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: Des Moines Personal Injury Lawyer

FDA Product Recalls and Safety Alerts

By Megan Roth

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The FDA is constantly issuing product recalls and safety alerts on both prescription and over-the-counter medications.  Here's a brief overview of the organization's latest findings and the effects they may have on your health:

 

·          Tussionex Pennkinetic Extended-Release Suspension (Tussionex)

o         A long-acting cough suppressant which contains hydrocodone - an ingredient which may result in respiratory depression and even death when consumed in excess.

o         This product is not recommended for use in children under six, it should not be taken more than once every twelve hours, and physicians should provide measuring devices with each prescription in order to prevent patients from misjudging the amount in one dose.

·          Tysabri (natalizumab)

o         An antibody used to treat relapsing forms of multiple sclerosis.

o         There substantial evidence supporting the claim that Tysabri is responsible for damaging the liver of patients as early as six days after the first dose is consumed.  The extent of the injuries may be so severe as to require a liver transplant (in some cases, they may even lead to death).  Patients with jaundice, liver damage, or symptoms of liver damage are strongly advised not to use this product.

·         Tamiflu (oseltamivir phosphate) and Relenza (zanamivir)

o         Both medications, which are used to treat and prevent influenza, have undergone revised labeling in order to inform that either drug could potentially cause delirium and abnormal behavior amongst patients. 

o         Though the aforementioned effects are not known to result directly from either drug, they have occurred in correlation with use of the medications; the updated labels are intended as a precautionary measure. 

·          HyperRAB S/D and GamaSTAN S/D

o         The directions have been revised for these two immune globulin products (HyperRAB is an anti-rabies product; GamaSTAN is used in cases involving hepatitis A, measles and other infectious diseases).

o         Both of the drugs are injected via uncalibrated prefilled 2 mL syringes with fixed needles.  The revision of directions was in response to difficulties using the aforementioned prefilled syringes and is intended to better accommodate the needs and dosage recommendations for individual patients.

·          Prezista (darunavir)

o         An alert has been issued advising of the medication's (which is used to treat patients with HIV) relation to drug-induced hepatitis and liver injuries (several of which have been fatal). 

o         The risks of developing these conditions vary based on co-morbid medical conditions and the use of other medications; however, physicians should conduct hepatic lab tests before medication begins and should watch for symptoms of liver toxicity.  Treatment should be closely monitored and stopped at the slightest evidence of liver dysfunction.

·          AneuRx® Stent Graft System

o         Healthcare professionals were recently provided data on mortality rates associated with the device, which is used as an alternative to open surgery in preventing the rupture of abdominal aneurysms.  The data suggests long-term mortality rates are higher for patients on which the device was used than they are for patients who received open surgery.

o         Healthcare professionals were advised to use the device only on patients who are willing, compliant, and meet the appropriate risk-benefit profile.

Originally posted at InjuryBoard by Megan Roth

Full post as published by Des Moines Personal Injury Lawyer on June 07, 2008 (boomark / email).

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