Articles Posted in Defective Drugs

A Class I recall is the most serious type of recall, typically announcing the risk of a life threatening illness due to a defect in a product. Cardiologists and Risk Managers recently received notice that components in the Arstasis One Access System may fracture and/or separate which could result in an emergent life threatening situation.

The Arstasis One Access System is used to support a diagnostic test during upper leg catheterization procedures. The device supports the diagnostic test by providing access to the vascular system so the cardiologist can identify abnormalities in the vascular system.   The Arstasis One Access System also offers a means to help halt bleeding from the upper leg artery that is being tested.  Cardiologists and Risk Managers will be reporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

The Arstasis One Access Systems involved in this recall include: Models: AAD100, AAD101; Part Numbers: FG-02279, FG-03010; Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334. These products were distributed for five months beginning May 14, 2010.

The U.S. Department of Justice recently announced a conclusion from the Food and Drug Administration, Office of Criminal Investigations for the owner of JMM LLC, based out of Rhode Island, who smuggled erectile dysfunction drugs that were called Herbal Dietary Supplements from the People’s Republic of China.

The owner of JMM LLC pled guilty to the charges in the U.S. District Court in Providence, Rhode Island. This was after she imported literally thousands of Durasex and Super Sense One capsules that were mislabeled. U.S. District Court Chief Judge Mary M. Lisi accepted the guilty plea. The results were announced by U.S. Attorney Peter F. Neronha, Mark Dragonetti, Special Agent in Charge of the Food and Drug Administration (FDA), Office of Criminal Investigations, and Bruce M. Foucart, Special Agent in Charge of ICE’s Homeland Security Investigations in Boston.

Between last quarter of 2006 and last quarter of 2008, JMM LLC, ordered Durasex and Super Sense One capsules from Chengdu Kang Quan Health Product Company, based out of China. The products had false shipping labels and/or invoices. The shipping label and invoices described the products as “Cinnamon Extract,” “Ginseng Extract,” or “Multivitamin samples”. Then, JMM LLC falsely labeled the packages as “Made in the U.S.A.” The packages bearing the false products were distributed to other distributors and retail stores throughout the U.S.

Nuvigil, a drug used to treat jet lag, has been linked to Steven’s Johnson Syndrome which is a life threatening disease signified by skin rashes and skin death that may encompass many areas of the body.  Nuvigil, manufactured by Cephalon, was approved by the FDA to fight off fatigue and narcolepsy, but is not FDA approved for use in the treatment of jet lag. In fact, the FDA rejected the request of Cephalon to be approved for jet lag and the end result may be lawsuits.

Nuvigil is also associated with less severe side effects, such as, headaches, insomnia, and nausea.  However, the risk of Steven’s Johnson Syndrome is significant and must be considered when interested in using the drug.  Typically, a good rule of thumb is that the benefits of a drug have to outweigh the risks in order for the drug to be truly beneficial. So, if you are suffering from jet lag, the suffering of jet lag is less severe than the risk of Steven’s Johnson Syndrome.   Steven’s Johnson Syndrome involves skin sloughing and the damage is typically permanent. People often have to be treated in burn units and the final result can be fatal.  Some people who have Steven’s Johnson Syndrome and took Nuvigil may be entitled to financial compensation for their pain and suffering and that of their loved ones.

If you, your family or a friend have suffered damages and need assistance in asserting your rights for justice and compensation, contact PADOVE LAW, toll free at (877) 446 5294 for a free consultation.

Sanofi lawsuits may shortly be underway since two of its drugs have been linked to seizures and liver damage, resulting in serious personal injury. In 2009, the Food and Drug Administration approved Multaq to treat atrial flutter and atrial fibrillation, also known as, irregular heart rhythms that can result in reduced blood flow throughout the body and consequential strokes. There have been over half million prescriptions dispensed since the drug was approved in 2009. There have also been numerous reports of liver damage and two of these cases involved the removal of the liver for these patients.

Multaq already has a black box warning stating the drug can cause life threatening consequences and death, in people with recent severe heart failure and should not be used in those patients. The common side effects of the drug include: fatigue, loss of strength, diarrhea, nausea and vomiting. Signs of liver toxicity include: nausea, vomiting and fever in which case patients must have their liver enzymes tested and tests may be required to be repeated on a regular basis to ensure that liver toxicity or other harmful consequences do not occur.

The Sanofi-Aventis SA flu vaccine is also being investigated by health officials due to its link to fever related seizures in children less than two years of age.

All lots, totaling 13 million, of Rolaids Extra Strength Softchews, Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas soft chews that were distributed in the United States have been recalled. The reason for the recall is that there have been several complaints that the product is tainted with metal and wood particles. This is the latest in a string of recalls for McNeil Consumer Healthcare, a Division of McNEIL-PPC, Inc.

All lots of Children’s BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States and some other countries, as well as,  Junior Strength MOTRIN® Caplets, 24 count, have also been recalled.

McNeill has voluntarily conducted these recalls in cooperation with the Food and Drug Administration. The company has also investigated why these incidents have occurred. Following a preliminary investigation, it appears that the foreign particles may have been introduced into the product during manufacturing at a third party facility. McNeill has suspended production of the products until a final outcome has been determined and corrective action has taken place to prevent such incidents from happening again.

The dietary supplement known as Duro Extend Capsules, manufactured by Intelli Health Products, has been recalled throughout the nation.  Intelli Health Products took this step after the Food and Drug Administration produced results from an analysis of the product showing that it contains Sulfoaidenafil.  Sulfoaidenafil is an ingredient that is FDA approved for the treatment of erectile dysfunction.  The reason why Sulfoaidenafil must be FDA approved is because the drug can negatively interact with other prescription drugs when taken together, such as with nitroglycerin. In addition, Duro Extend Capsules may lower your blood pressure to a high risk level. These two noted risks place people with high blood pressure, diabetes, high cholesterol and heart disease in danger for serious adverse reactions that may be life threatening when taking Duro Extend Capsules with their prescriptions for their medical condition.

Duro Extend Capsules are sold across the U.S. in a blister pack containing one capsule per unit, 12-pack, 24-pack display boxes, or 3 count and 10 count bottles. All lot numbers have been recalled by Intelli Health Products.

People who have experienced an adverse reaction when using the dietary supplement should contact their physician immediately. All consumers using the product should stop using it immediately and return the unused portion to the place of purchase.

Last year alone, roughly 10 million people in the U.S. used propoxyphene, known under the brand names Darvocet and Darvon, to relieve post operative pain.  It is unknown how many people have died or been seriously injured since the drug was approved in 1957. Recently, Public Citizen, a consumer advocacy group, petitioned the Food and Drug Administration to ban the drugs from the U.S. market, stating that the drugs caused over 2000 deaths, are highly addictive, and are not more effective than other safer pain relievers.

In June 2010, Public Citizen alleged that the Food and Drug Administration violated the law by failing to act on a petition that was originally filed in 2006. The FDA discovered over 3000 serious side effect cases involving Darvocet or Darvon. In December of this year, Darvocet and Darvon have been banned from the U.S. market.

The list of life threatening side effects associated with Darvocet and Darvon include: serious or fatal heart arrhythmia, heart attack, cardiac arrest, heart valve issues, myocardial infarction, pacemaker implantation, overdose, and suicide. The Public Citizen group determined that the risks associated with Darvocet and Darvon outweighs the benefit of pain relief, which can be accomplished by other less harmful drugs.

Hostility, irritability and aggressive behavior are the serious side effects that are still being reported by parents whose children take Singular.   This comes as no surprise to the U.S Food and Drug Administration because in March of 2008 the agency reexamined the safety of Singular and required new labeling to disclose the risks associated with the drug for adults and children, including:

  • Anxiousness
  • Depression

Recently, there have been recalls involving blood products following the discovery that the donor posed a risk injury to any individual who may receive the product.  Typically, donors are screened to ensure that they are safe candidates to donate blood. It is not known why the blood products in the recall were distributed following the screening process. Given the traditional screening process, this problem does not usually occur. The following includes a list of the blood products that have been recalled in October and the reason for the recall.

  • LifeSource, Glenview, IL, Red Blood Cells collected from a donor who emigrated from an area considered endemic for malaria, 2 units. Recall # B-2630-10; Platelets. Recall # B-2631-10.
  • American Red Cross Southeastern Michigan Region, Detroit, MI Red Blood Cells Leukocytes Reduced collected from a donor for whom donor suitability was not adequately determined, 1 unit. Red Blood Cells Leukocytes Reduced. Recall # B-2586-10.

The Meredia Diet Pill has recalled by the Federal Drug Administration on October 8, 2010.  Previously, the dietary supplement was banned from Europe and Australia.  The drug is manufactured by Abbot Drugs, located in Lake County, Illinois. The reason for the ban and recall is because of very serious side effects associated with the drug. The drug has been known to increase the risk for cardiovascular disorders, strokes and other health issues.  This is especially true in patients who had previously suffered from cardiovascular issues in the past.

Now, Acquisitions LLC dba Leiner Health Products, of Carson, CA and Marlyn Nutraceuticals, Inc., of Phoenix, AZ have announced that a large group of their dietary supplements have been recalled due to undeclared soy from a selenium chelate raw material, including:

The Lemon-Lime Flavor Effervescent Tablets Dietary Supplement, 0 tablets per box, distributed under the following names and labels: