Drug Injury Attorney Blog

So far, the focus on the harmful side effects of the anti-GERD and anti-nausea drug Reglan has focused on the danger it poses to older patients. But now there is a case involving a young Louisiana child. Dawn Harris is suing the makers of the drug on behalf of her son, who is a minor. She claims that his prescription of Reglan caused the child to develop Tardive Dyskinesia (TD), and demands that the company provide compensation for the damage caused.

Harris is arguing that the makers of Reglan breached specific and implied warranties in their marketing of the medication. She claims that she was encouraged to keep her son on Reglan to help alleviate his digestive conditions, and that all implications were that the medicine was safe and effective. She largely maintains that the warnings against taking Reglan for too long, that those tying it to TD were too deeply buried for her to know about and that her physician did not take sufficient steps to warn her or her son about the risk for developing this condition.

The damages Harris is seeking compensation for include medical expenses, pain and suffering, disfigurement, mental anguish, loss of earnings and capacity, court costs, impairment and interest for pre- and post-judgment periods.

Tardive Dyskinesia is a movement disorder. It causes uncontrollable jerking and spasms in the body, particularly in the facial region and the extremities. While not pleasant for anyone, it can be devastating to a child who can't understand what made them sick, or why they can't be made better. Children should be able to trust their doctors and the medicines provided, not be rendered ill by the side effects of the drugs they have been prescribed.

Levaquin (levofloxacin) is a popular brand of antibiotic prescribed for treatment of some kinds of bacterial infections. It is a member of the fluoroquinolone form of antibiotics, and typically is prescribed for bacterial infections found in the sinuses and bronchi as well as for skin infections and certain genitourinary infections.

Levaquin also has many side effects. It's been known to generate liver damage. Symptoms of possible liver damage include stomach pain, nausea, vomiting, fever, or yellowing of the skin or eyes.

Levaquin users also report nervous system disorders. These symptoms can include convulsions, insomnia, confusion, anxiety and depression. Nervous system disorders can also include any change in sensations, such as weakness, burning, tingling, numbness or pain. These types of symptoms might signal Levaquin-induced nerve damage.

Many antibiotics claim diarrhea as a possible symptom after treatment has ended. But with Levaquin, there have been reports of inflammation of the colon with chronic diarrhea and bloody stools with cramping and fever. In some rare cases, Levaquin may cause a serious antibiotic-induced diarrhea condition called pseudomembranous.

Levaquin may increase the chance of tendon injuries. These injuries occur more frequently in seniors or those who also take corticosteroid medications. The most common injuries reported are tendon ruptures and tendonitis in the shoulder's rotator cuff, the hand and particularly the Achilles' tendon in the foot. To repair these tendon injuries, some patients may require extensive surgery.

Levaquin also has a long list of drugs that it may interact with. These include amiodarone, aminophylline antacids containing aluminum hydroxide, calcium, magnesium hydroxide (not to be taken within two hours of levofloxacin), anti-diabetes medications, anti-inflammatories (NSAIDs), buffered antiretroviral medications (like didanosine), caffeine, calcium supplements and multivitamins containing calcium (not to be taken within two hours of levofloxacin), cisapride, disopyramide, erythromycin, iron supplements and multivitamins containing iron (not to be taken within two hours of levofloxacin), medications taken to control heart rhythm, oxtriphylline, phenothiazines, quinidine, sotalol, sucralfate (not to be taken within two hours of levofloxacin), theophylline, tricyclic antidepressants, warfarin and zinc supplements and multivitamins containing zinc (not to be taken within two hours of levofloxacin).

If you have experienced tendonitis or a tendon rupture or any other tendon-related illness while on Levaquin, you may be entitled to financial compensation and should contact an attorney to see if you qualify for a Levaquin lawsuit.

The news wires have been busy lately with reports of yet more examples of drug companies marketing their drugs illegally. St. Louis-based Forest Laboratories agreed to a settlement this month, in which it will pay over $313 million in penalties for civil and criminal complaints that it illegally marketed its antidepressant Celexa (citalopram) for uses beyond those approved by the U.S. Food and Drug Administration. Two weeks earlier, Botox (onabotulinumtoxinA) maker Allergan agreed to a settlement in which it will pay $600 million for its illegal off-label marketing. Most dismaying to me as a dangerous medication attorney, both companies were charged with trying to sell their drugs for use by children even though the drugs were only approved for use by adults. Celexa has been linked to suicide and suicidal thoughts in some children and adolescents, so marketing the drug to them illegally seems especially dangerous and unethical.

Among the charges that Forest Pharmaceuticals, a subsidiary of Forest Laboratories, settled was a charge that the company was marketing Celexa to treat depression in adolescents and children, and that it was giving doctors misleading information about the drug's effectiveness for those age groups. According to the U.S. Department of Justice, the company publicized positive results of a study of Celexa's effect in adolescents, while keeping quiet about another study that found negative results. Forest also allegedly paid doctors to prescribe Celexa and another antidepressant, Lexapro, handing out “cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment, and other valuable goods and services,” according to the Justice Department's civil complaint. From 1998 to 2005, Forest representatives rewarded cooperative doctors with tickets to St. Louis Cardinals and Boston Red Sox games, Broadway shows, gift certificates to expensive restaurants and deep-sea fishing trips.

The company denies the civil allegations, but admitted that its employees lied to FDA inspectors in 2003, that it misbranded Celexa as appropriate for use in children, and that it illegally distributed an unapproved thyroid drug. Thus, Forest pleaded guilty to one felony and two misdemeanors. In the case of Levothroid (levothyroxine), the thyroid pill, Forest was charged with deliberately increasing its distribution of the drug in quantities that exceeded what the FDA allowed, even after receiving an FDA warning letter. Along with the fines and forfeitures of assets, Forest has agreed to a corporate integrity agreement making its drug marketing subject to monitoring by an independent expert for the next five years.

As a pharmaceutical liability attorney, I am glad that the Justice Department is cracking down on dangerous and illegal marketing that puts children at risk. Children's bodies are not the same as adults' bodies, and it's not safe to assume that drugs that are fine for adults will work the same way for children. The dosages may not work the same way in children’s smaller bodies, and we don't know how the drugs might affect a child's developing body and mind. This is precisely why the FDA does not approve a drug once for all age groups. Suicidal thoughts are a well known problem with antidepressant use in kids and teenagers, and as noted previously, Celexa studies have linked the drug to such thoughts in kids and teens. That makes Forest’s choice to market Celexa off-label for this age group particularly irresponsible.

Drug companies know very well that the law requires them to follow established safety procedures and warn the public of any risks associated with taking the drugs they manufacture. When a drug company engages in illegal, deceptive marketing, it does the opposite. Failing to get FDA approval for an age group (or any other group) bypasses the regulatory structures that are intended to keep us safe. There's only one reason that companies do this: profit. Illegal marketing gives them an unfair advantage over their competitors who do obey the rules and get FDA approval for their medications, and that unfair advantage helps them and hurts everyone else. That's why consumers who are harmed by taking a prescription or over-the-counter medication are entitled to make the drug manufacturer pay for any costs associated with that harm. Those costs may include more than just medical bills: the victim may also sue for lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused.

Continue reading " Drugmakers Agree to Pay Huge Settlements for Illegally Marketing Drugs to Children " »

A short time ago, the pharma company Mylan was given an exclusive arrangement to sell a generic formulation of Glaxo Smith Kline's antidepressant Paxil CR. These arrangements typically last 180 days when granted, and are meant to prevent oversaturation of the market and mayhem caused by unregulated competition. Now, Mylan has leveled a suit against Glaxo, claiming that the pharma giant is allowing another company — Apotex Inc. — to manufacture another generic version of Paxil CR.

The basis of the case is, of course, largely economic. Mylan is arguing that allowing Apotex to produce an “authorized” version of Paxil CR would drastically undercut Mylan’s market share and destabilize the market in general. Further, Mylan officials contend that Glaxo has breached a 2007 agreement between it and Mylan which granted Mylan exclusivity to sell the generic form of the drug before the patent's expiration in 2016. The courts have, for the moment, agreed with Mylan, issuing an order blocking Apotex from going forward with production or sale of the antidepressant.

This all might seem a bit dense and obscure to the average patient. This is because none of these discussions is taking place with the eventual patient in mind. The arguments in such cases are solely for financial concerns, with companies attempting to protect their perceived turf against encroachments from other companies.

None of the documents in this case for example brings up or even is affected by the ongoing litigation related to the safety of SSRIs such as Paxil CR. While people still are calling attention to the increased rate of birth defects in children whose mothers took Paxil while pregnant, as well as to the increased rate of suicidal thoughts and attempts in patients taking Paxil at a young age, companies are busy fighting out who gets to market the cheap, generic versions of the drug that will be put on the market with the same effects and risks as the parent drug.

As more people file lawsuits and as increasing amounts of information continues to become public, general awareness of the side effects of the SNRI known as Effexor is on the rise. As a case in point, recently there was an excellent article on Livestrong detailing the potential dangers that have been associated with this drug. As always, there is no dispute that Effexor and other antidepressants are necessary medications that can do a great service to people seeking to control a debilitating condition. However, in order to make sure that the treatment is properly applied, public awareness about all aspects of the drug must be increased.

Side effects discussed begin with a fairly serious one: blood pressure disorder. Effexor has been known to elevate a patient's blood pressure, which in the short term can lead to headaches, but in the long term can cause severe strain on the heart and lungs.

Other side effects raised include one that we've come to understand already — an ironic worsening of symptoms. This is an underlying problem with mind-affecting medications. While SNRIs do allow the brain to retain and benefit from mood-lifting chemicals, this is not a magic spell that will result in an elevated mood. It can, in some cases, cause a backlash, making the symptoms worse. In certain patients, it has been clearly demonstrated to increase suicidal ideation and attempts.

One side effect that hasn't been discussed as often is the very rare but incredibly serious Serotonin Syndrome. Resulting from a bad bodily reaction to the elevated Serotonin levels, the syndrome causes side effects such as chills, shakes, nausea, vomiting, diarrhea and other severe symptoms. Any combination of such symptoms is potentially life-threatening, and patients should seek emergency attention immediately.

The article goes into other symptoms as well, but these seem to illustrate the case being made. Yes, the core focus of the lawsuits to date on Effexor and its distant cousin Paxil has been on the potential for birth defects. However, the problems go far beyond the simple rationales, and the whole picture must be considered.

Medical advertisements have been on shaky ground for some time. Drug companies naturally want to get airtime showcasing the benefits of their medicines to receptive markets, while consumer advocacy groups are concerned that these promotional materials are misleading credulous people into making decisions that ultimately end up costing them. The case in point to date is Bayer, the makers of the Yasmin and Yaz oral contraceptives. Bayer has been slapped down on two different occasions for improper marketing practices.

The first incident was regarding Bayer's claims that Yasmin is “a different kind” of contraceptive, and that it was safer than most other drugs in that class. Unfortunately for Bayer — and Yasmin users — no evidence had been presented to indicate that either claim is accurate. The second incident concerned a commercial that claimed Yaz was able to treat symptoms such as acne, PMS and weight control issues. Once again, the FDA had not cleared Yaz for any such treatments at all.

Now there is evidence that Bayer continues to skirt the line of decency in attempting to market its products. While not specifically advertising for Yaz in this case, there is evidence that Bayer hired presenters to go to parties and talk up the value of Bayer's other contraceptive, an IntraUterine Device. As before, Bayer focused on image and trendiness, implying that users of the device were a sexy, social set of people who needed an easy and clever solution. While these claims might not seem bad in and of themselves, Bayer once again did not explain or downplayed the potential for risk while making a high-pressure and misleading sales pitch.

Should Bayer be permitted to market its medicines? Of course it should; people can make better medical choices when they know they have a handful of options rather than just one or two. And knowing the names of medicines allows patients to ask their physicians about them. However, a private party is not the correct venue for marketing contraceptive materials, and Bayer needs to get its act together if it wants to salvage its reputation.

Though my work as a dangerous drugs attorney focuses on helping people who were victimized by defective medications, I believe strongly that scientists and regulators have an important role in keeping us safe from dangerous drugs. In a recent New York Times article, I read about one such person, Dr. Frances Oldham Kelsey, who will be honored by the U.S. Food and Drug Administration for her lifetime of work on the behalf of patients and consumers. Kelsey, now age 96, was one of the first FDA scientists to insist that drug manufacturers demonstrate that their products are safe and effective, rather than allowing them to push through their applications for approval without rigorous review.

Fifty years ago, Kelsey reviewed the William S. Merrell Company's application for approval to sell Kevadon (thalidomide), a drug that was being prescribed to many European women to alleviate morning sickness during pregnancy. Thalidomide is now famous for causing severe birth defects: "thalidomide babies" were born without limbs, or with flipper-like limbs. When it applied for approval to sell the drug in the U.S., Merrell already had a bad relationship with the FDA. Kelsey sensed that the company was holding back important information, so she insisted that the company provide test results that showed that thalidomide was safe. Merrell complained to her superiors, insisting that she was "depriving" people of the medication's benefits, but her bosses backed her up. It soon became clear that she was right to be suspicious. She found reports that the drug caused nerve damage, which Merrell had withheld. The company backed away.

Kelsey might have recognized that something was amiss with thalidomide because of her earlier pharmacological work at the University of Chicago. There, she had helped a professor establish that a widely used medicine, elixir of sulfanilamide, contained a poisonous industrial solvent. The drug had been marketed without any restrictions even though it was linked to scores of deaths, and in the aftermath, Congress passed the 1938 Food, Drug, and Cosmetic Act to force drug companies to test the safety of their products.

But by 1960, Congress had not yet given the FDA the authority to force companies to show that their drugs were safe and effective. Drug manufacturers could simply file information with the FDA and begin selling their drugs 60 days later, as long as the FDA didn't object. Drug manufacturers sent their new concoctions to doctors and simply asked them to try them out in patients, rather than performing the controlled tests that are now required. After the Washington Post ran a front-page article about Kelsey's refusal to approve thalidomide for sale in the U.S., Congress finally gave the FDA power to require the drug industry to show their products' safety and effectiveness. President John F. Kennedy awarded Kelsey the Distinguished Civilian Service Medal. Kelsey and her colleagues then created the rules that are still in effect today for how medical testing must be performed, with three separate phases for clinical trials in humans, and protections for human subjects and against conflicts of interests.

On Sept. 15, 2010, Kelsey received the first Kelsey Award from the FDA, an honor to be bestowed on an FDA staffer each year. For the last two decades, the FDA has leaned more toward drug manufacturers' desire to get their drugs approved swiftly, even without detailed data about the drugs' safety and effectiveness. But now that the Kelsey award has been established, as a dangerous medication lawyer, I hope that more FDA staffers will follow in her footsteps and focus on patient and consumer safety over drug companies' interests. Kelsey's experiences show clearly that drug companies do not assume that it's their job to keep patients safe. Drug companies have been trying to fast-track the approval of their drugs for decades, regardless of the drugs' safety and effectiveness, because there are profits to be made in doing so. The case of thalidomide demonstrates that the public should not trust drug manufacturers to look out for public interests, nor even the FDA in all cases, since FDA scientists before Kelsey had not necessarily insisted on proof of drugs' safety either.

The law gives patients and consumers their own weapons to fight back against drug companies when necessary. Drug companies are legally required to warn consumers of risks that may come with taking their drugs. If they don't, and patients suffer because they took a drug that they wouldn't have if they'd known the risks, drug manufacturers can be held responsible for the harm that their drugs caused. Patients who suffer injuries can require the drug manufacturers to pay for medical expenses, lost wages, permanent injuries, and pain and suffering related to the injuries that these drugs caused.

Continue reading " FDA Doctor to Be Honored for Fighting Against Manufacturers of Dangerous Drugs " »

Once a company's initial patent period for a prescription drug expires, the medication enters the public arena in the form of generic formulations. Alternative companies are permitted to begin manufacturing their own versions of the medicine, under their own names and their own marketing programs. However, few people understand that this process is not as simple or clear cut as that explanation makes it seem. In reality, it's a period of arguments, suits, counter-suits and accusations from one group to another as the parent company tries to protect its interests for as long as possible and as new companies try to get themselves in a position to benefit from the circumstance.

The situation with Effexor is a classic example of the kind of impatient jockeying that occurs when a popular drug goes generic. Effexor's parent company, Wyeth, has sued the Indian manufacturing firm Dr. Reddy's. Wyeth is arguing that Reddy's has infringed on its patent and should be stopped from marketing the Reddy generic version of Effexor. In the meantime, Israel-based Teva Inc. has begun selling its generic version of Effexor XR as of July 1st.

While this might sound on the surface like business as usual, it does raise some questions that patients deserve to have answered. First, what is the benefit to the patient in all these suits? There are still ongoing lawsuits pertaining to SSRIs and SNRIs like Effexor, focusing on their propensity to cause suicidal ideation and their increasingly evident link to the formation of infant birth defects. Secondly, notice that the suit versus Reddy's is not a matter of questioning the company's ability to control the quality of the drug, but a patent violation. This makes it rather obvious that Wyeth is not arguing out of concern for patient welfare so much as attempting to keep their fingers firmly around their drug's $4-billion-a-year market share.

There is no doubt that prescription medications contain very effective treatments. Many conditions that couldn't be dealt with at all now are treatable and oftentimes completely eliminated with the proper use of applied medical therapy. No one of serious scientific background is disputing the fact that Reglan works to control acid reflux and nausea in cases where other drugs have failed. The problem comes in that the manufacturers and marketers have been less than forthright about the medicine's consequences and side effects.

The real cost of this kind of attitude goes beyond the simple financial or personal damage done as a result. Even once settlements are made and patients have gone on with their lives, you have sites like this (link) popping up. Notice the statement the site makes about band-aids and medicines unable to treat the underlying condition. There's an interesting point to be made there, but in a different direction than this site suggests.

GERD is a difficult condition to treat. Reglan is prescribed as a last resort, when other medicines, such as proton pump inhibitors, don't work as effectively as intended. This is not a case of doctors trying to line their pockets, but a genuine case where our medical knowledge simply doesn't extend to the realm of curing the condition, and can only go as far as treating and managing it for the time being.

However, the reluctance of medical companies to be honest and forthright about the conditions of their medicines and the limitations those medicines operate under gives sites like this room to grow, and allows false opinion to take root. Ultimately, this lack of honesty and the ignorance that results from it allows untested and potentially fruitless advice to take root in its place. In the long run, this causes just as much damage as putting inadequately tested drugs onto the market.

The FDA is requiring changes in label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.

The gadolinium constrast agents are sold under the brand names: (1) Ablavar (gadofosveset trisodium), (2) Eovist (gadoxetate disodium), (3) Magnevist (gadopentetate dimeglumine), (4) Multihance (gadobenate dimeglumine), (5) Omniscan (gadodiamide), (6) Optimark (gadoversetamide injection), and (7) Prohance (gadoteridol).

BACKGROUND: GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse

The number of plaintiffs filing lawsuits related to Reglan-induced Tardive Dyskinesia (TD) has grown into the hundreds, according to court records. The lawsuits don't discriminate between generic and name brand versions of the drug either, with both types represented in equal frequency among the cases filed to date.

Perhaps the most well known of the cases is that of Susan Swicegood. Swicegood based her case on the alleged failure of Reglan's parent companies to properly explain the risks of developing the neurological disorder as a result of exposure to the potent medication. Swicegood was prescribed the medication to alleviate a stomach disorder, which is a common basis for prescribing Reglan. But as a result of taking the drug as directed, she developed TD.

Plaintiffs Ellen Austin and Leslie Keeper both have filed suits against the makers of generic Reglan as well, this time in Louisiana. In addition to making claims similar to Swicegood — that the drug makers didn't accurately warn about the risks of the drug — they also go a step further in arguing that these manufacturers and their marketing teams presented misleading information or even falsified data that suggested Reglan was safer than it is, downplaying the risk of TD significantly.

There is currently no known cure for TD, and while the condition can spontaneously resolve itself, it is just as likely to remain permanently. Reglan has warnings on the label explaining the risk of Tardive Dyskinesia, as well as admonitions not to continue prescription beyond 12 weeks. However, many gastrointestinal ailments are persistent. They are also painful enough that treatment of them feels like a priority concern, and there are numerous patients that continue to take the medicine beyond this mark. The resulting TD is often linked to long-term exposure to the medication, making it feel like a punishment for trying to get well.

As a defective medication lawyer, I was interested to read that the U.S. Food and Drug Administration will convene an expert advisory panel in September to determine whether to allow Meridia (sibutramine), a weight-loss pill produced by Abbott, to remain on the market. Abbott's own company-sponsored study has shown that Meridia increases the risk of nonfatal heart attack and stroke in patients who have underlying heart disease. European drug regulators have already banned the drug, known in Europe under the brand name Reductil. Given the drug's modest-at-best effectiveness in helping patients lose weight, it hardly seems worth the increased risk to patients to keep it on the market -- except perhaps to the company who stands to profit from the drug's sales.

Meridia, an appetite suppressant, gained FDA approval 13 years ago. A monoamine reuptake inhibitor, Meridia works in a way similar to Prozac and some other anti-depressants, using the neurotransmitter serotonin to help patients feel full for a longer time after they've eaten. Before approval, the FDA was concerned that the drug significantly raised blood pressure and heart rate, and increased patients' risk for developing cardiovascular disease. But the argument for the drug was that if it helped patients to lose weight, that in itself would benefit their heart health.

As it turns out, not only does Meridia increase patients' risks of nonfatal heart attack and stroke, but studies show that it also doesn't help them lose weight. A study that followed nearly 10,000 overweight or obese people for 3.5 years found that Meridia helped patients lose an average of nine pounds, or 4.5% -- which is below the 5% threshold that the FDA considers the minimum for weight loss drugs. Worse, it increased patients' risk of heart attack by 28% and stroke by 36% compared to a sugar pill. That's why an editorial in the New England Journal of Medicine has called for the drug to be pulled from the market. Abbott has defended Meridia by saying that the drug's label advises doctors not to prescribe it to patients who have known cardiovascular disease. But this wouldn't help people who have undiagnosed cardiovascular problems. About half of all patients who die suddenly from heart attacks do not have a known history of such problems, and many overweight and obese patients do face cardiovascular health problems, whether they are aware of them or not.

Patients depend on drug manufacturers, doctors, and the FDA to ensure their safety when they take medications. We can't all have the medical training that would equip us to make our own fully informed decisions about drugs that we might take to improve our health and save our lives. That's why, as a pharmaceutical liability attorney, I think that when a medical journal as highly respected as the New England Journal of Medicine calls for Meridia's removal from the market, doctors, patients and especially the FDA should listen.

Unfortunately, sometimes the system we depend on to ensure our safety doesn't work. Even though drug manufacturers are required by law to warn consumers of risks that they know to be linked to their products, sometimes drug manufacturers fail to live up to this responsibility, and patients are harmed by defective, dangerous drugs. When that happens, patients can recover financial compensation from the drug manufacturer whose product harmed them. When consumers incur medical costs, miss work and/or are unable to work, and their quality of life suffers because of negative effects of an over-the-counter or prescription drug, they can require the drug manufacturer to pay these costs, which the manufacturer ultimately caused. Consumers who trust that a medication is safe should not have to bear all the consequences alone if they find that the medication is actually unsafe, especially if the manufacturer knew about it.

Continue reading " Meridia Weight Loss Pill Increases Patients' Risks for Heart Attacks and Strokes " »

Things have looked bad for GlaxoSmithKline's flagship antidepressant for a fair amount of time now. But bad press continues to plague the SSRI and its manufacturer, both in and out of the legal arena.

First, one must consider the extensive lawsuits filed against GSK, alleging that Paxil is responsible for the formation of birth defects in children born to mothers who were taking Paxil during their pregnancies. These defects included heart malformations, PPHN, and mis-formed body parts such as incompletely formed anal openings, clubbed feet and over- or under-sized craniums. A large chunk of these lawsuits recently was settled for several billion dollars in damages.

Next, there is the continuing evidence that Paxil causes aggravated feelings of suicide in younger patients — and this despite the fact that the FDA hasn’t approved the drug for use in younger patients. The evidence includes a controversial study that recently was performed in Japan in children as young as 7 years old. Stranger still, Paxil is required to carry a black box warning indicating that it can aggravate suicidal thoughts in children; the condition and effect are already known. So now Paxil is doing yet another study to see if this is true. Why?

Last, but perhaps not least, is the recent conviction of Dr. Maria Carmen Palazzo. GSK hired Palazzo to perform a series of clinical tests on Paxil patients 10 years ago. A few weeks ago, Palazzo pleaded guilty to numerous counts of fraud, confessing that her studies were almost entirely falsified. She performed tests on children based on diagnoses that were patently untrue, claiming that the children suffered from conditions such as major depressive disorder when it was abundantly clear they did not have any such affliction.

In essence, there has been no seriously good news for GSK or Paxil for several months at this point. Admissions of defeat and deceit alike continue to come in, raising serious questions about the long-term viability of Paxil in this image-conscious market.

Still more patients are filing lawsuits against the makers and distributors of the controversial antibiotic Levaquin. According to records, the plaintiffs are alleging "Levaquin-induced tendon injury (involving) the degradation of the tendon tissue, leading to severe and permanent injuries." This newest round of lawsuits was filed as of July 8 this year, and has resulted in the combined cases of 96 patients, not an insubstantial number considering that settlements for individual medical injury cases can involve hundreds of thousands, if not millions, of dollars.

The basis of the lawsuit once again centers on the claim that information about Levaquin's risks either is incomplete or poorly presented, failing to accurately stress the danger of toxicity to muscle and connective tissues. The plaintiffs allege that the prescription of Levaquin led to a number of maladies, including outright tendon ruptures, which is a highly painful and potentially crippling affliction, often requiring extensive physical therapy and potential surgery to properly recover from.

The lawsuit further alleges that manufacturer Johnson & Johnson is more than aware of the medicine's risks, and has taken consistent steps to actually conceal the risk information about Levaquin from the public. The suit mentions a sorting algorithm that J & J introduced which excludes more than 70 percent of Levaquin injury cases. The protocol only mentions patients who have required corrective surgery following a tendon rupture, which doesn't account for patients who were similarly injured, but only needed a cast or corrective boot of some nature. Additionally, the plaintiffs point to the fact that this same study only focused on one specific type of rupture in the Achilles tendon, and ignored the possibility of tendon toxicity in general.

Levaquin is an antibiotic in the same class of medications as Cipro, a drug that came to increasing popularity following the 2001 Anthrax attacks. It is considered a big-gun medicine to be used in treating the most difficult infections.

The initial lawsuits against the contraceptive Yaz have focused predominantly on the cardiovascular damage the drug is alleged to cause, and the majority of these suits have been filed by women who were taking the medicine for its original purpose. However, the makers of Yaz have aggressively promoted the pill as being effective in controlling other conditions such as body weight, acne and even premenstrual syndrome. On this last point, Bayer was warned that the drug was not approved for treating this condition, and told to cease mentioning it in their advertisements.

Now, a new round of lawsuits is being filed by women who took Yaz for these alternative, so-called “off-label” purposes. Young patients such as 16-year-old Katie Anderson embraced the trendy new medication as a virtual cure-all for a variety of teenage “problems.” The teen years are a tumultuous time for anyone, with newfound worries about appearance, body image and the responsibilities of physical intimacy — what responsible, impressionable young teen wouldn't be at least partly swayed by dramatic claims of such a pill that could handle all three concerns? Katie eventually suffered a blood clot that went from her leg to her heart and might have killed her — although, fortunately, it did not.

Katie and others like her are beginning to add their voices to the number of suits filed against Bayer for failing to adequately warn patients of the dangers. These include patients from Canada as well that have added gallbladder symptoms to the list of damage the pill has done.

For its part, Bayer continues to state in all legal and public records that Yaz is no more dangerous than other contraceptives. This is a significant departure from their advertising that implied a safe, easy, different form of birth control that could fit into any young person's life; still, the legal battle will certainly continue to debate the point for some time.

With all the focus on the many possible links between the antidepressant Effexor and birth defects in children of mothers who take the medicine while pregnant, other troubling side effects of the drug sometimes end up being overlooked. Effexor is without a doubt an effective antidepressant that has helped many people deal with this debilitating condition. However, it is also host to a slate of secondary effects on patients prescribed it, some of which may even play into the potential for birth defects.

In particular, one could look at the physical side effects that alter body chemistry. One of these is the potential for the medicine to elevate the parent's cholesterol level. Others are problems regulating body temperature, leading to chills or possibly night sweats and hot flashes. Each of these changes the body of the mother slightly, and the body of the mother is, for better or worse, the environment in which the child matures. If these effects are too drastic, it is easy to see how they could contribute to destabilizing the pregnancy.

Other effects have less direct impact on the body environment, but can still cause changes that can be measured. The medicine can cause anxiety, or alternatively a loss of emotion in general. It can lead to a sense of disaffect, or a lack of interest in normal activities. It is not uncommon for patients experiencing this to have difficulty remembering when to eat or exercise. Still less direct but no less serious or uncomfortable are effects such as loss of appetite or excessive dizziness. Perhaps the most disturbing is the phenomenon of “brain zaps.” These are small sensations similar to a brief electric shock, causing the body to convulse in surprise and pain. They might not be life threatening on their own, but any disruption of the body's neurosystem should surely be treated with caution.

Not every mother who takes an antidepressant during pregnancy starts doing so after she has become pregnant. Indeed, in many cases the mothers were taking antidepressants before they ever got pregnant, and simply continued their regimen throughout the development of their baby. With more and more cases coming to light about the potential link between antidepressants and the formation of birth defects in the children of mothers on such medicines, the question might be asked why mothers keep taking these medicines and don't simply stop, like some expectant mothers quit smoking or drinking during pregnancy.

It turns out, however, that the situation may not be as simple as “just stopping.” Information indicates that discontinuing antidepressants can have symptoms as brutal as withdrawals from much more addictive substances like opiate painkillers. These withdrawals can include a number of symptoms such as anxiety and irritability, or more serious ones such as depression. Given that the medicine was originally prescribed to treat depression, getting depressed all over again can be a serious hurdle to clear when trying to come off the pills. Even worse are the strange, unexplained electric shocks that the body will occasionally give itself when withdrawing from antidepressants, known as “brain zaps.” Paxil, in particular, is difficult to come down from, because the body clears the drug from its system relatively quickly after a last dose.

Depression in the expectant mother is already known to have a detrimental effect on the health of the baby. Aggravating this with withdrawal symptoms that come from stepping down off an antidepressant medication — at a time when the mother's biochemistry has admittedly changed in drastic ways — might not be as easy a solution as some might argue when investigating claims into the link between these medicines and the formation of birth defects. Indeed, this line of reasoning really comes to little more than attempting to blame the victim.

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