Posted On: December 30, 2011

Loyola Research: Blood Test May Predict Paxil Efficacy in Some Patients

New research conducted by scientists at Loyola University Medical Center suggests that scientists may have found a new way to test the potential quickness of the efficacy of antidepressant medications like Paxil on an individual basis.

This new Loyola study has discovered that using a blood test that detects a protein called vascular endothelial growth factor (VEGF) may be able to help predict successful treatment. The researchers discovered that among depressed patients with above-average levels of VEGF, more than 85 percent of them experienced some relief from their symptoms after they took Lexapro, another antidepressant medication. They also discovered that less than 10 percent of the patients that had low VEGF levels actually responded positively to the drug.

“This would be the first time we would have a predictor for how well a patient would respond to an antidepressant,” said Angelos Halaris, M.D., Ph.D., first author of the study.

The researchers also learned during the study that 60 percent of the patients suffering from depression did not fully respond to the Lexapro, which means that doctors continue to have to use a trial and error method when prescribing medications. Halaris admits that “it would greatly benefit our patients if we could predict ahead of time whether a given medication would be effective for a certain patient.”

The Loyola study monitored 35 patients who were taking SSRIs like Paxil, Zoloft and Prozac as a treatment for their depression. SSRIs have proven to be dangerous to patients in that the drugs have been linked to birth defects, aggressive and suicidal thoughts and behavior. It is for this reason that the current trial and error game is too dangerous. The drugs are also known to be habit-forming. This new blood test may be able to cut down on the guess-work for doctors and their patients, which could lessen the adverse side effects patients experience when trying to find the right medication.

Posted On: December 28, 2011

Study: All Antidepressants Work the Same

Results from a new study suggest that all antidepressant medications — including Prozac, Paxil and Zoloft — work the same. So it really doesn’t matter which one you take. What this means is that doctors can very well base their prescription choices on each patient’s personal requirements, such as cost, side effects and personal preference.

Dr. David Schlager, a clinical assistant professor of psychiatry and behavioral science at Texas A&M Health Science Center College of Medicine, says, "They're all equally effective. They're interchangeable except for side effects, so psychiatrists do tend to 'exploit the side-effect profile' to find suitable medications for individual patients.”

According to information for the study, which appears in the Dec. 6 issue of Annals of Internal Medicine, as many as 27 million people in United States have taken antidepressants since 2005, including SSRIs like Prozac, Paxil and Effexor. The study was led by Dr. Gerald Gartlehner, and the analysis was mostly paid for by the U.S. Agency for Healthcare Research and Quality.

For the study, authors looked at information from 234 previously-published studies as well as data from random trials that each included information on at least 1,000 participants each. What the researchers found was that while there was no difference in the efficacy of the drugs, there were differences in how the drugs took effect, how they affected a patient’s quality of life and how severe the side effects were.

For example, the study found that Remeron worked faster than Prozac and Paxil. The study also found that Buporpion has less sexual side effects than Paxil, Zoloft and Lexapro.

"If a patient has insomnia, you would pick something more immediately sedating," Schlager said. "If the patient has decreased appetite and weight loss, you would pick something more likely to cause weight gain like mirtazapine."

Dr. Radu Saveanu, a professor of psychiatry at the University of Miami Miller School of Medicine, commented about how the cost of a drug may influence which drug would be chosen. He also pointed out that dosages should be brought into consideration when opting for one drug over another "because studies have shown that if patients have to take the drug less frequently, compliance is higher, which will make a big difference in terms of efficacy."

What this study shows is that since all of the drugs have proven to be equally effective, the drugs patients are prescribed are basically just a guessing process based on what patients can take both physically and financially. Future studies are hoping to be able to help doctors figure out which drugs to prescribe first to avoid the dangerous side effects linked to some of the medications.

"The real heart of the matter is, if they don't respond to one type of antidepressant, is there any guidelines about what you should try next?" Schlager asked.

Posted On: December 26, 2011

Health Canada: Yaz Blood Clot Risk Increases 3 Times Over Other Pills

On December 5, Canadian health officials announced that they agree with other countries that Yaz and Yasmin birth control pills can increase the risks of women developing blood clots more than when they take other, older birth control pills.

Health Canada’s announcement explained that they “had completed a review of the two Bayer birth control pills, determining that Yaz and Yasmin may increase the risk of blood clots 1.5 to 3 times over some older birth control pills.” Because of this risk, Health Canada chose to change the labels on the pills to reflect their blood clot dangers. The Canadian agency's conclusions concur with the FDA’s. The FDA had conducted its own review of the pills and determined that the pills caused an increased risk of blood clots by as much as 75 percent and that the pills doubled the chances of patients suffering from heart attacks or strokes when compared to levonorgestrel-based pills.

On December 8, an FDA advisory panel met to discuss the blood clot risks in the hopes of making some recommendations to the FDA about what regulatory actions should be taken. Even though these recommendations will not actually be binding, they will carry weight with the FDA on what the pills' manufacturer, Bayer, should do. Still, it won’t much matter to the public, since Yaz and Yasmin remain the most popular pills on the market today regardless of the warnings attached to them. Women will continue to suffer from the pills’ adverse side effects and lawsuits will continue to be filed.

With so much research proving the dangers associated with Yaz and other drospirenone-based pills, it is a wonder that the pills aren’t completely recalled. However this week, yet another generic version of Yaz was approved, which suggests that the pills will never be recalled no matter how dangerous they are.

Posted On: December 23, 2011

Another Levaquin Lawsuit Added to Minnesota MDL

Another new case has been joined to the Levaquin MDL in Minnesota. This lawsuit was filed on December 2, 2011, and joins the MDL in the in the U.S. District Court, District of Minnesota.

In her complaint, plaintiff Vivian B. Smith is claiming that she has suffered from tendon injuries after taking Levaquin. Specifically, Smith, a resident of Inman, S.C., says that she developed a condition called Achilles tendonitis in her left leg. Smith says that because of her injury she has lost her ability to perform normal daily tasks, which has also severely diminished her quality of life.

Smith’s case is a good deal like most of the other Levaquin lawsuit plaintiffs who claim that the controversial antibiotic causes severe adverse side effects like tendon injuries and ruptures. Smith’s lawsuit is asking for “compensatory damages for her injuries, and special damages to compensate her for past and future medical expenses, rehabilitation, lost income, permanent disability, pain and suffering.”

Levaquin has long been linked to tendon injuries, and many of the warnings issued by the FDA have stated that the drug is particularly dangerous to seniors over the age of 65 and those taking corticosteroids. Smith was just 65 years old when she started taking Levaquin as a treatment for bronchitis in 2008. She claims that the makers of the drug, Johnson & Johnson and Ortho-McNeil Pharmaceutical Inc., failed to properly warn her of the tendon injury dangers linked to Levaquin before she started taking it.

Smith’s lawsuit joins thousands of Levaquin cases that have been filed across the country. All of the plaintiffs are claiming the same thing: that the defendants didn’t properly warn them or healthcare professionals of the dangers. Some plaintiffs are also claiming that the defendants specifically marketed the drug to senior patients even though they knew the dangers.

Posted On: December 21, 2011

First Individual Yasmin Lawsuit Filed in Canada

Family members of a young woman who died after taking Yasmin have launched the very first individual civil lawsuit against Bayer, the makers of Yasmin, amid claims that the drug caused the fatal pulmonary embolism that killed her.

Vicky Caprice Mersereau, 26, died after developing a pulmonary embolism while taking Yasmin birth control pills in 2009. Yasmin is a controversial, drospirenone-based oral contraceptive that is known to cause blood clots that can lead to pulmonary embolisms. One of Canada’s highest-selling birth control pills, Yasmin is widely considered to be a "fourth generation" pill that is said to be a lower dose than Yaz. The lawsuit was launched on Friday, November 26, in London, Ontario.

Thousands of lawsuits have been filed in the U.S. against Bayer over Yaz and Yasmin. Each lawsuit alleges that patients were not properly warned about the increased of developing potentially fatal side effects, which include gallbladder disease, blood clots that can lead to heart attacks, strokes, pulmonary embolisms and deep vein thrombosis. Just last month, the FDA issued a warning about the pills that contained drospirenone that stated that the pills “increase the risk of blood clots by 74 percent, compared with older pills on the market.” The cause has gotten so much negative attention that some of the Yaz lawsuits have been consolidated into Bellwether trials, which will begin in January 2012 with Judge David R. Herndon presiding.

Back in May of this year, Health Canada announced a safety review of the pills, and CBC Marketplace also launched its own investigation into Yaz and Yasmin that was called “Spinning a Pill." While this is not the first ever lawsuit filed against Bayer over Yaz, it is one of the first civil lawsuits filed in Canada. On March 10, 2010, a law firm in Canada filed a class-action lawsuit that is sure make headlines once the verdict comes down.

Posted On: December 19, 2011

Elevated Potassium Levels Just Another Yaz Side Effect

In another Yaz lawsuit that was filed on November 18 in New York, the plaintiff is claiming that Bayer knew how dangerous Yaz and Yasmin are and didn’t try hard enough to alert doctors and patients of the dangerous side effects linked to the pills.

Arran Dutkowsky’s lawsuit has listed an elevated level of potassium (also called hyperkalemia) as one of the adverse side effects that Yaz has caused her to suffer from. The elevated potassium levels, which are caused by the synthetic progestin drospirenone, can cause patients to suffer from irregularities in the heart rhythm. In Dutkowsky’s lawsuit, she acknowledged that Yaz labels do include strict warnings about the drug’s links to hyperkalemia. Her suit is claiming, however, that the labels do not mention how the birth control pills can cause blood clots. This is relevant because while taking a generic equivalent to Yaz, Gianvia, Dutkowsky has suffered from deep vein thrombosis and pulmonary embolisms.

Dutkowsky has been taking Yaz since 2008 and was diagnosed with the conditions in 2010. Yaz side effects have been the cause of thousands of lawsuits being filed against Bayer, but the company refuses to accept the pills’ real dangers. Bayer has stubbornly stuck behind Yaz and has claimed repeatedly that Yaz and other drospirenone-based pills are no more dangerous than other birth control that do not contain drospirenone.

Some of the side effects that have been linked to Yaz include gallbladder disease, blood clots that can lead to heart attacks, strokes, pulmonary embolisms and deep vein thrombosis. Many of those patients that developed these conditions have also been diagnosed with high potassium levels. If you are planning on taking the widely-popular oral contraceptives, you must read the label before you begin the regimen as some pre-existing conditions can increase your chances of developing some of these adverse side effects.

Posted On: December 16, 2011

Study: Switching Antidepressants Doesn’t Change Side Effects

A new study that was published in the latest issue of General Hospital Psychiatry is suggesting that the patients who experience severe depression and don't see any signs of improvement while taking an antidepressant often end up switching medications or adding another antidepressant to their medication. When making these medicinal changes, many doctors try to consider how dangerous the side effects will be beforehand, but the study found that no one drug is more likely to cause harm than another similar drug.

Depression is a common diagnosis in adult Americans these days, and there are dozens of different antidepressant medications used to treat the symptoms of the condition. In fact, according to research that was published in both the American Journal of Psychiatry (2006) and the Annals of Internal Medicine (2008), only 30 to 50 percent of the people taking antidepressants like Paxil or Effexor actually benefit from the treatment. This fact is why many doctors are prescribing a switch to a different antidepressant medication, or adding another one to an established antidepressant treatment. This approach to depression treatment is called augmenting.

The problem is that these antidepressant medications like Paxil and Effexor cause various adverse side effects, including birth defects in babies whose mothers take the drugs while pregnant and aggressive or suicidal behavior. Before this new study, doctors believed that changing and/or switching these medications would actually make the side effects worse. However, this new study suggests that this is not the case.

“We believed the augment group would have more side effects than the switch group,” said study author Richard Hansen, Ph.D., head of the department of pharmacy care systems at Auburn University.

Hansen also said that doctors could learn something from this study, and said, “For treatment-resistant depression, the decision to augment or switch medications should be based on individual patient’s clinical status, as well as the possible benefits and risks of each treatment.”

While this means is that adding or switching from one antidepressant medication to another does not increase your chances of suffering from adverse side effects, the risk of experiencing side effects doesn't decrease, either. Caution is still advised in taking these medications.

Posted On: December 14, 2011

FDA Findings Likely to Boost Yaz Lawsuit Claims

On November 2, 2011, plaintiff Jane Montgomery filed a Yaz lawsuit amid claims that she developed a pulmonary embolism after taking the controversial oral contraceptive.

The lawsuit, which was filed in the Superior Court of California, lists Bayer Healthcare Pharmaceuticals as the defendant. Montgomery holds the drug makers liable for her pulmonary embolisms, since she believes that Bayer failed to properly warn her that the pills could cause serious adverse side effects, which include blood clots. While the woman’s case is still on the California docket, Montgomery’s action has been ordered stayed. This may be due to the fact that her case may be transferred to the Yaz MDL that is set to take place in Illinois.

As with other Yaz lawsuits, settlement amounts will depend on the evidence that the plaintiff can provide to verify their claims that Yaz and other drosperinone-based pills caused their illnesses. When it comes to the claims that Yaz caused pulmonary embolisms, plaintiffs and their lawyers may get a boost in their cases thanks to the FDA’s own research which seems to prove the plaintiffs developed pulmonary embolisms after taking Yaz or Yasmin.

At the end of October of this year, the FDA posted their findings from a study it conducted that specifically looked to see if Yaz causes blood clots. The study was conducted with researchers collecting information from more than 800,000 women. The women all used a diverse collection of geographically-mixed health plans. In the end, the study showed that Yaz and Yasmin and other drosperinone-based pills cause blood clots and that the patients have a 1.5-fold higher chance of suffering from the blood clots and illnesses caused by them. This information was in comparison to other birth control pills that are not drospirenone-based.

This information is bound to add a boost to plaintiff claims, since Bayer has been steadfast in their claims that Yaz and other drospirenone-based pills are no more dangerous than other pills that do not contain drospirenone. Arguments will be fairly scarce when the FDA even found research to substantiate plaintiff claims.

Posted On: December 12, 2011

Paxil and PPHN

The fact that babies born to mothers who took antidepressant medications like Paxil during pregnancy can suffer from birth defects is hardly brand new information. But one of those defects can leave some parents scared and confused — a condition called PPHN.

Persistent pulmonary hypertension of the newborn (PPHN) is a potentially fatal lung disease that affects one or two in every thousand babies born to mothers who took antidepressant meds like Paxil during pregnancy. PPHN kills roughly one baby for every 10 that have the condition. Those babies that do survive this condition often experience permanent hearing loss or brain damage, according to a study which was first published back in the Feb. 9, 2006 issue of The New England Journal of Medicine. That is an alarming trend that should prevent doctors from prescribing Paxil or other antidepressants to pregnant women, and yet many women are still being given the drug.

There are various studies that show just how dangerous Paxil is to these babies, and many doctors have opinions about the findings. Dr. Sandra L. Kweder, MD, said "We find these results very concerning. We [the FDA] find the reported association of SSRI antidepressants with this very serious condition to be very worrisome."

While the study mentioned above was first published in 2006, there have been many others conducted since then that have shown similar findings. In fact, PPHN is only one of the birth defects that is caused by antidepressant use. Other defects that have been caused by Paxil include cleft palate, neural tube defects and heart and brain birth defects. The reason why I brought up the older study is to remind people how long this information has been available.

With this information being publicly available since as far back 2006, it almost seems insane for healthcare professional to continue prescribing antidepressants to pregnant women — especially when recent studies have shown that these meds may not actually work at all in relieving cases of mild to moderate depression symptoms. Research has come a long way since 2006 and one thing that is certain is that women should avoid taking Paxil and other antidepressants during pregnancy.

Posted On: December 9, 2011

Judge Rejects Woman’s Bid to Give Yaz Case Files to FDA

Recently Judge David R. Herndon rejected one woman’s request to show the FDA specific protected documents that a Yaz litigation found during the discovery process. Herndon rejected the idea even though the plaintiff proved that the “confidential” internal documents might show that there is important safety information about Yaz that the health regulators don’t already know.

The woman who asked to share the documentation is Kaitlyn Dietrick, and she is one of the thousands of women who have filed a lawsuit against Bayer Healthcare over the company’s alleged failure to properly warn them of the real dangers associated with taking Yaz and Yasmin. Dietrick tried to get the confidential documents unsealed in an attempt to have them present during the FDA’s advisory committee meeting next month.

Dietrick and her lawyer argued that the documents requested would show important safety information as well as potential conflicts of interest that may occur between panel members and independent advisors who are set to get together on December 8 to discuss Yaz safety risks. Dietrick and her lawyers did manage to get Bayer to agree to release 10 of the documents, but both sides reached a stalemate about the other 48. Dietrick also stated during her argument that it was her First Amendment right to have those documents released. Bayer argued that publishing the documents was a violation of German laws and that releasing those documents could expose Bayer employees to criminal prosecution for violation of privacy.

In the end, Herndon denied Dietrick’s motion on November 10. Herndon found that Dietrick had no First Amendment rights with regard to the release of the documents; he also indicated that “doing so would damage the discovery process in the Yaz litigation.” Herndon agreed with Bayer that the requested documentation may include trade secrets which gave the company good cause to keep them confidential.

Posted On: December 7, 2011

Study Suggests a Link Between Birth Control Pills, Prostate Cancer

If you think that you have already learned all there is to know about the side effects associated with birth control pills like Yaz, you are in for a real surprise. A new study is suggesting that women’s use of birth control pills may be linked to the increasing cases of prostate cancer developing in men.

The study, which was published on November 15, 2011, in the British Medical Journal's BMJ Open, has found that countries that contain the highest number of women taking birth control pills like Yaz have a larger number of men who have been diagnosed with prostate cancer. This is the first time researchers have discovered a link between birth control pills and prostate cancer — a link that seems highly unlikely, since birth control pills are taken by women and prostate cancer is male condition.

So far, it is not clear just how oral contraceptives like Yaz are linked to prostate cancer; however, researchers believe that the estrogen hormones that are released through urine and then recycled through the water supply could be the culprit.

“There’s reason to suggest there’s an environmental component (to prostate cancer) and not solely genetic,” said Dr. Neil Fleshner, head of urology at the University Health Network in Ontario and co-author of the study.

Studies that have been previously conducted would suggest that certain chemicals such as pesticides and medications that have been contaminating the water supply can be blamed for an increase in endocrine-related diseases, which can include different types of cancer. Fleshner agrees that the research has supplied them with more questions than answers and admits their hypothesis is based on educated guesses.

Right now men living in Europe and North America have a higher risk of developing prostate cancer and that risk increases in those countries where the use of birth control pills like Yaz is significant.

“This is just a hypothesis-generating idea," Fleshner adds. "Women should not be throwing away the pill because of this.”

Posted On: December 5, 2011

Study Suggests a Link Between Birth Control Pills, Prostate Cancer

If you think that you have already learned all there is to know about the side effects associated with birth control pills like Yaz, you are in for a real surprise. A new study is suggesting that women’s use of birth control pills may be linked to the increasing cases of prostate cancer developing in men.

The study, which was published on November 15, 2011, in the British Medical Journal's BMJ Open, has found that countries that contain the highest number of women taking birth control pills like Yaz have a larger number of men who have been diagnosed with prostate cancer. This is the first time researchers have discovered a link between birth control pills and prostate cancer — a link that seems highly unlikely, since birth control pills are taken by women and prostate cancer is male condition.

So far, it is not clear just how oral contraceptives like Yaz are linked to prostate cancer; however, researchers believe that the estrogen hormones that are released through urine and then recycled through the water supply could be the culprit.

“There’s reason to suggest there’s an environmental component (to prostate cancer) and not solely genetic,” said Dr. Neil Fleshner, head of urology at the University Health Network in Ontario and co-author of the study.

Studies that have been previously conducted would suggest that certain chemicals such as pesticides and medications that have been contaminating the water supply can be blamed for an increase in endocrine-related diseases, which can include different types of cancer. Fleshner agrees that the research has supplied them with more questions than answers and admits their hypothesis is based on educated guesses.

Right now men living in Europe and North America have a higher risk of developing prostate cancer and that risk increases in those countries where the use of birth control pills like Yaz is significant.

“This is just a hypothesis-generating idea," Fleshner adds. "Women should not be throwing away the pill because of this.”

Posted On: December 2, 2011

Yaz Stroke Lawsuit Filed in Los Angeles

On November 4 of this year, another Yaz lawsuit was filed against Bayer over a common adverse side effect that has long been linked to the controversial oral contraceptive. While blood clots and gallbladder disease have been the primary focus of many different Yaz lawsuits recently, this lawsuit focuses on strokes.

Karyn Galindo filed her November 4 lawsuit in the Superior Court in Los Angeles County amid claims that Bayer didn’t properly warn her that Yaz could cause her to suffer from a stroke. Galindo’s lawsuit specifically asks for “general and special damages, and compensation for loss of income and medical bills, both past and future.”

Strokes caused by Yaz and other contraceptives containing drospirenone are one of the more serious side effects linked to the pills, and generally are caused by another of the side effects, blood clots. Strokes occur when the blood clots reach the brain, which cuts off the brain’s oxygen supply, making the brain cells get damaged and die. Symptoms of a stroke are generally easy to see and they include a huge, sudden headache, changes in the senses and loss of balance, memory and speech.

Strokes are often fatal when not treated promptly, which is more likely in young women that are generally healthy since they often attribute stroke symptom with something less perilous. Other potentially fatal side effects linked to Yaz include the previously-mentioned blood clots, heart attacks and gallbladder disease. These side effects have caused thousands of Yaz lawsuits to be filed against Bayer, the makers of the pills. The side effects have also forced the FDA to host a meeting of an advisory committee to discuss the perils of the pills on December 8 of this year.

Contact a doctor immediately if you have experienced any of the above mentioned symptoms.