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Fairfield Pharmaceutical Products Law Blog

Drug injury hot topic: Pradaxa and other anticoagulants

Anticoagulants are widely used among patients in the United States, including many here in Connecticut. These types of drugs can be extremely helpful in preventing further medical issues, particularly in patients who are at risk for developing blood clots or who suffer from heart issues. Unfortunately, some patients have experienced injury -- or worse -- as a result of using this type of medication.

Pradaxa, in particular, while intended to help, has actually resulted in several hundred deaths and many more injuries. While this drug is meant to assist in the prevention strokes and heart attacks, it has been proved to increase the risk of these medical issues by approximately 33 percent. Problems with this medication, and others similar to it, include:

  • Uncontrollable bleeding
  • Dizziness
  • Bruising
  • Abnormal pain and/or swelling
  • Death

Manufacturer forced to close doors after investigation

In the past year, several dietary supplements were recalled due to banned or unsafe substances being used in the products. As these types of products are not tested by the FDA unless concerns are reported, these supplements may remain on store shelves for a significant amount of time. Recently, the investigation of a major supplement manufacturer has come to a close, and the findings in this case may affect Connecticut consumers.

Health One Pharmaceuticals, which is based on the West Coast, is being forced to close its doors after a recent FDA probe. This company produced dietary supplements that were distributed all across the country. A recall for all supplements produced and sold since 2011 will be issued, and all of these products are to be safely destroyed.

Manufacturer responsibility concerning to the FDA

The Food and Drug Administration has the difficult task of establishing the safety of certain products. With so many products out on the market here in Connecticut and nationwide, setting quality standards for manufacturers and ensuring those standards are being upheld can present a number of challenges. A recent program launched by the FDA is intended to help with manufacturer responsibility and ensure product safety.

The new program recently started by the FDA will specifically target the pharmaceutical industry. Issues with quality control have led to numerous drug recalls in the past year. Approximately 70 million units of pharmaceutical grade drugs were recalled between 2013 and 2014. Some leading to consumer injury and others, thankfully, were caught before any significant harm was done.

Potentially fatal consequences prompt recall upgrade

A product recall that was issued in 2014 for defective medical devices was recently upgraded to a Class 1 by the FDA. The products in question are the INRatio and INRatio2 Monitor Systems by Alere. According to the FDA, this upgrade is a necessity, as the use of this product may have fatal consequences. These monitoring systems are used nationwide, and residents in Connecticut may be affected as a result.

The INRatio and INRatio2 were previously recalled due to issues with the systems providing false readings. These monitors are used primarily by patients who are taking blood thinners as a way of tracking the ability for their blood to clot. An inaccurate reading could lead patients to take the wrong amount of medication, placing them at higher risk of massive blood loss -- or worse.

Apparent improperly designed cancer drug recalled by manufacturer

Cancer patients face a number of obstacles when looking for a cure or other ways to slow the progression of their disease. While medical advancements have made it possible for many victims of different cancers to survive or at least prolong their lives, problems with these advancements may contribute to failing health. Recently, a nationwide recall of a cancer drug has been issued due to it possibly being improperly designed, ultimately creating issues with potency and impurities. As this specific drug is distributed worldwide, including here in the the United States, cancer patients in Connecticut may be affected.

Hospira Inc. is an American based company with product manufacturing plants located in a variety of places across the globe. Recently, the company issued a recall of the drug mitoxantrone, which is used to help treat cancer patients. The particular lots affected were produced in a foreign-based plant but have been distributed to various locations throughout the world, including here in the United States.

Issue with RSV drug prompts recall; no current reports of injury

RSV is an illness that strikes young children all across the United States, including many here in Connecticut. This is a horrible respiratory virus that, if not treated in a timely manner, can have devastating effects on those infected. In severe cases, certain prescription medications are deemed necessary for a full recovery. Recently, one popular RSV medication was recalled due to problems with the drug that may cause injury to patients.

The manufacturers of Virazole, Valeant Pharmaceuticals, issued a recall of the medication after it was discovered that one lot of the drug may have been contaminated by microbials. The medication in question is a powdered antiviral drug that comes packaged in a four-pack of 100 mL vials. The lot affected has an expiration date of Oct. 2018.

Suctioning tube recalled by manufacturer, labeled a Class I

When patients are admitted to medical facilities for emergent and/or critical care, a number of medical devices may be utilized by staff in order to stabilize the patient. Patients in Connecticut, and their family members, count on that equipment being safe for use. Unfortunately, defective equipment does sometimes make its way into hospital inventory. A recent recall of a piece of equipment often used in critical care settings was issued by the manufacturer, due to a problem with a particular component that could cause serious injury -- or worse -- to patients.

Halyard Health, makers of KimVent Microcuff Subglottic Suctioning Endotracheal Tubes, recently recalled specific lots of the device believed to be defective. According to information provided by the FDA, a component of the tube may detach, causing the cuff to deflate and decrease the amount of air that is able to reach a patient's lungs. This could lead to serious respiratory distress, oxygen loss and possibly death.

Connecticut dangerous and defective drugs: Propecia

Hair loss affects millions of men and women across the country, including many here in Connecticut. This is a problem for which most of these individuals would love to find an easy and noninvasive solution. For some, pharmaceutical drugs seem to be the answer they have been looking for. Unfortunately, all medications carry risks and can be considered dangerous and defective drugs, including popular hair loss drugs.

Propecia has been prescribed for male pattern baldness for several years. While available studies show that this drug has proven effective in treating hair loss, a number of side effects have also been found, which are often irreversible. Common side effects with Propecia use include:

Substances found in weight loss drug could harm consumers

It is that time of year again -- millions of Americans are making resolutions for the New Year. A few resolutions many often make include dropping pounds and getting in shape. Numerous individuals, in Connecticut and elsewhere, may turn to supplements to aid in their progress. There are a variety of supplements consumers can choose from, but many of these supplements can actually harm users. One particular weight loss supplement was recently pulled from shelves due to banned substances being included in its chemical makeup.

The manufacturer of SLIM-K Capsules, Bethel Nutritional Consulting, Inc., recently recalled one lot of the weight loss supplement. The FDA apparently found several substances found in the drug which were either removed from the market years ago, or are not approved for use in the United States. Many medical issues are often seen with the use of these substances including seizures, heart attacks, strokes and arrhythmia.

Recall notice: Where to find it and what to do if injury happens

Recall notices are released any time a problem with a product is considered a serious safety concern. For some, these recalls may come too late, after an injury has already happened. For others, these recalls can help prevent any harm from happening. Connecticut residents who are concerned about product safety may like to know where they can find recall information and what they can do if they or a loved one has been injured by a recalled product.

Recalls can be issued for all product types. While all recalls are important and should be taken seriously, problems with medical devices and/or drugs can be particularly concerning. Recall notices are typically sent directly to consumers or medical providers. However, for those who would like to check for recall notices on their own, it is possible to do this. There are actually several ways consumers can get obtain recall information, including:

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