Wednesday, March 30, 2011

Multaq Liver Damage ? Update for April 2011

Sanofi-AventisImage via Wikipedia
Multaq (dronedarone) is a popular antiarrhythmia drug manufactured and marketed by Sanofi – Aventis SA, has been linked by the US FDA to acute liver damage, severe liver toxicity, acute hepatic failure, acute liver failure and other complications and damage of the liver and hepatic system, often requiring surgery and in acute cases, a liver transplant.

Multaq is used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Multaq (dronedarone) is said to reduce the risk of patient hospitalization for these heart arrhythmia problems. Since the FDA’s approval of Multaq in July 2009 until October 2010, almost a half a million Multaq prescriptions have been dispensed.  During that same time, approximately 147,000 patients filled Multaq prescriptions at retail pharmacies in the United States on an outpatient basis. In addition to outpatient Multaq prescriptions filled at retail pharmacies, a significant number of Multaq prescriptions have been filled and dispensed in hospital settings on an inpatient basis.

As of late January of 2011: 857 people reported to have side effects when taking Multaq. Among them, 21 people (2.45%) have Abnormal Liver Function Test Results. In this study of Multaq users, 21 people tested abnormal for liver function while taking Multaq. The length of Multaq use as well as gender and age of the users, and severity of the abnormal liver function test were included.

From the FDA site:

FDA has received several case reports of hepatocellular liver injury and hepatic failure in patients treated with dronedarone, including two post-marketing reports of acute hepatic failure requiring transplantation. Because these reactions are reported voluntarily from a treatment population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The two cases of acute hepatic failure requiring transplantation occurred at 4.5 and 6 months after initiation of dronedarone in patients with previously normal hepatic serum enzymes. Both patients were female and approximately 70 years of age. In the first case, the patient had underlying intermittent atrial fibrillation, arterial hypertension and stable coronary artery disease. She was treated with dronedarone for 4.5 months. Two weeks prior to hospitalization she reported increased exhaustion and tiredness. One week prior to admission she discontinued dronedarone, and at the time of admission she was noted to have jaundice, coagulopathy, transaminitis and hyperbilirubinemia, which progressed to hepatic encephalopathy over the next nine days. A pre-transplant workup did not reveal another etiology of liver failure. In the second case, the patient had a medical history of paroxysmal atrial fibrillation and Sjogren's syndrome. Following 6 months of treatment with dronedarone she developed weakness, abdominal pain, coagulopathy, transaminitis and hyperbilirubinemia.

She was transplanted 1 month later; no alternative etiology for liver failure was identified in the transplant work-up. In both cases, the explanted liver showed evidence of extensive hepatocellular necrosis.
Multaq (dronedarone) is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent history of AF/AFL and associated cardiovascular risk factors (age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥ 50 mm or left ventricular ejection fraction <40%) who are in sinus rhythm or who will be cardioverted.

Dronedarone is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.

Alabama: Nine are dead after an Infection Outbreak

Nine Alabama hospital patients who were treated with contaminated intravenous feeding bags have died and the maker has pulled the product off the market.

Ten more people treated with the bags that provide nutrients through IV tubes also were sickened by the outbreak of serratia marcescens bacteria, health officials said.

A single pharmacy, Birmingham-based Meds IV, made the bags. Williamson said the company has notified its customers of the contamination and discontinued production.

When Select Specialty Hospital in Birmingham learned one of its suppliers may have distributed bags containing the bacteria, it started investigating and stopped using the Meds IV product, said the hospital's chief executive officer.

Tuesday, March 29, 2011

Topamax News from the FDA (3/29/11)

The FDA has recently issued a warning about the epilepsy and migraine drug Topamax because of a claim that it may increase the risk of causing birth defects. The FDA’s Topamax warning came after recently released data showed that women taking the drug while pregnant were 21-times more likely to give birth to a child with cleft lips or cleft palate deformities.

In addition to that warning the FDA upgraded the drug to its Pregnancy Category D. This means that the drug has a known risk of causing birth defects. Because the oral cleft defects associated with Topamax occur early in pregnancy, the FDA also has informed women of childbearing age who are taking Topamax to talk with their doctor about alternative treatment options.

From the FDA site: 

RECOMMENDATION: Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.

Link Between High Doses of Cholesterol Meds (Altorvistatin) and Diabetes?

Folks who take Lipitor in higher does may face a slightly increased risk of developing type 2 diabetes according to a recent study published this week  -- generically as atorvastatin) and other cholesterol-lowering statin drugs to a small increase in users' risk of diabetes.
The study does seem to suggest that risks may exist among those who may likewise have the well established  risk factors for type 2 diabetes -- including excess weight, high blood sugar, elevated triglycerides (a type of blood fat) and high blood pressure.
From the Journal site:
Objectives: We sought to examine the incidence and clinical predictors of new-onset type 2 diabetes mellitus (T2DM) within 3 large randomized trials with atorvastatin.
Background: Statin therapy might modestly increase the risk of new-onset T2DM.
Methods: We used a standard definition of diabetes and excluded patients with prevalent diabetes at baseline. We identified baseline predictors of new-onset T2DM and compared the event rates in patients with and without new-onset T2DM

Monday, March 28, 2011

Key Case on Daubert and Admissibility of Expert Evidence

11th Circuit Court of AppealsImage by Kevandy via Flickr
On the heels of the SCOTUS opinion in Zicam is this opinion, a 1st Circuit Opinion. Worth a read if you litigate anywhere in the USDCT:   

Ethicon Inc., a Johnson & Johnson co., is voluntarily recalling hundreds of thousands of surgical drain products after customers complained that the packaging might not be sterile.

The notice on Ethicon's Inc.'s says, "The company identified the potential for the sterile barrier of the product packaging to be compromised after receiving customer complaints." The company also states that it has not received any reports of adverse events related to this issue, and it has notified the U.S. FDA.

The recall affects multiple lots of Blake Silicone Drains, Blake Silicone Drain Kits, Blake Cardio Connectors, J-VAC Reservoirs and J-VA Drain Adapters, with distribution dates of May 10, 2010 through February 28, 2011.

They include:

BLAKE® Silicone Drain
BLAKE® Silicone Drain Kit
BLAKE® Cardio Connector
J-VAC™ Reservoir
J-VAC™ Drain Adapter

Wednesday, March 23, 2011

Nationwide Recall of U-Prosta, a Product Marketed As a Dietary Supplement That Contains Undeclared Terazosin Hydrochloride

From the FDA:

There is a nationwide recall of the Company's supplement product sold under the name “U-Prosta Natural support for prostate health”. The Company has been informed by representatives of the U.S. Food and Drug Administration (FDA) that lab analysis by FDA of U-Prosta samples found the product contains terazosin, the active ingredient of an FDA-approved drug used to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug.
The most likely adverse health consequences that could occur with the use of this product would be hypotension, dizziness, or syncope. Patients who are currently being treated with prescription medications for high blood pressure or enlarged prostate would be at increased risk of these events. In these patients, the hypotensive events may be more severe. No illnesses have been reported to the company to date in connection with this product.
Link here

Friday, March 18, 2011

Consider donating to Japan through the Red Cross

Japan tsunami relief – Red Cross button

American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection

Logo of the U.S. Food and Drug Administration ...Image via Wikipedia

From the FDA :

A voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. Potential adverse events after intravenous administration of solutions containing particulates, may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. Intramuscular administration could result in foreign body inflammatory response, with local pain, swelling and possible long term granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues, if these lots of product are administered to patients.

Dexamethasone Sodium Phosphate Injection, USP, is a synthetic adrenocortical steroid used to treat a variety of inflammatory and allergic conditions. See the Full Prescribing Information at www.americanregent.com1 for a complete listing of indications and uses.

The product was distributed to wholesalers and distributors nationwide.
Hospitals, emergency rooms, infusion centers, clinics, physician offices and other healthcare providers and facilities should not use American Regent Inc., Dexamethasone Sodium Phosphate Injection, USP 4mg/mL, 1mL Single Dose Vials, 5mL and 30 mL Multiple Dose Vials with the lot #s listed in the attached Appendix for patient care and should immediately quarantine any product for return.

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Light Posting Week Because of Trial

Engraving of Gilbert and Sullivan's Trial by Jury.Image via Wikipedia
It's been a light posting week because I've been in a jury trial all week. I'll be posting again regularly starting this morning.
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Pain Drug Embeda Recalled Because of Formula Defect

Image representing Pfizer as depicted in Crunc...Image via CrunchBase
100,000 bottles of the  pain medication Embeda were recalled due to a defect in the drug's formula. Pfizer Inc., the drug manufacturer, said in a statement that Embeda would not be available for months due to a stability defect in the extended-release product.

The pain medication contains naltrexone, an opiate antagonist drug, and did not meet degrading standards when tested by the manufacturer. Naltrexone discourages misuse and abuse of Embeda as naltrexone disintegrates when chewed or crushed.

According to a press release from the company, Embeda has been recalled from U.S. wholesalers and retailers, and patients may continue to take the medication as prescribed. All dosages of Embeda extended-release capsules may be subject to recall.

Source here. 
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Friday, March 11, 2011

Seroquel: $68.5 Million Settlement to U.S. States Over Seroquel Marketing

Seroquel-tablets, 100 and 25 mgImage via Wikipedia
In a lawsuit against the makers of Seroquel, Astra Zeneca - it was claimed that the company marketed Seroquel for uses that weren’t approved by the U.S. Food and Drug Administration, the federal and state governments claimed. AstraZeneca promoted the drug, approved for schizophrenia and bipolar disorder, for dementia, depression and anxiety in violation of federal drug rules, according to the states.

The company agreed to pay $68.5 million to 37 U.S. states and the District of Columbia to resolve allegations that the company deceptively marketed its anti-psychotic drug Seroquel.

 Link here.

Tuesday, March 08, 2011

Risk of oral clefts in children born to mothers taking Topamax (topiramate)

From the FDA

The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.

The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.

Topiramate was previously classified as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.

Kaletra (lopinavir/ritonavir) oral solution dangers?

baby AdamImage by Magalie L'Abbé via FlickrFrom the FDA:

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution.

Kaletra oral solution contains the ingredients alcohol and propylene glycol. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems.

A safe and effective dose for babies less than 14 days of age (whether born premature or full term) has not been established.

Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning. The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity.

Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults. Taking antiretroviral medications for HIV will not cure the infection, but can help children and adults with HIV-1 infection stay healthier for a longer period of time.

Leaky Insuline Pump Cartridges Recalled

J and Jhas recalled hundreds of thousands of potentially leaky insulin pump cartridges that could lead to serious health problems and death.

It also has been warned by the Food and Drug Administration over manufacturing concerns for heart devices made at its Cordis unit's San German, Puerto Rico, facility.

J&J's Animas unit, the maker of the recalled cartridges and insulin pumps in which they are used by diabetics, said in a letter to patients last month that it found some of the cartridges can leak, resulting in delivery of less insulin than intended.

Insufficient insulin can cause high blood sugar and a serious condition known as diabetic ketoacidosis, which can be fatal. A leaking cartridge could also cause the pump to fail to sound an alarm if there were blockage in the infusion set, Animas said.


Tuesday, March 01, 2011

J and J Faces Kickback Charge

Johnson & Johnson must defend a lawsuit by the DOJ claiming the company paid kickbacks to influence sales of its antipsychotic drug Risperdal to nursing home patients.

J&J asked the judge to dismiss the complaint, arguing that payments it made to Omnicare Inc., the largest U.S. pharmacy for nursing home patients, were allowable rebates and not illegal kickbacks. U.S. District Judge Richard Stearns ruled in federal court in Boston that the case may proceed against J&J, the world’s largest maker of health-care products.


Actos (Diabetes Drug) Under Investigation by State of Texas

The Attorney General of Texas has asked drug makers Takeda Pharmaceutical Co. and Eli Lilly & Co. to produce documents as part of an investigation related to the diabetes drug Actos, the companies has informed this week.

  Lilly received a civil investigative demand from the Texas official in December, Lilly disclosed in an annual report filed with the Securities and Exchange Commission.The demands seeks "production of a wide range of documents and information related to Actos

Source:  here.