Physicians Observations Preceed Generic Drug Recall

toprol

Cleveland Clinic's cardiologist, Dr. Harry Lever, noticed repeat occurrences patients reporting chest pain when switched off of brand name Toprol and onto generic equivalents of this beta blocker used to treat high blood pressure. Once returned to Toprol brand version of the drug, the chest pains disappear. Dr. Lever reported this to the FDA but had no proving evidence aside from his observations. Sadly, his observations had a base as we now see two large Indian manufacturers, Wockhardt and Dr. Reddy’s Laboratories, announcing recalls of more than 100,000 bottles because their products were … [Read more...]

Internal Stir Between Marketing and Safety for Blood Thinning Drug

pradaxa

The generic blood thinning agent used for decades stands to be replaced as new drugs emerge that claim to need less focus on monitoring blood levels in users. As these competing new drugs hit the market, one known as Pradaxa, has experienced a stir amongst its internal factions, those whose interests are in marketing and those whose concerns are safety in usage. While grossing over $2 billion in sales since its approval in 2010 and having been prescribed to some 850,000 patients who have received prescriptions, Pradaxa has been linked to over 1,000 deaths. The concerns of an internal study and … [Read more...]

Acetaminophen Allergies Can Be Fatal

Acetaminophen

Although rare, allergic skin reactions to acetaminophen can lead to hospitalization, even death. The Food and Drug Administration recommends that those who experience skin reactions should halt usage of the drug. Despite the rarity percentage-wise,  acetaminophen is the most commonly taken drug on the market and therefore public awareness of the possibility of reaction is warranted.  Currently, over the counter medications are required to post a warning on the label, and soon, prescription medications that contain acetaminophen will also. From 1969 to 2012, there were reported 107 cases … [Read more...]

Questions Arise Regarding Handling of Defective Hip Replacement

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Over a year ago, Johnson & Johnson announced a new head of their orthopedics division claiming a fresh start after recalls of their hip replacement. New information surfaces about the new head of orthopedics, Andrew Ekdahl, who is tied to the development and promotion of the failed implant in ways that raise questions about Johnson & Johnson's choice for the position. The following article is take from the New York Times, reported by Barry Meier on January 30, 2013. During Trial, New Details Emerge About Hip Maker When Johnson & Johnson announced the appointment in 2011 of an … [Read more...]

Meningitis Death Toll at 15 – Company Under Intense Scrutiny

meningitis

Federal Agents from the Food and Drug Administration raided the NECC (New England Compounding Center) which is linked to the recent outbreak of meningitis in several states. Fifteen are dead and hundreds sickened. Read the following article from Reuters' Greg McCune as news floods the media about this serious health incident. New England Compounding Center, Pharmacy Tied To Meningitis Outbreak, Raided By Feds CHICAGO (Reuters) - The company that produced contaminated medications linked to an unprecedented fungal meningitis outbreak faced mounting scrutiny on Saturday over whether it … [Read more...]

Regulation Advised for Compounding of Drugs

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Some local pharmacies offer compounding services to meet special needs of patients. However, some pharmacies are acting as miniature drug companies replicating products already available on the market to compete with large pharmaceutical companies. This has created an element of risk that is talked about in this Editorial from the New York Times which calls on Congress to enact legislation to give increased regulatory power to the F.D.A. This health risk is responsible for repeated incidents such as the recent outbreak of meningitis and thousands who were exposure to tainted steroids. Read … [Read more...]

Victory for Big Pharma: Texas Adopts “Learned Intermediary” Rule

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Big Pharma had a major victory on June 8th, when the Texas Supreme Court handed down its ruling in Centocor, Inc. v. Hamilton.  The Court held that "When a drug manufacturer properly warns a prescribing physician of the dangerous propensities of its product, the manufacturer is excused from warning each patient who receives the drug. The doctor stands as a learned intermediary between the manufacturer and the ultimate consumer."  Further, "A prescription drug manufacturer fulfills its duty to warn end users of its product's risks by providing adequate warnings to the intermediaries who … [Read more...]

Depakote Maker to pay $1.5 Billion to Settle Criminal and Civil Investigations

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Last week, the Department of Justice Announced a record $1.5 Billion settlement with Abbott Laboratories over their mislabeling of the drug Depakote. "Global Health Care Company Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today.  The resolution – the second largest payment by a drug company – includes a criminal fine and … [Read more...]

Tort Reform has not Increased the Number of Doctors in Texas

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A new study by  David A. Hyman, Charles Silver, and Bernard Black shows that Texas Tort Reform measures have not increased the number of doctors in Texas since 2003. "Does state tort reform affect physician supply? Tort reformers certainly believe so. Before Texas adopted tort reform in 2003, proponents claimed that physicians were deserting Texas in droves. After tort reform was enacted, proponents claimed there had been a dramatic increase in physicians moving to Texas due to the improved liability climate. We find no evidence to support either claim. Physician supply was not … [Read more...]

DuPuy / J&J Hip Recall Abroad

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The following article by Mark Hollmer at FierceMedicalDevices.Com reports how the Johnson & Johnson (Dupuy Orthopaedics) hip implant is being treated in courts and by regulatory agencies in the U.K, Australia and New Zealand. Read below. Johnson & Johnson  is facing more bad news over its metal-on-metal artificial hip implant products, this time in New Zealand and Australia. Both countries' regulatory agencies issued a recall of the MITCH TRH hip components made by J&J's Finsbury Orthopaedics unit. In New Zealand, the problem involves a loosening and movement of part of … [Read more...]