Wilmington Personal Injury Lawyer - FDA & Prescription Drugs

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

Susan Galinis Warning to Other Women Taking Yaz Birth Control

Aileen Wu Viorel — Tue, 10 Nov 2009 11:24:05 GMT

Take the time to watch the linked video below. Susan Galinis speaks out in efforts to warn other women who may be at risk due to taking Yaz birth control. Like many other cases that have recently surfaced, Susan suffered a stroke only a month after she started taking Yaz. Susan's life will never be the same. Susan's story is just one of many. Yaz is still on the market and many women taking this birth control are still at risk.

View Video

Originally posted at InjuryBoard by Aileen Wu Viorel

Watch For Prescription Errors This Cold And Flu Season

Jean Martin — Tue, 27 Oct 2009 12:27:18 GMT

It's cold and flu season again, and you know what that means: more trips to the doctor's office, and more prescriptions to fill out at your local pharmacy.

Unfortunately, as pharmacies fill out more and more prescriptions, the risk of medication errors increases. Take, for instance, the story of Gwen Dalley:

It never occurred to Gwen Dalley that there was anything wrong with the prescription antibiotic pills she picked up at a Loganville pharmacy. But within a day of taking them, while driving her usual school bus route, she was so overcome with dizziness that she had to pull over and radio for a substitute driver.

As Dalley continued to take the pills, her symptoms got worse. She was nauseated, started having headaches and her vision blurred. She was briefly hospitalized, but doctors couldn’t figure out what was wrong.

Eventually she noticed that some of the pills in the pharmacy bottle were larger than others. It turned out most of them were not the antibiotic her doctor had prescribed, but an antidepressant with significant side effects, according to a complaint Dalley filed in January with the Georgia Board of Pharmacy.

Unfortunately, stories like Dalley's are far too common. According to one source, about 3 percent of prescriptions filled annually have a potentially harmful error. Errors on the pharmaceutical side of medicine can range from accidentally substituting the prescribed medication for one with a similar name or appearance to misprinting the required daily dosage. Physician errors can include a misdiagnosis that leads to the prescription of the wrong medication or the failure to alter a medication when needed.

The frequency of prescription errors means that you as a patient need to be proactive with your doctor and your pharmacist. When talking to your physician, make sure you understand what medication he is prescribing, what diagnosed ailment he or she is treating you for, and how you should administer the prescription once you receive it. When you pick up the medication, make sure the prescription on the bottle matches the medication name your doctor gives you. Also, make sure to let both your physician and pharmacist know about any other medications you are taking, as well as any allergies that you have, so that they can give you a medication that won't do more harm than good.

Speak up, ask questions, be proactive, and stay informed in the prescription-filling process. These are simple precautions to take, but they could be life-saving.

Originally posted at InjuryBoard by Jean Martin

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

Plaintiff Wins First Zometa Trial

Jean Martin — Thu, 22 Oct 2009 16:28:12 GMT

A jury in Montana has ordered drug manufacturer Novartis to pay $3.2 million to a woman who developed osteonecrosis of the jaw (ONJ)after taking Zometa. The case of Peggy Stevens was the first of its kind to go to trial.

In a case of tragic irony, Zometa is used to strengthen bones by treating high levels of calcium, brought on by cancer or multiple myeloma. Unfortunately, many users of Zometa have developed the rare condition known as ONJ which is a loss, or breakdown, of the jaw bone. ONJ is a serious condition which basically causes your jawbone to die.

Approximately 550 cases have been filed against Novartis for ONJ due to Zometa.

I'm so glad that the jury got this one right. The first trial for the related drug Fosamax ended in a mistrial last month when the jurors could not reach a consensus. ONJ is a terrible and debilitating condition and those who innocently took Zometa and Fosamax and now are suffering deserve compensation.

Originally posted at InjuryBoard by Jean Martin

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

Anticipation - Waiting for the Jury in the First Fosamax Case to Go to Trial

Jean Martin — Thu, 03 Sep 2009 10:08:11 GMT

Closing arguments were held yesterday in the first trial against Merck concerning the osteoporosis drug Fosamax. Millions of women have taken Fosamax to counter bone loss associated with menopause. Unfortunately, many of those women developed a painful and debilitating condition called osteonecrosis of the jaw (ONJ). ONJ causing the jaw bone to literally deteriorate because the bone tissue dies. ONJ is a rare medical condition that dentists have explained to me used to be only briefly discussed in dental school because it was thought that dentists would never see it. But after Fosamax was approved by the FDA in 1995 and started being so widely prescribed, dentists started seeing ONJ more frequently.

In terms of numbers of cases, the Fosamax litigation is small, but the results are huge. A favorable outcome for plaintiffs, which will hopefully happen, could impact Merck's impending merger with Shering-Plough.

ONJ is a terrrible condition and, through the course of this trial, the plaintiffs have put forth evidence that Merck was aware of the problems associated with Fosamax but continued heavily promoting the drug without any warnings or studies.15 million prescriptions for Fosamax were written in 2007. Fosamax had sales of $1.55 billion last year, and that was even with a 50% decrease from 2007.

It is reported that Merck has set aside $42 million to defend this litigation. I think that Merck should quit paying its lawyers and start paying the innocent victims. The women that are suffering from ONJ as a result of taking Fosamax deserve to be compensated by Merck. Let's hope the jury gets this one right.

Originally posted at InjuryBoard by Jean Martin

New Study Shows Yaz Birth Control Pill Carries Greater Risk of Blood Clots

Jean Martin — Mon, 31 Aug 2009 09:27:24 GMT

Women’s birth control is an area of pharmaceutical medicine that sees innovation and improvement at a faster rate than nearly any other type of pharmaceutical drug. One of the more recent contraceptive pills to come out on the market and which became quite popular very quickly was the Yaz pill which is manufactured by Bayer. Yaz claimed that it could treat moderate acne and that it would treat the symptoms of premenstrual dysphoric disorder. For many women, this pill seemed like a miracle; it was a traditional birth control pill but it also would treat the irritability, mood swings, cramps, etc. which are common side effects of a menstrual cycle.

However, Yaz may not be as safe or as beneficial as it claims. A new British report has outlined the risks and problems associated with Yaz. While all oral contraceptives carry a risk of causing blood clots in those who take them, Yaz seems to have an increased risk of these clots. While the dosage of hormones in a birth control pill has been known to affect the occurrence of blood clots, it also appears to be that the type of hormone may increase risk as well. Nearly all oral contraceptive pills contain estrogen and progestin and the lowest doses of estrogen correspond with the lowest risk for blood clots. However, the Yaz pill contains a type of progestin called drospirenone which has been shown to increase the risk of blood clots 6.3 times. Drospirenone is a fairly new type of progestin and the reason it seems to cause so many problems is that it leads to an increased potassium level in the blood which then leads to a condition called hyperkalemia. Hyperkalemia often has no symptoms at all but can lead to cardiac arrest and kidney failure in patients suffering from it.

In October of 2008, Bayer was cited by the U.S. Food and Drug Administration for deceptive claims in some of their Yaz advertisements. The ads, said the FDA, were overstating the benefits of Yaz while distracting viewers from the risks by playing fast-moving images and music while risks were read out loud or displayed on the screen. Bayer agreed not to run those ads anymore and began running a different series of ads in 2009 which corrected these issues. However, these new ads and warnings may have come too late for some consumers.

There are at least 32 federal Yaz lawsuits or Yasmin lawsuits currently pending against Bayer, which all involve claims that the medications caused women who took the birth control pills made by Bayer to suffer injuries like heart attacks, strokes, deep vein thrombosis (DVT), pulmonary embolism (PE), gallbladder disease or sudden death. In addition, it is expected that the number of claims will increase substantially in the coming months, as Yaz / Yasmin lawyers are currently investigating hundreds of other cases for women throughout the United States.

The Yasmin and Yaz lawsuit complaints all contain similar allegations that Bayer failed to adequately research their products, fraudulently concealed the risk of injury, negligently failed to warn about the degree of risk women faced and misrepresented the safety of Yasmin and Yaz in comparison to other available birth control pills. In the United States, a manufacturer or producer has a very high duty to which they must adhere when placing pharmaceuticals on the market for consumers. Consumers expect that the products they purchase and put in their bodies are safe, or at least, that the risks have been adequately explained. It is likely that with new studies and reports coming out like the British report and with more women coming forward, the number of law suits and claims against Bayer will continue to rise.

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