Dangerous Drugs | Blizzard Law PLLC

Does Tamiflu Have Dangerous

March 12, 2018/in Dangerous Drugs, News /by damg16

As one of the worst flu seasons in the past few years comes to end, some experts are concerned one of the few prescription medications available to treat the flu may have potentially life threatening side effects. Tamiflu has been available for over a decade, but reports that it causes abnormal behavior, particularly in children, are becoming increasingly apparent. This has led some experts to the conclusion that Tamiflu isn’t right for every patient.

Tamiflu’s label includes a warning stating that individuals with the flu, including patients taking Tamiflu, may experience “delirium and abnormal behavior leading to injury.” These dangerous side effects were first noted in a clinical trial in Japan where researchers also observed “these events were reported primarily among pediatric patients…”

Because of these reports, the U.S. Food and Drug Administration (FDA) warns “children and teenagers with the flu may be at a higher risk for seizures, confusion, or abnormal behavior early during their illness.” The U.S. Centers For Disease Control and Prevention (CDC) also warns neuropsychiatric side effects have been reported with Tamiflu.

It is extremely difficult for researchers to determine the exact link between Tamiflu and neuropsychiatric side effects. While the flu itself can cause these side effects, it is also possible Tamiflu is causing these side effects with fatal results.

Reports of abnormal behavior resulting from the ingestion of Tamiflu this flu season included an Indiana teenager who committed suicide shortly after beginning treatment with Tamiflu. Reports have also included very young children, such as a six-year-old girl from Texas who suffered hallucinations and tried to jump out of a window.

While the link between Tamiflu and dangerous neuropsychiatric side effects has not yet been fully studied, extreme cases like these have caused some patients to wonder if the benefit is worth the risk. The trouble is that there are very few medications available to effectively fight the flu, and if left untreated in vulnerable patients, the flu can be fatal.

Patients Have A Right To Know All Of The Side Effects

Patients have a right to know all of the risks and side effects associated with a medication. Without full knowledge of risks, patients cannot make informed decisions about their medical care. When drug companies fail to disclose all of the risks and patients suffer injuries, they have a right hold the drug company responsible through filing a personal injury lawsuit.

Access To Clinical Trial Data Just Got Easier

February 19, 2018/in Dangerous Drugs /by damg16

Clinical trials are crucial to understanding the safety and effectiveness of medications and medical devices. While the U.S. Food and Drug Administration (FDA) uses clinical trial data to evaluate new drug and device applications, clinical trial data has not been very accessible to patients. Transparency of clinical trial data is incredibly important for patients – they’re the ones taking the medication or utilizing the medical device after all. Luckily for patients, the FDA announced it is taking steps to make more clinical trial data easily accessible to those who will be most affected by any dangers or side effects – the consuming public.

FDA commissioner, Dr. Scott Gottlieb, has stated the agency is going to take steps to increase transparency. The first step in making clinical trial data more accessible is launching a pilot program to evaluate how releasing summaries of clinical studies impacts the public’s access to drug approval information. This first step will help the FDA understand how patients consume information about certain drugs and studies, thus allowing the agency to better cater to patients. The summaries will also be incredibly valuable to patients. While there is clinical trial data available to the public, it is often difficult for patients to understand the medical jargon.

In addition to a pilot program, the FDA is taking huge strides by linking information from its own database of clinical studies to the communications it sends out regarding specific trials. The FDA posts certain clinical trial data online which is available to the public. The agency is going to add identifying numbers to all clinical trials in the online database. This identifying number will link to any and all FDA communications regarding that specific study.

Previously, clinical trial data and the FDA’s communications and warnings regarding certain trials have not been presented together. This means patients could look up clinical trial data, but not learn about FDA warnings regarding the trial. FDA communications regarding trials often include information about injuries suffered by patients as a result of the trial, the discovery of compromised trial data, or other serious situations.

Putting Patients First

Patients have a right to understand all of the risks associated with any drug or device before choosing to utilize it. For some patients, this means more than just reading the prescription label. Patients have a right to understand the history of the drugs they take, from the laboratory testing to clinical trials on humans. By obtaining this information, patients have a much better understanding of the risks associated with a drug or device.

FDA Sends Far Fewer Advertising Letters in 2017

January 2, 2018/in Dangerous Drugs /by damg16

The U.S. Food and Drug Administration (FDA) is responsible for policing all prescription and over the counter medications and medical devices. The agency ensures devices and drugs comply with mandated safety standards and ensures manufacturers abide by advertising rules. Unfortunately, the FDA sent far fewer advertising letters out this past year.

In 2017, the FDA only sent out three warning letters for advertising violations compared to 11 in 2016. While some might believe the decrease is caused by better adherence to guidelines, this isn’t entirely true. Advertising regulations are meant to protect consumers from false claims made by drug and device manufacturers, and without strict policing of violators, consumers can easily be duped.

One of the warning letters the FDA sent out for advertising violations was for false and misleading information included in promotional materials for the insomnia drug Zolpimist. Promotional materials must be sent to the FDA for approval before use, but certain materials including a webpage did not receive approval. The other two warning letters addressed false and misleading claims from the manufacturers of the opioid ConZip and the weight loss drug Contrave.

False or Misleading Claims

Most advertising violations are for false or misleading claims. For the FDA, this can mean manufacturers minimized risks in advertisements, presented information or data that is untrue, or failed to include important information regarding the drug or device. Manufacturers must always include risk information on all advertising materials so physicians and consumers can make informed decisions about using a drug or device use. Without including the appropriate risk information, many consumers could end up taking medications and suffering serious side effects they knew nothing about.

All patients have a right to know the risks associated with medications and devices. Unfortunately, not all manufacturers express these risks and abide by advertising rules and the FDA only catches some of the violators.

FDA Paves The Way For More Drug Inspections Overseas

December 4, 2017/in Dangerous Drugs /by damg16

There is a fine balance between providing lifesaving medicine to the public and protecting the public from potentially harmful medicine. This is the line the U.S. Food and Drug Administration (FDA) must walk as it regulates drugs and medical devices. However the agency is making tremendous strides in patient safety by allowing more drug inspections in manufacturing facilities overseas.

The FDA recently announced it is taking steps toward the implementation of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA). This agreement allows regulators from both countries to use each other’s inspections of pharmaceutical manufacturing facilities to ensure they are meeting the appropriate health and safety standards. The FDA will now recognize the authority of drug regulatory agencies in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom to inspect facilities to see if they meet with FDA requirements.

This will have a huge impact on the availability of new medicines, as many medicines approved by the FDA are partially or completely manufactured overseas. Before recognizing these drug authorities, the FDA alone was responsible for overseas inspections. However, with massive numbers of drug companies and facilities, overseeing them all was a difficult task for the FDA.

The partnership prevents duplication of facility inspections, allowing more resources to be devoted to countries and facilities where there may be a greater risk of substandard manufacturing practices. By partnering with other countries, more facilities are inspected more often to ensure they are using good manufacturing processes.

Unfortunately, these overseas strides only seek to remedy a small part of what medications and devices can do to harm patients. Sometimes drugs meeting the FDA’s manufacturing requirements still cause significant injuries to patients. Oftentimes dangerous side effects are only discovered after a drug has hit the market. Drugs like anti-nausea medications and heartburn relievers can cause permanent injuries to unknowing patients.

What Patients Can Do

All medications and medical devices come with risks. However, patients have a right to know all of these risks upfront, so they can make informed decisions about their care. The FDA releases warning letters to the public when a manufacturer fails to meet FDA standards, including manufacturing standards and/or safety standards. Patients can look up the compliance history of any drug, manufacturer, or facility on the FDA’s website. By investigating the history of a drug or device, patients can make better informed decisions about their healthcare.

First Bellwether Trials Scheduled in Taxotere Litigation

September 18, 2017/in Dangerous Drugs /by damg16

For women who suffered permanent hair loss after undergoing cancer treatment, many questions were left unanswered by the manufacturer of the popular breast cancer drug, Taxotere. Luckily, federal court lawsuits filed against the company are making progress, and four bellwether trials have been scheduled.

Federal court Taxotere lawsuits have been centralized in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana. The lawsuits allege Taxotere’s manufacturer, Sanofi-Aventis, knew about the permanent hair loss risk, but failed to warn patients and doctors.

The labels for Taxotere in several other countries were updated in recent years to include information about the permanent hair loss risk, but the company’s U.S. arm decided not to update labels.

Studies have shown Taxotere can cause permanent hair loss, called alopecia, in approximately 9% of patients. However, there are safer and equally effective alternative treatments available. Many plaintiffs in the consolidated litigation state that had they known about the permanent hair loss risk, they would have sought alternative treatment options.

Women who suffered permanent hair loss after being treated with Taxotere are seeking to hold Sanofi-Aventis responsible. While several settlement conferences are scheduled throughout the next year, the court overseeing the litigation has also scheduled four bellwether trials beginning in 2019. The bellwether trials will be begin on:

January 28, 2019
April 8, 2019
July 15, 2019
November 4, 2019

While the first trial is over a year away, Sanofi-Aventis is likely considering its options very closely. There are already hundreds of lawsuits in the MDL and the number is expected to continue growing. The company will have to decide if pursuing each case in court is the best option, or if they should agree to a settlement.

Common Heartburn Drugs Increase Risk of Death

July 24, 2017/in Dangerous Drugs /by damg16

Millions of Americans suffer from heartburn, a condition where stomach acid backs up into the esophagus and creates an uncomfortable burning sensation. To help manage heartburn, many Americans use popular heartburn medications called Proton Pump Inhibitors (PPIs), but a recent study revealed these drugs are incredibly dangerous.

How PPIs Work

PPIs work by targeting the enzyme in the stomach’s lining that creates acid, and preventing the enzymes from making more acid. This reduces the amount of acid in the stomach, thereby relieving heartburn.

However, PPIs have been linked to a variety of permanent and life-threatening side effects. In April 2016, a study published in the Journal Of The American Society Of Nephology found patients who take PPIs had a 28% increased risk of developing chronic kidney disease. Additionally, the study also determined patients who take PPIs had a 96% increased risk of developing end-stage kidney failure within five years of starting to use the medications. Other health risks linked to PPIs include severe stomach infections, heart disease, osteoporosis, and dementia.

Increased Risk of Death

Because of the increasing number of dangerous side effects, researchers wanted to investigate how these side effects were impacting patients. Researchers from Washington State University School of Medicine analyzed a large patient database to compare death rates among patients who took PPIs with patients who took another class of heartburn medications called H2 Blockers.

Researchers looked at nearly 350,000 patients taking heartburn drugs and tracked them for up to five years. They determined that there was a 25% increased risk of death in patients who took PPIs compared to patients who took H2 Blockers. The researchers also determined that a patient’s risk of death increased with the length of time they took PPIs.

Increased Rate of Stomach Cancer

The past few years have seen the publication of several different studies linking the use of common PPIs like Nexium and Prilosec to serious side effects, but these pale in comparison to the latest study from researchers in the UK.

Researchers looked at patients who took PPIs daily to manage heartburn and discovered they were at a much higher risk of developing stomach cancer. Patients who use PPIs long-term have a 2.4 times greater risk of developing stomach cancer.

The risk of developing stomach cancer also increased with the frequency and duration of use. For patients who took PPIs for over a year, the risk of developing stomach cancer increased five-fold and for patients that took PPIs for three or more years, their risk increased eight-fold.

While this isn’t the first link between PPIs and stomach cancer, this was the first study excluding patients suffering from an infection causing bacteria in the gut that can also cause stomach cancer. The study allowed doctors to look more closely and accurately at the effects of PPIs over time.

Five Ways To Avoid Medication Mistakes

July 5, 2017/in Dangerous Drugs /by damg16

Millions of Americans rely on prescription medications to help them stay healthy. However, these medications only work if patients take them correctly. When medication mistakes do occur, patients are at risk for suffering serious side effects. To best prevent medication mistakes, patients can follow these five tips:

Know the names of your medications. Many patients have prescriptions filled without even knowing the names of their medications. To help avoid medication mistakes, talk to your doctor about your prescriptions and over-the-counter drugs, and the dosage so you will know if a pharmacist incorrectly fills your prescription or if your medications might interact poorly.
Check the label every time. To prevent medication mistakes, patients need to check the label of each medication every single time they take the medication. If patients don’t check the label, they could end up grabbing the wrong bottle and taking the wrong medication.
Know what your medication treats and how your medication works. Patients who understand their medications are more likely to take them correctly. A patient needs to have clear expectations of how a medication will work, such as if it can provide immediate relief of symptoms or if it works over time with regular doses.
Create a schedule. Patients who have trouble remembering to take their medications should write out a dosage schedule. This is particularly helpful for patients taking multiple medications at different times of the day. Not only is a taking medication at the appropriate time important for the effectiveness of the medication, but forgetting a dose could cause serious side effects.
Don’t be afraid to ask questions. If you don’t understand something about your medications, you need to ask a healthcare professional or pharmacist. With many medications, there is very small room for error, so it is important you don’t let any of your concerns or questions linger.

One-Third of All FDA Approved Medications Pose Safety Risks

May 30, 2017/in Dangerous Drugs /by damg16

As patients, we expect the prescriptions our doctors give us to be safe to take. However, a recent study found this might not be the case. Researchers determined one out of every three medications poses additional safety risks after approval from the U.S. Food and Drug Administration (FDA).

The study, published in the Journal of the American Medical Association (JAMA), looked at 222 separate medications approved by the FDA between 2001 and 2010 and tracked them through February 2017. Researchers discovered the FDA took some kind of action on nearly 32% of the medications.

Three of the tracked medications were completely removed from the market and 61 were given black box warnings, the most severe warning issued by the FDA. Unfortunately for patients, the average amount of time it took for the FDA to take action on a medication was 4.2 years.

Patients Facing Increasing Drug Dangers

The high number of medications posing additional safety risks coupled with the length of time the FDA takes to issue warnings, leaves patients facing increasing dangers from prescription drugs. One of the reasons behind increasing drug dangers is that drug companies often use very small samples of patients and many of their drug studies only last six months or less.

Because drug manufacturers produce insufficient clinical data, the true effects of their products are not known until long after they are released onto the market. The increasing dangers of prescriptions drugs put patients in a tough position.

Know Your Rights

Drug manufacturers are required to warn both patients and doctors of the risks associated with their products. This allows patients and doctors to make informed decisions about their care. When a pharmaceutical company harms patients through failing to warn of risks, improper labeling, inadequate testing, or other negligent actions, it can be held legally responsible for the resulting damages.

What To Know About Taking Prescription Medication During Pregnancy

February 13, 2017/in Dangerous Drugs /by damg16

Despite incredible advances in medicine, one segment of the population has not been intensely studied: pregnant women. While much is known about how to care for a pregnant woman, very little is known about how medications affect unborn children. Despite a wide knowledge gap, according to the Centers for Disease Control and Prevention (CDC), approximately 70% of pregnant women take at least one prescription medication during pregnancy.

For pregnant women considering taking prescription medications, there are several things to understand. Because very little is known about how medications work differently in pregnant women, the U.S. Food and Drug Administration (FDA) classifies medications into five different categories based on what clinical evidence suggests about their safety.

The FDA only classifies a dozen prescription medications as completely safe for use by pregnant women. While many medications are determined to be reasonably safe, the reality is there is a shortage on clinical data.

To determine if pregnant women can safely take a medication, the FDA looks at both clinical trials in humans and in animals. Unfortunately, there are serious limitations when looking at clinical trials in humans because pregnant woman are mostly excluded from clinical trials.

What Could Happen?

The two most common occurrences when pregnant women take prescription medication are the medication is ineffective or the medication causes birth defects. Both scenarios can be extremely dangerous and threaten the life of both the mother and the baby. Children born with birth defects often require a lifetime of care, extensive medical treatment, and special education for development.

Because of the serious side effects prescription medication can have on both mother and child, it’s crucial that drug companies provide consumers with all available information about the safety and risks associated with their drugs. This allows patients and their doctors to make informed decisions about whether prescription drugs are safe during pregnancy.

Dangerous Prescription Drugs

From antidepressants to anti-seizure medication, many drugs have proven harmful to pregnant women and their babies. Unfortunately, there are an even greater number of drugs whose dangerous side effects to pregnant mothers and unborn babies are yet unknown. When a child suffers birth defects as a result of a medication taken by its mother during pregnancy, families have a legal right to seek compensation.

What To Know About Raising A Child With Birth Defects

December 19, 2016/in Dangerous Drugs /by damg16

Every year, over 120,000 babies are born with birth defects. While there could be many causes, many are caused by the exposure of the fetus to certain prescription medications in utero. For pregnant mothers, certain anti-depressants like Celexa, Lexapro, and Zoloft can cause their unborn children to develop defects.

What Is A Birth Defect?

A birth defect is a medical condition arising at or before birth affecting how the body looks or works or both. They can vary greatly in severity depending on the part of the body affected. Some like cleft lip, cleft palate, or club foot are easily diagnosed, but others like heart defects often require special tests to detect.

What Parents Need To Know About Raising A Child With Birth Defects

While some birth defects can be corrected with surgery, others lead to lifelong afflictions. For parents raising children with birth defects, here are a few things to keep in mind:

Birth defects can be diagnosed before, during, or after birth. Some can be detected in utero and doctors may be able to treat or correct them. However, others might go unnoticed for several years until they start causing complications.
Your child may need extensive medical care. Life-threatening birth defects like congenital heart defects could require constant monitoring and/or surgeries to prevent further injuries.
Some may permanently affect your child’s life. Severe birth defects like shortened or absent limbs, malformation of vital organs, blindness, deafness, and Down’s syndrome, among others, can greatly impact your child’s life. Your child may have many special needs requiring professional medical treatment.
The cost of defects can be expensive. Special needs education, specialty medical equipment, surgeries, and physical therapy can all put a huge financial burden on families of children with birth defects.