged to have been promoting it for common symptoms including stress, fatigue, and low sex drive, netting the company earnings of over $1.15 billion in 2013.

FDA Study

The FDA first announced on January 31, 2014 that it was reviewing the risk of stroke, heart attack, and death among men taking any approved testosterone drugs. The investigation was launched following several studies published in recent months that addressed the potential link between low t drugs and heart attacks.

One such study published by the medical journal PLOSOne in January 2014 found that low testosterone treatments may double the risk of heart attack in younger men with heart disease and in those over 65, regardless of any prior heart conditions. It is expected that several thousand cases will ultimately be included in the low t MDL.

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