Product Liability Attorney Blog

Research now shows that taking the popular antidepressant Paxil can completely nullify some forms of breast cancer treatment.

It turns out that the combination of taking Paxil and tamoxifen, a drug that halves the chances of a breast cancer patient’s estrogen-positive breast cancer from returning, causes a very common drug interaction. But this drug interaction has the potential to be life-threatening, says David Juurlink, senior scientist at the Institute for Clinical Evaluative Sciences. In fact, it turns out that the longer a woman took the combination of the drugs, the higher her risk was of dying from breast cancer.

And adding insult to injury, antidepressants like Paxil often are prescribed to help fight hot flashes among breast cancer patients.

Juurlink has said that oncologists already knew that that this combination of drugs was causing a problem before the research was undertaken, and that the research just helped to clarify how bad the problem really was. He said that the women that have been prescribed this combination of tamoxifen and Paxil should talk to their doctor because naturally one of the drugs would have to be removed from the list of treatments.

Since Paxil is an SSRI, it is the most common prescription for those diagnosed with depression. The main thing that should be pointed out is that women don't have to stop taking antidepressants just because of this study. They can take other SSRIs while taking tamixofen, as the research did not find an increased risk of death with the women that took tamoxifen in combination with other antidepressants.

Paxil is one of the most widely-prescribed antidepressants on the market; every day patients start the drug as part of a new regimen to help treat their anxiety and depression symptoms. What is not so commonly known is that Paxil also has the most side effects of other antidepressants.

Just like with any other drug, there is a risk of dependence and Paxil has proven itself to be no exception. According to medical experts and attorneys, the drug can be so highly addictive that a person can start to feel withdrawal symptoms as quickly as a couple of minutes after the drug has left the system. Paxil first was introduced to the market in 1992 and since then thousands of patients have already become addicted to it.

Paxil also has been proven to host a lot of side effects. Some of the side effects are more serious than others. A large number of the people that were taking Paxil have claimed that they we uninformed of the many side effects of taking the drug. Many of these people have also claimed to have suffered harm, injury or even death as a result of taking Paxil. Some of the known side effects of taking Paxil include the following:

• nausea,
• insomnia,
• drowsiness,
• headache,
• stomach aches/diarrhea,
• weight gain/loss,
• changes/aggressive behavior,
• rash, itching,
• sweating,
• muscle weakness,
• sexual dysfunction,
• joint pain,
• fever, chills, flu-like symptom and
• suicidal behavior.

Although effects like these have been reported in patients of all ages, they were the most common among children, teens and seniors. Coming down from Paxil withdrawal is much like trying to come off of illegal drugs, many patients claim.

The makers of GlaxoSmithKline currently are dealing with many lawsuits which allege that the risks Paxil poses that were unreported. If you are taking Paxil and think that you may be addicted, consult your doctor immediately.

The FDA recently came to the conclusion that many drugs are actually causing the problems that they claim to prevent. One such drug is Avandia.

Used to treat type 2 diabetes, Avandia recently has been under fire for increasing user risks of having heart attacks and strokes. Since two-thirds of all diabetics die of heart complications, it seems almost ridiculous to prescribe a diabetic drug that causes the heart problems that it is meant to protect these diabetics from.

It was for these reasons and a few others that Europe took the drug off the market — and why the FDA eventually issued a severe restriction that prevents Avandia from being widely available in the United States. So many Americans currently are battling chronic diseases, and the fact that they’re taking a wide variety of drugs to combat them has FDA officials increasingly careful about drug safety. So far it isn't clear what the nation should do in regards to the overwhelming use of prescription drugs that are taken to combat all of these chronic diseases, but safety restrictions have to be taken into account.

The hard part is trying to figure out the best way to assess the safety of drugs that a patient will be using for decades. This is difficult because the clinical trials that are being used right now only chronicle the use of the drugs for a couple of years at most. Drugs are shipped out to the market before they have been tested properly through clinical trials to assess just how risky they are. By the time anyone figures how significant the risks are, the lawsuits are already pending.

Right now, all that is done to test drugs like Avandia is to ask doctors to report adverse reactions and rely on researchers to look at patient experiences through different databases, such as checking the records of large health plans.

“There has to be a better system,” says Dr. Clifford J Rosen, director of the Maine Center for Osteoporosis Research. “The basic underlying theme is that we don’t have good, long-term safety indices for common chronic diseases that we are treating with major drugs.”

Not only does Rosen study osteoporosis, he also served on an FDA advisory committee that checked the proof that Avandia had links to heart risks. The current system of assessing these drugs clearly doesn't work. While Congress recently gave the FDA the ability to require studies even after drug approval, the agency hasn't done so except in rare cases.

Alongside recent news about the FDA's severe restrictions placed on the type 2 diabetes treatment drug Avandia, it has been reported that the drug’s makers, GlaxoSmithKline Beecham, secretly conducted a study to see if Avandia was safer to use than its competition Actos, made by Takeda.

The success of Avandia was crucial for GSK because at the time that the drug was set to be released it didn't have any other new drugs on the market. All of the company’s hopes were tied into the success of Avandia. The test that was conducted in 1999 proved that Avandia was riskier to the heart than Actos was. But instead of publishing the test results, GSK spent 11 years trying to hide them and did not send them to federal drug regulators. (Companies are required by law to submit such results.)

In an e-mail containing the test results, dated March 29, 2001, was discovered by The New York Times, Dr. Martin Freed, a GSK executive, expressly stated a desire to keep the results private.

“This was done for the company way under the radar, and these data should not see the light of day to anyone outside of GSK,” the e-mail reads.

A study that was conducted by the Cleveland Clinic in 2007 was the first to demonstrate how strong the cardiovascular risks are to people taking Avandia. This research forced GSK to post its data on the company’s website after many lawsuits came up. It was only then that GSK admitted to knowing about the potential risks Avandia posed since 2005.

Documents now show that GSK already knew about the risk Avandia patients had of developing heart problems since the drug first came out, but company officials did everything they could to keep that information from the public. One document shows that the company sought to limit the amount of lost sales that would happen if Avandia’s heart safety risk “intensifies.” The company has explained that the drug was safe and that Freed wasn't working for GSK anymore.

With the many lawsuits and settlements currently making waves and this new information about how GSK hid previous test data, it is no wonder that such severe restrictions have been placed that make Avandia widely unavailable to the public.

FDA regulators had ordered GlaxoSmithKline, the makers of Avandia, to send a letter to doctors that explained the results of a hearing that took place in July. At that hearing, an expert advisory board talked about the risks of the controversial drug that is used to treat type 2 diabetes.

The letter that was produced but raised some controversy of its own when federal officials and members of the panel claimed that the letter is misleading and could cause some patients danger. This all happened only a couple of weeks before the FDA decided to use strict warnings on the labels and restrict the wide availability of the drug.

And these moves come on the heels of a trial that conducted by GSK, comparing Avandia's risks to that of Actos (made by Takeda). The study had revealed that Avandia posed the higher risk via heart attacks and strokes by its users and Avandia since has been forced into severe restrictions by the FDA after further investigations into GSK's research tactics were reported.

The letter that GSK produced at the time is said to be biased. Dr. David Graham, a medical officer at the FDA, begged that the study be stopped because he said that thousands of patients in the trial were being exploited. This is a fact that was not included in the letter.

“This summary is biased, misleading and not truthful,” Graham notes. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”

Many doctors on the panel have made statements that the letter was untruthful, misleading and very Avandia-friendly. As to whether this letter actually had a lot to do with the FDA's decision to apply severe restrictions on Avandia and prevent the drug from being widely used, no one can say for sure. However, with complaints that GSK blatantly hid test data, this letter certainly didn't offer a dispute.

Doctors are starting to worry about patients developing an antibiotic resistance to popular drugs like levaquin.

The pervasive use of levaquin (levofloxacin) and other popular antibiotics that are used to treat various bacterial infections have some doctors worried that the body will start to become resistant to many of the antibiotic drugs that are currently on the market. Research shows that humans have developed resistance to the antibiotic drugs that are used to treat gonorrhea.

Different antibiotics work in different ways when it comes to killing off bacteria. Levaquin is a type of antibiotic that generally is referred to as a fluoroquinolone. Fluoroquinolone antibiotics are known as bactericidals, meaning that they combat and kill the bacteria that are causing the infection. There are other types of antibiotics that actually prevent the bacteria from growing in the first place. Fluoroquinolones largely rely on concentration-dependent drugs which can kill bacteria more effectively because they have a larger amount of medicine that can reach the area of infection.

When those that are using antibiotics like levaquin take too much of it, the bacteria begins to "get used" to the drug in the system and it mutates accordingly. These mutations help to make the bacteria harder for the drugs to kill. There are 3 ways that you can help to ensure that you don't develop a resistance to levaquin:

1. Take the dose that your physician had prescribed for you. Don't use an antibiotic that was prescribed for someone else, even if you have the same condition as they.
2. Be sure to take the drug on the time schedule that your doctor gives you and in the correct amount.
3. Even if your symptoms go away, you should take antibiotics until they are gone so that you can help prevent your infection from returning.

Accutane, a drug used to treat sever acne, has been linked to Inflammatory Bowel Disease (IBD) and Crohn's Disease, according to research conducted at the University of North Carolina.

While Accutane (generic name isoretinoin) originally was used for treatments in chemotherapy, it has been used since 1982 to treat severe acne where antibiotics don't help. Accutane’s main side effect warning was against pregnant women using it because it may cause birth defects. There also were warnings against symptoms such as depression, suicidal behavior and its impact on IBD.

IBD is made up of two specific illnesses. One of them is Crohn's disease and the other is Ulcerative Colitis. Both of the diseases cause major problems with the digestive system in the body. They both give people repeated inflammation problems that cause a lot of pain. They also give you symptoms like diarrhea and sometimes even bowel obstructions.

Crohn's disease can enter the body through almost any orifice, including the mouth, anus and the intestines. Ulcerative Colitis enters the body primarily through the colon and rectum. Researchers at the University of North Carolina found a significant link between users of Accutane and IBD. They said that Accutane users had almost two times the chances of getting serious bowel problems than those that didn't use the drug.

For those that use Accutane in its generic form for a long time, the risk of IBD is even higher than those who just use it for a little while. It is likely for these reasons that the manufacturers Accutane removed the drug in 2009, but the generic version is still widely available. At the time, the company claimed the move was for economic reasons.

If you or someone you know have experienced symptoms of IBD while taking Accutane, you should contact your doctor.

Researches have discovered that Reglan (also know by the generic name metoclopramide) is being used to treat premature babies even though it isn't cleared by the FDA to do so. Of course, many prescription drugs are used for more than their intended purposes. However, this trend is alarming specifically because it involves our smallest society members.

In 1979, Reglan was approved for short-term use, or a period of no more than 90 days, to treat several types of gastrointestinal problems. But as late as 2009, the drug received a black box warning (the most serious warning a drug can get) because of its link to tardive dyskinesia. In fact, the drug has been named the leading cause of tardive dyskinesia in U.S. patients.

Reglan started being used on premature babies about 10 years ago. At that time, the only drug on the market that was used for treating gut motility had just been taken off the market due to of safety concerns. Reglan was then introduced as a treatment for gut motility in premature babies, whom often are born with underdeveloped muscles that contract and help them digest food. It was discovered that Reglan helped jump-start the process.

Even though research shows that women and the elderly are more likely to develop tardive dyskinesia while using Reglan, the full effects on infant use have yet to be determined. Some caregivers even claim that it is safe since most of the side effects only affected older children, women and the elderly. It will probably continue to be used on infants until the lawsuits start rolling in, or until parents become informed enough to refuse the Reglan treatments on their premature infants.

If you are concerned about the negative side effects of Reglan in your infant (particularly face and body spasms), contact your doctor.

With so much negative press on the dangers and side effects of taking various prescription medications, many people are looking to come off of them. While it is common for doctors to prescribe Paxil to treat depression and anxiety — even obsessive-compulsive disorder — the effects of quitting the drug are rarely mentioned by your doctor unless you ask them directly. By the time the subject comes up, patients usually are suffering through some pretty bad side effects.

Quitting Paxil is much like coming off of many other drugs; however, most of the symptoms expressed are quite severe. Since Paxil is an SSRI inhibitor, it acts on the serotonin receptors in the brain by changing the physical properties of some brain cells. As Paxil has the shortest half-life of other drugs, the body breaks the drug down faster than other SSRIs.

Quitting Paxil causes the body to decline very fast; this is what causes the adverse affects like sever withdrawal. Some of the adverse reactions include dizziness, abnormal dreams, nausea, extreme sweating, insomnia, internal feelings of being shocked/electrocuted, slurred speech, severe headaches, motor problems and intense restlessness. Some of the adverse cognitive symptoms are extreme confusion, extreme anxiety and severe mood swings.

The fact that quitting Paxil can also cause suicidal and violent behavior as well make this a very dangerous drug to be weaned off of without proper supervision by a doctor. It is for these reasons that many lawsuits have been filed in California. Claimants sued GlaxoSmithKline (the makers of Paxil) for not issuing proper warnings to the public about the dangers of quitting.

If you are thinking of quitting Paxil, you should do so with the supervision of a physician. You shouldn't try to quit Paxil cold turkey. It is best to weaned off of the drug.

The popular drug Avandia (which is used to treat type 2 diabetes) has come under increased fire lately, with some calling on the FDA to order that the drug be taken off the market.

Avandia first was approved for treatment of type 2 diabetes in 1999. Even back then, concerns about Avandia's potential risks and side effects led to suggestions that Avandia be removed from the shelves. However, the FDA didn't even warn the public of its potentially fatal effects.

Then in 2007, a study conducted by the Cleveland Clinic and published in the New England Journal of Medicine reported that Avandia increases the risk of a heart attack by a staggering 43 percent. The same study concluded that Avandia increased the risks of cardiovascular death by an astonishing 64 percent.

The FDA's Role

The FDA originally based its decision not to remove Avandia from the shelves on recommendations that were made by an expert panel. The FDA instead issued a black box warning. Since the new concerns arrived, there are accusations that the drug's manufacturers, GlaxoSmithKline, withheld data that showed problems with Avandia. The accusations also claim that GlaxoSmithKline didn't properly warn the public and users of the drug of its potentially fatal side effects.

Currently there is evidence that proves that the FDA's internal staff also was warned but ignored the warnings. However, GlaxoSmithKline still maintains that the drug is safe for use and should not be removed from the shelves.

Critics of the FDA already have shown that their current procedure is a big factor that is preventing the agency from acting efficiently when a problem with a new drug has been found. The reason for the critics’ complaints is because the same department that is responsible for the initial investigation into a new drug's risks is also the department that decides if the drug will be approved. Most feel that this fact poses a sincere conflict of interest in the judging. Any information about risks that is discovered should be forwarded directly to the FDA commissioner so that proper action can be taken quickly, as opposed to transferring the information through the various levels of bureaucracy that the FDA currently uses, members of this camp argue.

With heart attacks being the leading cause of deaths in diabetics, this information should have been released to the public sooner. Had the FDA acted sooner and not ignored the initial warnings, chances are that many deaths could have been prevented. If you or someone you love thinks that they may have been hurt from using Avandia, contact an experienced attorney to learn more about your options.

With so many well-known and well-published lawsuits filed against Bayer claiming that the company’s popular drug Yaz/Yasmin demonstrates a higher risk of causing blood clots, you would think that the fact that the drug was recalled in November 2009 would be popular news topic. It isn't. In fact, almost no one knew that the FDA recalled Yaz at all.

The reason why no one knew that the FDA recalled Yaz/Yasmin is simple: Bayer reported that the drug Yaz/Yasmin was within specifications when it wasn't. It changed the numbers of the dosages of drospirenone and ethinyl estradiol in each pill, changing the analytical value so that its reports would ensure the drug met the specifications needed for FDA approval. Get this... No one noticed the change at all.

When the recall was actually issued in November 2009, the results of the recall weren't even listed where they were supposed to be on the FDA website, which at its best can be impossibly difficult to navigate. The recall information was posted in an "Enforcement Report" section of the website, when it was supposed to be listed in the "Recalls, Market Withdrawals, and Safety Alerts" section.

The recall information is important to the lawsuits for several reasons. First of all, the recall involved the dosage of the drospirenone that was in the pill. This is the main ingredient that the claimants in the suit say makes Yaz/Yasmin more dangerous than the original recipe for the drug. Secondly, the recall was actually a massive one. The FDA recalled 32,856 boxes of Yaz/Yasmin, with each box containing 3 packs in it. It also recalled 122,208 boxes of Ocella, an identical copy of Yaz.

The last reason is the most important detail of the recall. While the recall was officially dated by Bayer as taking place on November 29, 2009, the FDA actually inspected them in March 2009 where Bayer was warned against rearranging their averages again in August 2009.

The public isn’t the only ones left in the dark about the recall.

"Even the lawyers that were suing Bayer didn't know about it," Janet G. Abaray told BNET. I'll bet that this was just the kind of news that the lawyers needed.

NEWS RELEASE

October 6, 2010

St. Louis – Carey, Danis & Lowe, a personal injury, medical malpractice, pharmaceutical liability and product liability law firm, proudly announces that retired St. Clair County, Ill. Judge Michael J. O’Malley has joined the firm and will head the firm’s Belleville, Illinois office.

O’Malley, 57, graduated with a bachelor of arts degree from Southern Illinois University-Edwardsville in 1975 and received his law degree from Lewis University Law School in 1979.

O’Malley served as assistant state’s attorney in St. Clair County, Illinois from 1979 to 1982. From 1982 to 1985, O’Malley was in private practice. In 1985, he was appointed an associate circuit judge in St. Clair County. In 1990, he was elected circuit judge and was then re-elected in 1996, 2002 and 2008.

The address of the new office is 5111 W. Main Street, Belleville, Illinois 62226.

Founded in 1995, St. Louis-based Carey, Danis & Lowe is a 22-lawyer firm with offices in Missouri and Illinois. The firm handles personal injury, pharmaceutical liability, product liability, medical malpractice, class actions, and commercial cases throughout the United States and has recovered over $1.4 billion on behalf of its clients. For more information, contact Elizabeth Conzelman at 618.212.6300 or email EConzelman@careydanis.com.

###

Johnson & Johnson, the makers of the high-grade antibiotic Levaquin, is under fire for allegedly conspiring to promote the drug to nursing home seniors. Specifically, a lawsuit has been filed that J & J conspired with the pharma consultant Omnicare in an effort to get seniors interested in the drug. According to consumer advocacy groups, this is a violation of federal Medicare laws.

The charges are incredibly serious. The lawsuit alleges that patients were charged very high prices for their medicines in general, and were switched without their consent to J & J products, which included Levaquin. At last time of check, it was illegal to change someone's medication without his or her informed consent.

Further allegations include the charge that J & J paid Omnicare directly to promote its drugs as “preferred” brands, or medicines considered very effective and desirable in treating elderly patients such as those in nursing homes, and the geriatric community in general.

Levaquin wasn't the only drug allegedly being promoted in this rather shady fashion, either. Other medicines promoted include Floxin, Risperdal, Ultram, Duragesic, Procrit and Aciphex. This list includes everything from fairly strong painkillers in the opioid category to proton pump inhibitors.

Of course, these accusations rest atop the still-troubling risk of prescribing Levaquin to anyone, for any reason. While very effective at combating particularly “dug in” infections that other medicines have trouble dealing with, Levaquin is increasingly under question for its powerful side effects. Severe tendon toxicity related to the drug has been shown to cause ruptures and painful injuries. The elderly are at acute risk for Levaquin tendon toxicity, which makes this situation even more unacceptable.

No court dates have yet been filed, and there is no word from J & J, Omnicare or their subsidiaries on the specifics of the case. The case was filed in Sacramento, California.

An Ontario teen named Sara Carlin took her life after a battle with depression. The jurors that examined the case did not explicitly say that they believed the antidepressant Paxil played a role in her suicide, but they did advise the creation of a regulatory body to examine the prescription of such medicines.

Studies have frequently and consistently shown that antidepressants such as Paxil can aggravate or even originate suicidal impulses in young patients. Yet the medicines continue to be described to youth, often for conditions such as minor depressive disorder instead of the major depressive disorder such medicines were intended to combat.

Medicine is a difficult business. The human body didn't evolve to take in all the drugs people keep putting into it. There is always a tradeoff between the beneficial effects and undesirable side effects of any medicine. A doctor elects to make a treatment, hoping the positive effect will outweigh the consequences. For antidepressants, the goal is to give the patient enough chemical balance to be able to function normally in society instead of feeling crippled by uncontrolled feelings of guilt, frustration, impotence and despair.

However, suicidal impulse is not something someone can logically consider an acceptable risk. More than one study has shown that chemical antidepressants can aggravate an existing suicidal impulse in younger patients, and potentially even originate it. How is it, then, that doctors continue to prescribe these medicines for younger and younger patients, sometimes as young as seven years old?

Because the jury didn't have authority to assign blame in the examination of Sara's death, there is no official link between her suicide and her prescription of Paxil for her depression. That should not discourage parents from taking a long, hard look at the nature of the problem and asking their doctors as many questions as possible before putting their children on such a potent medicine.