Dangerous Drug and Recall News » Abbott Laboratories

FDA Approves Label Changes to Meridia

Legal Advocate — Thu, 15 Apr 2010 21:04:53 +0000

Meridia is a drug that’s manufactured by Abbott Laboratories, and it was originally approved in 1997 for use for the treatment of obesity. While the drug seemed to work quite well for a time, reports of serious and dangerous Meridia side effects eventually began to surface. These reports prompted an uptick in Merdia side effects lawsuits brought by Meridia side effects lawyers representing injured patients across the United States.

Now comes word that in response to this intense level of scrutiny brought about by the public at large, Meridia side effects lawyers and the United States Food and Drug Administration (FDA), changes to the labels of packages of Meridia have been approved that contain clear warning language regarding the specific risks of Meridia side effects.

Meridia Side Effects Warnings on Labels:

According to the FDA’s Web site, the label now states the following:

CONTRAINDICATIONS

with a history of coronary artery disease (e.g., angina, history of myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack (TIA))
with inadequately controlled hypertension > 145/90 mm Hg
over 65 years of age

WARNINGS

Concomitant Cardiovascular Disease

Due to an increased risk of heart attack and stroke in patients with cardiovascular disease, Meridia…

PRECAUTIONS

Geriatric Use section

Clinical studies of sibutramine did not include sufficient numbers of patients over 65 years of age. Sibutramine is contraindicated in this group of patients

If you or someone you love has been harmed by Meridia side effects, you need to contact the Meridia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation. The firm has decades of collective experience in holding manufacturers of defective drugs accountable for the harm they have caused, so contact the firm today to get the process of protecting and enforcing your legal rights started.

FDA, European Drug Regulators Seem to Disagree on Meridia’s Benefits

Legal Advocate — Tue, 26 Jan 2010 18:09:42 +0000

The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) play similar roles in regards to regulating the safety of drugs and prescription medications. While the FDA’s jurisdiction falls within the United States, the EMA oversees the countries within the European Union. Recent events have revealed an interesting contrast in their reaction to news that Meridia side effects appear to be a real risk. Meridia side effects lawyers have already filed claims in the United States on behalf of their injured clients, but as of now those claims have been filed in the absence of the strongest regulatory step from the FDA. Below is a look at the contrast in positions between the two regulatory agencies.

Meridia Side Effects Lawyers – Reasons for Reaction

Meridia side effects have been reported with increasing frequency in recent months, and it was only last year that the FDA stated that it would make a decision regarding how to handle Meridia when the results of a massive ongoing study became available. This study, known as the SCOUT study, is expected to be finalized in March, but preliminary conclusions have already been released.

Aside from the previous reports of Meridia side effects that included the risks of developing such problems as heart valve damage and Primary Pulmonary Hypertension, or PPH, these new preliminary conclusions draw a troubling connection between those patients who have a history of heart problems and the higher risk of suffering from a heart attack, stroke or other heart-related side effect if these patients use Meridia to fight obesity.

Meridia Side Effects Lawyers – The Contrast

In the wake of the most recent news regarding the SCOUT study, the FDA has announced that it was requiring Abbott Laboratories, the manufacturer of Meridia, to place what’s known as a ‘Black Box Warning’ on all labels of the medication. This warning must clearly alert medical professionals and patients of the risks involved with taking this drug and the potential Meridia side effects that could develop. The FDA has also indicated that it would wait to make a final decision regarding Meridia until the final results of the SCOUT study are available in March.

Meanwhile, the EMA has already released the text from a ‘Dear Doctor’ letter that it is sending to doctors and pharmacists in the European Union. This letter basically states that medical professionals are hereby recommended to cease and desist with the prescription and administration of Meridia to their patients given the clear risks of Meridia side effects that are involved. Meridia is sold under different brand names in Europe that include Reductil.

Meridia Side Effects Lawyers – How to Proceed

As can be seen, the analysis regarding Meridia’s benefit vs. its risks is beginning to turn towards the negative for Abbott Laboratories. More importantly, it’s seen as a risk for patients across the world. Even though the FDA has not yet taken the strongest action possible, that does not affect a claim that’s filed by someone who has suffered from Meridia side effects. If this includes you or someone you love, you need to contact the Meridia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation.

Reports of Meridia Side Effects Prompt Action by FDA

Legal Advocate — Wed, 25 Nov 2009 14:04:12 +0000

In recent years, reports have indicated that the obesity rate in the United States is as high as 30%, depending on the specific definition used by a particular outlet. Regardless of the semantics, Americans have what some are calling a serious weight problem, and companies of all types have been working to formulate products that are designed to help fight this dangerous condition. One such company, Abbott Laboratories, released a prescription medication known as Meridia onto the market after it was approved by the FDA in 1997. Unfortunately, reports of Meridia side effects have since surfaced, prompting calls for help from Meridia side effects lawyers. Below is an overview of the issue.

Meridia Side Effects – The History

After a few years on the market, reports of Meridia side effects in patients began to surface in high enough numbers that the medical community began to take notice. These Meridia side effects included:

Primary Pulmonary Hypertension (PPH)
Heart attacks
Cardiac valve damage
Heart valve disease
Death

These Meridia side effects are all quite serious, and overall, at least 29 people have died during or after using the drug and hundreds of others have suffered from any of the other side effects listed above. All of these reports began to prompt different actions, one of which was taken in Italy, where authorities there banned the sale of Meridia within that country after two people who had been using Meridia died of heart attacks.

Meridia Side Effects – The Study that Got the FDA’s Attention

In 2002, a cooperative effort between Abbott Laboratories and several different European agencies began a study known as the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT). This study tracked 10,000 people, some of whom were given Meridia and others who were given a placebo. The preliminary results indicated that those who were using Meridia encountered a higher risk of developing cardiovascular events not unlike those mentioned above.

In response to these preliminary findings, the FDA has recently announced by way of an Early Meridia Communication that it intends to take a closer look at this study’s findings, other evidence and additional factors in an attempt to determine what, if anything, should be done in a regulatory sense in regards to Meridia. No timetable has been given, but the FDA promised an expedited process given the obvious dangers potentially involved with the use of this product.

Meridia Side Effects Lawyers – How to Proceed

If you or someone you love has suffered from Meridia side effects, you need to obtain the answers you need regarding your legal rights and options. Contact the Meridia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation.