Articles Posted in Pharmaceutical Errors

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A recent story by The Baltimore Sun shows that thousands of lives have been saved over the years because Americans now routinely use seat belts and don’t drive drunk. In the meantime, a new crisis has arisen with driving, and that seems to be the use of texting and cell phones. Overdoses of prescription medicine have also affected car safety.

Andrea Gielen, director of the Johns Hopkins Center for Injury Research & Policy, co-authored a report released by the Trust for America’s Health and the Robert Wood Johnson Foundation.

The report brings to the fore the identification of ten important injury prevention measures. Some states have adopted many of these provisions. The report aims at influencing public policy and laws to change the behavior of individuals.

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The US Army is investigating whether the death of two soldiers was in any way caused by workout supplements. Both soldiers died after being engaged in physical activity on a Southwest Army base. Dimethylamylamine (DMAA), the active ingredient in these workout supplements, was later found in both soldiers’ toxicology reports. The Army is trying to determine whether there is a connection between health problems and these popular workout supplements.

Perhaps the most well known examples of these pre-workout “boosters” are Jack3d and OxyElite Pro, both manufactured by USPlabs. Both products contain DMAA and are advertised as being able to increase the taker’s energy and lead to better workouts. Currently both Jack3d and OxyElite Pro are classified as dietary supplements and subsequently do not need to be approved by the Food and Drug Administration (FDA).

A recent New York Times article quoted Kerri Toloczko, a USPlabs spokeswoman, as stating that “there have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among those taking the workout boosters as directed. But while those responsible for manufacturing and marketing these products claim they are safe when used as directed, medical experts are claiming there might be serious health concerns when taking DMAA.

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Yet another weight loss drug has been accused of posing a safety risk due to its potential causing of liver damage or failure. Yesterday the U.S. Food and Drug Administration (FDA) completed its safety review of the the weight loss drug Orlistat, which has been marketed under the names of Alli and Xenical, in connection with reports of severe liver injury. Alli is manufactured by GlaxoSmithKline (GSK), while Xenical is manufactured by Hoffmann-La Roche (Roche).

These reports of potential liver damage due to a weight loss drug come on the heels of similar reports of liver injury associated with Hydroxycut, which led to a massive recall of the weight loss supplement.

After undergoing an investigation into the safety of Xenical and Alli, the FDA found that Alli and Xenical could in fact cause liver damage in rare cases and therefore has approved the weight loss drugs to stay on the market as long as their labels are changed to include warnings of potential liver damage.

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The U.S. Food and Drug Administration (FDA) announced what could amount to a nationwide recall of children’s Tylenol and dozens of other over-the-counter medicines. The FDA conducted an inspection at a McNeil drug plant in Pennsylvania that has resulted in the recall of more than 40 varieties of liquid pediatric medicines Tylenol, Motrin, Benadryl and Zyrtec. These products may contain metal particles over the limit allowed to meet safety requirements.

Following the discovery that some of the Tylenol products from its plant could contain metal, McNeil initiated a voluntary recall of all products manufactured at that plant. According to McNeil, its April 2010 recall was a precautionary measure and was not based on “adverse medical events”. The McNeil recall included not only Tylenol products, but also other popular children’s medicines, such as children’s Motrin, Zyrtec, and Benadryl products
Tylenol is one of the brands made by a unit of Johnson & Johnson. One of the major distributors of these pediatric liquid products is Perrigo, a company based in Michigan that supplies children medicines to big pharmacy companies like Walgreens and CVS. Perrigo has also received a warning from the FDA that it has committed serious manufacturing errors of its own. Tablets of ibuprofen reportedly contained metal shavings.

Also reported by the FDA are questions of safety and reliability of these products. Other deficiencies in the report included bacterial contamination of raw products, inadequate maintenance of equipment and the fact that no follow up was conducted to investigate 46 consumer complaints as to foreign materials and black or dark particles in the products. Some of the complaints are more than a year old.

Click here for the full list of all the recalled Tylenol products.

For additional information on the timeline of the Tylenol recall, see Parija Kavilanz’s article at CNNMoney.com.

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A settlement was reached with the family of a 13 year-old quadriplegic boy whose injuries were sustained in a 2008 car crash in Skokie, Illinois. As a result, the boy is limited in his ability to communicate and is relying on a ventilator to breath. He is paralyzed from the neck down.

According to a lawsuit that was filed in 2009 against the driver of a sport utility vehicle that collided with a station wagon that was driven by the boy’s father, the boy was a passenger in the front seat when it was struck by the northbound SUV attempting to turn east onto Old Orchard Road from Skokie Boulevard. This crash took place in front of the Old Orchard Shopping Center, a usually congested traffic area.

During the discovery phase of the case, the parties disputed the speeds of the different vehicles, lanes in which they were travelling and the color of the traffic lights.

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In a recent Illinois pharmaceutical error case, the First District Appellate Court of the State of Illinois reversed a $25 million punitive damage award against Walgreen Co. in Marston, etc. v. Walgreen Co., 1-07-0209. The case revolved around the death of an elderly man who was given the wrong prescription allegedly as a result of a pharmacy mistake. The 77 year-old decedent had requested an anti-gout medicine, but was instead given a drug that treats diabetes by lowering blood sugar.

The court upheld a Chicago, Cook County jury award of $6.35 million in compensatory damages after finding that the plaintiff established that taking wrong drug caused the decedent’s kidneys to fail, which led to his death. The plaintiff died during pretrial proceedings.

At trial, the Walgreen’s pharmacist testified that he incorrectly filled the decedent’s prescription. Evidence was also presented that suggested the pharmacist was abusing narcotics and stealing pharmaceuticals from the Walgreen’s store. The evidence showed that the pharmacist did not remember if he was taking drugs on the date of the misfilled prescription.

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A new study by researchers at the University of Chicago Medical Center has stated that at least 2.2 million U.S. adults take medicine in combinations that could trigger dangerous drug interactions. Some of the possible dangerous interactions include muscle breakdown, gastrointestinal bleeding, disruption in heart rhythm, and other serious problems.

Perhaps even more alarming is that at least half of these dangerous interactions involve the use of over-the-counter medications, such as aspirin or dietary supplements. According to the study, one in 25 older adults are at risk for serious drug interactions, the study has found. And for men ages 75 and 85, the risk is as high as 1 and 10.

However, the risk might be even higher because the research focused on major interactions among the 20 most common drugs and dietary supplements. “The public has an awareness that two prescription medications used together might be dangerous,” said the study author, Dr. Stacy Tessler Lindau. Lindau is the assistant professor of geriatric medicines, obstetrics and gynecology at the University of Chicago Medical.

The dangerous drug interactions cited in the study were more a byproduct of individuals unknowingly mixing medications rather than the result of pharmaceutical prescription errors by medical providers.

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In a recent and controversial accusation, Elsevier has been questioned about publishing favorable medical reviews of pharmaceutical company Wyeth’s hormone replacement therapy drug. The allegations claim that the medical publishing editors at Elsevier were not unbiased, but received payment from Wyeth. In response to these accusations, Elsevier has launched its own investigation into the legitimacy of the claims.

Senator Charles E. Grassley, Iowa (R) was the person who first questioned the article. As a member of the Senate Finance Committee, Grassley is investigating drug companies’ influence on doctors and contends that Wyeth, the pharmaceutical giant, commissioned ghostwriters to plug its drugs through several academic journals, including perhaps Elsevier.

The Elsevier article in question by Dr. John Eden was published in a May 2003 issue of the American Journal of Obstetrics & Gynecology. Progestins and Breast Cancer (Am J Obstet Gynecol 2003;188:1123-31), stated that drugs such as Wyeth’s Prempro could not be tied to breast cancer as there was “no definitive evidence” that the hormones caused breast cancer. Eden’s article was published a little over a year after a landmark federal study linking Wyeth’s Prempro hormone product to breast cancer.

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