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Popular Diabetes Medication: Metformin, Recalled Due to Carcinogenic Ingredient

Popular Diabetes Medication: Metformin, Recalled Due to Carcinogenic Ingredient

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Popular Diabetes Medication: Metformin, Recalled Due to Carcinogenic Ingredient

Boesen Law is always watching for recalls in medications. It is important to us to inform the general public about any changes in prescriptions. This week, we are researching the popular Diabetes medication: Metformin and the cancer-causing impurity: NDMA.

What is Metformin? 

 

Metformin ER (Extended Release) is a popular Diabetes medication that is currently in the process of being recalled due to higher than FDA acceptable levels of NDMA, a cancer-causing impurity. 

 

What did the FDA have to say? 

 

According to the FDA website, a statement made in December 2019, by Janet Woodcock, M.D., who is the director of the FDA’s Center for Drug Evaluation and Research, was documented. In the statement, Dr. Woodcock reported “.. impurities found in (the) Diabetes drug outside of the U.S.”. In regards to Dr. Woodcock’s statement, she also reported that the FDA was investigating the “.. presence of genotoxic impurities, called nitrosamines, in some types of drugs.” In the investigation, that lasted for over a year and a half, it was found that some drugs were found to contain small amounts of those nitrosamines like N-Nitrosodimethylamine (or NDMA, the carcinogenic substance found in Metformin). In the statement, Dr. Woodcock says that the medication, Metformin, was within the acceptable amount for the United States but there would be testing done to reach a conclusion. On May 28th, 2020, the FDA had a press release, alerting patients and health care professionals about the NDMA findings in certain Metformin Extended-Release products. Fortunately, a short time later, pharmaceutical companies began to voluntarily recall their batches of Metformin ER. It is important to note that with further FDA testing, there isn’t any shown NDMA in Metformin Immediate Release (IR), which is the most commonly prescribed type of Metformin. 

 

What is NDMA? 

 

N-Nitrosodimethylamine, or NDMA for short, is a common and naturally occurring contaminant found in water and foods like cured or grilled meats, dairy products, and vegetables. It is also a probable human carcinogen when taken in large quantities or over a long period of time. This is not the first time medication has been recalled due to NDMA. Medications like Zantac and Losartan have been recalled as well for their quantities of NDMA present. 

 

What pharmaceutical companies are recalling Metformin ER?

 

According to the FDA’s website, there have been a total of 16 laboratories that have voluntarily recalled the extended-release Metformin. Most recently, in January of 2021, Nostrum Laboratories recalled the medication. 

 

What should I do if I, or a loved one, are taking Metformin ER? 

 

If you or a loved one have been taking Metformin ER, please consult with your doctor right away to find a safer alternative. It is important to note that it can be dangerous for patients with Diabetes to suddenly stop taking Metformin without first talking to their doctor. According to the FDA, it is recommended to continue the use of Metformin until a safer choice is provided because stopping “cold turkey” can worsen actualized symptoms. 

Boesen Law always remains vigilant so you don’t have to. If you or someone you know have taken Metformin and needs legal representation, please do not hesitate to call us at (303) 999-9999 or visit our website: http://www.boesenlaw.com. We are always here to help.

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Mesothelioma & Pharmaceuticals

Type-2 Diabetes Medication: Onglyza and its Link to Increased Risk of Heart Failure

The legal team at Boesen Law is investigating claims regarding Onglyza linked to increased risk of heart failure.

What is Onglyza?

Onglyza is a medication approved by the FDA in 2009 with the purpose of treating Type-2 diabetes. According to the official website for Onglyza, it is also “..proven to lower A1C levels”. This was established through a 24-week clinical study involving adult patients with Type-2 diabetes who reported that their blood sugar was not controlled enough by taking Metformin IR (Immediate Release) alone. The study had a total of 743 adults where more than half were given Onglyza plus Metformin IR. After the study term of 24 weeks was over, the results stated that those who took Onglyza and Metformin IR saw significant A1C reductions versus those who took a placebo and Metformin IR. However, though there was only one test study conducted, individual results may vary. 

How does Onglyza work?

Onglyza increases incretin levels (incretin is a hormone that stimulates insulin secretion in response to meals) which helps release insulin. The released insulin will help control blood sugar levels. According to the Onglyza website, there are claims that the medication may lower morning blood sugar.

Blood sugar can rise while someone is sleeping due to the pancreas releasing too much glucagon ( a hormone involved in controlling blood sugar levels) which in turn, makes the liver release too much sugar. By taking Onglyza, it will reduce the amount of sugar released throughout the night causing lower blood sugar numbers in the morning.

The official website also claims that Onglyza may lower after-meal spikes which occur when the pancreas doesn’t release enough insulin or the body is not using insulin properly. By taking the medication, it may lower spikes by helping the body increase the levels of insulin after mealtime. 

Who may have been prescribed Onglyza? 

Onglyza was prescribed to adult patients 18 years and older with Type-2 diabetes. The medication was used alone (if recommended by your doctor) or with insulin/ other antidiabetic medicines.

What is causing the increased risk of heart failure while taking Onglyza?

Studies show that the main ingredient in Onglyza, saxagliptin, is causing an increase in heart failure. Saxagliptin is a class of medication called “dipeptidyl peptidase-4 inhibitors” or DPP-4.

What if I am experiencing any heart failure symptoms?

If you have any symptoms of heart failure like increased shortness of breath/ trouble breathing especially when lying down, unusual increase in weight, swelling/fluid retention (feed, ankles, or legs), or unusual tiredness/fatigue please call your doctor! If it is an emergency, please stop and call 911 immediately.

What are the side effects? 

Like most medications, there is a list of negative side effects which include:

  • Shortness of breath
  • Tiredness and lethargy
  • Increased hunger
  • Shakiness
  • Sweating
  • Headaches
  • Rapid heartbeat
  • Vision changes

These are just a few of the side effects described in the pamphlet we received. After more research on the official website for the medication, one can see that there are even more negative side effects. One of the more concerning side effects is inflammation of the pancreas (pancreatitis) and the most alarming一 heart failure.

It is said that the side effects were already existing when the drug was approved more than 10 years ago by the FDA. The manufacturer did not warn any of their patients about the effects until 2016. Here we have added the major risks detailed in the pamphlet. 

Major risks: 

  • Increased risk of heart failure
  • Low blood sugar
  • Joint pain
  • Pancreatitis

Some of the major risks seem pretty trivial; however, one should know that these major risks have landed people that have taken Onglyza in the hospital. These risks can be major life-altering events and at Boesen Law, we aim to keep everyone safe. 

If you believe you, or someone you know, have been affected by Onglyza and have been sick, contact the Boesen law offices as soon as possible. Our consultations are always free of charge and we strive to get each person the help they need and deserve. Our number one priority is your health and safety. Please call us at (303) 999-9999.

Information gathered by the following links:

https://www.onglyza.com/side-effects.html

https://www.medicines.org.uk/emc/product/9368/pil#gref

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Mesothelioma & Pharmaceuticals

Criminal Investigation Coming for Some Pharmaceutical Companies over Opioids

[:en]US government officials have launched a criminal investigation into whether pharmaceutical companies intentionally allowed painkillers to flood communities, and contribute to the opioid epidemic. 

Controlled Substances Act

According to an article from Markets Insider, investigators are looking into whether companies such as Teva are in violation of the Controlled Substances Act. The law requires companies to track certain drugs and report any suspicious orders or activity to authorities. 

Opioid Legal Issues

Other pharmaceutical companies are already feeling the legal heat over the opioid epidemic. The Sackler family who is behind powerful pharmaceutical company Purdue Pharma, known for the painkiller Oxycontin has filed for bankruptcy. Several states have also sued the company claiming aggressive marketing tactics to push the drugs to doctors and other medical providers have also influenced the severity of the epidemic. 

Injured by Oxycontin or other Drug? 

If you or someone you know has been injured through the use of Oxycontin or other pharmaceutical drugs000 contact our team at (303)-999-9999 or (303)-835-9342 to schedule a free consultation. Click here to view our practice area page on pharmaceuticals for more information. 

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Opioid Trial on Hold As Possible Deal Struck

[:en]Another settlement deal in the opioid epidemic may be on the horizon between pharmaceutical distributors, a developer, and the federal government. 

Trial Set to Begin Today

The first day of the trial was set to begin this morning in U.S. District Court in Cleveland, Ohio. The claims were brought against distributors such as AmerisourceBergen according to an article from Denver 9 News. Some defendants were left out of the deal, like distributor Henry Schein and popular pharmacy brand Walgreens. At this time, it is unknown if the trial will still go forward. 

A Different Angle

This trial is set to look at the opioid crisis in a different way. Instead of focusing solely on pharmaceutical developers and their marketing of opioids, this trial looks at how distributors of these drugs also contributed to the epidemic. The article also mentioned how pharmaceutical company Purdue Pharma recently came to a possible settlement agreement with the federal government last month. The agreement has the potential to be worth up to $12 billion, however may be reworked due to the company now having filed for bankruptcy.

Injured from Opioids or other Bad Drugs?

If you or someone you know has suffered an injury through the use of an opioid or another pharmaceutical drug, contact our team at (303)-999-9999 or (303)-835-9342 to schedule a free consultation. Click here to view our practice area page on pharmaceuticals for more information.  

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Purdue Pharma Files for Bankruptcy as New Sackler Family Information Comes Out

[:en]Purdue Pharma is filing for bankruptcy, as new information about the Sackler family who owns the company has come to light. 

Part of Settlement Agreement

According to their federal settlement agreement, Purdue Pharma has filed for bankruptcy as reported by USA Today. However not everyone is jumping on the bandwagon. Multiple states have come out against the agreement as they feel it does not give enough financial help to the victims. 

New Sackler Revelations

The filing of bankruptcy occurs just as news about the Sackler family moving around money has come to light. According to new court documents, the Sackler family has received around $4 billion dollars in profit from Purdue Pharma, as well as have additional wealth outside of the country. State attorney’s like Pennsylvania AG Josh Shapiro is accusing the family of trying toevade responsibility and lowball the millions of victims of the opioid crisis.” 

Uncertainty Ahead

It remains to be seen how the impact of the federal agreement, as well as separate lawsuits filed in state courts shape the future of Purdue Pharma. While the company could end up going out of business, there is a possibility that new ownership takes charge if a judge decides to go that route. 

Injured by OxyContin?

If you or a loved one has been injured through the use of OxyContin or other prescription drug, contact our team at (303)-999-9999 or (303)-835-9342 to schedule a free consultation. Click here to view our practice area page on pharmaceuticals for more information. [:]

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Colorado Rejecting Possible Federal Agreement with Purdue Pharma

[:en]The state of Colorado is rejecting a tentative federal agreement with Purdue Pharma, the company behind popular prescription drug OxyContin which helped spark a national opioid crisis. The agreement apparently involves the condition of the Sackler family who owns Purdue Pharma giving up control of the company, as well as paying out $12 billion dollars to victims over a period of time. 

Purdue Pharma Agreement Isn’t Adequate for CO

According to an article from the Colorado Sun, State Attorney General Phil Weiser commented on the agreement stating “No current offer adequately addresses the harm that Purdue and the Sacklers have caused to communities and individuals in Colorado by contributing to the opioid crisis.”

Mr. Weiser is currently pursuing a case against Purdue Pharma in state court. Many Colorado counties and cities are included in the possible settlement, including Denver. However, it remains to be seen how the settlement funds will be spread out. 

Pushing Ahead on their Own

Colorado isn’t the only state to reject the agreement. Multiple other states such as New York, Minnesota, and Connecticut have also come out against the agreement. 

Despite the possible settlement, Purdue Pharma and the Sackler family are still facing legal headaches. Multiple states in addition to Colorado have also decided to go after the company in state courts, so additional payouts could potentially occur. 

Injured By Opioids or other Bad drugs?

If yourself or a loved one has been injured through the use of opioids or other prescription drug contact our team at (303)-999-9999 or at (303)-835-9342 to schedule a free consultation. Click here to visit our practice area page on pharmaceuticals for more information. [:]

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Breaking: Johnson & Johnson Hit with $572 Million Verdict over Opioid Crisis in OK

[:en]An Oklahoma judge has found Johnson & Johnson’s pharmaceutical subsidiary Janssen Pharmaceuticals guilty of contributing to the opioid crisis in the state. 

$572 Million 

The judge ordered Johnson & Johnson to pay the state $572 million according to an NBC News article about the ruling. This is a significant verdict, as this trial was the first of its kind to be heard involving the opioid crisis.

Aggressive Tactics by Johnson & Johnson

Oklahoma Attorney General Mike Hunter argued that the company created a “public nuisance” by using extreme marketing tactics to push their prescription painkillers to the medical community and glossing over the risk of addiction. As a result, an epidemic has occurred nationally, with Oklahoma experiencing over 6,000 deaths as a result of the crisis.

Future Impact

This ruling can potentially impact how other state’s cases against pharmaceutical companies over the opioid epidemic will be viewed going forward. With this ruling, there is a potential for judges to want to side with states over pharmaceutical companies when determining who is at fault. 

Injured by an Opioid or other Bad Drug?

If you or a loved one has been injured through the use of an opioid or another pharmaceutical drug, contact our team at (303)-999-9999 or (303)-835-9342 to schedule a free consultation. Click here to visit our practice area page on pharmaceuticals for more information. [:]

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Sanofi-Aventis Asks for Delay in Start of Taxotere Trial

[:en]Sanofi-Aventis LLC, the pharmaceutical company behind chemotherapy drug Taxotere has asked a federal judge to delay the start of a trial brought by plaintiffs who claim using the drug caused them to have permanent hair loss. 

Needing More Time

According to an article from Law.com, the legal counsel for Sanofi-Aventis LLC argued that other pending pre-trial motions have not been heard yet. They also argued that a ruling by the Supreme Court in a separate case involving Merck Pharmaceuticals, that states “judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination.” 

Motion Denied

At the end of the day, however, it was a win for the plaintiffs. The federal judge denied the motion for at least one of the plaintiffs, and attorneys for the plaintiffs expressed their frustration at the request considering the judge had already granted the respondents a delay back in May.

It remains to be seen how the judge will rule regarding the other individuals. Legal counsel for the plaintiffs has also argued that a delay for the trial is unfair to the other plaintiffs in the lawsuit, as many of them are ill and/or have passed away and are not being allowed a fair shake in the proceedings. 

Injured by Taxotere?

If you or a loved one has suffered permanent hair loss as a result of using Taxotere or had any other adverse medical reaction due to the use of a pharmaceutical drug contact our team at (303)-999-9999 or (303)-835-9342 to schedule a free consultation. Click here to view our practice area page on pharmaceuticals for more information. [:]

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Pivotal Ruling to be Expected in MA OxyContin Lawsuit

[:en]A motion has been filed in Suffolk Superior Court by Purdue Pharma involving the lawsuit filed against the company by state Attorney General Maura Healy.

Dismiss the Case

The company’s legal counsel filed the motion arguing that the evidence used by AG Healey is “full of hyperbole” according to an article from Legal Scoops. The company also argued that the lawsuit does not represent Purdue Pharma’s role in the opioid crisis in an accurate way and that the company is taking active measures to resolve the crisis. 

Maura Healey filed a lawsuit against the company claiming that they used extreme marketing tactics to push their painkiller OxyContin to medical providers even when they had knowledge of its addictive qualities. She also claims that these tactics are what has fueled the state (and nationwide) opioid crisis. 

Pivotal Ruling in OxyContin case

While no ruling has been announced yet, the forthcoming decision by Judge Sanders who is presiding over the case could potentially affect other lawsuits filed by states going forward. Purdue Pharma is facing a legal tsunami of sorts – 48 states so far have filed lawsuits against the company over the opioid crisis. 

Injured by OxyContin or another Bad Drug?

If you or a loved one has been injured through the use of OxyContin or other pharmaceutical drugs contact our team at (303)-999-9999 or (303)-835-9342 to schedule a free consultation. Click here to view our practice area page on pharmaceuticals for more information. [:]

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J&J’s Appeal for Risperdal Gynecomastia Case Denied by PA Supreme Court

[:en]The Pennsylvania Supreme Court declined Monday August 5, 2019 to hear an appeal of a Risperdal case involving Johnson & Johnson and an Alabama family according to an article by the Pennsylvania Record. The appeal was made by Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, developers of the Risperdal drug.

Developing Gynecomastia

With the original lawsuit, the plaintiffs claimed that using the Risperdal drug which is an antipsychotic for their son who has autism, caused him to develop a condition known as gynecomastia where males develop large breasts. Without a surgical procedure (a mastectomy) the condition is permanent.

Johnson & Johnson tried to paint plaintiffs as trying to game the trial system after they switched out a doctor who had given a deposition but was not licensed to practice medicine in Alabama. The legal counsel for the plaintiffs used another doctor during the trial proceedings. However, the judge said the pharmaceutical company seemed to be waiting for just the right time to bring the issue up and possibly turn the tide in their favor.

Possible Future Damages

The lawsuit has now been sent back to lower courts to determine if punitive damages are allowed in this case. Johnson & Johnson continues their legal fight, as many other cases involving Risperdal and the development of this condition have been filed by other plaintiffs.

Injured by a Bad Drug?

If you or a loved one has been injured through the use of Risperdal or other pharmaceutical drugs contact our team at (303)-999-9999 or (303)-835-9342 to schedule a free consultation. Click here to view our practice area page on pharmaceuticals for more information.[:]