According to a Bloomberg.com report this week, Byetta® has more problems. The Food and Drug Administration has confirmed four more patients taking the type 2 diabetes drug Byetta® have died from pancreatitis.

That brings the drug-related fatalities to six in the last few months, though the FDA said no definite link between the additional deaths and Byetta® has been proven.

Federal regulators are working with Amylin Pharmaceuticals and Eli Lilly & Co. to develop a stronger warning label for the widely used drug. Regulators stress that patients who exhibit symptoms of pancreatitis should stop taking Byetta right away. Those symptoms include nausea, vomiting and abdominal pain. Regulators warn that it can be very difficult to tell the difference between acute and less dangerous forms of pancreatitis.

Already, a Virginia man has filed a defective drug lawsuit in a California court alleging Byetta’s manufacturers failed to adequately test and monitor the side effects, and didn’t warn doctors or patients of the risk of developing pancreatitis.

The Food and Drug Administration has released a warning about injection site reactions from Alkermes, Inc.’s drug Vivitrol, known generically as naltrexone. Vivitrol has been approved by the FDA since 2006 for the treatment of serious alcohol addiction. It is administered as an injection into a buttock monthly.

Serious injection site reactions associated with Vivitrol include abscesses, cellulitis, indurations, hemotomas, and necrosis. Sixteen of the nearly 200 reported injection site reactions required surgery to fix.

If you or loved one are receiving Vivitrol injections, you should consider the following:

• Though pain, swelling, bruising, pruritus and redness at the injection site are not uncommon, anyone who experiences these symptoms for more than two weeks after the medication is administered should be referred to a surgeon.
• Vivitrol should be administered into the gluteus muscle, alternating buttocks. Risks increase when Vivitrol is injected into fatty tissue.
• Vivitrol uses a special 1-1/2 inch long needle. No other needle should be used.
• Because of the limited needle length and the necessity to inject Vivitrol into muscular tissue, patients who have thicker gluteal fat (such as women) may be physiologically at risk of developing injection site reactions.

If you have any adverse symptoms to a Vivitrol injection that last more than a couple of weeks, contact your doctor.

Products marketed as cancer cures are scams. The Food and Drug Administration has identified 23 companies inside the United States and two foreign that have been marketing so-called cancer prevention and cancer curing tablets, extracts, teas, tonics, salves and creams over the internet.

These products contain such homeopathic substances as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat’s Claw, an herbal tea called Essiac, and various kinds of mushrooms.

Some common marketing pitches include:
• “Treats all forms of cancer.”
• “80% more effective than the world’s number one cancer drug.”
• “Skin cancers disappear.”
• “Target cancer cells while leaving healthy cells alone.”
• “Shrinks malignant tumors.”
• “Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments.”

None of these products are approved to treat, cure, or prevent cancer. They are simply hoaxes, and dangerous ones at that, since taking off-label medication may interfere with a patient’s legitimate cancer treatment through drug-drug and drug-supplement interactions. Homeopathic products such as those listed above are not regulated like FDA-approved medications are, and may differ dramatically from lot to lot.

If you are self-medicating with any one of these products, consult your doctor immediately.

You can view the complete list of fake cancer cures here:

http://www.fda.gov/cder/news/fakecancercures.htm

In a class action defective drug lawsuit against Pfizer Inc, plaintiffs in Pennsylvania are challenging how drug manufacturers can promote their generic products.

The lawsuit claims that purchasers of the epilepsy drug Neruontin and its generic equivalent, gabapentin, were given as prescriptions for an off-label use. The case states that the drug manufacturer illegally promoted the drug by manipulating medical literature and by using other tactics, and should be liable to consumers who were prescribed generic versions of the drug.

Generic drugs must contain the same active ingredients as the original brand-name drug. The US Food and Drug Administration (FDA) states that generic drugs are identical, or the bioequivalent, to the brand name drugs. This means that generics are identical in dose, strength, safety, route of administration, and intended use. Generics are usually available once the patent protections of the original drug have expired.

Good drugs used like this are no better than defective drugs. If you or a loved one has been harmed, it is important that you consult with an expert defective drug attorney for professional insight.

The US Food and Drug Administration reported this week it has been notified that patients are developing a potentially deadly form of pancreatitis while taking the popular diabetes drug Byetta.

The FDA received six new reports. Two of the patients died and four are recovering.

Federal regulators are working with Amylin Pharmaceuticals and Eli Lilly & Co. to develop a stronger warning label for the widely used drug. Regulators stress that patients who exhibit symptoms of pancreatitis should stop taking Byetta right away. Those symptoms include nausea, vomiting and abdominal pain. Regulators warn that it can be very difficult to tell the difference between acute and less dangerous forms of pancreatitis.

This isn’t the first time the FDA has addressed this problem. In October 2007, the FDA issued an alert that about 30 patients developed problems while taking the drug, though none of those patients died.

Earlier this week, a Virginia man filed a defective drug lawsuit in a California court alleging Byetta’s manufacturers failed to adequately test and monitor the side effects, and didn’t warn doctors or patients of the risk of developing pancreatitis.

Watson Pharmaceutical is recalling more of their fentanyl pain patches because of their tendency to leak harmful fentanyl gel.

The manufacturer is recalling the 75mcg/hr fentanyl transdermal system patches sold in the US from wholesalers and pharmacies. These defective drug patches are used to manage persistent chronic pain that requires constant treatment with opioids.

The recalled patches in particular are from lot number 92461850 and have an expiration date of August 31, 2009. These patches were shipped to customers between January 30, 2008 and March 19, 2008.

According to Watson, some of the patches in this lot have been leaking fentanyl gel and exposing it to patients or caregivers. Fentanyl gel is a highly addictive opiate that is 80 times more potent than morphine. Direct exposure can cause serious effects such as trouble breathing, extreme tiredness, confusion, or death.

A recent British study has found that the widely-used epilepsy drug Topamax® (topiramate) raises the risk of birth defects when taken by pregnant women. When combined with the drug valproate, the risk of the occurrence birth defects is even higher.

The results are still statistically uncertain because the study included only 203 women, but experts were not surprised with the findings because Topamax® has been shown to cause defects in animals.

Of the 203 pregnancies in the study, 18 ended in spontaneous abortion, five in induced abortions, and two in stillbirths. Of the 178 babies born, 16 had major birth defects. In three of those cases, the mothers had only taken topiramate and the other 13 involved topiramate and other drugs. Cleft palates or lips were present in four of the babies, an occurrence 11 times the normal rate of 1 in 500 among women not taking epilepsy drugs. Four male babies had genital birth defects, up 14 times the normal rate of 1 in 300.

Doctors urge epileptic women to continue taking the drug during pregnancy despite the enormous risks because of the danger of seizures on the unborn babies. Women who are taking the drug to prevent migraines should stop if they become pregnant or are planning to become pregnant.

The lawyers at Cappolino, Dodd & Krebs (experienced birth trauma and head injury attorneys) know how news of horrific medical mistakes by doctors and hospital staff can be found everywhere from newspapers and magazines to television and internet.

Even one story of a surgery gone awry can be enough to scare a patient out of a necessary procedure. However, there are steps that you can take to minimize your risk of wrong-site surgery and other avoidable blunders. Nick Avgerinos of InjuryBoard.com lists on his blog 5 tips for avoiding medical mistakes.

1. Check the experience of your doctor and hospital
Ask your doctor how many times they have done this procedure, and compare with other doctors. You can visit http://www.leapfroggroup.org/ to find hospitals ranked by specialty.

2. Tell everyone who you are and what procedure you’re having done
Avgerinos suggests you tell all doctors, nurses and other hospital staffers your name, date of birth, and procedure to prevent a confused hospital official from giving you the wrong medical chart.

3. Have your doctor initial your surgical site
The American Academy of Orthopaedic Surgeons asks its members to literally sign their initials on the surgical site before the operation to prevent wrong-site surgeries. This is a great tip for patients undergoing orthopedic surgery and other procedures where the reason for the operation is not visible on the surface.

4. Confirm the surgical site immediately before the surgery
Just to be safe, make sure that your surgeon knows the correct site before you enter the operating room.

5. Bring a trained proxy
Since you will likely be asleep during and just after your surgery, bring a friend or family member with you who understands your procedure and knows all of your personal information. They can help you check the initials on your surgical site, and answer any questions, and contact your surgeon or primary physician if necessary.

With our health care system overloaded and our doctors overworked, medical professionals need all the help they can get. You can use the five tips listed above to decrease your chances of wrong-site surgery and other medical mistakes.

If all else fails, remember that there are medical malpractice lawyers out there to help you seek the compensation you deserve.

The more we learn about the defective drug Trasylol, the angrier we become.

The drug, manufactured by Bayer, was used heavily during heart bypass surgery to reduce the need for transfusions and reduce bleeding beginning in the 1990s.

Since Trasylol is give during heart procedures, most patients don’t even know they were given the drug.

In January of 2006, it was reported that Trasylol may increase the risk of renal toxicity. Other reports link Trasylol with increased risk of kidney failure, cardiovascular events (myocardial infarction or heart failure), cerebrovascular events such as a stroke, encephalopathy or coma.

But Bayer kept the drug on the market until November 2007. The result of this delay is that as many as 1,000 people a month may have died  due to the use of Trasylol during coronary artery bypass graft surgery.

In February 2008, the New England Journal of Medicine published two studies, both confirming that Trasylol causes an increased risk of death and kidney damage compared to alternative medicines or no medicine at all.

Another article, published in May 2008, was actually funded by Bayer but withheld from the FDA! This study showed that the risk of death is 64 percent higher with Trasylol than less expensive alternatives.

If you or a loved one and an open heart surgery or valve surgery at any time from January, 1998 to the present, and had kidney failure or complications within 72 hours of their surgery, please call the defective drugs attorneys in this office for professional insight.

The Center for Public Integrity has launched an investigation into the allegedly safe pesticides that are causing more than 25 percent of fatal and nearly fatal human poisonings. The pesticides in question use pyrethrins from flowers (or their synthetic counterparts, pyrethroids) to ward off insects as opposed to organophosphates that were originally made from nerve gas.

These insecticides were known as the safest in the market until the Center for Public Integrity’s analysis of EPA pesticide incidence reports. As it turns out, the pesticides containing pyrethrins cause significantly more serious human poisonings than any other group of insecticides. They are used in a wide range of products including Hartz Dog Flea & Tick Killer, Raid Ant and Roach Killer, bug-repellant clothing, flea collars, automatic misting devices, lawn-care products, and carpet sprays.

The EPA holds that most side effects are minor or result from improper use, such as accidentally being sprayed in the face. However, there are plenty of real-life horror stories of pyrethrin products gone bad. You can read the heart-breaking story of 2-year-old Amber who died after her mother used Osco Lice Treatment shampoo on her infested hair on the Center for Public Integrity’s “Perils of the New Pesticides” page.

These figures could still be understated. Experts point out that not everyone who has a pesticide-poisoning incident reports it. They estimate that the EPA receives only a fraction of the actual number of cases.

Serious conditions that arise from exposure to pyrethrins and/or pyrethroids are usually caused by an allergic reaction to the chrysanthemum-derived substances. People who have ragweed allergies or asthma are the most susceptible.

The Food and Drug administration has recognized the potential harm in the “safe” pesticides for more than 15 years. The EPA had planned to look at pyrethrin and pyrethroid pesticides in 2010, but now says that they will speed along the process.

For more information about the study from the Center for Public Integrity, visit the link below:

http://www.publicintegrity.org/investigations/pesticides/pages/introduction/

If you feel like you or a loved one has been harmed by one of these products or a defective drug, attorneys with Cappolino, Dodd and Krebs can help you.