The first trial dealing with contaminated blood thinner heparin produced a verdict of $625,000 for the family of a man who died after being treated with the defective medication as part of his dialysis treatment. The trial was held in an Illinois state court. The contaminating ingredient originated in China. The defendants in the case were Baxter Healthcare Corp. and Scientific Protein Laboratories, which marketed and supplied the drug, respectively.
Endo Pharmaceuticals recalled Endocet (oxycodone/acetaminophen) 10mg/325mg tablets after one bottle was found to contain 10mg/650mg tablets. A higher-than-intended dosage of acetaminophen can cause liver toxicity. Qulitest Pharmaceuticals recalled its butalbital-acetaminophen-caffeine tablets and hydrocodone bitartrate and acetaminophen tablets after one 500 count bottle of butalbital-acetaminophen-caffeine tablets were incorrectly labeled as a 1,000 bottle of hydrocodone bitartrate and acetaminophen tablets. Patients who unintentionally ingest butalbital can experience lightheadedness and nausea.
Ortho-McNeil-Janssen Pharmaceuticals recalled one lot of Risperdal 3mg tablets and one lot of risperidone 2mg tablets after receiving reports from consumers of an odor coming from the bottles. The odor is thought to be caused by TBA (tribromoanisole), a byproduct of a chemical applied to wood containers in which medications are often transported. Risperdal is used to treat schizophrenia and bipolar mania.
Johnson & Johnson recalled approximately forty thousand bottles of Risperdal. The recall was prompted by a suspicious odor thought to be indicative of a chemical used to treat wood in shipping pallets. The recall covers both 3 mg and 2 mg tablets of Risperdal, an atypical antipsychotic drug approved to treat schizophrenia, bipolar disorder and which is commonly prescribed off-label for several emotional conditions.
A study reported in the American Journal of Medicine questions the safety of over the counter pain drugs for patients with heart disease. The study included 22,576 adults with coronary artery disease and compared those who chronically used over the counter non-steroidal anti-inflammatory drugs (NSAIDs) with those who occasionally or never used NSAIDs.
The study found that 4.4% of those who chronically used NSAIDs suffered another heart attack, stroke, or die in the next year, compared to 3.7% in patients who did not use NSAIDs chronically. The researchers adjusted the data for factors such as body weight, smoking, diabetes, and cholesterol but still found a higher incidence of another major cardiac event or death in the chronic NSAID users.
FDA communicated new safety risks associated with 80mg dosage of the drug simvastatin and signaled its label would soon change. Simvastatin is a statin prescribed to lower LDL along with diet and exercise. It is sold on its own as Zocor and under several generic names, but is also present in Vytorin and Simcor, combinations of simvastatin with other ingredients. FDA estimates that in 2010 as many as 2.1 million patients were prescribed the 80mg dosage of simvastatin.
Simvastatin increases the risk of damage to muscles in the 80mg dosage, often due to interaction between simvastatin and other drugs. The new label will inform doctors and patients of contraindications as well as dose limitations for simvastatin when used in conjunction with other medicines. Though rare, conditions resulting from simvastatin may result in damage to the kidneys that is ultimately fatal.
FDA communicated safety issues regarding a class of drugs known as 5-ARI, short for 5-alpha reductase inhibitor. Finasteride and dutasteride are approved drugs in this class and are the active ingredients behind such drugs as Proscar, Propecia, Avodart, and Jalyn.
The warning accompanies a label modification to warn patients of the statistically risk of a more serious form of prostate cancer. FDA learned of this risk through analysis of two studies that measured the performance of finasteride and dutasteride as treatments for prostate cancer. The studies both concluded that both drugs lowered the overall risk of prostate cancer but that men who took one of the two drugs was more likely to develop a high-grade prostate cancer.
Manufacturer Pfizer recalled several lots of the cholesterol medication Lipitor (atorvastatin calcium) 40mg tablets. The recall was instituted due to an odor emanating from the bottles in which the medication was packaged. The smell is likely caused by a chemical used as a preservative. No injuries have been reported thus far and the smell is not believed to be harmful.
Manufacturer Ortho-McNeil-Janssen Pharmaceuticals has recalled two lots of Topamax 100 milligram tablets. The drug is used to treat seizures and prevent migraines. The company initiated the recall after receiving consumer reports of a strange odor emanating from the tablets. The odor was likely caused by small amounts of TBA, a byproduct of a chemical preservative. TBA is not believed to be toxic. While some patients have reported gastrointestinal symptoms, there have not been reports of serious injury.
Manufacturer, The Ritedose Corp. recalled 0.083 percent albuterol sulfate inhalation solution. The solution is administered through a nebulizer and is used to treat acute asthma attacks. The recall was issued because certain vials were labeled with a lower concentration of the active ingredient than they actually contained. The manufacturer feared that physicians would attempt to compensate for what appears to be a lower dose and thus actually administer a dangerously high dose to patients. Among other things, an overdose of albuterol sulfate can cause tremors, dizziness, seizures, high blood pressure, and rapid heart rate.