Drug Injury Watch

Lemtrada Review By European Drug Regulatory Agency Covers Various Serious Side Effects In MS Patients

EMA Will Investigate Reports Of Associated Conditions Beyond Those That Were In November 2018 FDA Drug Safety Communication

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We recently learned by means of this April 12, 2019 European Medicines Agency (EMA) press release, "Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing", that the multiple sclerosis (MS) drug Lemtrada (alemtuzumab) is facing more scrutiny from drug regulators.

As background, we reported in this December 4, 2018 post, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label", that in November 2018 an FDA Drug Safety Communication was issued and there was a Lemtrada label change, which included an increased risk of strokes warning being added to the "Black-Box Warning" for Lemtrada.

From this April 14, 2019 Medscape article, "PRAC Restricts Use of Alemtuzumab for MS Pending Ongoing Review", we get these details about the latest drug safety issues associated with Lemtrada:

New reports of serious side effects affecting the heart, blood vessels, lungs, and liver of patients with relapsing-remitting multiple sclerosis (MS) who are taking [Lemtrada (alemtuzumab)] have prompted the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to launch a review and to place temporary restrictions on use of the drug while the review is ongoing.

In addition to the restrictions, PRAC has recommended an update of the product information for [Lemtrada (alemtuzumab)] to inform patients and healthcare providers about cases of immune-mediated conditions, including autoimmune hepatitis and hemophagocytic lymphohistiocytosis; problems with the heart and blood vessels that occur within 1 to 3 days of treatment, including bleeding in the lungs, heart attack, stroke, and cervicocephalic arterial dissection; and severe neutropenia.

__________________________________________________________________

Lemtrada

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

Returning to the April 2019 EMA press release about their Lemtrada safety investigation, we get the following from the "Information for patients" section:

• New cases of side effects have been reported with Lemtrada, including some affecting the heart, blood vessels, lungs and liver.
• You should get medical help immediately if you experience symptoms of:

-- acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
-- bleeding in lungs: such as trouble breathing and coughing up blood
-- stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain
-- liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
-- an inflammatory condition known as haemophagocytic lymphohistiocytosis: such as fever, swollen glands, bruising and skin rash.

Looking forward, the PRAC’s final recommendations about Lemtrada will be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for their consideration.

We will continue to monitor drug regulatory actions regarding Lemtrada in the US, Europe, and elsewhere.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Actemra Side Effects: Pulmonary Hypertension, Interstitial Lung Disease, Pulmonary Alveolar Proteinosis

FDA Watch List Includes Actemra: Evaluating Regulatory Action Based On Possible Signs Of Serious Risk, New Safety Information

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In July 2018 the FDA issued this document, "Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): January - March 2018", which is sometimes generally referred to as the "FDA Watch List".

Included on this July 2018 FDA Watch List is the Actemra (tocilizumab) injection.

In particular, the FDA is evaluating the need for Actemra drug safety regulatory action due to adverse event reports involving these three medical conditions:

• pulmonary hypertension;
• interstitial lung disease; and,
• pulmonary alveolar proteinosis.

These pulmonary or lung conditions are listed under the heading "Potential Signal of a Serious Risk/New Safety Information" for Actemra on this FDA Watch List. Put otherwise, these pulmonary or lung conditions may be Actemra side effects.

__________________________________________________________________

Actemra

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

As background, Actemra is approved by the FDA for the treatment of several different medical conditions:

1. Moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs);
2. Giant Cell Arteritis (GCA) in adult patients;
3. Polyarticular Juvenile Idiopathic Arthritis (PJIA) in patients 2 years of age and older; and,
4. Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older.

The responsible drug company is Genentech, Inc.

We first wrote about Actemra back in June 2017 as regards another possible Actemra side effect: "Despite The High Number Of Actemra - Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label".

We will continue to monitor the FDA for any regulatory action concerning Actemra regarding pulmonary hypertension, interstitial lung disease, and pulmonary alveolar proteinosis, as well as pancreatitis.

Of course, if you have any experiences or observations relevant to Actemra which you would like to share, you can post a Comment below or you can email me.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

FDA Recommends A Recall For Limbrel "Medical Food" Product But Primus Pharmaceuticals Is Not Complying

Reports Of Drug-Induced Liver Injury And Hypersensitivity Pneumonitis Are At Center Of This Unusual Drug Safety Controversy

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

---

UPDATE: Primus Pharmaceuticals Inc. Finally Removes Its Osteoarthritis Capsule Limbrel From The Market

... "We are not shipping. We're not promoting. We're not sampling doctors," said Primus President and CEO James Weir. "We have terminated all of those activities in good faith even though we don't believe our product is life threatening."

Primus sells Limbrel as a "medical food," but the FDA said last month that the product is an unapproved drug linked to 194 adverse events over the last decade.

[Article continues at original source]

(1/5/18)

---

 

According to the "What is Limbrel?" page of the Limbrel.com website (accessed 12/8/17) which is presented by Primus Pharmaceuticals, Inc.:

Limbrel contains flavocoxid, a proprietary blend of natural ingredients from phytochemical food source materials. Flavocoxid is comprised primarily of the flavonoids such as baicalin and catechin.

From the "FDA Limbrel Alert" page of the Limbrel.com website (accessed 12/8/17):

Limbrel has not been recalled though the FDA has asked Primus to make a voluntary recall. Primus is waiting to obtain the documents on which FDA has based its safety alert and recall request prior to making a final decision, although the opinions of independent experts and the medical literature conflict with FDA’s safety alert and request for recall.

We first reported about the November 21, 2017 FDA warning about Limbrel last month in this post, "Osteoarthritis 'Medical Food' Limbrel Tied to Life-Threatening Events".

Since then there was this December 4, 2017 FDA statement:

The U.S. Food and Drug Administration recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to manage the metabolic processes associated with osteoarthritis. The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products.

The FDA reminds consumers not to use any Limbrel products because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking any Limbrel products should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.

__________________________________________________________________

Limbrel

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

More information about the apparent stand-off between the FDA and Primus Pharmaceuticals can be found on that same web page, "FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel", which includes these three points in the "Fast Facts" section:

• The FDA continues to investigate a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form currently marketed to “manage the metabolic processes associated with osteoarthritis.”
• On November 30, 2017, the FDA reiterated to Primus Pharmaceuticals the agency’s safety concerns and serious health risks associated with continued use of the product. The FDA recommended a voluntary recall, but so far the company has declined to take the product off the market.
• The FDA is advising consumers not to use any Limbrel products because of the risk of drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. If you are taking this product, discontinue it immediately and contact your health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.

On that same FDA page, the next section, "What is the Problem and What is Being Done About It?", provides some additional information about this unfolding Limbrel situation:

On November 8, 2017, the FDA first contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA. The FDA also obtained product samples from the company and the samples are undergoing testing.

The FDA continues to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.

We will continue to follow this developing drug safety issue. Further, we welcome anyone with insights to the Limbrel situation to post their information in a Comment below or share it with us privately by sending me an email.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Multiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac Failure, Interstitial Lung Disease, And Hepatotoxicity

In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action?

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Pomalidomide (brand name: Pomalyst in the US; Imnovid in Europe) is a multiple myeloma drug. 

In more detail, from the Celgene Corporation Prescribing information for Pomalyst (accessed 6/3/15):

POMALYST, in combination with dexamethasone, is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

________________________________

Pomalyst Case Evaluation
Strictly Confidential, No Obligation.

________________________________

 
On May 20, 2015 Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom issued this Drug Safety Update, "Pomalidomide: risks of cardiac failure, interstitial lung disease and hepatotoxicity", which stated:

A review by the MHRA and other EU medicines regulators concluded that [Pomalyst (pomalidomide)] can cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. This conclusion was based on data from clinical trials, reports from clinical practice and published case reports.

This May 2015 MHRA Drug Safety Update included this detailed information about each of these Pomalyst side effects:

Cardiac failure

The review concluded that this side effect is common (ie occurs in between 1/10 and 1/100 patients who take [Pomalyst (pomalidomide)]). In most cases, this side effect occurred in patients with cardiac disease or cardiac risk factors and within 6 months of starting [Pomalyst (pomalidomide)]. The review also concluded that [Pomalyst (pomalidomide)] can cause atrial fibrillation, which may precipitate cardiac failure.

Interstitial lung disease

[Pomalyst (pomalidomide)] can cause ILD and related events such as pneumonitis. The review concluded that this side effect is common (ie occurrs in between 1/10 and 1/100 patients who take pomalidomide). Onset of respiratory symptoms is usually within 6 months of starting treatment. However, there have been cases where ILD occurred approximately 18 months after starting [Pomalyst (pomalidomide)]. ILD usually resolves with steroid treatment and stopping [Pomalyst (pomalidomide)].

Hepatotoxicity

It is already known that [Pomalyst (pomalidomide)] can elevate alanine aminotransferase and bilirubin levels. The review found that [Pomalyst (pomalidomide)] can also cause serious hepatotoxicity, mainly acute hepatitis. Hepatitis was considered an uncommon side effect (ie occurrs in between 1/100 and 1/1,000 patients who take [Pomalyst (pomalidomide)]). There have also been reports of acute liver failure in patients receiving [Pomalyst (pomalidomide)]; however the review could not determine if [Pomalyst (pomalidomide)] caused the liver failure in these cases. The risk of serious hepatic events appears to be highest in the first 6 months of treatment, therefore regular liver function monitoring is recommended during this period. The available data do not provide sufficient evidence to support specific guidance on monitoring frequency.

We will continue to monitor the safety profile of Pomalyst (pomalidomide) including watching for any similar side effects warnings by the FDA.

 

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Case review done by attorney Tom Lamb)

Xolair Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems

Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or Not

(Posted by Tom Lamb at DrugInjuryWatch.com)

______________________________________________________________________________

UPDATE: "Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths"

(12/29/14)

______________________________________________________________________________

In late September 2014 we learned more about serious side effects that have been linked to Xolair since this injectible drug for certain patients with asthma or chronic hives was approved in 2003.  The drug companies responsible for Xolair are Genentech and Novartis Pharmaceuticals.

From this document, "FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events", we get the latest news on this Xolair drug safety issue:

A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain....  As a result, we have added information about these potential risks to the drug label....

Our review of a 5-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with Xolair compared to those patients not treated with Xolair. The heart and brain blood vessel problems included mini-strokes known as transient ischemic attacks or TIAs; heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins. Although the data are suggestive of a serious safety signal, due to weaknesses in how the safety study was designed and carried out, we are unable to definitively confirm or determine the exact increased level of these risks with Xolair.

_____________________________________________________________________

 

Free Xolair Case Evaluation 

Strictly Confidential, No Obligation.

______________________________________________________________________________

It was back in July 2009, when the FDA issued its Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair), that the agency first started reviewing interim safety findings from a study of the asthma drug omalizumab (Xolair) which suggested that the medication may be associated with increased risk for ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and thromboembolic and thrombophlebitic events.

We reported on that earlier development in this September 2009 post, "Asthma Drug Xolair Is Being Investigated By FDA For Possible Cardiac Problems".

Returning to the September 2014 FDA Drug Safety Communication about Xolair, there is also discussion in that item about a cancer as a possible side effect:

Some previous clinical trials have shown slightly higher rates of various cancers in patients treated with Xolair compared with non-Xolair-treated patients. Our review of the 5-year safety study found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, we cannot rule out a potential risk of cancer with Xolair, so we have added this information to the Warnings and Precautions section of the drug label.

We will continue to monitor the safety profile of Xolair and report significant developments here.

______________________________________________________________________________

DrugInjuryLaw.com: Current Legal And Medical Information About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Legal case review done by attorney Tom Lamb) 

Multaq: Increased Risks Of Side Effects, Including Death, Outweigh Any Benefits Say Researchers Who Reviewed Clinical Data

In Addition, They Are Highly Critical Of Relationship The Sanofi Aventis Drug Company Had With Those Doctors Who Developed Prescribing Guidelines

(Posted by Tom Lamb at DrugInjuryWatch.com)

As we know, now, since being approved by the FDA in 2009 and soon becoming an often-prescribed atrial fibrillation drug, Multaq has been associated with increased risks of serious side effects, including liver failure, interstitial lung disease (ILD), stroke, and sudden cardiac death.

In the February 2014 edition of JAMA Internal Medicine one finds this rather hard-hitting article, "Dronedarone for Atrial Fibrillation: The Limited Reliability of Clinical Practice Guidelines".

From the Abstract for this recent medical journal article about the highly controversial heart drug Multaq, we get this information:

Concerns have been expressed about the reliability of clinical practice guidelines. We analyzed 3 guidelines from medical specialty societies about [Multaq (dronedarone hydrochloride)], an antiarrhythmic drug related to amiodarone hydrochloride, for treatment of patients with atrial fibrillation....  In our analysis, as a rate control drug, [Multaq (dronedarone)] was better than placebo only for a surrogate outcome (heart rate). As a rhythm control drug, [Multaq (dronedarone)] was associated with 13 (95% CI, -15 to 61) excess deaths per 1000 patients treated as compared with placebo. Compared with amiodarone, [Multaq (dronedarone)] was less effective (214 [95% CI, 130 to 294] more recurrences of atrial fibrillation per 1000 patients treated) and similarly tolerated (-28 [95% CI, -69 to 33] more serious adverse events requiring drug suspension per 1000 patients treated)....  Our findings raise questions about the reliability of these clinical practice guidelines, as well as the financial associations between many of the panel members and [Sanofi-Aventis (the manufacturer)] of [Multaq (dronedarone)].

While that excerpt may read a bit dense for most of us, the importance and significance of this February 2014 JAMA Internal Medicine Special Communications piece is presented well by this report, "Dronedarone and Clinical Guidelines: A Dark Chapter That Must Be Reread", that was published on the Medscape website.

______________________________________________________________________________

Free Multaq Case Evaluation 

Strictly Confidential, No Obligation.

______________________________________________________________________________

From that Medscape article by reporter John Mandrola:

This week, in a special communication to JAMA Internal Medicine, a group of Italian investigators performed a systematic review of the evidence base for [Multaq (dronedarone)] and came to the conclusion that if a drug as dubious as [Multaq (dronedarone)] could find its way into clinical guidelines there must be a major problem with the entire process -- a reliability problem....

The story of how a marginally effective and perhaps even hazardous drug made it to first-line status of major guideline documents is a hard image to revisit. Also difficult to look back at were the lavish steakhouse dinners, the webinars, the "sponsored" programs, and then the result: legions of general cardiologists and primary-care doctors prescribing [Multaq (dronedarone)] en masse. With [Multaq (dronedarone)], for a time at least, hype trounced science....

In 2009, Dr Allen Sniderman (McGill University, Montreal, Canada) and Dr Curt Furberg (Wake Forest University, Winston-Salem, North Carolina) wrote in the Journal of the American Medical Association that guideline-making needed reform.They offered seven commonsense suggestions to improve the current morass. These included simple but obvious things such as bringing epidemiologists and statisticians into the fold, not publishing recommendations as unanimous unless they were unanimous, posting a preliminary version of the statement online for comments, providing independent scientific review, providing full and complete financial disclosures, and insisting on stricter rules governing conflict of interest for both individuals and medical societies.

It seems no one listened. It's time now. Better late than never.  [emphasis added; footnotes omitted]

Our hat is off to the Italian medical researchers who wrote this medical journal article about the dangers of Multaq together with the drug's lack of efficacy, and to reporter John Mandrola for connecting the dots as well as putting this research about the Multaq prescribing guidelines into perspective for us.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

Multaq Associated Lung Disease And Pulmonary Toxicity Pointed Out By New Safety Warnings In September 2012 Revised Label

Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening

(Posted by Tom Lamb at DrugInjuryWatch.com)

Multaq (dronedarone) is a drug used to treat abnormal heart rhythm (atrial fibrillation or atrial flutter).

In September 2012 the FDA informed the drug company Sanofi-Aventis that it had approved some label changes for Multaq, including one about certain types of lung disease and pulmonary toxicity as being serious side effects of Multaq use.

From a September 7, 2012 FDA letter to Sanofi-Aventis, we get this information directed at doctors:

Full Prescribing Information

10. Under Warnings and Precautions, the following new sub-section has been added:

5.6 Pulmonary Toxicity

Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in patients treated with MULTAQ in the post-marketing setting [see Adverse Reactions (6.2)]. Onset of dyspnea or non-productive cough may be related to pulmonary toxicity and patients should be carefully evaluated clinically. If pulmonary toxicity is confirmed, MULTAQ should be discontinued.

It is unclear at this point whether there will be any so-called "Dear Doctor" letter sent regarding this new Multaq drug safety issue.

______________________________________________________________________________

Free Multaq Case Evaluation 

Strictly Confidential, No Obligation.

______________________________________________________________________________

And from that same September FDA letter, there is this information for patients who may use Multaq:

Medication Guide

3. Under “What are the possible side effects of MULTAQ,” the following information has been added:

Inflammation of the lungs, including scarring and thickening. Call your doctor if you develop shortness of breath or a dry cough during treatment with MULTAQ.

As some of you already are aware, no doubt, the safety profile of Multaq has been beaten down quite a bit in the past couple of years.

• December 2011: FDA said Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).
• July 2011: FDA said some clinical trial data showed a two-fold increase in death, as well as a two-fold increases in stroke (CVA) and hospitalization for heart failure in patients receiving Multaq compared to a placebo.
• January 2011: FDA issued a drug safety alert for Multaq concerning severe liver injury, such as liver failure requiring liver transplantation, associated with Multaq use.

We will continue to watch for any "Dear Doctor" letter from Sanofi-Aventis about this September 2012 Mutlaq label change as it concerns interstitial lung disease and pulmonary toxicity, such as pulmonary fibrosis and pneumonitis.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug Injury Case Evaluation - Free & Confidential

Zocor Label Change: Interstitial Lung Disease (ILD) Added As Possible Adverse Reaction

November 2010 FDA Approval Of Merck Action Raises Profile Of This Emerging Drug Safety Issue

(Posted by Tom Lamb at DrugInjuryWatch.com)

As we reported recently, the October 2010 issue of the Canadian Adverse Reaction Newsletter (CARN) included an article titled "Statins and interstitial lung disease".

Now, in November 2010, the FDA has approved a Supplemental New Drug Application (sNDA) submitted June 16, 2010 by Merck & Co., Inc. -- under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) -- adding interstitial lung disease (ILD) to the "ADVERSE REACTIONS, Post-Marketing Experience, subsection of the Zocor package insert", or label.

As some of you may recall, we first wrote about this ILD lung disease side effect for Zocor in June 2010, when we pointed out an August 2008 article published by the Chest medical journal, "Statins and Interstitial Lung Disease: A Systematic Review of the Literature and of Food and Drug Administration Adverse Event Reports”.

We will continue to monitor this emerging drug safety issue for Zocor (simvastatin) as well as the other statin drugs such as Pravachol (pravastatin), Lescol (fluvastatin), and Lipitor (atorvastatin).

If you or someone you know has developed interstitial lung disease (ILD) while using using Zocor or one of the other cholesterol drugs in the statin class, you may want to share your information by submitting a MedWatch report to the FDA.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug Injury Case Evaluation - Free & Confidential

Health Canada And FDA Issue Adverse Reaction Updates In Second Half Of 2010 Which Involve Popular Drug Zocor (Simvastatin)

Cases Of Interstitial Lung Disease (ILD) And Rhabdomyolysis / Myopathy Associated With Cholesterol Drugs Known As Statins, Including Zocor 

(Posted by Tom Lamb at DrugInjuryWatch.com)

_________________________________________________________________________________________

UPDATE:  FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury

[06-08-2011] The U.S. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage [i.e., rhabdomyolysis]....

Read more at the FDA's web page

*************************

What is rhabdomyolysis?

Rhabdomyolysis is a rare but very serious condition. It occurs when muscles are damaged and muscle cell contents are released into the bloodstream. If not detected early and treated promptly, rhabdomyolysis may result in acute renal failure, kidney damage, or other organ damage which may be fatal.

What are the symptoms of rhabdomyolysis?

Patients who develop rhabdomyolysis can have several different symptoms, but most often complain about muscle aches involving their calves, back, or their entire body. In addition to this type of muscle pain, weakness, fever, nausea, vomiting, and passing of dark urine can occur.

Free Zocor Case Evaluation 

Strictly Confidential, No Obligation.

_____________________________________________________________________

The October 2010 issue of the Canadian Adverse Reaction Newsletter (CARN) included an article "Statins and interstitial lung disease" which began with these two "Key points":

During the last 15 years, 29 cases of interstitial lung disease (ILD) suspected of being associated with statins have been published.

Health Canada has received 8 adverse reaction (AR) reports of ILD, or pathologies associated with ILD, suspected of being associated with statins.

As background, drugs in the statin "class" include Zocor (simvastatin), Pravachol (pravastatin), Lescol (fluvastatin), and Lipitor (atorvastatin).

As for "what is" interstitial lung disease, also known as parenchymal lung disease, we return to the October 2010 CARN issue:

Interstitial lung disease (ILD) is a heterogeneous group of disorders that could be acute or chronic and, if left untreated, could lead to pulmonary fibrosis and pulmonary insufficiency.  Signs and symptoms include difficulty breathing, nonproductive cough and diffuse crackles heard on auscultation.  [footnotes omitted]

As pointed out by this Health Canada CARN publication, a  systematic review of the suspected association between ILD and statins was published in a CHEST medical journal from 2008, "Statins and interstitial lung disease: a systematic review of the literature and of food and drug administration adverse event reports."

About a month earlier, the FDA included Zocor on its latest list of possible drug safety concerns, "Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2010" (Page Last Updated: 08/27/2010).
 
Specifically, the 80mg dose of Zocor (simvastatin) is listed for muscle injury, with this status: "FDA is continuing to evaluate this issue to determine the need for any regulatory action."

As you may recall, it was a March 2010 FDA Drug Safety Communication, "Ongoing Safety Review of High-dose Zocor (simvastatin) and Increased Risk of Muscle Injury", that initially indicated the FDA is concerned about an increased risk myopathy and rhabdomyolysis -- which is sometimes called "rhabdo" as its short name -- in patients using the highest dose of Zocor, 80mg.

We will continue to monitor the safety profiles of the statin drugs, and Zocor in particular, and report any significant developments, here.

Meanwhile, if you or someone you know has developed interstitial lung disease (ILD) while using a cholesterol drug in the statin class or suffered rhabdomyolysis (rhabdo) while using Zocor 80mg daily, you may want to share your experience or information by submitting a Comment, below.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug Injury Case Evaluation - Free & Confidential