February 19, 2010

More illegal off-label marketing? Fentora now under investigation

The drug Fentora is Cephalon’s next generation narcotic painkiller which is only approved for cancer patients who are in severe pain and already taking morphine or other painkillers. In other words, this drug should only be used for those cancer patients whose normal pain medications are not providing pain relief. This highly addictive drug is considered a “Class II” opiate, 80 times more powerful than morphine. So why are thousands of patients taking this drug for migraines, back pain and other injuries?

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November 6, 2009

New Safety Warnings About Diabetes Drug and Kidney Functions

Recently, the safety warnings were strengthened for the diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease. Specifically, the US Food and Drug Administration ("FDA") notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

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October 11, 2009

Even More Dangers of Taking SSRIs When Pregnant Revealed

According to a recently released Danish study, pregnant women taking an SSRI were twice as likely to have pre-term delivery as other women, and their babies were also more likely to be admitted to an intensive care unit after delivery. Specifically, women taking an SSRI delivered their baby an average of five days earlier and babies exposed to antidepressants during pregnancy were far more likely to have a five-minute Apgar score -- a measure of a newborn's health scored between 0 and 10 -- of seven or below. Any score below seven is generally regarded as low.

Additionally, the study found that women who take more than one SSRI quadrupled the risk of their babies experiencing a septal heart defect, which is a defect in the wall that divides the heart’s left and right sides. For those women taking only one SSRI, the study revealed that use of Celexa and Zoloft early in pregnancy doubled and tripled the risk for the heart defect, respectively. While the association between SSRIs and birth defects has been reported for several years, this is the first study to specifically highlight the increased risk with Celexa and Zoloft.

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August 15, 2009

Risks of Heart Attack and Stroke with Asthma Drug Xolair

On July 16, 2009, the FDA announced that it has begun a safety review of Genentech's asthma drug Xolair (omalizumab) after reports of an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The Xolair safety review was prompted by interim results from an ongoing study of 5,000 patients with allergic asthma, in which half of the patients took Xolair and half did not. The early results showed a "disproportionate increase" in certain cardiovascular and cerebrovascular problems in patients treated with Xolair.

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August 14, 2009

SSRIs and the Suicidality Risk: Class Numbers Belie a Deeper Story

On August 11, 2009, the British Medical Journal published an article detailing the results of a study aimed at measuring the association between modern antidepressants (Prozac, Paxil, Zoloft, Celexa, Lexapro, etc.) and increased suicidal thinking and conduct. August 11, 2009 BMJ Article

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August 10, 2009

FDA Warns of Cancer Risks with TNF Blockers

On August 4, 2009, the Food and Drug Administration stated that it had completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. Therefore, the FDA said that a new cancer-related warning will be added to the black boxed warning that’s already on this category of drugs, which includes Remicade, Enbrel, Cimzia, Simponi, and Humira. Additionally, the FDA is requiring that the warning also be modified to specifically reflect the occurrence of leukemia and new-onset psoriasis in patients of all ages being treated with TNF blockers. The current boxed warning only alerts users to a risk of serious infections that can be fatal.

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August 3, 2009

Zicam Causing Loss of Smell?

Recently, the FDA advised consumers to stop using Zicam intranasal products, including Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs (Kids Size). These products contain the active ingredient zinc gluconate and are manufactured by Matrixx Initiatives, Inc., which had been marketing and selling the products as over-the-counter homeopathic cold remedies.

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August 1, 2009

Steam Dietary Supplement Recall

On July 29, 2009, the FDA reported a voluntary recall of the dietary supplement “Steam,” which is manufactured and sold by Nutracoastal Trading, LLC. FDA Safety Summary.

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July 28, 2009

Body-Building Supplements May Contain Steroids

Yesterday, July 28, 2009, the FDA issued a Public Health Advisory recommending that consumers not use certain over-the-counter products marketed as containing “steroid-like ingredients.”

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July 25, 2009

Federal Court Grants Public Access to Evidence of Wyeth's Ghostwriting

In his July 24 ruling, U.S. District Court Judge Bill Wilson, Jr., granted public access to evidence that Wyeth Pharmaceuticals "ghostwrote" medical articles regarding its hormone therapy drug Prempro, which a national study has shown increases a woman's risk of stroke, heart attack, blood clots, cardiovascular disease, and cancer. The Arkansas federal judge held that there was no good cause for secrecy and ordered that the documents be made publicly available as of 5:00 p.m. on Friday, July 31.

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July 7, 2009

Lantus Insulin Linked with Increase in Cancer

The European Association for the Study of Diabetes ("EASD"), which publishes the journal Diabetologia, released new data suggesting that there is a “possible link” between French drug maker Sanofi-Aventis’s Lantus insulin (or insulin glargine) and a higher risk of cancer. Lantus insulin has been widely used since 2000 among diabetes patients who depend on insulin to regulate blood sugar because the injection is needed only once-a-day in lieu of more frequent therapies. Of particular import is that this type of insulin is synthetic, not human insulin. The EASD article suggests that further evaluation of the possible association is necessary but does not purport to recommend that anyone stop taking their insulin.

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June 17, 2009

Norian Corp. and Synthes, Inc. --- Indicted for Illegal Testing of Bone Cement without FDA Approval Resulting in Patient Deaths

The U.S. Attorneys Office in Philadelphia has filed charges against various executives of Synthes, Inc., a subsidiary of Norian Corp., for “illegally tested bone cement during spinal surgery on about 200 patients, three of whom died on the operating table.”

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June 15, 2009

Heartburn Drugs Linked to Pneumonia in Hospital Patients

A new study from the May 27 issue of the Journal of the American Medical Association (JAMA) entitled "Acid-Suppressive Medication Use and the Risk for Hospital-Acquired Pneumonia" has found that hospital patients who are given certain heartburn drugs like Prilosec, Nexium, and Prevacid are at higher risk for pneumonia than those who are not given these medications. In fact, the study determined that there was a 30% increased risk for pneumonia among hospital patients taking these types of medications, called proton-pump inhibitors (PPIs).

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June 5, 2009

FDA Warns of Hepatoxicity with Propylthiouracil

This week, the Food and Drug Administration (FDA) notified doctors and other healthcare professionals about the risk of serious liver injuries, including liver failure and death, related to use of the antithyroid drug Propylthiouracil. Propylthiouracil is considered a second-line drug to Methimazole in the treatment of hyperthyroidism and Graves' Disease. Methimazole only had five reports of serious liver injuries associated with it compared to the thirty-two (32) reported cases associated with Propylthiouracil. Thirteen of those thirty-two cases resulted in death.

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May 30, 2009

Another Digoxin Product Recall

Earlier this month, the Food and Drug Administration and AS Medications Solutions LLC (a repackaging company) announced a nationwide recall of all lots of Caraco brand digoxin distributed prior to March 31, 2009. There is uncertainy over the actual amount of the active ingredient present in each pill, with some tablets containing more or less than the intended .25mg. Digoxin is a drug used in the treatment of heart failure, atrial fibrillation, and abnormal heart rhythms. Accordingly, any unintended dosage can have serious consequences. An overdose of digixin can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, slow heart rate, and even death in extreme cases. Meanwhile, a patient getting a lower dose than expected is at risk for heart failure or abnormal heart rhythms.

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April 17, 2009

FDA finally orders Black Box on Reglan and others containing metoclopramide

At the end of February, the FDA ordered that a "black box" warning highlighting the risk of tardive dyskinesia ("TD") and other serious neurological side effects be placed on all drugs that contain metoclopramide, including Reglan. Although the FDA has long been aware of the risk of TD when dopamine blockers such as Reglan are used, apparently the drug is still being prescribed for longer periods of time than the 4-12 week recommendation, which only further increases the likelihood of developing TD, an untreatable disorder with life-altering, sometimes permanent, symptoms.

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April 9, 2009

Psoriasis Drug - Raptiva - Withdrawn From the Market

As we reported in October, pharmaceutical drug manufacturer, Genentech, was required by the Food and Drug Administration (FDA) to put a black boxed warning on the labeling for Raptiva regarding its association with dangerous and life-threatening infections like progressive multifocal leukoencephalopathy ("PML"). Today, Genentech voluntarily withdrew Raptiva, a psoriasis drug, from the market as a result of those risks.

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March 6, 2009

MRI Transdermal Patches --- Risk of Skin Burns

The U.S. Federal Food & Drug Administration is warning healthcare professionals today that transdermal patches (medicated patches applied to the skin) “containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch.”

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December 16, 2008

Black Box Warning added on Visicol and OsmoPrep for Effects on Kidneys

Before having a colonoscopy, patients have to go through the process of flushing out their bowels. However, new information indicating that this may be the most dangerous part of the procedure, as the drugs products that assist in the flushing may pose a risk of acute kidney injury.

The Food and Drug Administration has mandated Salix Pharmaceuticals Ltd., the manufacturer of two of the most commonly used prescription flushing products, Visicol and OsmoPrep, to put a "black box" warning on its labels. A "black box" warning is the most severe warning that the FDA issues on prescription medications. The agency further directed the drug manufacturer to conduct a clinical trial to specifically assess the risk of the products, especially to the kidneys.

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December 8, 2008

Asthma Drugs (Advair, Foradil, Serevent and Symbicort) -- FDA Reports a Mixed Bag

After reviewing clinical trial data for four asthma related medications, including Advair, Foradil, Serevent and Symbicort, the FDA has released the results of its findings, including that "Serevent, had a significantly higher rate of serious complications, and even deaths."

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November 7, 2008

FDA Mulls a Ban on Avandia

The FDA recently announced that it would consider whether to pull GlasxoSmithKline’s former top-selling drug, Avandia, off the market or allow it to stay on the market with stronger warnings after discovering evidence indicating that the drug may cause liver toxicity, resulting in liver failure and death.

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October 28, 2008

Decoy Indication: New Hybrid Method for Off Label Promotion of Medications?

A recent article published by the Public Library of Science Medicine (PLoS Medicine), has highlighted new innovative ways in which pharmaceutical companies are promoting medications for off-label use.

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October 20, 2008

Pfizer Will Agree to Pay $894 Million to Settle Celebrex and Bextra Claims

Pfizer has recently announced that it will "resolve substantially all of the personal injury cases, consumer fraud cases and state attorneys general claims involving its non-steroidal anti-inflammatory (NSAID)" pain medications Bextra and Celebrex, which Pfizer voluntarily withdrew from the U.S. market in 2005.

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October 19, 2008

Psoriasis Drug Raptiva Gets “Black Box” Warning - Associated Risk of Infection and PML

Just this week, the psoriasis drug Raptiva received a “black box” warning, the FDA’s strongest, regarding progressive multifocal leukoencephalopathy (PML) and other potentially fatal infections. Raptiva, manufactured by Genentech, is a medication given via weekly injection to treat moderate to severe plaque psoriasis in adults only. Raptiva is a biologic drug that works to suppress the immune system with the goal of fewer psoriasis flare-ups. However, as with any immunosuppressant, the use of Raptiva compromises the immune system to such an extent that it increases the risks of serious infections, some fatal, and other malignancies.

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October 13, 2008

Pfizer Supressed Neurontin Study Showing Lack of Effectiveness for Chronic Nerve Pain

In newly filed court documents, evidence has surfaced showing that top marketing executives from Pfizer "suppressed a large European study suggesting their blockbuster medication Neurontin was ineffective for chronic nerve pain."

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October 2, 2008

Unapproved BSS and Papain Products

On September 23, 2008, as part of what the FDA is calling its “unapproved drug initiative,” the FDA ordered manufacturers of two different unapproved drug product types to stop manufacturing and shipping the products.

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September 22, 2008

New Study Finds New Anti-Psychotics for Kids No Better Than Generics

A recent government study published in the American Journal of Psychiatry, has concluded that two of the most commonly prescribed atypical anti-psychotics, Janssen's Risperdal and Eli Lilly's Zyprexa, “neither performed any better in children and adolescents than an older generic drug.”

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September 2, 2008

Recently Filed Levaquin Tendon Rupture Case Highlighted

On August 28, 2008, the Law firm of Pogust, Braslow, & Millrood, LLC filed a complaint in the U.S. District Court for the District of Minnesota, against Johnson & Johnson, Inc., alleging that its antibiotic Levaquin caused a woman to suffer a tendon rupture.

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August 25, 2008

Mandatory Disclosure of Doctor-Drug Industry Payments?

The American Medical Association (AMA) is ramping up its efforts to stifle the stigma of impropriety among consumer advocates and patient groups, by proposing to add specific guidelines requiring physicians to disclose their financial ties to the pharmaceutical and medical device industry with patients.

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August 21, 2008

Possible Association Between Vytorin, Zocor, and Zetia and an Increased Risk of Cancer

Use of the cholesterol drugs Zocor (Simvastatin), Zetia (Ezetimibe), and Vytorin (Simvastatin + Ezetimibe) may be associated with an increased risk of some types of cancer.

On August 21, 2008, the FDA posted an alert on its website, advising that early results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial indicated not only that Vytorin appears to be ineffective in reducing overall cardiovascular risk, but that the drug may bring with it an increased risk of a variety of cancers, including skin cancer.

In typical fashion, the FDA’s communication, available at http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm, follows the language alerting of the SEAS results with language equivocating as to the accuracy of the results, stating that other larger studies have shown no link between cholesterol-lowering drugs and cancer.

Although the FDA advises that consumers should not stop taking these drugs, it does not expect final SEAS results for another 3 months and will take an additional 6 months to review those results.

If your doctor has advised you that your ingestion of a cholesterol lowering drug may have contributed to any form of cancer that you have developed and you would like to consult with an attorney, please visit our website at http://www.pbmattorneys.com, or call us directly at (888) 348-6787.

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August 15, 2008

A Rise in Instances of Undeclared Ingredients in Herbal Supplements

Yet another supposed “all natural” or “herbal” supplement for erectile dysfunction contains precisely the ingredient that frequent users are intending to avoid. After an FDA lab analysis of a sample of the Viapro revealed that it contained an undeclared and potentially harmful ingredient, thio-methisosildenafil, EG Labs, LLC, announced that it is recalling all lots of its supplement product in 375mg capsules. Thio-methisosildenafil is an analog of sildenafil, which is the active chemical ingredient of several FDA-approved drugs used for Erectile Dysfunction (ED) in men to enhance sexual performance.

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August 8, 2008

Pain Pumps Only Causing More Shoulder Pain

In a 2006 presentation at an American Academy of Orthopedic Surgeons meeting, evidence was presented that showed that the anesthetics contained in pain pumps used after shoulder surgery lead to Postarthroscopic Glenohumeral Chondrolysis (PAGCL). In fact, studies now suggest that up to 63% of arthroscopic shoulder surgery patients who receive a post-operative pain pump may develop PAGCL. The condition leads to a lifetime of suffering, has no consistently successful treatment, and often results in permanent shoulder pain, loss of mobility and further surgery, specifically shoulder replacement surgery.

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July 31, 2008

Off-Label Use and the First Amendment: The Pathway to Naivety?

Daniel E. Troy, recently appointed General Counsel for GlaxoSmithKline and Former Chief Counsel for the FDA, has recently authored a letter to the editor in the New England Journal of Medicine entitled “Pharmaceutical Promotion and First Amendment Rights.”

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July 22, 2008

Vytorin’s Impotence -- Second Round of Clinical Trials Show Lack of Efficacy

The Associated Press is reporting Schering-Plough and Merck's recent clinical trial fiasco involving their highly touted anti-cholesterol pill Vytorin, whereby a “European study in patients with heart valve disease found the drug didn't prevent worsening of the disease or lower the need for valve surgery.”

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July 9, 2008

Cholesterol Screening for Children as Early as Age 2?

The American Academy of Pediatrics is now recommending cholesterol screening of children and adolescents, starting as early as the age of 2 and no later than the age of 10, especially if they come from families with a history of high cholesterol or heart attacks before 55 for men and 65 for women.

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July 8, 2008

Levaquin --- The New Reality, A Black Box Warning

The FDA has now issued a Black Box Warning to healthcare professionals setting forth the "increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use."

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July 5, 2008

Neurontin and Suicide: The FDA’s Big Gamble

On January 31, 2008, the FDA issued a warning to Health Care Professionals of an “increased risk of patients having suicidal thoughts and behaviours as a result of taking antiepileptic drugs for epilepsy, bipolar disorder, migraines, and other conditions.”

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July 3, 2008

Levaquin’s Achilles Heel: Tendon Ruptures

The current labeling for Levaquin presently warns that “ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin.”

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July 1, 2008

Depo-Provera -- The Onset of Osteoporosis?

On November 18, 2004, Pfizer, Inc., the manufacturer of Depo-Provera, a contraceptive injection, issued a warning to Health Care Professionals that “women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density.”

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June 30, 2008

Hormone Therapy Update

Hormone therapy has been in use as a purported treatment for women’s menopausal symptoms and the prevention of osteoporosis for almost three decades. Throughout the United States, in both State and federal courts, there are currently about 7,900 claims pending by women who have allegedly been injured by combination hormone therapy. The thrust of these lawsuits, which are being prosecuted against Wyeth and other makers of synthetic hormones, is that combination hormone therapy (horse estrogen plus synthetic progestin) can cause breast cancer, that Wyeth and the other drug makers have known about this risk for decades, and that the drug makers failed to warn physicians or consumers until they were forced to do so in July 2002. Publication of the results of a government-run study entitled the Women’s Health Initiative (WHI) in July 2002 revealed that women taking combination therapy, including Wyeth’s Prempro, are at in increased risk for invasive breast cancer, heart attack, stroke, pulmonary emboli, and deep vein thrombosis. The lawsuits also allege that Wyeth and the other drug makers illegally promoted the drugs for unapproved indications, including the prevention of cardiovascular disease, and that the companies over-promoted the benefits of the drugs while attempting to downplay their risks.

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June 28, 2008

Antidepressant Lawsuits: Paxil, Celexa and Lexapro

Products liability cases involving modern antidepressants in the class known as Selective Serotonin Reuptake Inhibitors (“SSRIs”) have enjoyed a relatively consistent, if intermittent, place in the media spotlight since the turn of the millennium. The SSRI group includes Prozac, Paxil, Zoloft, Luvox, Celexa, and Lexapro, and there have been a number of events thrusting these drugs into the spotlight, including two of the more prominent cases: that of 12-year-old Christopher Pittman, who killed his grandparents while he was experiencing what was alleged to be a violent reaction to Zoloft and Paxil; and that of 60-year-old Donald Schell, who killed his wife, their daughter, their granddaughter, and then himself after taking only two doses of Paxil. The former resulted in a murder conviction and thirty-year jail sentence in South Carolina, while the latter resulted in a civil verdict of approximately $8 million in Wyoming federal court against the maker of Paxil, SmithKline Beecham.

The deadly effects of SSRIs on children and adolescents has been well-documented: the potential to initiate or exacerbate depression or even cause suicidal thinking or behavior. Several manufacturers began sending out “Dear Dr.” letters warning physicians of these risks in and throughout 2004. By January 2005, manufacturers of SSRIs – and a few other modern antidepressants not technically considered SSRIs (e.g., Effexor, Wellbutrin, Cymbalta) – began warning of the risks in a black box warning contained on the labeling for each of the drugs. In 2006, the black box warning was extended to those beyond their adolescent years, all the way up to age 25.

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June 25, 2008

Failure to Warn of the risk of Suicide and Antidepressants is malpractice

It continues to amaze me that some physicians still do not warn their patients of the dangers of anti-depressants despite the specific and bold warnings on these drugs to carefully monitor patients for worsening depression and suicidality. Even the drug manufacturers admit that it is absolutely necessary for patients’ families to closely monitor patients for any changes in behavior after beginning or changing a dose with antidepressant drugs.

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June 25, 2008

Another Recall - Digitek

Recently, the pharmaceutical drug Digitek was recalled because Actavis Group, the manufacturer of Digitek, produced the drug with twice the intended dose of the active ingredient. In other words, a defect in the manufacturing process led to a doubling of the active ingredient contained in each tablet. Therefore, patients prescribed Digitek were receiving twice the intended dosage of the drug, and as expected, suffered severe adverse reactions effects to this unintended overdose - especially if they were previously suffering from renal failure.

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June 25, 2008

Baxter Recalls Contaminated Heparin

Recently, Baxter recalled its heparin products in the United States because of a contaminant found in the drug. Heparin is a drug used to prevent the formation of clots in the blood. The contaminant, a compound that looks like heparin under the microscope, was most likely added to the manufacturing process of the drug while in China.

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June 4, 2008

Brief History of NSF/NSD and Gadolinium

The Federal Drug and Food Administration issued in June of 2006 (and later with additional FDA Alerts in December 2006 and May 2007), a warning to Health Care Professionals, concerning Gadolinium Based Contrast Agents (GMCAs), used for Magnetic Resonance Imaging (MRI) and the risk of contracting Nephrogenic Systemic Fibrosis (NSF).

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