Drug Injury Attorney Blog

Since 1982, patients have taken Reglan to treat their acid reflux disorders. While the drug works at combating reflux conditions like GERD, it also causes patients to suffer from various side effects, including tardive dyskinesia. Because of these side effects, many patients have filed lawsuits. However, the amount of money they may be able to collect is completely dependent on their histories.

The first hurdle that the plaintiffs will have to jump over is proving beyond a shadow of doubt they the side effects that they suffer from are because of the Reglan alone and not some other underlying condition. The most common condition caused by Reglan is tardive dyskinesia, which causes patients to suffer from Parkinson’s-like symptoms like involuntary ticks and facial movements.

Tardive dyskinesia is also linked to various anti-psychotic drugs like Zoloft, Thorazine, Prozac and Lithium. For the patients that already suffered from psychiatric illnesses like schizophrenia or bipolar disorder, and have taken any of the medications listed above, they might have a harder time getting any settlements from their Reglan lawsuits. The reason for this is because the drug maker can argue that the other drugs are responsible for the TD and not Reglan.

It also can be argued that the other pre-existing conditions can put the patients at a higher risk of developing tardive dyskinesia. What I mean is that if a patient has been suffering from fetal alcohol syndrome, or any other type of brain disorder, then they are more likely to develop tardive dyskinesia after taking Reglan. Facts like this can dramatically lower any settlement amounts that they may be entitled to. It can even cause them to lose the verdict completely and end up with nothing at all.

An article posted on Cleveland.com which focuses on treatments for premenstrual symptoms includes treatments for premenstrual dysphoric disorder (PMDD) — and one of the treatments listed is the controversial and potentially dangerous SSRI medication Paxil.

The NetWellness column is authored by Dr. Esa M. Davis, assistant professor, Department of Family Medicine, School of Medicine, Case Western Reserve University. In it, she says that selective serotonin reuptake inhibitors (SSRIs), which include fluoxetine (Prozac, Sarafem), paroxetine (Paxil) and sertraline (Zoloft), have been successful in reducing symptoms such as fatigue, food cravings and sleep problems. These drugs are generally taken daily. But for some women with PMS, use of antidepressants may be limited to the two weeks before menstruation begins.

This seems like an extreme and potentially dangerous treatment option for an uncomfortable, but common side effect from a menstrual cycle. While regular PMS generally makes women suffer from various conditions like fatigue, bloating, cramps, headaches and nausea, moodiness and anxiety, the more serious PMDD can cause similar symptoms that are more severe. However, as uncomfortable as PMS or PMDD can be, treating the condition with more dangerous medications may be overkill, especially since SSRI medications like Paxil and Effexor have been proven to cause the exact same symptoms plus suicides and aggressive behaviour.

Current research shows that only 35-40 percent of patients' conditions improve while taking SSRI medications like Paxil versus a placebo, while 60 percent of those patients suffered from severe side effects from the drugs. While the article does warn women to talk to their doctors before taking any of the treatments mentioned in it, the words are still out there.

While the NetWellness article page states that “NetWellness provides the highest quality health information and education services created and evaluated by faculty of our partner universities,” the article doesn’t mention how dangerous some of the medications that they are mentioning as possible treatments really are. The makers of Paxil have had thousands of lawsuits filed against them amid claims that they failed to warn the public of some of Paxil’s worst side effects, which can include suicide and aggressive behaviour toward others.

There is sad news for Johnson & Johnson, as the U.S. Food and Drug Administration has approved the first generic versions of the drug giant's popular, but controversial, antibiotic Levaquin (levofloxacin). The applications to manufacture generic versions of the drug were filed by 12 different companies. Some of those companies include:

• Akorn
• Dr. Reddys Laboratories
• Mylan Pharmaceuticals
• Teva
• Aurobindo Pharma
• Glenmark Generics
• Lupin
• Wockhardt

These companies and others are now allowed to sell their versions of Levaquin in the United States, which so far has earned $ 1.45 billion for a period of 12 months ending in September, 2010. The FDA approved the drug to be sold in tablet form, as an oral solution and as an injectable solution.

"Generic drugs are important options that allow greater access to health care for Americans," said Keith Webber, Office of Pharmaceutical Science Deputy Director, FDA. "FDA-approved generic drugs must meet rigorous standards and are required to be of high quality so that people can be assured that their medications will act the same in the body as the brand-name product."

The fact that Levaquin is still so widely used after countless information has been released about the risks of tendon ruptures and injuries may be surprising enough, but even the numerous lawsuits filed against the makers of the drug will not put a dent in the billion-dollar sales. Johnson & Johnson's Levaquin is only one of many drugs whose patent expiry sets them up for generic competition; however, the competition has yet to put a drug company out of business.

Levofloxacin is currently being used to treat bacterial infections in the skin, sinus infections, as well as infections of the kidneys, bladder and prostate. The drug has also been used as a treatment for certain bacterial infections that cause bronchitis and pneumonia — it even helps treat those people who have been exposed to inhalational anthrax, says the FDA.

The FDA issued a news release on May 31 that stated it is in the process of looking over two studies that show that Yaz and Yasmin makes women 2-3 times more likely to suffer from blood clots than women who took another form of birth control.

Both of the studies were published by the British Medical Journal (BMJ) on April 21 of this year. The studies don't just say that Yaz and Yasmin cause blood clots, they also claim all other birth control pills that contain the synthetic progestin drosperinone cause increased risks of blood clots. Some of the other pills included in these study results are Beyaz, Safyral, Ocella and Zarah. Thousands of lawsuits have been filed against the makers of Yaz by women who have developed blood clots. Some women even died because of the adverse effects of the pills.

The FDA has finally taken a public stance on the pills, and they are standing by them... to a point. In fact, the FDA maintains that women should not stop taking the pills; however, they are urging them to contact their doctors immediately if they begin to experience any of the symptoms that could spell big trouble for their health. Some of the symptoms they are urging women to watch out for include “persistent leg pain, severe chest pain or sudden shortness of breath.”

The European equivalent of the FDA, the European Medicines Agency (EMA), announced that it is going to update the information and warning labels on Yaz, Yasmin and other birth control pills which contain drosperinone a few days before the FDA released that it was looking into the pills. The FDA standing behind women taking these pills may finally put to rest any questions that people have about a recall being issued.

As a dangerous drug attorney, I’ve written here before about the problems with the birth control pills Yaz and Yasmin, both of which use a newer formula than other birth control pills. So I was interested to see a decision from the Seventh U.S. Circuit Court of Appeals in a Yasmin case that put procedural issues at the forefront before anything could be decided on the merits. In Cathy M. Walton v. Bayer Corporation et al, Walton sued Bayer and other companies as well as Niemann Foods, the pharmacy where she purchased the drug.

Bayer first removed the case to federal court, arguing that Niemann was improperly included in the case so it could be in state court. The federal district judge seems to have agreed, dismissing Niemann as a defendant from the case. This allowed the case to stay in federal court. Walton then abandoned the entire case because the district judge refused to remand it to state court, failing to respond to a discovery request from the defendants. The district judge eventually dismissed the case, and Walton appealed to the Seventh Circuit.

That court scrutinized Walton’s arguments that there was no federal jurisdiction over the case. Judge Posner, writing for the majority, brushed off her principal claim that the district court should not have dismissed Niemann as a plaintiff (which allowed the case to stay in federal court). Because pharmacies are “learned intermediaries” in Illinois, and because Walton does not allege that the pharmacy knew she was especially susceptible to Yasmin’s side effects, dismissal was valid. Nor could Walton argue that all of the defendants had a common defense, it wrote, because she alleged different actions by them. Finally, the court suggested that her claim would fail in state court anyway because she would be estopped from making the opposite arguments in state court from the ones she made to the Seventh. Thus, the appeals court upheld the dismissal by the district court.

This case might look unfortunate for all Yasmin and Yaz claims, but Walton’s case made stumbles that our experienced defective drug lawyers would not make. Most importantly, Walton made failure to warn claims against the pharmacy and several Bayer-affiliated distributors, but not against the arm of Bayer that did the manufacturing. This matters because it’s manufacturers who have a legal obligation, under all states’ laws, to warn defendants about safety risks of their products. In fact, Bayer has been in trouble for failing to do this in past television advertising, and it currently faces numerous lawsuits for failure to warn individuals of the risk of blood clots from drospirenone (the active ingredient in Yaz and Yasmin). As a pharmaceutical liability attorney, I hope Walton and others who have been harmed by drospirenone can pursue their claims successfully by choosing the right courts (and counsel).

Continue reading " Seventh Circuit Upholds Dismissal of Illinois Woman’s Yasmin Lawsuit – Walton v. Bayer Corp. " »

Alarmed by all of the women suffering from severe side effects from taking Yaz and Yasmin oral contraceptives, officials from an organization called the U.S. Drug Watchdog is encouraging those women to contact them right away.

“We are horrified with the stories we are getting from women from the United States, Canada [and] Australia related to the birth control pills called Yaz, Yasmin, or the generic version Ocella," the U.S. Drug Watchdog says in a statement. "We are talking about heart attacks, strokes, pulmonary embolisms and, we fear, death. These are not old women. In most instances we are talking about women in their early twenties. Even more worrisome, in some cases the young women we are talking about are extremely athletic, and extremely fit."

The U.S. Drug Watchdog is also appealing to the women that have taken the generic version of those pills. The generic version, called Ocella, has proven that it is just as dangerous as the brand name version of Yaz and Yasmin. The organization also is saying that pill initiatives are now going to be the most important women's health initiative ever.

The reason why they are focusing on the those women who took Yaz, Yasmin or Ocella is because they were young and/or healthy before taking the pills and then suffered from heart attacks, strokes and pulmonary embolisms. They are asking women that suffered from these conditions to contact them immediately should they experience any adverse side effects at all after taking Yaz, Yasmin and Ocella.

With Yaz Bellwether lawsuits finally making it inside the courtroom, this sense of urgency may seem late to some, but many are thinking that it is better for them to be late than to never speak up at all.

With unemployment rates steadily increasing and the general population’s growing distrust of major drug companies, many consumers are now refusing to pay for brand name medications when the generic versions are offering the same level of efficacy for less money.

The Bedford Report keeps an eye on healthcare companies and provides research reports on Teva Pharmaceutical Industries Limited (makers of generic Yasmin) and Mylan Inc., the makers of Effexor. IMS Health is expecting the sales and production of brand name prescription drugs could be lowered as much as half within the next five years. This is mostly caused by patents running out on brand name meds and consumer interest in saving money on prescription drugs. And why not, since generic drugs offer you almost identical benefits, for as little as half the price? Recipes for generic drugs and brand name drugs are virtually the same where medicinal ingredients are concerned. The major variations stem from the non-medicinal ingredients in generic brands.

Many drug companies that make brand-name drugs will likely start correcting their brand name sales losses by making their own generic versions of their most popular drugs. Mylan has even gone so far as to launch a website that is dedicated to educating the public about generic drugs. More and more brand name drug companies have taken on this practical, “if you can’t beat them, join them" attitude with an eye on the bottom line.

Teva makes hundreds of generic versions of popular prescription medications like Levaquin, Yaz, Yasmin (Ocella) and Effexor (venlafaxine), making the company the largest generic drug company in the world right now. Mylan Inc. makes both generic and name brand drug “spin offs,” including Effexor and its counterpart venlafaxine, as well as others. With the expected drop in sales of brand name meds looming as their generic counterparts start selling like crazy, you will likely see more and more drug giants administering their own generic versions in the near future.

As a dangerous drug attorney, I know the newer crop of diabetes drugs has had its share of problems. So I was disappointed but not too surprised to see that the FDA has issued a new safety warning for the diabetes drug Victoza/liraglutide. Victoza is an injectable drug that is supposed to work together with diet and exercise to fight Type II diabetes, although recent research suggests it could also be used in Type I diabetes. After turning up evidence that doctors were prescribing it as a first line treatment, against recommendations, the FDA ordered manufacturer Novo Nordisk to send letters to doctors reminding them that Victoza poses an elevated risk of pancreatitis and thyroid cancer. It asked doctors to monitor Victoza patients for signs of those diseases.

Victoza was approved in early 2010, but the approval vote was split because of evidence that it increases risk of thyroid cancer in laboratory animals. The FDA allowed the drug to be approved but told doctors that it should be used only if other treatments are ineffective. Pre-approval trials found that Victoza is effective and even seemed to cause weight loss, but also increased the risk of pancreatitis and thyroid cancer over control groups. The thyroid cancer risk rose with the size of the dose and the length of treatment. The FDA did not require doctors to monitor patients for signs of thyroid problems or pancreatitis, but advised them to send patients for testing if those signs show up. Novo Nordisk was required to conduct another study and start a thyroid cancer registry.

At first glance, none of this is news — the FDA is merely reiterating its cautions. However, as a defective drug lawyer, I’m disturbed that the FDA is only reiterating those cautions after discovering that some doctors didn’t pay attention the first time. Cancer and pancreatitis are both major health problems that could kill the patient or reduce quality of life for good. Patients and doctors should be well advised about these risks before they choose Victoza over another diabetes drug. If more active patient monitoring for signs of cancer is what it takes to remind doctors of the risk, perhaps the FDA should consider ordering that monitoring. And Novo Nordisk should continue its (required) efforts to warn patients, because any attempt to hide this kind of safety information could leave it open to a defective drug lawsuit.

Continue reading " FDA Orders New Safety Information on Diabetes Drug for Cancer and Pancreatitis Risk " »

As the American military is still in combat in Afghanistan, it is not surprising that many soldiers are experiencing signs of depression and anxiety. The things that they go through every day would make anyone depressed or anxious; however, more and more frequently, the soldiers are being treating with antidepressants like Paxil and Effexor while still on tour rather than being sent home.

The Army is making an effort to treat traumatized soldiers "in theater" (where they're stationed). The reasoning behind this move is that it is believed that the soldiers will heal better if they are kept around other soldiers that know what they are going through rather than being sent home to seek treatment among strangers. This move has some people wondering if the policy is a self-serving one on the part of the military, since treating soldiers on-site lets them quickly get the soldiers back into battle. The risks that have been linked to Paxil and Effexor can also cause some of the soldiers to snap and become a danger to themselves, other soldiers and civilians. This forces the military to spend far more time monitoring the soldiers that are suffering from combat stress.

Sgt. Thomas Riordan is one of the soldiers that is currently taking Effexor. His commanders with the 3rd Squadron, 61st Cavalry of the Army's 4th Brigade Combat Team, stated that they are doing what they can as far as his treatment goes while in Afghanistan, even though Riordan initially wanted to go back home. The 4th Brigade Combat Team are right to be concerned, since Fort Carson has recently gotten a great deal of attention in the news after returned soldiers have committed a string of murders there.

Riordan believes that in-theater treatment has helped a lot of his fellow soldiers; however, he also says that it's never really done much to help him as the constant treatments just make him feel worse. While still stationed in Afghanistan, Riordan isn’t permitted to go anywhere that is outside the wire because he is not considered as stable. He also has admitted to having no friends in his unit.

With the war posing an obvious reason for depression and anxiety, it can post the question of just how dangerous Paxil and Effexor can be for these soldiers — especially with recent studies pointing out that antidepressants may not even work. One thing is certain: These drugs can make ordinary people want to kill. So just how damaging can these side effects be to trained soldiers? Even Terri Tanielian, a military health policy researcher with the RAND Corp. think tank, can’t answer that question with authority.

"There's not been a lot of studies on those types of interventions," Tanielian says. "There isn't necessarily a magic formula that says who's going to go back and be okay and who isn't."

A few months ago, a research paper released by the Journal of the American Academy of Child and Adolescent Academy (JAACAP) concluded that Paxil was “generally well-tolerated and effective for major depression in adolescents.” While the paper since has been proven wrong by more recent research, the JAACAP was bombarded with requests for a retraction. The retraction has finally been printed, thanks to the efforts of one crusading politician.

Back in February, I wrote a blog post where it was noted that “as early as last June, the journal had been mentioned in as many as 200 other articles attempting to argue that Paxil remains an effective treatment for youngsters under 18 to treat depression.” At the time, it was noted that academics Jon Jureidini, associate professor of psychiatry at the University of Adelaide, and Leemon McHenry, lecturer in philosophy at California State University, had asked the journal to retract the article and the journal has finally conceded. The men’s opinions behind the retraction request at the time were best summed up when they said, “The JACAAP was the most important instrument through which the results of Study 329 were misrepresented to physicians.”

The study gained prominence two years ago; however, its contents came under suspicion after UK investigations by regulators and the former New York Attorney General, as well as pending lawsuits, charged that GlaxoSmithKline hid the risks that were associated with Paxil.

One of the 22 co-authors of the report was Stan Kutcher, a doctor that is now running for the parliament in Canada. It was The Coast newspaper (Nova Scotia and Halifax) that first mentioned the politician’s involvement in the retraction. The article quoted Alison Bass, former writer at The Boston Globe (and author of “Side Effects,” which is about this entire ordeal) as saying, “They essentially distorted the outcome measures, and essentially lied. They also omitted information about adolescents who became suicidal on Paxil and withdrew from the study. And they miscoded those teenagers — they said they were non-compliant, when in fact they had been withdrawn from the study because they became suicidal.”

That quote by Bass apparently is what caused the apology to run in the paper. The full story has since been removed from The Coast’s website.

A woman from Nelson has overdosed on venlafaxine, which also goes by the brand name Effexor, only days after the death of her husband.

Denise Sherwin, 55, was taking Effexor to treat severe depression and anxiety. At an inquest into her death, it was discovered that Denise died of an overdose of Effexor. According to the woman’s family, Denise was extremely down after the death of her husband, who they said had been her “rock.” The inquest was held by Burnley Coroner’s Court.

Aside from Depression and anxiety, Denise also suffered from a heart condition and relied on her husband to help her in overseeing her medication. Denise’s husband kept her medication locked inside of a briefcase. During the post-mortem exam of her body, pathologist Dr. Zuhair Twaij stated that Denise’s dosage of pills was high enough to have caused poisoning. No one knows how Denise got her hands on the fatal number of tablets that she took.

Denise’s sister Valerie Dawson stated that the family all tried to help Denise after husband died and also helped her make the funeral arrangements.

“It was a terrible shock for her and she did struggle to cope," Dawson said. "All she kept asking was to get her through this. The anxiety was so bad. It was just a normal day. She was only on her own for about 10 minutes in the kitchen. She said she had spilt some water and then within a split second went into a fit.”

“Only days before, her husband, who had been her rock, died of natural causes," the coroner said. "She was prescribed venlafaxine for her depression and anxiety and by some means had taken too many of these which sent her into a fit from which she sadly never recovered. I dismiss any suggestion that she deliberately took her own life. She died from venlafaxine which was prescribed to her.”

While this is a tragic story, it also shows how dangerous SSRI drugs like Effexor can be when they are taken to extreme. It may also serve as a warning to potential patients of how one of the severe side effects of taking the drug includes suicidal thoughts and behavior. While it is not known if the drugs caused Denise to commit suicide, it is clear that Effexor played a big role in her death.

The federal judge who currently is presiding over thousands of lawsuits against Levaquin has decided that it is ok to release confidential company documents from Johnson & Johnson that were previously admitted in the John Schedin Levaquin lawsuit.

Schedin’s Levaquin case awarded him a verdict of $1.8 million in compensatory and punitive damages after it was decided that J&J hid the side effects that were associated with the popular antibiotic —specifically tendon ruptures. J&J is appealing this verdict.

Levaquin (levofloxacin) is a popular yet controversial antibiotic that is manufactured by Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. However, it has been linked to tendon damage and ruptures, resulting in thousands of lawsuits. So far, Johnson & Johnson is currently facing about 2,600 lawsuits against Levaquin alone, and was recently ranked as the company that is facing the highest number of lawsuits in the State of New Jersey.

Schedin’s was the first Levaquin trial to reach a courtroom and get a verdict. The documents from the Schedin trial were sealed after the case was closed. New plaintiffs are now asking that those 115 documents be opened and the protective order against them lifted. Johnson & Johnson’s efforts to prevent the documents from becoming public were refuted by Judge Tunheim when it was ordered last week that they be released, along with the punitive damages order that mentioned some of them. Tunheim’s reasoning behind this decision is based on the judge believing that the drug giant didn’t meet the burden that is necessary in overcoming the “presumption in favor of publication of evidence submitted at trial.”

The court determined that the right for public access to trial documents outweighs the company’s concerns, and that the drug manufacturer failed to give the court sufficient reason to keep the documents secret.

One of Johnson & Johnson’s arguments claimed that the documents were harmful to the company and could cause them to have to face “adverse publicity” that could cause a bias in future lawsuits against them. The judge argued that J&J already accomplished that themselves when they lost the Schedin case.

As a pharmaceutical liability attorney, I’m always interested in news about over-the-counter drugs because so many millions of people take and trust those drugs. However, a June 3 story from ABC News reminded us that those drugs aren’t always worthy of our trust. The article said a Philadelphia jury has awarded $10 million to Brianna Maya of Tennessee, who was blinded and suffered severe burns after she developed Stevens-Johnson syndrome and toxic epidermic necrolysis syndrome in reaction to the children’s Motrin her pediatrician had recommended. Her parents successfully sued drug maker Johnson & Johnson/McNeil because the company failed to warn parents about the risks.

Maya was three in 2000, when she developed a high fever. Her parents followed the doctor’s instructions to alternate children’s Motrin and children’s Tylenol and followed the package directions. But unlike most children, Maya had a bad reaction that included a skin rash, redness around the eyes, and eventually, burns inside and outside her body and oxygen deprivation. Now 13, she is blinded in one eye, suffers seizures and recurring infections, and will never be able to have ordinary sexual intercourse or children. In December of 2005, the FDA required over-the-counter drugs in Motrin’s category (nonsteroidal anti-inflammatory drugs like ibuprofin) to add information about symptoms of an “allergic reaction” without mentioning SJS or TENS by name.

Maya’s mother, Alicia Maya Donaldson, said she’d prefer more information so that patients can make well-informed decisions. I strongly agree with this. As a dangerous drug lawyer, I work frequently with patients who used drugs exactly as directed and still got sick. While it’s not always possible to predict an allergic reaction, warning patients about the risk of one allows them to identify the problem and get help quickly, hopefully minimizing the damage. At least two other people hurt by SJS have filed similar lawsuits; one, in California, is pending. Millions of Americans take ibuprofin and other NSAIDs, so even if a reaction is rare, it’s not at all impossible — and it chances victims’ lives forever.

Continue reading " Jury Awards $10 Million to Family of Girl Injured by Rare Reaction to Children’s Motrin " »

There is no doubt that mysterious forces in recent decades have paved the way for psychologists and psychiatrists to have lengthened the list of psychological disorders. In addition, it takes a lot less effort for them to diagnose these disorders than it did before. One book sheds light on this phenomenon and forces its readers to wonder if these increased and easily-labeled disorders are a produce of drug company actions.

The book, Shyness: How Normal Behavior Became a Sickness (Yale University Press, 2007), is written by Christopher Lane. In it, the author tells us that all of these psychiatric labels are driven primarily by drug companies and, to a degree, even a personal intolerance toward people with different personalities. He notes that while it is common for the American establishment to preach about the benefits of cultural diversity, it also requires citizens to follow a basic and collective social norm if they are to fit in with everyone else. According to Lane, possessing a nonconforming personality trait that used to be seen as “eccentric” now qualifies as a personality disorder.

Lane's assessment doesn’t seem out of reach considering the record numbers of people taking prescription medications these days. One study that was conducted 2 years ago shows that 10 percent of the American population was taking antidepressants like Paxil and Effexor. In fact, Lane’s book takes a great deal of time talking about Paxil. When you consider the side effects associated with medications like Paxil and Effexor, the book does raise an interesting point.

With doctors more willing than ever to associate every personality quirk with some sort of disorder that requires medication, are the only people who benefit the owners of the drug companies that make them? Lawsuits are popping up by the millions because of the harmful effects that these drugs are having on patients, and yet more and more disorders continue to be pushed on the public that require drugs to treat. The fact is that people are dying from all of these medications and drug companies keep pushing more drugs onto the marketplace. Manufacturers are willing to spend millions in lawsuits because in the end, they are profiting billions in sales. If nothing else, Lane’s book may be a wake-up call for the public.

While the FDA doesn’t acknowledge a difference between brand-name antidepressants like Paxil and generic versions, some doctors warn that making the switch could cause a relapse in depression symptoms.

Dr. Jonathan Edward Alpert, chief of clinical psychiatry at Massachusetts General Hospital in Boston, says that there hasn’t been a “systematic problem” associated with the generic versions of antidepressants.

“In general they’ve been very good," he says, before warning that "doctors need to be vigilant.”

Alpert is referring to the fact that sometimes patients experience a return of the old sadness, anxiety and feelings of helplessness that the name brands like Paxil helped to get rid of. Other times, the patients will get an unusual jolt of the exact same side effects from the generic versions as they got while first taking the name brand. That may be cause for patients not to make the switch to generics at all.

During one study, a group of Canadian psychiatrists mentioned seven cases where the depressed patients were taking Paxil or Celexa. When the patients switched to the generic versions, paroxetine and citalopram, the patients experienced a relapse of their depression. Some of the patients reported that they were suffering from recurrences of the side effects that they had when they switched to generics. At least one of the patients said that the depression came back after switching.

What makes the generic versions different may be what causes the symptoms. While generic versions are pretty much made with the same medicinal ingredients, there are a few differences. The FDA requires that generic drug offer blood levels of a drug that is 80 to 125 percent of the brand name version's. However, the generic antidepressant may be made with different non-active ingredients than the name brands. These are mostly composed of the outer coating that surrounds the pills, and this can cause changes in how fast the pill gets into the system.

Of this, Dr. Alpert says, “In general, generics have been as effective as brand-name antidepressants. And they’re less expensive, so it makes sense to use them, but the differences for a given individual might be enough to throw off that individual’s response or to cause additional side effects.”

In this sense, cheaper may not necessarily be better.

I’ve written here several times, from my perspective as a dangerous drug attorney, about the unreasonable risks posed by birth control pills containing drospirenone. The pills, whose most famous commercial names are Yaz and Yasmin, have been criticized for an alleged increased risk of life-threatening blood clots compared to older birth control methods. Now, the FDA announced May 31 that it will conduct a new safety review of birth control pills containing drospirenone, in response to two recently published studies showing a dramatic increase in that risk. Those studies, published in the online British Medical Journal, have also led European regulators to update the prescribing information for Yaz, Yasmin and their generics, and Health Canada announced that it too is reviewing the pills’ safety.

Venous thromboembolism is the scientific name for blood clots deep in the legs, which can be life-threatening if they break away and move through the body to the lungs, where they can cause sudden death through lack of blood flow, or shortness of breath, rapid heart rate and other serious symptoms. All birth control pills carry at least some risk of veinous thromboembolism, but the two studies, published in late April, found that women 15-44 were two to three times more likely to develop venous thromboembolism on drosperinone than they were with pills containing levonorgestrel, an older synthetic hormone. That was true even after the scientists controlled the data for other risk factors for blood clots.

These are not the first studies connecting drospirenone with blood clots, but they are the newest and most serious evidence. Previously, two 2009 studies made that connection, but two other studies found no increased risk compared to levonorgestrel or other synthetic hormones. The FDA added this information to its prescribing information requirements, but the new studies may spur it to add more serious warnings. The older studies also led to thousands of lawsuits against Bayer, the maker of Yaz and Yasmine, for failure to warn patients about the risks, misleading marketing and more.

As a defective prescription drug lawyer, I hope the FDA takes this new information as seriously as it warrants. Blood clots can kill, and at least some evidence suggests that they can kill people without obvious risk factors who are taking drospirenone. As I wrote last month, a New Jersey woman is suing Bayer over the death of her daughter, a college freshman who died suddenly of a fatal blood clot at the age of 18 — half the age of women considered at higher risk. The young woman had been described Yaz for acne control. Bayer maintains that the risk of blood clots is no higher with its drug than with other birth control, but the scientific evidence increasingly says otherwise. I hope the FDA places patient safety first when it decides how strong the warnings on the drugs’ labels should be.

Continue reading " FDA Announces Safety Review of Yaz and Yasmin After Studies Show Blood Clot Risk " »

Thousands of patients that have taken the acid reflux drug Reglan — and suffered from the adverse side effects that are associated with the drug, as well. What many people don’t know is that some of those side effects are the same as those experienced by patients taking antipsychotic medications.

With claims that the drug makers didn’t properly warn the patients of the potential for them to develop severe side effects like tardive dyskinesia, thousands of lawsuits have been filed. The Judicial Panel on Multidistrict Litigation (JPML) denied a request to have all of the federal cases consolidated into an MDL, although 1,000 lawsuits have been consolidated in New Jersey which is where the makers of the drug is based. Tardive dyskinesia the main side effect that is suffered by the majority of plaintiffs in the lawsuits. TD is characterized by Parkinson’s-like symptoms. This side effect is commonly seen in patients taking antipsychotic medications.

One difference between Reglan and antipsychotics is that Reglan/metoclopramide is used specifically used to treat gastrointestinal disorders such as gastric reflux (GERD) and gastric stasis, whereas antipsychotics are used to treat mental disorders such as schizophrenia. Reglan is a gastrointestinal stimulant; it works because it increases peristalsis of the duodenum and jejunum. These are the two parts of your small intestine. The drug helps to make the body's gastric contractions stronger. Reglan also helps the pyloric sphincter relax so that the valve that is used to connect the small intestines to the stomach can get food to pass through the upper GI tract a bit faster.

Even though Reglan and antipsychotics often result in the same side effects, they are not used to treat the same disorders. Recently, the FDA has enforced label changes on Reglan that alert patients to avoid taking the drug for periods that are no longer than 12 weeks after it became clear that many patients had been prescribed the drug for periods as long as years.