Drug Injury Attorney Blog

Yet another young woman has died with her mother blaming the controversial birth control pill Yaz for her death.

Michelle Phleger, age 18, passed away on September 24, 2010. The girl was taking Yaz and suffered from a pulmonary embolism which is a well-known side effect of the drug. The girl’s pulmonary embolism was caused by a blood clot rising in her lungs; this also can cause sufferers to go into cardiac arrest. The girl’s mother has since filed a lawsuit against the makers of Yaz, Bayer, on May 10, 2011. She wants to hold Bayer responsible for her daughter’s demise.

Michelle’s mother, Joan Cummins, did make a statement to the media about her daughter’s death.

"One day she was a freshman at college so full of hope and promise and the next she was gone," Cummins said. "I can only hope that by publicizing what happened to Michelle, I can keep another family from having to go through this."

Right now, there are as many as 7,000 cases against Yaz and Yasmin from women who are claiming that they didn’t get enough warning of the dangerous side effects that are caused by the popular birth control pills. At least 50 of those cases were filed on behalf of young women who died from complications that arose as a result of taking them.

What makes Yaz and Yasmin stand out among other birth control pills is the combination of drosperinone (a synthetic progestin) and ethinyl. The drosperinone is effective at preventing unwanted pregnancies but it also comes with severe side effects such as blood clots. The drosperinone also includes some positive benefits in that it has been shown to improve skin acne and even lessen severe PMS symptoms. In fact, it was marketed as such, but the ad campaign was pulled by the FDA due to the many women who were suffering from adverse side effects.

A just-released study says that Paxil, when taken with the popular cholesterol medication Pravachol, can cause a significantly high rise in blood sugar levels. The results of this study will likely mean the most to diabetics, whose sugar levels are already dangerously high.

"This interaction may affect as many as 1 million Americans who might be on these two drugs and who are getting a bump in their blood glucose that may be unnecessary," says the lead researcher involved in the study, Dr. Russ Altman, a professor of bioengineering, genetics and medicine at Stanford University. "It's possible that the blood sugar spike triggered a diagnosis of type 2 diabetes in some patients, and we might have been able to avoid that diagnosis if they hadn't been on these drugs."

While neither drug has raised blood sugar on its own, researchers involved in this study made it clear that they can’t explain yet just how the combination causes that effect. It should also be noted that other antidepressants mixed with cholesterol-lowering drugs don’t have that effect, either. This study was published online May 25 in Clinical Pharmacology and Therapeutics. Researchers used data mining to get the information that they needed for their study.

Data mining involves researchers sifting through large databases with the hopes of finding information that can help them mix their data in a new way. For this study, Altman's team used information collected from the U.S. Food and Drug Administration's Adverse Event Reporting System, as well as information from Stanford, Harvard and Vanderbilt Universities, to identify the links that normally wouldn’t be put together by physicians who treat the patients. In looking at combined data (that doctors aren’t privy to unless they treat every patient included in the database), the researchers were able to discover 135 non-diabetic patients that were taking both Paxil and Pravachol whose blood sugar rose to 19 milligrams per deciliter once they began their treatment. They also found 104 diabetics whose blood sugar rose on average of average of 48 mg/dl when they were taking the drugs together.

The assignment of who will preside over approximately 1,000 Reglan lawsuits has been announced: Judge Carol E. Higbee of the New Jersey Superior Court will be overseeing those cases. Higbee will preside over the majority of the Reglan cases that have been consolidated to the New Jersey court system.

While Judge Higbee is based in Atlantic City, N.J., she brings to the table a great deal of experience with mass Reglan lawsuits. The Reglan cases have been being filed for nearly two decades because of the drug’s link to serious side effects, including tardive dyskinesia. That is not the type of side effect that you would think of getting from a gastrointestinal drug, especially since there are milder treatments on the market that are nearly symptom-free.

Reglan was one of the most widely-prescribed medications to treat patient gastrointestinal problems including GERD before the side effects began to take precedence over the benefits of the drug. However, it may not be all the doctors’ faults for prescribing it since most of the lawsuits are aimed at the makers of Reglan, Wyeth, for not properly giving warning about the risks.

Reglan (metoclopramide) was first given to the American public in 1982; it wasn’t until 2009 that the FDA finally forced Wyeth to include proper warnings about the side effects like tardive dyskinesia on the label. Since it took the FDA so long, it is fair to say that the agency at least partially responsible; however, manufacturers and distributors of Reglan are the only parties being held liable in courtrooms.

At this point, Judge Higbee is only overseeing the earliest stages of pretrial coordination and discovery. It isn’t expected that the first lawsuit will reach the courtroom until later on in the year. It will happen in a New Jersey Court.

Our law firm has kept an eye on reports about the diabetes drug Avandia (rosiglitazone) and its relatives for several years, since studies began connecting them to a significantly increased risk of heart attacks. So as a dangerous drug attorney, I was very pleased to see the FDA’s announcement last week that it would sharply limit patients’ access to Avandia because of its cardiovascular risks. According to a May 19 article from HealthDay News, the FDA will no longer allow retail pharmacy sale of Avandia starting in November. Instead, patients taking Avandia will have to enroll in a special program qualifying them to receive it by mail-order. Echoing a previous safety decision, the FDA will limit the pool of people eligible for a prescription and require them to acknowledge receiving information about the risks.

Avandia has been in trouble since at least 2007, when an analysis of multiple studies concluded that patients’ risk of a heart attack could be as much as 43 percent higher when taking the drug. It has also been linked to increased risk of stroke and other cardiovascular problems. To make matters worse, the drug’s maker, GlaxoSmithKline, has been accused in Congress of intentionally suppressing information about the risks. In 2010, the FDA moved to restrict Avandia’s sale to only those patients who had the risks explained to them and agreed in writing that they understood. However, the new move restricting Avandia to mail-order pharmacies is expected to make the drug very rarely prescribed. Dr. Steven Nissen, the author of the 2007 meta-study, told HealthDay that “It’s like a decade-long nightmare coming to an end” because “virtually no one will be able to get it.”

As a defective drug lawyer, I agree with Nissen that this is great news for patient safety. The results of independent studies on Avandia have not been mixed; several studies have found results similar to Nissen’s. In fact, the drug is already banned in the European Union and New Zealand for safety reasons. And the manufacturer has already settled thousands of Avandia injury lawsuits. However, I also agree with safety advocates that this action by the FDA comes too late and more slowly than it should have, given the elevated risk of death from taking Avandia. As HealthDay pointed out, the other drug in the same class, Actos (pioglitazone), doesn’t show nearly the same heart health risks, making it a safer alternative. With an alternative clearly available, it’s disappointing that the FDA is taking 14 months between deciding Avandia is unsafe and curtailing its availability.

Continue reading " FDA Dramatically Curtails Availability of Avandia After Studies Show Heart Risks " »

Bayer tried to prevent the media from bashing its blockbuster birth control pills Yaz and Yasmin by taking a Swiss television station to court — but was denied a victory.

With Bayer's suit falling on deaf ears in the European court, the company isn’t getting the kind of sympathy it was hoping for. The appeals court rejected the drug giant’s request that the television station be punished for reporting about the 190 deaths that occurred because of side effects associated with Yaz and Yasmin. The television station got the information on the deaths from the FDA's database of adverse reactions. The database included information that is confirmed and unconfirmed about various reports on different drugs including Yaz and Yasmin.

Bayer’s main argument in the court was that the information that the drug database contains didn’t give a proper account of how dangerous Yaz really is. Regardless of how accurate the information in the database is, thousands of women have filed lawsuits against the drug giant because of serious side effects they suffered while taking the contraceptives.

While it is known that all birth control pills can cause blood clots, it is the ethinyl estradiol and drospirenone in Yaz and Yasmin that studies have shown increases the risk even more than regular birth control pills. This once “wonder pill” has been proven to hold more risks than benefits in the long run. Some of those risks include heart attacks, strokes, blood clots, pulmonary embolisms, gallbladder disease and sudden death.

Bayer is stubbornly sticking by Yaz and Yasmin. Since it can’t fight the claims made against the pills in the U.S., Bayer thought it might be able to halt reports on Swiss TV by saying that the station’s report about the deaths were manipulative. Bayer also claimed that because the station aired the story, it was in breach of the “statutory requirement of factual accuracy.” Bayer lost both its original court case and its appeal in federal court.

So far, there have been thousands of Reglan lawsuits filed — so many, in fact, that they have been consolidated in a New Jersey court. This is called centralized management, not to be confused with multidistrict litigation (MDL) or a real class action. Still, centralized litigation offers the same expediency in dealing with the many lawsuits.

The Judicial Panel on Multidistrict Litigation (JPML) that ruled in favor of the centralized litigation had many reasons for denying the lawyers the MDL that they requested. This panel consisted of seven federal officials of high rank. They ruled that MDL was just not the right choice with regards to the Reglan lawsuits. One of the reasons they decided this was because a lot of the litigation that was to be consolidated was “substantially advanced,” in that five out of the eleven lawsuits began many years before the JPML decision.

The panel also decided that since there was no single defendant involved in the case, it would be too difficult to consolidate into an MDL. While Schwarz Pharma owns the patent on the brand-name version of Reglan, there are many companies that make and sell the generic version. The last reason why the Reglan lawsuits were centralized instead of handled as an MDL is because the JPML decided that a great deal of the pre-trial workup that is usually done for an MDL had happened already, so it would be a waste of resources to repeat it.

“Metoclopramide litigation has a lengthy history," the chairman of the JPML, Judge J. Frederick Motz, wrote when denying the transfer. "The record indicates that a significant amount of the common discovery has already taken place.”

While this may force the litigation to take longer, there were just too many reasons not to funnel the lawsuits into a single federal court. Thousands of Reglan lawsuits are expected to be tried before manufacturers see the end in sight.

Our law firm has closely followed the problems associated with the birth control pills Yaz and Yasmin, both of which contain the active ingredient drospirenone. So as a dangerous drug attorney, I was not surprised to see another lawsuit filed in the United States by a family claiming Yaz caused a fatal blood clot in a young woman of 18. According to the Lehigh Valley Express-Times, Joan Cummins of Hackettstown, N.J. sued Bayer, the manufacturer of Yaz and Yasmin, May 10. Her suit follows thousands of others in North America, alleging that Bayer should have recalled the drug, has advertised it misleadingly and failed to warn doctors and patients about the risks. Many claims have been consolidated into a class-action lawsuit in Illinois.

Cummins is suing over the death of her daughter, Michelle Pfleger, who was just 18 and a college freshman at Elon University in North Carolina. Pfleger collapsed on her way to a class in September, and an autopsy report found that she had a pulmonary thromboemboli — a blood clot in her lung — that caused cardiac arrest. She had been prescribed Yaz to control acne. Cummins alleges that Bayer consciously decided not to warn patients and doctors of the risk of death and serious injury from blood clots.

All oral contraceptives carry some increased risk of blood clotting, but at least six studies have turned up an increased risk of clots for patients taking birth control containing drospirenone. As a result, Yaz and Yasmin, and their newer generics, got more safety warnings on the labels in 2010. More recently, in April, two studies published in the online version of the British Medical Journal confirmed that connection with a study of U.S. prescription data. Even after women with other risk factors for thrombosis were ruled out — which previous studies hadn’t done — the researchers still found a greater risk of blood clots compared to women taking pills with the older levonorgestrel. Bayer has also been disciplined by the FDA for advertisements that overstated the drug’s uses and played down its risks.

As a defective prescription drug lawyer, I’m pleased that this story is getting so much media attention. Cummins is far from the first person to file a Yaz/Yasmin lawsuit, but perhaps her sad and compelling story will point widespread attention toward the risks of these drugs. Despite the six studies, FDA action and thousands of lawsuits, Bayer has consistently denied that the risk from its drugs is higher than the risk from other birth control pills. But when a presumably healthy 18-year-old develops a fatal blood clot after taking Yaz, it’s worth asking whether it’s safe to use. Many individual families are fighting their way through the courts to address the issue, but I hope the FDA takes appropriate action on these studies as well.

Continue reading " Another Yaz Lawsuit Filed by Mother of College Freshman Who Died of Blood Clot " »

A new generic version of the popular and controversial birth control pill Yaz has finally hit the market. This generic version is called Loryna, and it is manufactured by the company called Sandoz.

The generic version of Yaz was recently approved by the Food and Drug Administration (FDA) despite the thousands of lawsuits against the makers of the brand name version. This copy is the second generic Yaz that will be widely available in the U.S. The first generic version was called Gianvi, and was launched by Teva Pharmaceuticals in June 2010. While Loryna won’t actually hit the shelves for a couple more weeks, it is expected to cause the same serious side effects that have plagued Yaz and Yasmin.

Loryna also contains the same combination of synthetic hormones like drospirenone and ethinyl estradiol. The drug will also be given in the exact same way under the same dosages as the name brand version of Yaz. It is more than likely that the generic version will cause such severe side effects as blood clots that can lead to strokes, pulmonary embolism and deep vein thrombosis, as well as gallbladder disease and even death.

There are many lawsuits that have been filed against other birth control pills that are similar to Yaz in their make ups as well. Yasmin, which is very much like Yaz and also contains drosperinone, has been named in hundreds of lawsuits. Some other oral contraceptives that have been named in lawsuits include Ocella and Zarah, which are both generic versions of Yasmin.

Safyral and Beyaz, which are being touted by Bayer as the healthier oral contraceptives that were made to include metafolin (folic acid) as helping reduce the rate of birth defects for babies of mother who get pregnant immediately after taking the pills, also have been included in the Yasmin lawsuits.

The sales of Yaz may be in a slump right now due to all of the lawsuits against Bayer over claims of the increased risk of severe side effects — but the profits are still rising, according to current reports.

At the end of April, Bayer raised its overall forecast because the company’s commodity prices got a big boost, and this increased the sales of the company’s crop-science products. During Bayer’s announcement, company representatives stated that profits rose as much as 8.4 percent ($1.01 billion) and that the company's total sales managed to get as high as $14 billion.

All of Bayer’s success is astounding considering that the company has been losing sales to generic counterparts. They have also been battling against negative press thanks to the thousands of Yaz lawsuits amid claims that the company purposely hid the drug’s side effects and illegally marketed Yaz’s off-label uses.

In the first quarter of this year, Bayer’s pharmaceutical sales made as much as $3.9 billion, which was a 4.7 percent increase. In a letter the company wrote to the stockholders, it said American Yaz sales “declined significantly” in the first quarter. Yaz is the company’s second-best seller, surpassed only by the drug Betaseron which is used as a treatment for multiple sclerosis.

Even with generic competition, Bayer is likely losing sales because of the bad press and lawsuits. So far, more than 7,000 women have filed a Yaz lawsuit. So many of them, in fact, that the litigations have been consolidated in a multi-district litigation in Illinois. The cases will be heard by Judge David R. Herndon. Depositions currently are being taken and the cases are not expected to reach a courtroom until later on this year.

These days, the courts are slowly being inundated with cases that involve generic drug manufacturers. Some of these cases involve the acid reflux drug Reglan.

The courts are hearing the case of two women whose cases have been consolidated, Gladys Mensing and Julie DeMahy. Both women have used metoclopramide for years between the years of 2001-2006 to treat sinus infections and acid reflux. Both women were diagnosed with tardive dyskinesia as a result of that prolonged use. The time periods that those women used generic Reglan are important since the brand name version of Reglan didn't receive a proper black box warning against prolonged use until 2009.

In 2009, the FDA included warnings on the label of Reglan that stipulated Reglan use should be limited to a period no longer than 12 weeks because of the drug's increased risk to patients developing TD. Before that, generic drug makers like Pliva Inc. (part of a lawsuit being heard by the Supreme Court) were prohibited by federal laws from including information from the name brand version on their labels — even though state laws required this information to be included in the generic labels.

This technicality of dueling laws may be just what the drug maker ordered in clearing Pliva and other generic drug manufacturers from liability. However, the debate is one that is long overdue in the court system and should prove to be a major turning point in the future on how drug manufacturers and pharmaceutical companies communicate drug risks.

Support for the plaintiffs is being expressed by the American Medical Association, 42 states and even President Obama's Administration. The decision in the case of Mensing v. Pliva Inc. will be decided by the Supreme Court in June and there is no doubt that almost everyone will be listening. With so much popular support for the plaintiffs and legal technicalities favoring the drug makers, it is no wonder why the court is currently split.

As a defective drug attorney, I’ve written here several times about the issue of using atypical antipsychotic drugs for off-label treatment of dementia patients. The FDA has not approved this class of drugs for dementia; they are approved for mental illness, and include name brands such as Risperdal (risperidone), Zyprexa (olanzapine) and Seroquel (quetiapine). However, despite a growing body of research showing they have dangerous side effects, particularly in the elderly, and a black box warning on the subject, they have become widely used to control the behavior of dementia patients. Now, a report from the Department of Health and Human Services has found that the vast majority of atypical antipsychotic prescriptions filled under Medicare — 88 percent — are for off-label use with dementia.

According to a May 11 story from NPR’s Shots blog, HHS’s Inspector General’s office reviewed Medicare data to reach that conclusion. The Inspector General also found that 14 percent of nursing home residents made claims for atypical antipsychotics. That’s a legal problem because a little more than half of the claims should not have been covered in the first place, wrote the Inspector General in a May 9 opinion piece. Medicare rules require that drugs be approved only for medically accepted indications and documented as actually provided to the patients. Furthermore, one in five patients received the drugs in ways that violated Medicare rules, including doses that were too high or medication courses that went on too long.

But perhaps even more important, the Inspector General noted, is the fact that atypical antipsychotics have dangerous metabolic side effects that are particularly pronounced in the elderly dementia patients who frequently get the drugs. Among other things, the drugs raise the risk of stroke, cardiovascular disease and metabolic disorders including diabetes and insulin resistance. This has led the FDA to order a black box warning stating saying atypical antipsychotics are associated with an increased risk of death in dementia patients. However, the article said, their use is still widespread, in part because manufacturers of these drugs have illegally but aggressively marketed them for off-label purposes. Multiple manufacturers have pleaded guilty or settled with the government over these charges, including one that intentionally withheld evidence that Seroquel causes diabetes.

These results concern me as a dangerous drug lawyer because they show how many dementia patients are still getting inappropriate and potentially dangerous drugs — on the federal government’s dime. Scientists have known for several years that atypical antipsychotics pose unacceptable risk of death in dementia patients, and at least one study showed prescriptions falling as a result. However, this report suggests that Medicare providers have not gotten the message, particularly those in nursing homes. Nursing homes like antipsychotics even though they’re inappropriate because they sedate dementia patients, who can be hard to control. But however convenient this is for caregivers, it poses an unacceptable risk of killing the patient.

Continue reading " Federal Audit of Medicare Use Finds Dangerous Overuse of Atypical Antipsychotics " »

Last week, Wyeth (a subsidiary of Pfizer) reached a settlement with Indian drug makers, Dr. Reddy’s Labs Ltd., over a generic version of Effexor XR, which is an extended release version of the popular antidepressant medication.

Wyeth had many different lawsuits filed against various generic drug makers, and this settlement is said to be the last one Wyeth will reach in its bid to keep a tight grip on the worldwide market for venlafaxine. Wyeth has already reached a settlement agreement with Orchid Chemicals earlier this month. Wyeth has also reached agreements with other companies as well, including Sun Pharma, Lupin, Aurobindo Pharma, Ranbaxy and Teva.

Right now, these generic drug firms are allowed to sell their versions of Effexor before Effexor actually reaches its patent expiry date as long as they successfully challenged the patents of the inventor in accordance with current U.S. patent laws. So far neither Wyeth nor Dr. Reddy’s has disclosed the terms of their settlement, but Dr. Reddy’s vice chairman and chief executive officer G.V. Prasad has said the settlement is “not significant. All firms involved in this litigation have settled,” to the Financial Chronicle.

The spokesperson from Pfizer also stated, "We can confirm that our Wyeth subsidiary has reached an agreement with Dr. Reddy's Laboratories that will enable a generic version of Effexor XR to enter the market on June 1, 2011. Terms of the agreement are confidential. It’s important to note that Wyeth previously had reached agreements with other generic manufacturers regarding Effexor XR."

One senior official for an Indian pharmaceutical company that previously reached a settlement with Wyeth has said, “Given the large number of generic firms that had challenged the patents of Wyeth over Effexor and the series of settlements Wyeth had entered into, the average settlement amount is insignificant, mostly slightly over the litigation charges incurred by the drug firms.”

The patents for Effexor will expire in 2017, but generic drug companies have been vying to sell their versions of the popular antidepressant. Previous settlements with Wyeth were under better terms than the most recent settlements, but with the drug’s money-making potential, drug makers just want to make as much money as they can before time runs out. The thousands of lawsuits against Effexor’s side effects seem to be a mere side note.

With all of the Levaquin lawsuits waiting to go on trial over the severe side effects of the popular antibiotic, patients may be ready to consider talking to their doctors about alternatives.

Side effects like tendonitis and tendon ruptures of the Achilles, rotator cuff and even biceps, hand and thumb have caused many patients to sue the makers of Levaquin, Ortho-McNeil. But are there better alternatives out there that can help patients?

Levaquin is used to treat various infections including sinus infections, urinary tract infections and respiratory infections. Levaquin, or levofloxacin, is a part of a class of antibiotics known as fluoroquinolones. They are synthetic in design, which basically means that they are made by man in a lab, bactericidal and broad spectrum. The drug works because it stops the bacteria’s ability to duplicate or reproduce its DNA. This is how bacteria divide. However, there are other fluoroquinolone antibiotics available today, including:

• Cipro
• Avelox
• Penetrex
• Noroxin
• Floxin

These antibiotics are actually in the same class as Levaquin — and because of that, they also pose the same risks. Studies have proven, however, that more than 60 percent of tendon ruptures that are related to these antibiotics are the result of using Levaquin. What this means is that Levaquin by far holds the higher risk of patients suffering tendon ruptures than all of the other similar medications combined. This fact naturally makes one assume that these other flouroquinolone antibiotics are safer in comparison.

If you are suffering from an infection and you want to avoid suffering from common Levaquin side effects, you should talk to your doctor about alternatives like those mentioned above. While they cannot guarantee that you will not suffer from severe side effects, these other medications could lower your chances; in the end, that is better than nothing.

In yet another MDL Reglan lawsuit that was first filed back in March in Illinois, the plaintiffs have grown to a staggering 1,000 in the case titled Agresta v. Walgreens.

This MDL is the result of 70 plaintiffs that have consolidated their cases. The lead plaintiff in this matter is Kathleen Agresta. She contracted the most frequent side effect from taking Reglan, tardive dyskinesia (TD). The condition is characterized by symptoms that are similar to those of Parkinson’s disease, including lip smacking, uncontrollable blinking and uncontrollable twitching of the extremities. Agresta was taking Reglan to treat acid reflux.

The various plaintiffs in the case have filed their lawsuits against the brand name makers of Reglan, Wyeth and Schwarz Pharma, as well as the makers of the generic versions like Teva Pharmaceuticals and Pliva Inc. However, the defendants don’t stop there. The plaintiffs have also included Walgreens in their complaint. Walgreens is the largest drugstore franchise in the United States. They were included in the lawsuits because the plaintiffs are claiming that Walgreens was negligent in giving out the prescriptions beyond the 12-week period that is supposed to be the cutoff point with the medication.

Reglan’s current warning label only approves patients taking the drug for 12 weeks because taking it longer increases the chances of patients suffering from the drug’s severe side effects like TD.

The Illinois MDL is being presided over by Judge Andrew Gleeson. Gleeson is going to host a status meeting on June 27. It is then that the judge may choose to include it with the 940 other Reglan lawsuits that are already consolidated in New Jersey state court. All of the plaintiffs that have filed Reglan lawsuits did so amid claims that the makers of the drug didn’t properly warn the public about the negative side effects that caused the FDA to issue a black box warning against Reglan in 2009.

As a defective prescription drug attorney, I know blood thinners can be life-saving for people who have heart problems — but they can also be dangerous when overdosed or misused. So I was disappointed to see that the FDA has recalled 1.85 million tablets of the drug Coumadin (warfarin) because of a manufacturing defect that made the drug too potent. According to a WebMD article, the recall affects one lot of 5-milligram tablets of Coumadin manufactured by Bristol-Meyers Squibb. The recall does not affect warfarin sold as a generic or under other brand names produced by other manufacturers. As of May 3, fortunately, no injuries to patients had been reported to the FDA.

Coumadin is used in people who have heart problems or circulatory problems that raise their risk of stroke or embolism. It prevents the blood from clotting as effectively as it naturally would. However, the amount necessary in each patient needs to be balanced carefully, not only for each person's metabolism and genes, but because it interacts with a variety of common medications, foods, herbs and alcohol. As a result, pills with too much of the active ingredient could cause harmful side effects like excessive bleeding, coughing up blood, blood in the urine and bruising. Patients also run the risk of unknowingly decreasing the Coumadin's effectiveness by using other drugs or foods.

I'm happy to read that no one has yet reported being harmed by the recalled pills. But as a dangerous prescription drug lawyer, I wonder whether a drug that can be thrown off balance so easily is a safe one. Patients taking Coumadin for the first time must go for weekly blood tests to establish which dosage is safe for them, because genetic and lifestyle factors make it dangerous to prescribe on the basis of body weight alone. Among the common foods and flavorings that interact with Coumadin are garlic, spinach, grapefruit, ginger and possibly cranberries. In fact, warfarin is so effective that it was originally discovered when cattle eating plants with the active ingredient began bleeding to death. That's why it's vital to make sure Coumadin supplies are manufactured exactly to specifications — and recalled promptly when there are problems.

Continue reading " FDA Recalls Name Brand Version of Blood Thinner Warfarin for Too Much Strength " »

American health regulators have finally given Wockhardt Ltd. permission to sell a generic version of Effexor XR, a popular but controversial SSRI antidepressant medication.

The generic version of Effexor XR is called venlafaxine hydrochloride and it will be sold in capsule form in India. Wockhardt is expected to launch the controlled released version of Effexor in the U.S. in June of this year. The American approval by the Food and Drug Administration allows Wockhardt to sell the drug in dosages of 37.5 mg, 75 mg and 150 mg.

The chairman of Wockhardt, Mr. Habil Khorakiwala, had this to say of the decision: “Our product selection strategies have revolved around maximizing our strengths in this area of pharmaceutical technology and Venlafaxine XR bears testimony to the same.”

The controlled release version of Effexor XR is manufactured by Pfizer and has been a top seller for the company in treating depression in the United States.

Recently, however, Pfizer has been subjected to various lawsuits over the side effects of Effexor. The plaintiffs all claim that the company didn’t properly warn the public about the adverse side effects associated with the drug, including aggression, excessive mood swings, suicidal thoughts and suicide. Despite the lawsuits, IMS Health says that Effexor has a global market size that is said to be as high as $2.3 billion. Wockhardt is based in Mumbai and plans to manufacturing the drug in plant at Chikalthana in Maharashtra, which is FDA-certified.

SSRI medications like Paxil and Effexor have recently been the focus of a research study that reveals the drugs can help to generate new brain cells in depressed people. While that may sound like a good thing, the risks associated with Effexor may not be worth it to many patients that opt to take the drug.

According to one researcher affiliated with Harvard University, scientists should spend more time examining the link between ovarian and breast cancer and SSRI medications like Paxil. The researcher, who reviewed 61 different studies, suggested that the controversial antidepressant increases the chances of patients getting cancer.

One report that analyzed older information and published in PLoS ONE said that the risk of cancer got higher by 11 percent for the patients that were taking SSRIs. Researchers also found that 20 of the studies conducted identified a link between the medications and increased risk of cancer.

In the report, the investigators of the research said, “Reviewing the evidence is a critical public health issue in light of the increasing prevalence of AD use, especially among women, and in light of the fact that one in eight women will be diagnosed with cancer of the breast during their lifetime.”

Lisa Cosgrove, a research lab fellow at Harvard’s Edmond J. Safra Center for Ethics in Cambridge, Massachusetts, led the review. She said that the information in the findings shows that there is a real need for more information to be gathered with more studies being conducted on SSRI use in women. Even more interesting is that Cosgrove also said that she would rather try a non-drug treatment if she experienced even mild depression now she has seen the information linking antidepressants like Paxil to cancer.

Drugs like Paxil have been associated with all sorts of adverse side effects that have caused many patients to file lawsuits against drug makers claiming that drug makers are hiding the risks from the public and physicians when they are put on the market. Most recently, studies have shown that while Paxil and other SSRIs work in severe cases of depression, they also have the same effects as placebos in dealing with mild cases of depression. That information suggests that SSRIs aren’t even necessary, and that the risks far outweigh the benefits in taking the drugs.