On March 31, 2009, Caraco Pharmaceutical Laboratories, Ltd. Issued a recall for generic Digoxin 0.125 mg tablets and 0.25 mg tablets due to concerns that some of the tablets distributed could differ in size and provide more or less of the heart drug then they are supposed to.

Similar to the Digitek problems, receiving too much of the heart drug could result in a build up of the medication in the body, posing a risk of an overdose known as digoxin toxicity. Side effects could include:

• Nausea
• Vomiting
• Dizziness
• Low Blood Pressure
• Cardiac Instability
• Bradycardia
• Sudden Death

Based on the information currently available, it is unclear how many of the oversized digoxin tablets may have been distributed throughout the United States or for how long the digoxin problems may have been occurring.

Digoxin is a medication which has been used in one form or another since the 18th century. However, it is a very dose-specific drug, which requires a specific amount of the medication to be effective and avoid the risk of potentially life-threatening digoxin side effects. As a result, manufacturers who choose to make and distribute the pill must take extra precautions to ensure that the correct dose is in each pill and quality control measures must be in place to prevent any undersized or oversized digoxin tablets from being distributed.

DIGOXIN TOXICITY LAWYERS

The Digoxin recall lawyers at Saiontz & Kirk, P.A. are reviewing potential overdose and digoxin toxicity lawsuits for individuals who received the heart medication and required medical treatment as a result of problems which may have been caused by receiving too much or too little of the drug.

If you, a friend or family member have experienced problems, contact our Digoxin attorneys and request a free consultation and claim evaluation.

On April 25, 2008, Actavis recalled all lots of their generic digoxin heart drug after it was found that some of the tablets were twice as thick as they were supposed to be, containing excess of digoxin. This poses a serious risk to users of the drug, as a digoxin overdose could lead to digitalis toxicity, with symptoms like nausea, low blood pressure, cardiac instability, bradycardia (slow heartbeat) or even death.

On December 24, 2008, eight months after the Digitek recall, a report was published by the Center for Public Integrity indicating that there was a spike in adverse event reports involving the drug earlier this year and that there have been over 650 Digitek deaths reported between April 1, 2008 and June 30, 2008.

This data seriously calls into question the assertions by Actavis that they caught all of the oversized Digitek tablets before they were distributed to the public.

The report also criticized the steps taken after the recall to notify consumers, healthcare providers and pharmacists about the recall and the risk of potentially fatal injury associated with continued use of Digitek.

DIGITEK RECALL ATTORNEYS

The Digitek attorneys at Saiontz & Kirk, P.A. are investigating a number of potential wrongful death lawsuits and other claims for injuries associated with the use of Digitek. Lawsuits are being evaluated on behalf of individuals throughout the United States and there are no fees or expenses unless a recovery is obtained.

Many users of the heart drug and family members continue to remain unaware of the Digitek recall or that serious injury or death suffered while taking the drug may be related to oversized tablets. To have a potential lawsuit evaluated and reviewed by our Digitek attorneys, request a free consultation.

Rep. John Dingell (D-MI), who is the Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), who is the Chairman of the Oversight and Investigations Subcommittee, sent a letter last week to the FDA Commissioner requesting information about all products the agency approved for Actavis since January 1, 2003.

According to the letter, they are trying to determine whether the FDA was “deceived” regarding the manufacturing practices of the company, or whether the FDA “simply fail(ed) to conduct adequate and timely inspections” of the drug maker’s facilities.

On April 28, 2008, Actavis Totowa, a subsidiary of the generic drug maker Actavis Group, issued a digoxin recall for all lots of their generic drug Digitek, which is used to treat heart failure and abnormal heart rhythms. The recall was issued because the drug maker’s poor manufacturing practices and lack of quality controls allowed thousands of Digitek tablets to be commercially sold that were twice as thick as they were supposed to be.

Double strength Digitek tablets could increase the risk that users suffer digoxin toxicity, which occurs when the medication builds up in the body. This is a particular risk for users with renal failure, and has been linked to serious and life-threatening injuries for users throughout the United States. Symptoms of digoxin toxicity could include nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia or death.

The digoxin recall was not the first sign of problems at the manufacturing plant in New Jersey where these Digitek tablets were produced. In February 2007, the FDA sent a warning letter to Actavis Totowa after an inspection found that certain products made at the plant were “adulterated.” The inspectors identified several quality control failures dating back to 2006, found there were inadequate assurances of cleaning between the manufacture of different drugs and at least one machine was found to be strapped with duct tape to prevent powder from escaping.

Following the digoxin recall, another FDA inspection revealed more violations at the Actavis Totowa plant in New Jersey, leading to another recall for over 65 more generic drugs in August 2008. Although both Actavis and the FDA have indicated that there were no health risks posed by these drugs, the lack of quality controls and the continued violations of good manufacturing practices raised concern for the Congressional committee.

DIGOXIN RECALL LAWSUITS

Since May 2008, the digoxin lawyers at Saiontz & Kirk, P.A. have been investigating potential Digitek lawsuits for individuals who received the heart medication since 2006 and experienced sudden health problems that may have been caused by digoxin toxicity. If you, a friend or family member have experienced digoxin problems, request a free consultation and claim evaluation.

The lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who have suffered a digoxin overdose as a result of defective and over strength Digitek tablets. In April 2008, Actavis Totowa LLC recalled all lots of their Digitek (generic digoxin) after manufacturing problems at their New Jersey plant allowed tablets to be sold which were twice as thick as they were supposed to be.

About 60 people have already filed digoxin lawsuits as a result of the defective Digitek tablets, and hundreds of other cases are being investigated for filing in the near future by lawyers throughout the country. Exposure to double strength Digitek tablets substantially increases the risk of digoxin overdose, also known as digitalis toxicity. This occurs when the active ingredient in Digitek builds up in the body, potentially causing sympsoms such as vomitting, diarrhea, vision changes, breathing difficulties or death.

The court ordered the Digitek lawsuit consolidation through a federal procedure known as Multidistrict Litigation, or MDL. Every digoxin lawsuit filed in Federal court as a result of the Digitek recall will be transferred to Judge Goodwin to eliminate duplicate discovery and deposition across hundreds, or potentially thousands, of cases. In addition, this will avoid the risk of inconsistent pretrial rulings on common factual or legal issues which could occur if the cases were maintained in the original courts where they were filed.

Although an MDL has many traits similar to a digoxin class action lawsuit, the cases do remain individual claims and there is no class representative representing all plaintiffs. Rather, each case remains an individual lawsuit, with individual burdens of proof. If the consolidated digoxin litigation does not resolve or settle during pretrial proceedings, the cases will be sent back to the courts where they were filed for trial.

DIGOXIN LAWSUIT ATTORNEYS

The Digitek lawyers at Saiontz & Kirk, P.A. are evaluating potential digoxin overdose lawsuits for individuals who have experienced severe illness or death since 2006. If you, a friend or family member have suffered problems which may be related to double strength Digitek, request a free consultation and digoxin lawsuit evaluation.

>>PRIOR POST (5/4/2008): Digitek Recall Due to Risk of Digoxin Overdose

Actavis Totowa, LLC, is a generic drug maker who produces a variety of different medications at the plant in Little Falls, New Jersey. An FDA inspection uncovered a number of violations of the proper standards for manufacturing drugs and poor quality controls, leading the company to ask pharmacies and hospitals to return all medications they produced.

>FDA LINK: Complete List of Medications Impact by Actavis Recall

In April 2008, Digitek tablets produced at this same New Jersey plant were recalled after it was discovered that some tablets were twice the width and twice as strong as they were supposed to be. The FDA issued a Class I Digitek Recall because use of the defective digoxin tablets could cause serious and potentially fatal digoxin overdose.

The Digitek lawyers at Saiontz & Kirk, P.A. have been investigating potential lawsuits for users of the heart medication since the recall was announced. Hundreds of users have reported severe illnesses after taking the defectively manufacturered tablets, including vomiting, diarrhea, nausea, dizziness, low blood pressure, heart instability, vision changes and breathing problems.

Since the Digitek recall, Actavis has provided very little information about the extent of the manufacturing problems which led to the defective tablets. Many have expressed concerns about the safety of other products made at the same plant, since quality checks at the plant allowed the obviously defective Digitek pills to be sold throughout the United States.

It is unclear why the recall of other drugs made at the plant was not issued earlier. In fact, evidence of manufacturing problems at this New Jersey plant were present well before the Digitek recall was issued in April. The FDA has sent prior warning letters to Actavis Totowa LLC in February 2007 and August 2006 about poor manufacturing practices at the plant.

>>PRIOR POST (5/21/2008): Manufacturing Problems at Digitek Plant

Previous FDA inspections identified various violations of good manufacturing processes, including inadequate cleaning processes between the manufacture of different drugs and one machine which was strapped with duct tape to prevent powder from escaping. In May 2006, a batch of hydrochloprothiazide tablets made at the Little Falls, New Jersey plant cleared Actavis’ quality control checks even though they did not meet the appropriate specifications for hardness.

Oddly, Actavis has only issued this latest recall for medications that are still at the retail level, at hospitals and pharmacies. Consumers who have received any of the recalled generic drugs have been advised by Actavis that they should not stop taking their medication, as suddenly stopping could have adverse health effects. Information posted on their website indicates that “if patients are concerned and wish to consider switching medicines, they should first consult with their health care providers or pharmacists.”

ACTAVIS RECALL LAWSUIT

The Digitek recall lawyers at Saiontz & Kirk, P.A. are monitoring the facts surrounding this latest recall from Actavis Totowa. It is unclear what, if any, specific health risks could be associated with the prescription drugs manufactured at this plant. If you, a friend or family member have suffered adverse reactions or side effects to any of the recalled generic drugs made at the New Jersey plant, request a free consultation and claim evaluation.

Digitek is a generic form of digoxin, which is a medication prescribed to help the heart beat stronger and regularly. It is often prescribed to individuals with congestive heart failure or conditions which cause fast heartbeats, such as atrial fibrillation or atrial flutter.

In April 2008, all lots of Digitek were recalled after it was discovered that tablets were sold that are twice as thick as they are supposed to be. These tablets could contain up to double the amount of digoxin, substantially increasing the risk of a serious and potentially fatal Digitek overdose, also known as digitalis toxicity.

A digoxin overdose is a known potential complication of Digitek, which could occur if too much of the medication is taken or if a patient has impaired kidney function, which prevents them from excreting the drug. However, double strength tablets substantially increase the risk of a Digitek overdose, even if the medication is taken as directed by individuals without kidney problems or other conditions which may predispose them to the complication.

Digitalis toxicity is a very serious complication which can lead to a life-threatening abnormal heart rhythm, known as ventricular tachycardia. Symptoms of an overdose could include:

• Nausea, Vomiting, Diarrhea and Loss of Appetite
• Confusion or Seizures
• Palipitations or Irregular Heartbeats, including fast or slow heart rhythms
• Changes in Urine Output, including decreased urination or excessive nighttime urination
• Vision Changes, such as light “halos” around objects, changes in color perception or blurred vision

Medical literature suggests that individuals who experience symptoms of a digitalis overdose should seek immediate medical attention. Most individuals who may have been given the double strength Digitek already received letters from their pharmacy or doctors. However, many family members of individuals who died or suffered severe injuries prior to May 2008 are just now learning that a Digitek overdose may have been caused by defective pills.

LAWYERS ARE REVIEWING DIGITEK OVERDOSE LAWSUITS

Potential lawsuits are being reviewed throughout the United States for individuals who suffered a Digitek overdose. Digitalis toxicity could have been caused by double strength digoxin that never should have been commercially released. To review a potential overdose lawsuit for yourself or a loved one, request a free consultation and claim evaluation

The lawyers at Saiontz & Kirk, P.A. began receiving calls from individuals with potential cases within days of the April 25th Digitek recall. Many people have described problems that surfaced during the months around the recall, but some have reported problems consistent with a Digitek overdose as early as 2006. Since the manufacturer has released very little information about the extent of the Digitek problems, all cases are being reviewed to determine if injuries could have caused by the manufacturing problems.

Digitek is a generic form of digoxin, which is prescribed to treat heart failure and abnormal heart rhythms. Overmedication could increase the risk of a serious and potentially fatal illness, known as Digitalis Toxicity. This occurs when the body is unable to eliminate the medication through the kidney, producing symptoms like nausea, vomiting, low blood pressure, cardiac instability and bradycardia (or slow heartbeat).

By selling pills that were twice as thick as they were supposed to be, the manufacturer exposed users to twice the active medication. Consumers rely on drug makers and distributors to have quality checks in place to prevent these types problems. By allowing multiple lots of Digitek to be sold which potentially contains double strength tablets, thousands of people could have been seriously injured.

Digitek is manufactured by Actavis Totowa, which is based out of New Jersey, and it was distributed by Mylan Pharmaceuticals of Pennsylvania and UDL Laboratories of Illinois. It is likely that many more Digitek lawsuits will be filed in different federal and state courts in the coming weeks. In addition, a petition will probably be filed in the near future to consolidate the federal cases in an MDL, or Multi-District Litigation, for pre-trial proceedings, which allows a large number of individual cases to be coordinated in a manner similar to how a Digitek class action would be handled.

REVIEW A DIGITEK LAWSUIT

If you, a friend or family member have taken Digitek and suffered symptoms of Digitalis Toxicity, request a free consultation and claim evaluation.

>>FDA LINK: Ethex Morphine Sulfate Recall

According to the manufacturer, one lot of morphine sulfate 60 mg extended release tablets (lot number 91762) distributed between April 16, 2008 and April 27, 2008 may contain defective pills. They were commercially released throughout the United States under an “ETHEX” label, with white oval pills.

Morphine is a highly potent opiate analgesic drug. Exposure to too much of the drug could cause a morphine overdose, with potentially fatal consequences. Double strength morphine side effects could include:

• Difficulty Breathing
• Lack of Breathing
• Low Blood Pressure
• Death

According to Ethex Corporation, the morphine recall only applies to the one lot of 65 mg tablets, and other strengths or lots were apparently not impacted. However, no information has been provided to explain how they know that the quality check failures that allowed tablets with double the morphine to be sold, did not extend to other lots.

Less than 60 days ago, Actavis Totowa issued a Digitek recall after they discovered that manufacturing problems also allowed tablets to be sold with double the active pharmaceutical ingredient and double the appropriate thickness. However, that recall was issued for all lots of the medication, since reports surfaced about possible side effects which could be linked to the double strength tablets as early as 2006.

MORPHINE RECALL LAWSUITS

Any users of Ethex morphine sulfate who are concerned about their medication should contact their doctor or pharmacist. Unfortunately, most users of the drug are likely to be very ill, with reduced strength and energy. As a result, they may not realize that their medication is overweight or oversized.

For those who have experienced a severe physical injury or death as a result of a morphine overdose after taking the medication, the lawyers at Saiontz & Kirk, P.A. are providing free consultations to review the legal rights which may be available. Any unused Ethex morphine sulfate 60 mg extended release tablets from lot number 91762 should be stored and marked so that they are not taken in the future. Request a free consultation and claim evaluation.

Digitek is a generic form of digoxin, which is prescribed for treatment of heart failure and cardiac arrhythmias. It contains digitalis, which can cause a severe illness known as digitalis toxicity when it accumulates in the body. On April 25, 2008, Actavis Totowa issued a recall for Digitek after it was discovered that some tablets that left their manufacturing process twice as thick as they are suppose to be, containing double the appropriate amount of active pharmaceutical ingredient.

The Digitek recall notice indicated that Actavis had received “several reports of illnesses and injuries” consistent with digitalis toxicity. In a May 2, 2008 Newsday article about the Digitek problems, an Actavis spokesperson indicated that the company and the FDA had received complaints of side effects since 2006. However, no estimates or indications have been released about how many of these defective tablets were sold, or how the manufacturer allowed this to happen.

PRIOR MANUFACTURING PROBLEMS AT DIGITEK PLANT

The 2008 Digitek recall was not the first sign of problems at the New Jersey plant where the pills were made. In February 2007, the FDA sent a warning letter to Actavis Totowa after an inspection of the facility found that certain products made at the plant were “adulterated’. The FDA indicated that Actavis failed to establish the identity, strength, quality and purity of drug products they were making at the facility and inspectors noted several violations of good manufacturing processes. Some of the findings outlined in the warning letter included:

• In May 2006, a batch of hydrochloprothiazide tablets which failed to achieve the target hardness passed initial quality control.
• The company’s cleaning processes were found to be inadequate, without assurance that there was proper cleaning between the manufacture of different drugs.
• At least one machine was found to be strapped with duct tape to prevent powder from escaping.

>>LINK: 2007 FDA Warning Letter to Actavis

According to a May 6, 2008 report from inPharmaTechnologist.com, an Actavis spokesperson denied that the issues identified in the 2007 warning letter were related to the 2008 recall. They indicated that all of the issues outlined were resolved to the FDA’s satisfaction. However, the prior violations certainly indicate that over the past few years production problems have existed at the plant.

Actavis was also involved in another recent recall involving manufacturing problems with their generic fentanyl patches. In March 2008, Actavis issued a fentanyl patch recall after it was discovered that some of their powerful painkilling patches contained “fold-over” defects which could allow the fentanyl gel to leak out and come into direct contact with the skin. It is unclear whether these defective pain patches were made at the same plant as the Digitex.

DIGITEK LAWYERS

The lawyers at Saiontz & Kirk, P.A. are investigating potential Digitek lawsuits for individuals who have suffered an injury consistent with digitalis toxicity. Symptoms of the illness that could be caused by the Digitek problems include:

• Nausea, Vomiting, Diarrhea, Dizziness, Confusion or Loss of Appetite
• Low Blood Pressure
• Cardiac Instability, Irregular Pulse, Heart Palpitations
• Badycardia (slower heartbeat)
• Vision Changes (halos, changes in color, blind spots, blurred vision)
• Changes in Urination
• Difficulty Breathing

If you, a friend or family member have experienced problems after taking Digitek which resulted in medical treatment, request a free consultation and claim evaluation.

The lawyers at Saiontz & Kirk, P.A. are reviewing Digitek lawsuits on behalf of individuals who have suffered severe reactions to the double strength digoxin tablets, known as digitalis toxicity. As a result of the increased exposure to the medication, some patients could accumulate too much digitalis in their body, leading to nausea, low blood pressure, decreased heart beat or death.

Digitek class actions suits have been filed against Actavis Group, their subsidiary, Actavis Totowa, LLC., and their distributors Mylan Pharmaceuticals, Inc. and UDL Laboratories, Inc. The plaintiffs are seeking to represent all individuals who purchased or used Digitek (generic digoxin). The lawsuits allege that the defendants knew or should have known that the Digitek was defective, potentially increasing the risk of digitalis toxicity, and that they failed to take steps to protect the public.

The lawsuits seek to establish state and national classes to obtain refunds for those who purchased Digitek, compensation for those who suffered side effects of Digitek and a medical monitoring class to provide screening, medical services, research and other steps to ensure that prompt treatment is provided to reduce the risk of life-threatening injuries.

DIGITEK LAWSUITS

For individuals who have taken Digitek and suffered severe physical injuries consistent with digitalis toxicity, they should consult with an attorney to review the potential for an individual Digitek lawsuit, as opposed to participating in a class action suit.

The Digitek lawyers at Saiontz & Kirk, P.A. are reviewing individual claims for individuals diagnosed with digitalis toxicity, those who suffered problems requiring medical treatment for low blood pressure, cardiac instability, bradycardia, or those who suffered fatal injuries. To review a potential case, request a free consultation and claim evaluation.

>>FDA LINK: Generic Digoxin Recall

Digitek is prescribed for heart failure and abnormal heart rhythms. It is a form of digitalis, which is a chemical that has been used as a heart medicine for over 200 years. However, the double strength digoxin tablets potentially sold over the past few years could lead to digitalis toxicity for individuals with kidney failure or renal insufficiencies.

Digitalis toxicity is a severe illness that can be fatal in some cases. It is associated with symptoms such as nausea, vomiting, dizziness, vision problems, low blood pressure, slow heart beat and death. Reports indicate that the manufacturer of Digitek received complaints involving the digoxin side effect as early as 2006, raising questions about why the Digitek recall was not issued earlier.

DIGITEK PHARMACY LETTERS AND PHONE CALLS

Although prescription medication recalls are not uncommon, it is rare for individuals who filled the prescriptions to be personally notified that their drug may be unsafe. Given the substantial risk of serious injury or death associated with use of the recalled Digitek, pharmacists have been asked to directly contact customers. Many pharmacies are reaching out to any individuals who had a prescription filled within the past 12 months.

The lawyers at Saiontz & Kirk, P.A. have been reviewing potential Digitek lawsuits since the recall was announced. Several of the individuals who contacted our office have already received phone calls or pharmacy letters. They are being advised to return any unused Digitek pills and to contact their physicians about health concerns.

DIGITEK RECALL CLAIM EVALUATIONS

Individuals who suffered from digitalis toxicity after taking Digitek could be entitled to financial compensation. Potentially toxic levels of digitalis were provided in pills that were prescribed to help improve health. If you, a friend or family member have suffered digitalis problems, request a free consultation and claim evaluation.

Digitek (digoxin) is a medication approved to treat heart failure and abnormal heart rhythms. The Digitek recall applies to about half of the digoxin supply in the United States. The tablets, which were manufactured by a division of Actavis Group, were distrubted by Mylan Pharmaceuticals, Inc. and UDL Laboratories,Inc. under the labels “Bertek Digitek” and “UDL Digitek”.

The Digitek recall was initiated after Actavis received a number of reports of severe illness, known as digitalis toxicity. According to some reports, the manufacturer began receiving notice as early as 2006 about potential Digitek side effects which could have been associated with twice the active ingredient being contained in the tablets.

Digitalis toxicity is a serious and potentially fatal illness which is known to occur in people with impaired kidney function, particularly those with renal failure. It is caused by excessive amounts of digitalis accumulating in the body. Symptoms of Digitalis Toxicity include:

• Nausea
• Vomiting
• Dizziness
• Low Blood Pressure
• Cardiac Instability
• Bradycardia

DIGITEK RECALL LAWYERS

The recall lawyers at Saiontz & Kirk, P.A. are investigating potential Digitex lawsuits on behalf of users of the medication who have required medical treatment as a result of digitalis toxicity. If you, a friend or family member have experienced Digitek problems, request a free consultation and claim evaluation.