The FDA is growing increasingly concerned about counterfeit drugs. In fact, the FDA is developing an internal task force to monitor, control and prosecute vendors of counterfeit drugs.
Counterfeit drugs are defined as medications sold without authorization, indicating the drugs can be mislabeled, fraudulent, defective and dangerous to consumer health.
The FDA believes that people who take counterfeit drugs are at risk of serious health consequences, including allergic reactions, worsening medical conditions, and more. Also, people who use counterfeit drugs may not be able to determine exactly what ingredients caused their adverse health reactions, which makes it difficult for doctors to appropriately treat the patients.
Counterfeit drugs are increasingly sold over the Internet. Consumers should use caution when purchasing drugs over the Internet, and follow the FDA’s guidelines of only purchasing FDA-approved medications from Verified Internet Pharmacy Practice Sites.
The FDA’s new task force will work to educate consumers, pharmacists and physicians about the dangers of counterfeit drugs. It will also work closely with border protection agencies to seize shipments of counterfeit drugs coming in to the U.S.
There were two major counterfeit drug headlines in recent news about Procrit and Lipitor. The counterfeit Procrit contained bacteria that threatened the health of patients, and the counterfeit Lipitor was also believed to contain harmful and fake ingredients.
Unfortunately, the people most affected by counterfeit drugs are the weakest patients, those who suffer from cancer, AIDS and organ failure. When drugs are counterfeit, they are either diluted and therefore don’t offer adequate doses of medications, or they contain other ingredients and therefore pose serious health threats.
Experts believe counterfeit drug trades could become more profitable than illegal drug trade. Americans spend more than $200 billion per year on prescription drugs.
Fire Star and Dura Star Balloon Catheters were recalled by the FDA on January 14, 2008. The recall is a Class I recall, which are the most serious types of recalls and means there is reasonable probability that using the device will result in injury or death.
Balloon catheters are used to open narrowed or blocked blood vessels and heart arteries. The Fire Star and Dura Star balloon catheters either do not deflate or deflate too slowly when inserted, resulting in a total blockage of blood vessels.
This can cause heart arrhythmia, heart artery damage, heart attack, or death. Some patients require further surgery to remove the catheter.
The catheters were manufactured in Mexico in 2007 and distributed in 2007 and 2008. All Fire Star and Dura Star models were affected. If you were injured by a Fire Star or Dura Star Balloon Catheter or if you required extra surgery to remove the device, contact a personal injury attorney immediately.
The FDA recalled another Medtronic product on August 3, 2007. Medtronic’s SynchroMed EL Implantable Infusion Pump was recalled because the pump motor can stall, which means the patient will stop receiving medication abruptly and without warning.
When the pump motor stalls on Medtronic’s infusion pumps, patients are left without medication, which can result in a return of the patient’s symptoms, withdrawal symptoms, and death.
Medtronic pumps are used to deliver medication to treat pain, spasticity and cancer. The pump is implanted in the patient’s side with or without a catheter.
Model numbers included in the recall are:
8626-10
8626L-10
8626-18
8626L-18
8627-10
8627L-10
8627-18
8627L-18
Contact your doctor immediately if you are using a Medtronic infusion pump, and contact a personal injury attorney if you are injured because of a Medtronic pump.
The FDA provides medical product safety alerts for patients and doctors. These alerts tell people when drugs and medical devices have been linked to illnesses or injuries, and if their labels have been updated.
Medical alerts are intended to encourage patients to discuss the risks and benefits of medical drugs and devices with their doctors before using them. Alerts are the most basic stage of adverse event reporting, and drugs and devices in this category have not been recalled or withdrawn from the market.
Drugs and products recently listed on the alert list include:
·Antiepileptic drugs
·Bisphosphonates
·Botox
·Colchicine
·Compounded Menopause Hormone Therapy Drugs
·Edetate Disodium
·Ezetimibe/Simvastatin
·Heparin Sodium Injection
·Leukine
·NuCel Labs Eye Drops
·Ortho Evra Contraceptive
·Varenicline (Chantix)
To find out more information about these products or other products listed on the safety alert page, visit the Drug Injury tab on Injury.com or visit www.fda.gov/medwatch/safety.
If you have been the victim of an accident, you may be entitled to compensation. Compensation for accidents is crucial to making a proper recovery. It allows you to pay for expensive medical bills and any loss of income. It also allows you to gain closure on the accident and move on with your life.
What kind of accident is entitled to compensation?
Accidents that are the result of the negligence, recklessness, or ill-intent of another party may be entitled to compensation. Compensation is based on the financial burden, emotional distress, and any future difficulties caused by the accident. It can come in the form of cash or some other kind of support.
What are the results of accidents?
In many cases, accident victims postpone seeking compensation. Sadly, the time passes for them to report and get the help they need. These accident victims are left on their own to deal with:
Long-term health complications
Inability to work long-term
Financial and emotional strain on family and friends
Funeral and burial expenses (in the event of death)
What if you have been involved in an accident?
After obtaining primary medical care, contact a legal professional. Many attorneys specialize in obtaining compensation for accident victims and will give you a free case consultation.
Teflon, invented and manufactured by DuPont, is used to coat the inside of cooking pots and pans and is used as a stain repellent on carpets. The cookware poses the majority of health hazards to humans and pets, because when it is heated, it emits harmful gasses and particles that are breathed into the lungs. The gasses have caused millions of pet bird deaths and an unknown amount of human injury and death, because no one realizes the cause of injury.
Teflon-coated cookware emits gasses between 400 degrees Fahrenheit and 1200 degrees Fahrenheit. Most cookware heats up to close the 1000 degrees when cooking. Within this range, Teflon poses multiple health risks:
At 400 degrees, Teflon releases ultra fine particles that have been proven to kill rats within 10 minutes of inhaling them. The particles cause severe lung damage.
Between 400 and 900 degrees, Teflon releases harmful carcinogens and acids, which are linked to cancer, liver disease, reproductive system failure, heart and respiratory failure, and lung disease.
At 932 degrees, Teflon releases Carbonyl fluoride, a known chemical warfare agent.
At 1112 and 1202 degrees, Teflon releases fumes that are thousands of times more harmful to the environment than carbon dioxide. These gasses last in the air for more than 50,000 years, and contribute to global warming in a way few other gasses can.
Unfortunately, DuPont does not warn people about the dangers of the cookware, and the FDA has not ordered a recall, although DuPont and seven other Teflon manufacturers have agreed to eliminate the harmful chemicals in Teflon by the year 2015.
This was a decision that was enforced by the Environmental Protection Agency after it was realized that the harmful chemicals are in the blood of 95 percent of Americans, including pregnant women, and has even been found in the blood of marine animals and polar bears.
DuPont also agreed to a $16.5 million settlement with the EPA after it failed to disclose health risks that are associated with its cookware. DuPont also settled when the company was accused of contaminating drinking water in Ohio and West Virginia near its manufacturing plants, and is involved in lawsuits in which children born with birth defects in those areas are suing for medical expenses, pain and suffering.
If you have been injured by Teflon products, contact a personal injury attorney immediately.
CDER stands for the Center for Drug Evaluation and Research. The CDER is a branch of the U.S. Food and Drug Administration, or the FDA. The CDER is responsible for regulating and evaluating new drugs before they are sold on the market. The center provides information so that doctors and patients can use drugs more safely.
According to the CDER, one of its main goals is to make sure the benefits of any drug evaluated outweighs its risks. “Drugs” can include other consumer products as well, including toothpaste, sunscreen, etc. The CDER evaluates:
prescription drugs
generic drugs
over-the-counter drugs
If the CDER approves a drug and later finds out about more risks, the center will change the label on the drug to update patients to the risks, or the drug will be removed from the market.
According to the CDER, one of the best ways to decrease health risks while taking a drug is to ask your doctor questions such as:
What is the name of the medication, and what is it for?
How and when do I take it, and for how long?
What are the side effects, and what should I do if they occur?
Is this medication safe to take with all other medications, including over-the-counter medication, that I am taking?
To be approved by CDER, drug manufacturers must prove the drug is safe and effective. Clinical trials are performed to evaluate the safety and effectiveness of the drug, and to gain more information about how the drug works and any possible side effects associated with the drug.
Tasmar is prescribed to treat symptoms of Parkinson’s disease. Tasmar is used as an adjunct to cardibopa and levodopa. On its own, levodopa must be used in large quantities in order to get a sufficient amount of dopamine to the patient’s brain. These large quantities can cause adverse health reactions. However, combined with cardibopa, smaller amounts of levodopa can be used.
Parkinson’s disease is a brain disorder that is characterized by a lack of dopamine in the brain, which is the chemical that creates coordinated muscle activity. Once 80 percent of the necessary dopamine is depleted, signs of Parkinson’s begin to become noticeable. These signs include tremors, slowness of movement, stiffness, balance difficulty, cramped handwriting, stiff facial expression, muffled speech, and depression.
What are some important things I should know about Tasmar?
Levodopa, which changes to dopamine in the brain, helps restore muscle control. However, because only small amounts changed to dopamine, patients had to take large amounts of levodopa. This made patients more susceptible to injuries like nausea and dyskinesias, which cause involuntary movements. Now, cardibopa prevents levodopa from being broken down before it reaches the brain, which allows for less quantities of levodopa. Tasmar is combined with two as an adjunct therapy to help treat symptoms of Parkinson’s.
Who is Tasmar for?
Tasmar is for people with Parkinson’s disease. However, because of its link to severe liver injury, people taking Tasmar need to monitor themselves for liver injury, and report to their doctors often to make sure no damage is being done to the liver.
What side effects can Tasmar cause?
As well as the risks of nausea and dyskinesias that levodopa poses, Tasmar can also cause:
serious liver injury
withdrawal symptoms
low blood pressure
hallucinations
suicidal thoughts
nausea
confusion
abnormal movements
When should I contact my doctor?
Patients taking Tasmar are more susceptible to injuries like nausea and dyskinesias, which cause involuntary movements. Tasmar can also react with other drug and cause allergic reactions. Contact your doctor immediately if you notice:
fatigue
nausea
diarrhea
uncontrolled movements
depression
hallucinations
difficulty swallowing or breathing
hives
discolored stools
bloody vomit
You should contact a personal injury attorney if you were injured by Tasmar.
Sinemet is prescribed to treat symptoms of Parkinson’s disease and restless legs syndrome. Sinemet is a combination of cardibopa and the banned drug levodopa. On its own, levodopa must be used in large quantities in order to get a sufficient amount of dopamine to the patient’s brain. These large quantities can cause adverse health reactions. However, combined with cardibopa, smaller amounts of levodopa can be used.
No one is sure what causes restless legs syndrome, but it is believed to be hereditary. Primary restless legs syndrome is incurable, but secondary restless legs syndrome, which is caused by pregnancy, anemia or iron deficiency, goes away once the underlying causes have been treated.
Parkinson’s disease is a brain disorder that is characterized by a lack of dopamine in the brain, which is the chemical that creates coordinated muscle activity. Once 80 percent of the necessary dopamine is depleted, signs of Parkinson’s begin to become noticeable. These signs include tremors, slowness of movement, stiffness, balance difficulty, cramped handwriting, stiff facial expression, muffled speech, and depression.
What are some important things I should know about Sinemet?
Levodopa, which changes to dopamine in the brain, helps restore muscle control. However, because only small amounts changed to dopamine, patients had to take large amounts of levodopa. This made patients more susceptible to injuries like nausea and dyskinesias, which cause involuntary movements. Now, cardibopa prevents levodopa from being broken down before it reaches the brain, which allows for less quantities of levodopa.
Who is Sinemet for?
Sinemet is for people who have primary restless legs syndrome or Parkinson’s disease.
What side effects can Sinemet cause?
As well as the risks of nausea and dyskinesias that levodopa poses, Sinemet can also cause:
low blood pressure
hallucinations
suicidal thoughts
nausea
confusion
abnormal movements
When should I contact my doctor?
Patients taking Sinemet are more susceptible to injuries like nausea and dyskinesias, which cause involuntary movements. Sinemet can also react with other drug and cause allergic reactions. Contact your doctor immediately if you notice:
uncontrolled movements
depression
hallucinations
difficulty swallowing or breathing
hives
discolored stools
bloody vomit
You should contact a personal injury attorney if you were injured by Sinemet.
Relenza was approved by the FDA to treat people with uncomplicated influenza. Relenza is designed for people age 5 years and older whose flu symptoms began less than two days before taking Relenza. Relenza is an anti-viral medication that can cause lung injuries like wheezing, worsening lung function and difficulty breathing.
What are some important things I should know about Relenza?
Relenza comes in powder form and is inhaled twice per day for five days. It should be started as soon as flu symptoms begin, and it should not be started after the second day of flu symptoms.
Who is Relenza for?
Relenza is for people age 5 years and older who have uncomplicated influenza. People who should not use Relenza include those who have underlying respiratory diseases like asthma and chronic obstructive pulmonary disease. Relenza should not be used as a substitute for annual influenza vaccinations.
Relenza should only be used in pregnant and nursing women if the benefits clearly outweigh the risks. The risks could include injury or death to an unborn or nursing baby.
What side effects can Relenza cause?
Relenza can cause bronchospasm, or wheezing, that can be fatal. People with underlying respiratory illnesses should not use Relenza. Relenza can also put people at risk of serious allergic reactions and can react with other medication, especially the influenza vaccination.
When should I contact my doctor?
Contact your doctor immediately if you become pregnant or plan to become pregnant. Relenza may cause injury to unborn or nursing babies. Contact your doctor immediately if you experience:
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