FDA Safety Announcement for Pradaxa
The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
On December 7, 2011, the U. S. Food and Drug Administration (FDA) issued a Safety Communication reporting that it was investigating reports of serious and fatal bleeds in patients taking Pradaxa. Injury lawyer Network Pradaxa lawyers are accepting cases for Pradexa.
What is Pradaxa ?
Pradaxa is an anticoagulant medicine that reduces the risk of blood clots forming in your body and causing a stroke. Having a stroke can cause permanent disability and death.
Do not stop taking Pradaxa without talking to your healthcare professional. Stopping use of your blood thinner suddenly can put you at risk of a stroke.
Be aware that while taking Pradaxa you may bruise more easily and it may take longer for any bleeding to stop.
Call your healthcare professional and seek immediate care if you develop any signs or symptoms of bleeding such as
- unusual bleeding from the gums
- nose bleeding that happens often
- menstrual or vaginal bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or that get larger
- coughing up blood or blood clots
- vomiting blood or vomit that looks like coffee grounds.
If you are using the blood thinner Pradaxa (dabigatran), you may be at risk of suffering a stroke, or even death from this dangerous drug. If you are suffering any of these side effects see your doctor immediately.
Pradexa side effects
- bleeding which can be serious, and sometimes lead to death
- it may take longer for any bleeding to stop
- unexpected bleeding or bleeding that lasts a long time
- unusual bleeding from the gums
- frequent nose bleeds
- menstrual bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- bruises that happen without a known cause or get larger
- bruising more easily
- coughing up blood or blood clots
- feeling dizzy or weak
- pink or brown urine
- red or black stools
- unexpected pain, swelling, or joint pain
- vomiting blood or vomit that looks like "coffee grounds"
Serious Side Effects of Pradaxa®
The FDA approved Pradaxa® in October 2010, for the prevention of strokes in patients with a heart condition called non-valvular atrial fibrillation (also known as "AF"). Thus, it's hardly 'over a year old' as an anticoagulant in the U.S., and some critics of Pradaxa® have contended that the drug wasn't tested thoroughly enough before it was put on the market.
Pradaxa® Internal Bleeding
In November of 2011, a European counterpart to the FDA cited over 250 cases of fatal internal bleeding linked to Pradaxa® (a differently named version of Pradaxa® was on the market in Europe before it was released in the U.S.). The FDA has also received reports of Pradaxa®-associated internal bleeding here in the U.S.
Signs and symptoms of internal bleeding from Pradaxa include:
- Throwing up blood or vomit that looks like coffee grounds
- Unexplained bleeding or bruising
- Swelling in the ankles, feet, lower legs, hands and/or arms
- Excess fatigue
- Nosebleeds, bleeding from the gums
- Coughing up blood
- Dark colored urine
Pradaxa® and Heart Attacks, Serious Side Effects for Pradexa
Studies have also shown that Pradaxa® may increase the risk of heart attack. In a study of 18,000 patients, it was found that Pradaxa® treatment produces a 38 percent higher risk of heart attack than warfarin, an anticoagulant that has been used for many years.
Lawyers investigating most serious side effects of Pradaxa including:
- death from severe or excessive bleeding
- gastrointestinal bleeding
- stomach pain (ulcers, nausea, heartburn, bloating)
- kidney failure (kidney bleeding)
- hemorrhagic stroke cerebral hemorrhage
- heart attack
- brain hemorrhaging
If you or a loved one has been seriously injured by Pradaxa call injury lawyer network Pradexa Helpline today.
Pradaxa may lead to excessive bleeding and other complications that could cause severe injury or even be life threatening. If you or a loved one has taken Pradaxa and experienced complications contact Our Pradaxa Injury medical Helpline today so that answer your questions and connect you with a Pradaxa Lawyer to discuss your potential Pradaxa Lawsuit.
Get an Actos Bladder Cancer Lawyer
Type II Diabetis is adult onset diabietis usually the result of the aging process or weight gain over time. Obesity can go hand in hadn with adult onset diabetis. In recent news article the cities and states in the U.S which have the most obesity were noted and included the statement "To be considered obese, a person has a body mass index (BMI) of 30 or higher. With the extra weight comes myriad health issues — obesity contributes to heart disease, diabetes, stroke, and some cancers." One would wonder if in these same cities ,where we would see more adult onset diabetis, we would also see more bladder cancer from the prescribing of the popular diabetis drug Actos. Actos has been shown to cause bladder cancer in long term use.
These cities noted are:.
5. Beaumont-Port Arthur, Texas
Obesity rate: 33.8 percent
4. Rockford, Illinois
Obesity rate: 35.5 percent
3. Huntington-Ashland, West Virginia-Kentucky-Ohio
Obesity rate: 36 percent
20 percent suffer from diabetis.
2. Binghamton, New York
Obesity rate: 37.6 percent
1. McAllen-Edinburg-Mission, Texas
Obesity rate: 38.8 percent
Symptoms of Diabetes
There are several symptoms of diabetes which include low blood sugar (known as hypoglycemia), memory problems, urinary tract infection (UTI), damage to eyes, kidneys and heart.
Symptoms of Bladder cancer include
- Blood in urine (hematuria) — urine may appear dark yellow, bright red or cola colored; or urine may appear normal, but blood may be detected in a microscopic examination of the urine
- Frequent urination
- Painful urination
- Urinary tract infection
- Abdominal pain
- Back pain
If you or a loved one is experiencing symptoms of or has been diagnosed woth bladder cancer due to Actos contact Injury lawyer Network for an Actos Lawyer.
If you took Effexor, Pristiq ,Paxil, Zoloft, Prozac, lexapro, Celexa during pregnancy which resulted in birth defects Injury Lawyer Network Dangerous drug lawyers are accepting cases. for:
In recent years, reports of serious side effects from taking antidepressant drugs have increased, and many lawsuits have been filed against drug manufacturers in connection with the side effects of antidepressants. The focus of these lawsuits is typically a products liability claim. Scientists have concluded that women taking Zoloft® while they are pregnant are at a greater risk of giving birth to a child with congenital birth defects. The strong link between Zoloft® side effects and congenital heart defects has prompted many doctors to warn pregnant patients to stop using Zoloft® during pregnancy.
One study of nearly 10,000 infants born with birth defects and nearly 6,000 healthy infants found that women who took sertraline (Zoloft) in the first few months of pregnancy had twice the risk of having a baby born with a heart defect, while those on paroxetine (Paxil) had more than three times the risk. Paxil also increased the risk of a rare hernia called an omphalocele. But this doesn't mean antidepressants are unsafe: The heart defects seen in the study normally occur in 5 out of 10,000 babies, so a doubling of the risk means they occur in 10 in 10,000 and a tripling in 15 in 10,000—thus, a baby's risk is still far less than 1 percent.
Reported Side Effects of Anti-Depressants
In recent years, the Food and Drug Administration ("FDA") has issued warnings linking the use of SSRIs to:
- a life-threatening condition called "serotonin syndrome"
- an increased risk of giving birth to an infant with a serious condition called "persistent pulmonary hypertension of the newborn" (when SSRIs are taken during pregnancy), and
- an increased risk of suicidal thinking and behavior (also called "suicidality") when taken by children, adolescents, and adults.
Depending on the specific antidepressant you are taking, there may be other possible side effects. For example, Serzone has been the subject of an FDA warning concerning possible liver damage.
Contact Injury lawyer Network Today.
Following Actos Warnings, FDA Delays Review of New Takeda Diabetes Drug
With the drugmaker already facing a number of Actos lawsuits, the U.S. Food and Drug Administration recently opted to delay its review of a new type 2 diabetes drug being developed by Takeda Pharmaceutical Company.
The U.S. Food and Drug Administration has notified drug partner Takeda Pharmaceuticals that review of investigational diabetes drug alogliptin has been delayed and an approval decision is now expected by April 25, 2012. The delay also affects the fixed-dose combination drug alogliptin/pioglitazone. Regulators had previously expected to make a decision by Jan. 25, 2012.
According to a release from the company, the FDA has decided to pause the review of the investigative type 2 diabetes therapy alogliptin as well as the combination medication alogliptin/pioglitazone. Pioglitazone is the active chemical in the brand name medication Actos.
With the delay having been announced, the new Prescription Drug User Fee Act (PDUFA) action date has reportedly now been set for April 25, 2012, after the federal agency initially assigned a date of January 25, 2012, according to the release from Takeda.
Despite the delay, David Recker, senior vice president of clinical science for Takeda Global Research & Development Center in the U.S., said in a statement that the company still supported the medication's effectiveness.
"Takeda is confident in alogliptin and alogliptin/pioglitazone as potential therapeutic options for the millions of patients living with type 2 diabetes," Recker noted. "We will work closely with the FDA to determine the appropriate next steps, and are dedicated to continuing our efforts to bring these important therapies to market in the U.S."
In the release, the company disclosed that alogliptin is a highly selective dipeptidyl peptidase IV inhibitor (DPP-4i) designed to treat patients suffering from type 2 diabetes when supplemented with the proper diet and exercise.
The drug reportedly works by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which are instrumental in the regulation of blood sugar levels, the company said.
Takeda also added that it has not adjusted its fiscal outlook as a result of the delay in the drug's review, according to the release.
Still, the Japanese drugmaker has been hit hard by the recent spate of Actos lawsuits stemming from Actos warnings being handed down in the U.S. and Europe. Actos, which is also designed to treat patients with type 2 diabetes, has been linked in studies to the potential increased risk of bladder cancer, particularly among patients who have been using the medication for an extended period of time.
As a result of these Actos warnings that have been handed down by the FDA and the European Medicines Agency, Takeda now faces a number of lawsuits across the U.S., and the drugmaker recently experienced a dip in first-half operating profit.
According to Reuters, the requests from the European Medicines Agency and the FDA to add warnings to the medication's labels have had a significant impact on Actos' sales. Sales of the drug fell 13 percent in the six month-period ending September 30. This, coupled with the strong yen, has significantly dented Takeda's profits.
Doctors and patients are becoming increasingly wary of the medication as the number of Actos lawsuits pile up. Thus far, there have been lawsuits filed in states such as Illinois and Louisiana, with plaintiffs often claiming the drugmaker purposely concealed the bladder cancer side effects of the drug at the expense of patients.
While these Actos lawsuits largely center on the risk of bladder cancer, Actos has also been linked to the eye disease macular edema, which is a leading cause of blindness in older adults, according to reports.
ACTOS can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. A new study presented in June at the American Diabetes Association’s (ADA) annual meeting suggested that Actos can also lead to vision loss or blindness. Was this really new information or not? I did a little bit more research on Actos and blindness and was shocked to see that back in April 2009, the American Journal of Ophthalmology also posted a “recent study” where nearly 1,000 patients developed Diabetic Macular Edema (DME) after taking Actos. Even more shocking was a 2003 study that showed results of a retrospective study that also indicated that Actos could result in DME. According to that article, presented at the annual meeting of the American Academy of Ophthalmology, patients in that study had macular edema.
Actos is a member of a class of drugs known as thiazolidinediones, which have been linked to bladder cancer,” the US Drug Watchdog said in a released statement. “Actos side effects include increased risk of congestive heart failure, and an increased risk for bladder cancer.
Injury Lawyer Network Actos Helpline has been taking calls from people with signs of bladder cancer form Actos as well as families for Wrongful death of a loved one from bladder cancer due to Actos. Actos lawyers are filing lawsuits against TAKEDA Pharmaceuticals for Actos. In light of complications from Actos Takeda appears to be taking a very ambitious step with this new drug. If approved Ibelieve it will be a very hard sell to physicians given the warnings for Actos. If you or a loved one has complications due to Actos contact the Actos Helpline
Darvocet Side Effects Prompt FDA Ban, Darvon Lawsuits Follow
Darvon and Darvocet, two brand-name painkillers containing the active ingredient propoxyphene, were banned by the FDA in November of 2010. All generic versions of propoxyphene were also included the recall. The FDA action was due to the high number of reported Darvocet side effects, which in many cases resulted in accidental death.
Darvocet and Darvon lawsuits surged in the wake of the recall, and have continued to mount in the year since the FDA’s decision. Prior to the ban, the drug was used for over 50 years, with more than 12 million prescriptions in all 50 states. According to an analysis of adverse event records from various reporting agencies, thousands of patients were regularly exposed to highly dangerous Darvocet side effects such as arrhythmia, heart attack and overdose
Range of Darvocet Side Effects
According to the National Institutes for Health fact sheet, Darvon and Darvocet use carries risk for a variety of mild to moderate side effects, including:
- Difficulty urinating
- Stomach upset; omiting
Under most circumstances, these conditions are considered normal and acceptable side effects for a typical pain medication. A Darvocet lawyer is unlikely to pursue a Darvon lawsuit based on these side effects alone.
Darvocet heart problems
A Darvon lawsuit based on Darvocet heart problems examine the effect the drug can have on the function of a previously healthy heart. These problems can be potentially life-threatening and have resulted in death.
Darvocet side effects rooted in heart problems include:
- Darvocet Arythmyia: an irregular heartbeat; the result of chemical changes to electrical impulses in the heart
- Ventricular Tachycardia: an abnormally rapid heartbeat that can ultimately result in heart spasms requiring defibrillation
- Torsade de pointes: another form of Darvocet heart arrythmia; effectively slowing the heart beat to the point that it no longer pumps blood effectively
Heart problems such as these can are the most dangerous and are typically the cause of a Darvocet accidental death
As with many painkillers, Darvon and Darvocet are especially dangerous when taken in combination with other sedatives. Darvon lawsuit claims for death and coma have alleged that drug interactions with Darvon and Darvocet were not sufficiently understood or warned against.
A Darvocet lawyer will review a case of a death following prescription of Darvon or Darvocet to confirm that an overdose did in fact cause the death of the individual. This includes cases of simple overdose, in which the patient took enough of the drug alone to cause death; and cases of interactive overdose, in which a safe amount of the drug was taken along with another substance that combined to create dangerous Darvocet side effects.
A Darvon lawsuit will specify such pertinent facts surrounding a particular allegation as well as the alleged proximate cause of a claim involving Darvocet death.
Multi-District Litigation for Darvon Lawsuit
In August, 2011, MDL proceedings were announced in the Eastern District of Kentucky for cases involving Darvocet side effects. The original order included 17 lawsuits from 9 different states. A year later since in the FDA ban of Darvocet, and in the months since the designation of MDL, the number of those filing a Darvon lawsuit has grown significantly.
Injury Lawyer Network Darvan, Darvocet lawyers are ready to help you.