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.
Continue reading "FDA Mulls a Ban on Avandia" »
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.
Continue reading "Decoy Indication: New Hybrid Method for Off Label Promotion of Medications?" »
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.
Continue reading "Pfizer Will Agree to Pay $894 Million to Settle Celebrex and Bextra Claims" »
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.
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."
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.
Continue reading "Unapproved BSS and Papain Products" »
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.”
Continue reading "New Study Finds New Anti-Psychotics for Kids No Better Than Generics" »
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.
Continue reading "Recently Filed Levaquin Tendon Rupture Case Highlighted" »
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.
Continue reading "Mandatory Disclosure of Doctor-Drug Industry Payments?" »
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.
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.
Continue reading "A Rise in Instances of Undeclared Ingredients in Herbal Supplements" »
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.
Continue reading "Pain Pumps Only Causing More Shoulder Pain" »
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.”
Continue reading "Off-Label Use and the First Amendment: The Pathway to Naivety? " »
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.”
Continue reading "Vytorin’s Impotence -- Second Round of Clinical Trials Show Lack of Efficacy " »
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.
Continue reading "Cholesterol Screening for Children as Early as Age 2? " »
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."
Continue reading "Levaquin --- The New Reality, A Black Box Warning" »
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.”
Continue reading "Neurontin and Suicide: The FDA’s Big Gamble" »
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.”
Continue reading "Levaquin’s Achilles Heel: Tendon Ruptures" »
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.”
Continue reading "Depo-Provera -- The Onset of Osteoporosis? " »
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.
Continue reading "Hormone Therapy Update" »