Articles Posted in Defective Drugs

Qualitest, a subsidiary of Endo Health Solutions (Nasdaq: ENDP), a US-based diversified healthcare company, has launched a voluntary, nationwide recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13. The recall began just this past Monday, September 10, 2012.

The recall was initiated when it became apparent that, possibly, some of the tablets from lot C1440512A may exceed the weight specifications and run the risk of being overly potent with the ingredients of hydrocodone bitartrate and acetaminophen. With bottles from the affected lot potentially having higher dosages of acetaminophen than ascribed on the labels, consumers have been put at risk of overdosing on the ingredients in the medication.

One of the primary risks of over-medicating with acetaminophen is an affected liver toxicity. This danger becomes especially significant for patients who are already taking other medications that contain acetaminophen, patients who suffer from liver dysfunctions, or those who have at least three alcoholic drinks per day. In the most extreme cases, an excess of acetaminophen could lead to severe liver damage, the need of a liver transplant, or death.

According to a study conducted by the US National Library of Medicine and National Institutes of Health, acetaminophen overdoses account for about 56,000 emergency room visits annually, along with 26,000 hospitalizations. National mortality files show that an average of 458 people die from a reaction to acetaminophen, with about 100 of those deaths being unintentional.
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The Food and Drug Administration has approved pioglitazone, which is the first generic version of Actos, a medication used to treat type 2 diabetes. The approval comes even as the number of Actos lawsuits continues to grow, as do concerns and mounting evidence that the drug may have a causal connection to bladder cancer. Pioglitazone comes from Mylan Pharmaceuticals. This generic will come with the same warnings as Actos, including one stressing that pioglitazone may cause or exacerbate heart failure or up the risk of bladder cancer.

A recent study that can be found in the Journal of the National Cancer Institute is the latest one to find that diabetes drugs with thiazolidinedione is linked to a two to three times greater risk of developing bladder cancer than if the patient were to take a diabetes medication with sulfonylurea. Conducted by researchers at the University of Pennsylvania, the study reported that this risk occurs when the drug is taken for more than five years. A little over a year ago, the FDA announced that taking Actos for longer than a year may up the bladder cancer risk.

Meantime, more people are coming forward to file their Actos lawsuits against drug maker Takeda Pharmaceuticals, its subsidiaries, and Eli Lilly, which has been active in marketing the diabetes drug in the US. Among the complaints is a California dangerous drug case involving 12 plaintiffs who believe that the reason they developed bladder cancer was because they were taking Actos. They believe the defendants should have done a better job warning about this cancer risk, knew this danger existed as far back as 1999 before it even sought FDA approval for the med, and that Takeda continued to hide this health risk with issuing inadequate warnings. They want compensatory damages for their personal injuries, mental anguish, pain and suffering, physical impairment, economic losses, and other damages.

Getting a diagnosis for bladder cancer can be a death sentence. It can also lead to invasive, painful, and costly procedures that can irrevocably alter your life and the lives of your loved ones. In addition to the physical pain and suffering, there is also the accompanying psychological and emotional pain that can result. Chemotherapy, radiation, and other treatments can take their toll. To find out that a medication that was supposed to help you caused your cancer can feel like a huge betrayal.

All Actos lawsuits are being consolidated in a federal court in Louisiana under the Actos Products Liability Litigation, MDL 2299. Working with a dangerous drug law firm that handles Actos lawsuits can increase your chances of a successful case outcome.

FDA approves first generic Actos to treat type 2 diabetes, US Food and Drug Administration, August 17, 2012

Association Between Longer Therapy With Thiazolidinediones and Risk of Bladder Cancer: A Cohort Study, JNCI, August 9, 2012

Twelve People File Actos Bladder Cancer Lawsuit in Los Angeles Alleging Manufacturer Misled Public Regarding Risks, the Consumer Justice Foundation Reports, Digital Journal, August 23, 2012

More Blog Posts:
Actos Lawsuits Allow Diabetes Patients to Pursue Dangerous Drug Compensation from Takeda Pharmaceuticals America, Inc., Drug Injury Lawyers Blog, August 1, 2012

Study Links Depo-Provera to Greater Breast Cancer Risk in Young Women, Drug Injury Lawyers Blog, July 16, 2012

Makers of Paxil, Celexa, Zoloft, and Other SSRI Antidepressants Named as Birth Defect Lawsuit Defendants, Drug Injury Lawyers Blog, August 13, 2012

New FDA Report Suggests Exercising Caution About Using Fosamax Long-Term, Boston Injury Lawyers Blog, May 11, 2012 Continue reading

On August 28, 2012, the Food and Drug Administration initiated a voluntary recall of the weight loss supplement, EphBurn 25. Brand New Energy, a dietary supplement retail distributor, began carrying out the recall of all lot codes of EphBurn 25. The pulling of EphBurn 25 became necessary after the Food and Drug Administration purchased and sampled a lot of the supplement and found that it contained ephedrine alkaloids, immediately making it an unapproved drug.

Controversy surrounding ephedrine alkaloids first became public in 1997. Mounting concern over harmful side effects initially led to the FDA capping how much could be used in each product and pushing for stricter labeling. In response, the supplement industry pushed back with studies from private firms confirming that ephedrine alkaloid was perfectly safe. The push and pull lasted for years with companies spending millions to suppress legislation. But along with death and disability occurring in young adult athletes, a few professionals were found to have died from the supplement. The ban in the United States officially came to fruition on February 6, 2004. The ruling was struck down in 2005 but then reversed back four months later. The injunction however does not apply to Chinese herbal remedies or herbal teas considered to be conventional food. And despite the ban, and the risks of the stimulant being public knowledge, it’s estimated that 14% of people using non-prescription weight loss products take ephedra.

Ephedrine is commonly used as a stimulant, for the suppressant of appetites, for enhancing concentration, as a decongestant, and for weight loss. The list of reported side effects attributed is considerable: elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, psychosis, memory loss, heart attacks, stroke, and death. There have not been any reported side effects with EphBurn 25. But the supplement was previously discontinued this past May.
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Approved by the Food and Drug Administration in 1993, over-the-counter pain medication Cataflam has been linked to serious birth defects in infants born to women who took the medication while pregnant. If your child was born with congenital abnormalities that you suspect may be a result of this drug, contact our Cataflam birth defect lawyers at Altman & Altman LLP today.

This non-steroidal anti-inflammatory drug is a Novartis Pharmaceuticals product. Cataflam is approved as a pain reliever and to treat symptoms-stiffness, swelling, tenderness, and pain-caused by rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Unfortunately, some researchers now believe that Cataflam may be the reason why some pregnant moms are delivering babies with serious birth defects, such as:

Spina bifida: This is a neural tube defect that involves the creation of an opening in the spinal area close to the skull. This exposes a baby’s spinal cord to the mother’s amniotic fluid, which can increase the risk of permanent nerve damage and paralysis.

If you are a mother who was taking antidepressants while pregnant and your child was born with a serious birth defect, you may have grounds for an SSRI birth defect lawsuit against the manufacturer. SSRIs, selective serotonin re-uptake inhibitors, is a class of anti-depressants that are Food and Drug Administration-approved to treat depression, anxiety disorders, panic conditions, obsessive-compulsive disorder, and premenstrual dysphoric disorder.

Unfortunately, there has been growing concerns that these medications, when taken by a women while pregnant, can significantly increase the chances of her baby being born with a birth defect, such as tetralogy of fallout, ventricular septal defects, a hole in the heart, persistent pulmonary hypertension, neural tube defects, cranial birth defects, club foot, a cleft lip, spina bifida, anal atresia, a cleft palate, neural tube defects, Omphalocele, limb birth defects, or other birth defects. Already, there have been SRRI lawsuits filed by families over the severe defects sustained by their infants because of these medications. Some of these defects are serious enough to warrant intensive medical care or even a full heart transplant.

Many of the plaintiffs believe SRRI antidepressant manufacturers have been failing to provide adequate warnings about how dangerous it is for a pregnant woman to take these medications.

Diabetes patients who are wondering whether their serious health complications may be a result of taking Actos should contact our drug injury law firm right away. Throughout the US, Altman & Altman, LLP represents clients with Actos lawsuits against manufacturer Takeda Pharmaceuticals America, Inc.

Actos is still sold in the US even though last year the US Food and Drug Administration put out a safety warning that pioglitazone-Actos is the brand version-may increase the chances of bladder cancer when taken for more than a year. Meantime, after an official French study found this same connection, Germany and France both suspended the sale and use of this drug.

The evidence of the serious health risks involving Actos keeps growing. Among several studies rendering similar results was the one published in the British Medical Journal in May. According to McGill University researchers in Montreal, an evaluation of over 115,000 patients found that taking Actos for more than two years doubles the bladder cancer risk. They also found that Actos users with type II diabetes that were taking the drug for the first time had an 83% greater risk of developing bladder cancer than other patients. Considering that the drug is generally prescribed to treat type II diabetes, this finding is disturbing.

Now, the number of people stepping forward to file their Actos injury lawsuits is growing. Among the plaintiffs’ allegations is that Takeda either knew or should have known that prolonged use of Actos came with such serious health complications and that the drug maker should have warned the public. Recently, one woman filed a $10 million Actos lawsuit against Takeda because she was diagnosed with bladder cancer last year after regularly taking the drug for five years. Many of the plaintiffs are also wondering why, with so much evidence linking Actos to bladder cancer, the manufacturer has not added adequate warnings to its label.

Thousands of Actos lawsuits are expected to be filed by the drug’s victims when all is said and done. In an addition to multidistrict litigation cases, there are large consolidated court cases in California and Illinois. Meantime, Takeda is also contending with a whistleblower lawsuit accusing the pharmaceutical company of regularly concealing incriminating information so that drug so that regulators would think that Actos didn’t come with such high risks.

The whistleblower, Dr. Helen Ge, formerly worked for Takeda. She is the one who put together a lot of the safety reports about Actos that were required by the FDA. She claims that her superiors pressured her to downplay the drug’s side effects and modify the reports.

Symptoms of Bladder Cancer:
• Blood in the urine • Straining or pain during urination • Urinating often • Incontinence • Fatigue • Bone tenderness • Pain • Weight loss
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer, FDA, June 15, 2011
The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study, British Medical Journal, May 31, 2012

More Blog Posts:
Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyer Blog, June 19, 2012

Pradaxa Lawsuits Seek Damages for Bleeding Injuries, Boston Injury Lawyer Blog, July 25, 2012

Study Links Depo-Provera to Greater Breast Cancer Risk in Young Women, Boston Injury Lawyer Blog, July 16, 2012 Continue reading

Two more plaintiffs have come forward seeking drug injury compensation from Boehringer Ingelheim Pharmaceuticals Inc. for the harm they have suffered from taking Pradaxa. They contend that the anticoagulant caused them to bleed profusely, resulting in serious health issues.

In her Illinois Pradaxa case, Jacqueline Boston says that she was hospitalized for two weeks after suffering from serious gastrointestinal bleeding within a few days of taking the medication. She claims that she now will have to undergo medical monitoring and continue on certain drugs for life because she took Pradaxa.

Boston is accusing Boehringer Ingelheim of failing to adequately warn patients about the risks involved with taking the anticoagulant. She says that had she known that bleeding profusely was a possible side effect, she wouldn’t have taken Pradaxa.

In his Louisiana Pradaxa complaint, Arnold R. Sykes claims that he suffered severe rectal bleeding and start to spit up blood not long after being prescribed the drug for treatment of atrial fibrillation in 2011. Just a month after taking the medication, Sykes collapsed and had to be admitted to an ICU, where he was given blood transfusion and told to get off Pradaxa ASAP. He says he underwent several medical procedures to save his life.

Sykes contends that no one ever told him that taking Pradaxa could result in life-threatening injuries or that the drug came with more possible serious side effects than blood thinner Warfarin. He says that if he’d known that he might bleed profusely from taking Pradaxa, he would have chosen a different course of treatment.

Pradaxa Lawsuits
Our Pradaxa injury lawyers cannot stress the important of drug manufacturers making sure that a medication’s label warns of any dangerous risks or side effects that can result. It is imperative that a patient is informed of what they might have to contend with should they suffer a serious reaction to taking any medication.

However, although the US Food and Drug Administration has authorized Boehringer Ingelheim to update Pradaxa’s drug label, which includes a warning that there is no reversal agent, where is the warning that the blood thinner comes with the risk of hemorrhaging and even death? Not only can Pradaxa cause a patient to bleed uncontrollably, but this blood thinner doesn’t have an antidote to counteract this particular blood thinner. How then can doctors stop such serious bleeding complications, except through emergency dialysis, which in itself is a complicated procedure with its own risks?

FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate), FDA, December 7, 2011

Pradaxa Warnings and Precautions, Drugs.com

More Blogs:
Pradaxa Lawsuit Claims Drug’s Side Effects Caused Woman to Bleed to Death, Boston Injury Lawyer Blog, April 30, 2012

Study Links Depo-Provera to Greater Breast Cancer Risk in Young Women, Drug Injury Lawyers Blog, July 16, 2012
Israeli Court Awards Highest-Ever Compensation in Class-Action Suit against Drug Company, Drug Injury Lawyers Blog, July 10, 2012 Continue reading