California Injury Attorney Blog

Since 1999, GlaxoSmithKline has been selling the drug Avandia for Type 2 diabetes. The medication Avandia has a single ingredient - rosiglitazone -- which has been linked to literally hundreds of heart attacks and heart failures. Other medications Avandamet and Avandaryl contain this ingredient. These medications still await their shelf life fate.

The risk of heart problems with this medication are well established and are the subject an FDA black boxed warning and FDA safety alerts issued in 2007 and 2010. In addition, in December 2008 the FDA issued Guidance for Industry recommending that manufacturers study heart safety in formulating diabetes treatments.

The 2007 black box warning clearly indicates that patients with symptomatic heart failure should not take the medication. It also states that the medication causes or exacerbates congestive heart failure in some patients. Finally, it notes that the data on the risk of myocardial ischemia are not conclusive and are under review.

The data still under review by the FDA includes a clinical study called "Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes" or RECORD, which was designed to evaluate the cardiovascular safety of rosiglitazone.

The FDA's completed review of this study is expected in July 2010. Once the FDA completes its review of the data from the RECORD study, the agency will present the cardiovascular safety data on rosiglitazone at a joint meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At this time, the Advisory Committee will provide updates on "the risks and benefits of rosiglitazone in the treatment of type 2 diabetes."

In the earlier warnings, the FDA noted the following recommendations to patients taking Avandia and medications with rosiglitazone, including: don't stop taking the medication without healthcare professional advice; talk with your healthcare professional about concerns regarding this medication; read the risks included in the medication guide, and report side effects to the FDA's MedWatch.

Earlier this year, The New York Times published an extensive piece on Avandia and rosiglitazone. The article noted the opinions of several scientists who have urged the removal of Avandia from the market and as well as the ongoing "fierce debate" at FDA over whether to allow it to continue to be sold.

If you or a loved one has taken Avandia or a medication containing rosiglitazone and have had suffered heart attack or other cardiovascular problems, contact Hersh & Hersh for a free consultation on your legal rights.

Related Web Resources

Visit the Food and Drug Administration's site for more information on how drugs are approved for use.

Continue reading "Heart Attack and Related Risks Continue with Avandia Use" »

Recently, the California Injury Attorney blog posted our readers on the dangers of the use of gadolinium as an MRI contrast agent with particular at-risk patients.

Who is at risk?
Patients with severe kidney disease or generally severe renal insufficiency, need to be very well-informed about gadolinium dangers if they are about to have an MRI or related study with a contrast agent.

Gadolinium use in these patients can lead to a condition called nephrogenic systemic fibrosis (NSF) or another condition nephrogenic fibrosing dermopathy (NFD). If such a patient has had an MRI with contrast and begins to have NSF or NFD symptoms, it is important to see a medical professional. The following are some things to be aware of with regard to MRI with contrast agents.

Talk with your doctor.
For patients with severe renal insufficiency, it is very important to talk with a medical professional about whether use of a contrast agent is necessary. If it is necessary, it is then critical that the amount of gadolinium used is carefully managed and that any prior use of contrast agents be taken into account. In other words, it is very important that there is some passage of time before this agent is used again before it has been eliminated from the patient's body.

Some doctors might suggest that hemodialysis patients have that procedure after a contrast MRI to help remove the gadolinium from these compromised patient's bodies.
There is no data on whether this "elimination" process can help reduce the risk of developing NSF or NFD.

Symptoms to watch for after an MRI.
After an MRI with a contrast agent make sure to watch for any issues involving changes in skin, such as hardening, thickening or tightening; color changes on the skin, such as reddening or dark patches; burning or itching of the skin; joint pain or tightness; pain in hips or ribs. Other symptoms include yellow spots on the whites of the eyes and deep pain in hips or ribs.

Continue reading "Symptom Watch After MRI with Contrast Agents" »

Many Americans have had an MRI. But many Americans may not realize the dangers involved for some patients in the use of contrast agents with MRI. Contrast agents help healthcare professional see internal structures more clearly on an MRI. There are some basics that are important to know.

Nearly three years ago, the United States Food and Drug Administration (FDA) issued a request for a black box warning for the labeling of gadolinium-based contrast agents used for the enhancement of MRI imaging. The warning was targeted to patients with severe kidney insufficiencies and those involved in liver transplantation (both before and after surgery) or with chronic liver disease.

The FDA's warning request was intended to generate warnings in the use of these contrast agents in patients with these severe kidney insufficiencies and other issues. Patients with severe kidney insufficiency that receive gadolinium-based agents are at risk for developing serious health issues including, nephrogenic systemic fibrosis (NSF) or another condition nephrogenic fibrosing dermopathy (NFD), from the use of gadolinium.

This 2007 warning request came after a June 2006 warning to health care professionals regarding some of these risks. These conditions are very serious indeed. The symptoms include serious problems with organs, skin and connective tissue that may not only result in broken bones, but seriously impact patient movement. Patients began to notice problems early on or some time after an MRI using these contrasting agents. Unfortunately, NSF or NFD can develop in patients that have been exposed to the contrast agent once, or multiple times.

At the time of the boxed warning request, the FDA said it had been "carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease." Years later, patients are still suffering from the debilitating impact of these serious conditions when MRI contrast agents have been used on them and they were at risk for these conditions.

There are five gadolinium-based contrast agents used in the United States and these include: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol).

If you would like to read more about the FDA's black box warning request and about gadolinium, click here.

Continue reading "Know the Dangers of Gadolinium Contrast Agents" »

Recently, the makers of Tylenol® (McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc.) consulted with the Food and Drug Administration to voluntarily recall many over-the-counter children's and infants liquid products. The specific bottles involved in the recall and their lot numbers are listed on the Tylenol website and include products that were made between April and June 2008.

These products have unexpired use dates and could still be inadvertently given to infants and children. All products involved in the recall were manufactured in the United States, but were distributed to several other countries.

The reason for the voluntary recall? In the company's words, "some of these products may not meet required quality standards." Although there have been no medical issues with the use of these products, the company is taking what they deemed a precautionary measure because, "some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles."

This explanation, although somewhat vague is actually a good step. The company advises that the potential for serious medical problems is "remote" they do not want these products used.

They also noted that prior to new manufacturing at the plant where these products were made, they have taken a look across their manufacturing operations to ensure quality.

The California Injury Attorney Blog has posted on recent recalls of products that could otherwise harm or injure children and adults.

Related Web Resources

For specific recall information, please visit the Tylenol website.

Continue reading "Voluntary Recall of Infants' and Children's Tylenol®" »