Vytorin and Zetia, Merck & Co.’s anti-cholesterol medications, are coming under fire again. A new study has found that a much older – and cheaper – drug reduced artery plaque much better in eight months than ezetimibe, the active ingredient in both Vytorin and Zetia.

According to USA Today, this latest study was released Sunday at an American Heart Association meeting and published online by the New England Journal of Medicine. (more…)

The U.S. Food and Drug Administration and Genzyme Corporation are advising endocrinological and genetics medicine healthcare professionals that Genzyme products marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen are potentially tainted with foreign particles. The medications are used to treat rare, serious, and life-threatening diseases.

The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients. Cerezyme, Fabrazyme, Myozyme, and Thyrogen are supplied as lyophilized powders requiring reconstitution before administration; Aldurazyme is supplied as a liquid solution. (more…)

Orthopedic and anesthesia healthcare professionals and hospital risk managers are being advised by the U.S. Food and Drug Administration (FDA) of 35 reports of chondrolysis—cartilage necrosis and destruction—in patients given continuous, intra-articular infusions of local anesthetics with elastomeric pain pumps used to control pain after joint surgery. The anesthetics in question are marketed under the names bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine

The 35 reports occurred between 2006 and 2008 primarily in the shoulder (97%) and were received via the agency’s Adverse Event Reporting System (AERS). The remaining reports occurred in the knee. Four additional reports of chondrolysis in patients administered continuous intra-articular infusions of lidocaine in the shoulder were reported after the initial 35 bupivicaine-related cases were reported from 2006 to 2008, said the FDA. (more…)

Acetaminophen, the active ingredient in Tylenol, is again being linked to increased health risks, this time to increased asthma risks in adults and children, said Reuters Health. The analysis involved 19 studies and was detailed in the journal CHEST.

Lead study author, Dr. J. Mark FitzGerald of the Vancouver Coastal Health Research Institute in British Columbia, told Reuters Health that even though this type of study does not represent the best method by which to link a medication to an illness, the relationship between acetaminophen and asthma and wheezing should be looked into further. “We know acetaminophen affects inflammatory cells in the airway,” said Dr, FitzGerald, who added that while acetaminophen may not increase the risk of asthma, it could be contributing to the recent rise in asthma, said Reuters Health. (more…)

It has been known that Neurontin is associated with a significant—80 percent, accoring to a prior LA Times report—increase in suicidal ideation and actions. Now, Reuters, is reporting that internal Pfizer Inc. documents point to the drug maker having “altered or omitted unfavorable study findings to expand its epilepsy drug, Neurontin’s, market,” citing U.S. researchers looking into how drug manufacturers massage research data. Pfizer is considered, said Reuters, the world’s largest drug maker.

The research found that although clinical trials respond to a specific scientific question, when looking at Pfizer documents and published studies on Neurontin for nonepilepsy conditions, it seems that nearly half—eight of 20—of the studies did not receive medical journal publication, said Reuters. Also, eight of 12 studies that were published, were published with a significant change: Pfizer changed The main scientific question. (more…)

Less than 24 hours after being inoculated against the H1N1 Swine Flu, a young Virginia boy has come down with the dangerous, often debilitating Guillain-Barre syndrome, MSNBC is reporting.

Jordan McFarland (14), is wheelchair-bound and developed severe headaches, spasms, and leg weakness, said MSNBC, and is expected to need to use a walker for up to six weeks and will have to undergo “extensive physical therapy,” following his shot. Jordon is not the only case, and this is not the first time a swine flu vaccine has been associated with the serious disorder, noted MSNBC. In 1976, there were increased reports of Guillain-Barre connected to that year’s swine flu vaccine; to date, the U.S. Centers for Disease Control and Prevention (CDC) has received five reports of the syndrome since October 6, reported MSNBC, in addition to Jordan’s. (more…)

There is progress to report in the Yaz and Yasmin multidistrict litigation (MDL No. 2100) currently underway in U.S. District Court for the Southern District of Illinois. Judge David Herndon, who is overseeing the Yaz and Yasmin MDL, has appointed members to the Plaintiffs’ Steering Committee. One of those appointed by Judge Herndon is Andres F. Alonso, Esq., a partner in the law firm of Parker Waichman Alonso LLP.

As we’ve reported previously, Mr. Alonso also serves as Co-Lead Counsel in the Denture Cream Liability Litigation (MDL No. 2051) currently pending before Honorable Judge Cecilia Altonaga in the United States District Court for the Southern District of Florida, Miami Division. (more…)

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30%, as well as 73 lots of Propofol Injectable Emulsion 1% products that begin with lot numbers 79 and 80. The recall has been implemented, said the U.S. Food and Drug Administration (FDA), because some of the containers may contain particulate matter.

The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall. (more…)

Last month we wrote that women who take antidepressants known as selective serotonin reuptake inhibitors (SSRI) during pregnancy may be more likely to experience premature birth than other women. Science Daily is now reporting that the likelihood of premature child delivery triples in pregnant women with a history of depression and who take certain psychiatric drugs.

The prior study was published in the Archives of Pediatrics and Adolescent Medicine and also found that babies born to women taking SSRIs were more likely to be admitted to an intensive care unit. Science Daily writes that researchers from the University of Washington, University of Michigan, and Michigan State University all found that the medication-depression combination, when present before or during pregnancy, was significantly associated to childbirth earlier than at 35 weeks’ gestation. (more…)

This year, the U.S. Food and Drug Administration (FDA) mandated Bayer—maker of the birth control pill, Yaz—to run a correction to its Yaz marketing that cost some $20-million. Bayer must also submit its ads to the agency for approval resulting from a legal settlement obtained by some state attorneys general and the agency.

Now, Yaz and Yasmin lawsuits originating in New Jersey might be deemed a mass tort. According to Law.com, a Passaic County request is being considered by the judiciary in that state for the mass tort status. (more…)