Wilmington Personal Injury Lawyer - FDA

Dementia Drug Use is claimed to be “killing many”

Angel Adams — Tue, 17 Nov 2009 16:13:13 GMT

According to an article in the BBC News, the use of anti-psychotic drugs is widespread in dementia care and contributes to the death of many patients, an official review suggests. According to the expert review, commissioned by ministers, 180,000 patients a year are given the drugs in care homes, hospitals and their own homes to manage aggression and other symptoms of dementia. However, the treatment was found to be unnecessary in nearly 150,000 cases and was linked to 1,800 deaths. The government in England has agreed to take steps to reduce use of the drugs.

It is estimated by www.emedicinehealth.com, a WebMD affiliate, there are 4-5 million people in the United States living with some form of the disease, affecting 1% of people between 60-64 and 30-50% of people over 85. According to www.aboutlawsuits.com the drugs, such as Seroquel, described in the study are not permitted for prescription in the United States and as of 2005 a “black box” label is required of “increased risk of premature death in elderly dementia patients” for antipsychotics. The warning is the most stringent labeling requirement possible under United States federal law. Still, in October of this year, theChicago Tribune , conducting a study, found that similar problems over prescriptions of antipsychotics, particularly in nursing homes. The analysis medical data of 275,000 people living in nursing homes with the disease dementia found that they were more likely to suffer a “nursing home fall or decline in health when taking anti-psychotics or other psychotropic drugs.” It was also found that two-thirds of all nursing homes in Illinois were cited at least once in the past eight years for violating drug use laws regarding anti-psychotics drugs.

This is a real issue, death resulting from anti-psychotics to reduce the effects of dementia and other diseases such as Alzheimer’s can happen to you or a loved one. You should make sure that every drug that you consume is FDA approved, in the least, and not producing studies that cause worse side effects.

Originally posted at InjuryBoard by Angel Adams

Unproven Drugs Are Still On The Market

Gary Shipman — Mon, 26 Oct 2009 15:47:28 GMT

According to the GAO, the FDA “has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn’t extend patients’ lives.” It is also said to be questionable if the FDA even performed follow-up studies on these drugs. The FDA’s 16 year accelerated approval program, was designed to allow drug makers to bring products to market sooner under the “strict” condition that they conduct follow-up studies. The GAO is critical of the FDA and their “so-called ‘accelerated approval program.” The GAO “identified several drugs still on the market that never lived up to their initial promise” and out of the 16 year program the FDA has “never once pulled a drug off the market due to missing or unimpressive follow-up data.”

Since the GAO has completed its reports, the FDA claims to have “overhauled [its] tracking system. Principal Deputy Commissioner Dr. Joshua Sharstein said that there is not a policy in place for the FDA to pull drugs off the market because “we don’t want to lock ourselves into a specific set of criteria.” Dr. Sharstein is also on record saying “the agency has a task force assigned to look at polices like drug withdrawals.”

Originally posted at InjuryBoard by Gary Shipman

FDA Required Black Box Warning On Phenergan

Gary Shipman — Thu, 22 Oct 2009 15:24:08 GMT

There was uproar concerning the courageous fight by Diana Levine, a musician from Vermont who lost her arm because of the drug Phenergan. Wyeth no longer sells Phenergan but many makers of generic drugs do. The Food and Drug Administration has since ordered a black box label to warn about the risks of IV push and Phenergan, also known as promethazine. This method of the "black box" warning is considered to be the strongest warning possible. When medical professionals see the "black box" it will clearly state that the preferred way to administer phenergan, also known as promethazine, is through intramuscular injection.

Originally posted at InjuryBoard by Gary Shipman

With Antibiotics Being Prescribed This Cold and Flu Season, Watch Out For Tendon Tears and Ruptures

Jean Martin — Thu, 01 Oct 2009 10:08:37 GMT

It's that time of year again.

Cold and flu season.

And now, in addition to being careful not to catch the cold or flu, you need to be careful about what medications you take if you should get sick. While antibiotics do not treat viral infections such as colds or flu, this time of year we see a rise in the number of prescriptions for antibiotics. Certain types of antibiotics, known as fluoroquinolones, have been known to cause tendon tears or ruptures. Fluoroquinolones are used to treat bacterial infections. These antibiotics include: Levaquin, Cipro, Avelox, and Floxin

The FDA has been aware for some time that these medications could cause tendonitis and tears or ruptures in the Achilles tendon, rotator cuff, biceps and thumbs. This risk is higher in patients over 60; those taking corticosteroids (such as Prednisone); and those who have had heart, lung or kidney transplants. However, after finding that there have been over 300 cases of tendonitis and over 400 cases of tendon ruptures due to the use of these medications, the FDA made it mandatory for manufacturers of these medications to put a black box warning on their products about the risk of tendon injury.

Johnson & Johnson- one of the main manufacturers of these drugs- has faced many tendon-rupture lawsuits from people who had come to realize what was causing their pain.

If you have to take an antibiotic this season, be aware of which medication your doctor prescribes to you and ask your doctor and your pharmacist about the potential side effects. If you must take one of the above-mentioned drugs, you should be aware of your level of physical activity, so that you can hopefully avoid a painful injury.

Originally posted at InjuryBoard by Jean Martin

More Evidence That Consumers Are Not Protected By FDA - Congressmen Influence FDA Device Approval

Jean Martin — Fri, 25 Sep 2009 10:03:28 GMT

The FDA released a report yesterday stating that the agency and its former commissioner, Dr. Andew C. von Eschenbach, succumbed to pressure by four New Jersey congressmen in approving a collagen implant patch for injured knees last year. That approval is now being re-visited and re-analyzed.

Apparently FDA scientific reviewers had declined approval for the Menaflex device manufactured by ReGen Biologics, Inc. for years citing its high failure rate. The decisions against approval had been unanimous - that is until four New Jersey congressmen - Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr and Steve Rothman - stepped in to assert their influence on behalf of the New Jersey-based manufacturer. Not surprising, all four legislators received significant campaign contributions from ReGen.

It is sad and scary to think that manufacturers can literally buy approval of their product and an agency as important as the FDA can give it to pressure by politicians and ignore their own scientists. This is yet another example of the FDA failing the American public. We think that if a pharmaceutical drug or medical device has FDA approval, then the product and drug has passed all types of stringent safety testing. It just isn't so. And the manufacturers want to hide behind this veil of "FDA approval" and take your right to seek compensation from them should you be the unfortunate one injured by their product? The public simply shouldn't stand for it.

Call your Congressman today and tell them to listen to you and not the manufacturers. Tell them to support the passage of the Medical Device Safety Act to protect the public from defective devices and hold manufacturers accountable.

Originally posted at InjuryBoard by Jean Martin

On The Road For Memorial Day Weekend - Watch Your Medications

Jean Martin — Fri, 22 May 2009 16:11:54 GMT

Many Americans will be on the road traveling this Memorial Day weekend. Unfotrunately, as we all know, holiday weekends with holiday travel present more risk for traffic accidents. We have all heard the warnings to slow down, be patient, leave plenty of room between you and the car in front of you, check your tire pressure, etc. But perhaps we should also warn people to check their medications.

First, as you head out for the holiday weekend, you want to make sure that you remember your medicines. If you are diabetic or have high blood pressure or another chronic disease, you do not want to miss your medications. So in those circumstances, your medicines should be the first thing you pack.

But if you have been taking Chantix in order to quit smoking, I would encourage you to leave that one at home, particularly if you are doing the driving this weekend. Over 170 serious events described as accidental injury, including more than 30 traffic accidents and 77 falls, have been reported with use of Chantix. The resulting injuries from the falls have included fractures of ribs, hands, arms, facial bones, spine and lower limbs. According to the manufacturer's own study, there is a doubling of the risk of accidental injury at at .5 mg does. In the 4th quarter of 2007, Chantix accounted for 988 serious injuries in the United States - more than any other individual drug.

The Federal Aviation Administration (FAA) does not allow pilots flying commerical planes or air traffic controllers to use Chantix. The Federal Motor Carrier Safety Administration has warned medical examiners not to prescribe Chantix for commerical drivers. The reason? Chantix is being blammed for blackouts and seizures. I don't have to tell you that the consequences of experiencing a blackout or seizure while driving can be deadly.

You have valuable cargo in your car this weekend, keep them and yourself safe - leave the Chantix at home!

Originally posted at InjuryBoard by Jean Martin

Medtronic Infuse Bone Graft - Patients Beware

Jean Martin — Sat, 25 Apr 2009 05:49:00 GMT

The Medtronic Infuse Bone Graft system is a cage type system implanted into the spine which containes a protein that is capable of initiating bone growth. The Medtronic Infuse Bone Graft has FDA approval to be used in the lumbar spine - or lower back. However, it has come to light that Medtronic pushed doctors to use the Infuse Bone Graft for the cervical spine - the neck - as well, without FDA approval. This non-approved use in the cervical spine has led to numerous complications including swelling of the face and neck and trouble breathing due to restriction of the airway. Others report difficulty swallowing and speaking. Unfortunately, even though the Infuse Bone Graft is not approved for use in the cervical spine, doctors receiving financial incentives from Medtronic have continued using them for cervical spine surgeries, including cervical spine fusions.

The Wall Street Journal has reported that Medtronic is being investigated becaue of the allegations that the company gave doctors numerous incentives to use the Infuse Bone Graft. Medtronic has paid out over $40 million to settle whistleblower lawsuits by former employees who alleged that Medtronic paid doctors to use the Infuse Bone Graft off-label and other spine products manufactured by Medtronic.

When implanted into the neck, the protein used by the Infuse Bone Graft can cause bone to form in teh neck, causing breathing and swallowing to be difficult, and can cause death. Doctors should stop this off-label use of the Infuse Bone Graft system and Medtronic should be held responsible for the harm it has created.

Originally posted at InjuryBoard by Jean Martin

Raptiva Withdrawn From Market Due to Risk of Neurological Disease Progressive Multifocal Leukoencephalopathy

Jean Martin — Wed, 08 Apr 2009 18:56:30 GMT

The FDA announced today that the manufacturer of the psoriasis drug Rapitva has begun a voluntary withdrawal of the prescription drug from the U.S. Market. The withdrawal is due to the risk of patients developing Progressive Multifocal Leukoencephalopathy (PML). PML is a progressive neurological disease caused by a virus in the central nervous system. It is often thought of as a brain infection and causing brain damage. Symptoms include clumsiness, muscle weakness, vision and speech impairment and mental deterioration, memory failure or dementia. there is no known treatment or cure for PML.

In October 2008, the FDA required that the label for Raptiva be updated to warn of the risk of serious infections, including PML. In February of this year, the FDA advised that 3 deaths due to PML had been associated with the use of Raptiva.

Patients should never stop taking prescription medication without the advice and approval of their doctor. Stopping Raptiva can have serious side effects, so patients should consult their physicians before taking any action.

Originally posted at InjuryBoard by Jean Martin

What Would Cause Someone to Blackout While Driving? Maybe It's the Chantix.

Jean Martin — Wed, 08 Apr 2009 08:14:00 GMT

My InjuryBoad Colleague Randy Appleton recently reported about an accident that occurred when a woman blacked out while driving. Too often accidents happen and the driver doesn't remember a thing. The police officer investigating the accident determines that the driver suffered a blackout and that led to the accident.

Not only is is tragic circumstances when the accident results in someone being injured, now the driver is left with the scary questions as to what caused the blackout. Doctors will look for a medical condition - seizure, epilepsy, heart problems, diabetes, etc - that caused the blackout. But now there may be another answer - Chantix.

Chantix is a medication that is used to help people quit smoking. While many people say that is has helped them in this regard, the side effects experienced were worse than the smoking habit. Chantix has been linked to seizures, suicides, heart problems, and diabetes. There have also been numerous reports of traffic accidents due to blackouts while the affected driver was taking Chantix. I think that it is telling that the Federal Aviation Administration will not allow pilots to be taking Chantix and the Federal Motor Carrier Safety Administration has banned operators of tractor trailer trucks from using this prescription drug.

If an accident happens due to a driver blackout, Chantix needs to be added to the list of consideration for potential causes.

Originally posted at InjuryBoard by Jean Martin

Removing Defective Medtronic Leads May Pose Big Risk

Jean Martin — Tue, 07 Apr 2009 09:56:15 GMT

Much has been posted about the dangers associated with the defective Medtronic Sprint Fidelis Leads. Just recently it was revealed that there are more deaths associated with this faulty lead wire than Medtronic had previously reported. Lawsuits for injuries due to malfunctioning of the Sprint Fidelis Lead wires have been dismissed on the basis of preemption - a simple meaning being that FDA approval prevents lawsuits under state tort laws.

Now to add insult to injury, the New York Times has printed a very alarming article about the difficulty in removing these lead wires. Not only have people died as a result of a malfunction of the wires, now people are dying as a result of doctors trying to extract the wires. The procedure is quite complicated and there are a few doctors who have the necessary experience to perform it. The deaths have resulted from damage to a vein or the heart during the risky procedure causing extensive bleeding. Even the physicians who have the most experience with explanting these wires are saying that the procedure presents many challenges to them.

It's really unfair that patients and their doctors have been put in this precarious position. And it's even more unfair that Medtronic might not be held accountable for their actions.

Originally posted at InjuryBoard by Jean Martin