Dangerous Drug and Recall News » Meridia

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.

Meridia Heart Attack Warning from FDA

Legal Advocate — Mon, 25 Jan 2010 22:00:03 +0000

Meridia is a drug that’s manufactured by Abbott Laboratories, and for many years it has been one of the leading medications in the world for people who were fighting obesity. Obesity has been a growing problem in the United States for several years, and those who are obese can face other very difficult health problems as a result of this underlying condition. It’s estimated that as many as 8 million people have used Meridia worldwide since it was originally approved by the FDA and introduced to the market in 1997. Unfortunately, the drug eventually began to generate reports of problems in those who had used it, and Meridia side effects lawyers began to take notice and enforce the legal rights of their clients.

Meridia Side Effects Lawyers – First Wave of Problems Arise

After a few years on the market, the first reports of serious Meridia side effects began to make their way into the media. These Meridia side effects were serious, and similar reports prompted the banning of the sale of Meridia for a time in Italy. These Meridia side effects included:

Primary Pulmonary Hyptertension (PPH)
Heart valve damage
Heart attacks
Cardiac valve dysfunction
Death

Of these initially reported Meridia side effects, PPH was the condition that drew the most attention because it was otherwise rare, easy to miss because of its symptoms being similar to other problems and progressive to the point where it was often too late after PPH was diagnosed. However, additional problems have recently arisen regarding Meridia side effects.

Meridia Side Effects Lawyers – The New Problem

While all of these reports of Meridia side effects were surfacing, the FDA only went as far as issuing a preliminary statement that it wanted to see the results of a large Meridia study that was in progress. That study is nearing its completion, and the first set of conclusions are becoming available. What seems to be the most prominent conclusion that’s been released at this point is the troubling tendency for those who have a history of heart problems to face a high risk of a heart attack if they use Meridia.

As a result of this finding, the FDA has announced that all containers of Meridia must now contain a warning that specifically states that patients with any history of heart problems face this higher risk of a heart attack. This requirement is one of the more serious steps that the FDA can take, and at this point there’s no telling how many people with a history of heart problems have used Meridia without the knowledge that they were facing this possible result.

Meridia Side Effects Lawyers – How to Proceed

If you or someone you love has been harmed as a result of using this medication, you need to contact the Meridia side effects lawyers at the Phillips National Injury Group as soon as possible to schedule a free initial consultation. The firm has helped those harmed by defective drugs for many years, and you need to protect your legal rights if you’ve suffered from Meridia side effects. Contact the firm today.