On April 30, 2013, the Food and Drug Administration (FDA) issued their second alert to patients and health care providers concerning the drug tolvaptan (SAMSCA). The warning had two main points: Tolvaptan use should be limited to no more than 30 days, and it should not be used at all in patients who have liver disease.
On March 14, 2013, Fresenius Medical Care North America (FMCNA), announced that it has received yet another reprimand from the FDA, indicating that the agency found that the company failed to properly study artificial kidneys being used in its dialysis machines. The letter is not a formal recall, but it comes in the wake of the mid-2012 GranuFlo and NaturaLyte dialysis product recalls. These products were recalled when it was revealed that there is a serious and high risk of sudden cardiac arrest or death due to elevated bicarbonate levels in these dialysis additives
Prolia, a drug used to treat osteoporosis, received FDA approval in June of 2010. Prolia is administered by injection every six months to postmenopausal women and to men, who have either low bone mass or osteoporosis, and are susceptible to fractures.
The FDA issued a warning for the popular antibiotic (azithromycin) commonly known as a Z-Pack and sold under the brand names Zithromax and Zmax. This common antibiotic is widely used to treat sinus infections and bronchitis. In 2011 alone, there were over 50 million prescriptions for the Z-pack with sales in excess of 464 million dollars.
On March 5, 2013, Pogust Braslow & Millrood, LLC filed its first personal injury suit against Eli Lily and Company over Cymbalta withdrawal symptoms. The case, Carnes v. Eli Lilly and Co., was filed in the United States District Court for the District of South Carolina. Cymbalta withdrawal symptoms can be severe, long-lasting, and debilitating. The complaint details that Mr. Carnes suffered from severe brain zaps and aggression, and alleges that the company should have known about the likelihood, extent, and severity of experiencing withdrawal symptoms and yet failed to adequately warn doctors and patients about the risk.
A 2010 study, published in the American Heart Association’s journal Circulation, found that the risk for heart attacks was the same for Actos as it was for Avandia. According to the study, patients taking Actos or Avandia were 4 percent more likely to experience heart attacks. The study included over 36,000 patients with an average age of 54. This study was conducted over 33 months, including 14 months of treatment on either medication. Among the patients, 602 Avandia users and 599 Actos users suffered a heart attack, heart failure, or died. Even more concerning, there were 217 deaths in each group. Despite these alarming numbers, some found the results of this study to be inconclusive.
Benzodiazepines, such as Valium, Ativan, Librium and Xanax (and their generic versions), have been around for a long time. They are the most popular drugs the world, selling an estimated $880 billion in 2011 alone. They are commonly prescribed for generalized anxiety and to help with insomnia. They also come with many dangerous known side effects, including the potential to cause drug-induced addiction.
Last month, the Institute for Safe Medication Practices (ISMP), an independent, non-profit FDA watchdog agency, issued its quarterly report, detailing the 90% increase in adverse events (AEs) reported to the FDA since 2008. Included in the report are findings from a specific investigation aimed at Cymbalta and withdrawal symptoms.
Keller Rohrback L.L.P., Keller Rohrback P.L.C., Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC File a Class Action Lawsuit Against Eli Lilly and Company Regarding Cymbalta
Seattle, WA, October 31, 2012 (GLOBE NEWSWIRE) – Attorney Advertisement Material. Keller Rohrback L.L.P., Keller Rohrback P.L.C., Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC filed a class action lawsuit today against Eli Lilly and Company (“Lilly”) (NYSE:LLY). Lilly, an Indiana based pharmaceutical company, is the maker of Cymbalta. The class action complaint was filed in the United States District Court for the Central District of California, in Los Angeles, on behalf of all consumers who purchased Cymbalta at any time since the product’s launch in August 2004 to the present.
Millions of patients suffering from kidney disease rely on dialysis and hemodialysis in order to have toxins removed from their body. Dialysis treatment is critical in keeping patients alive and assisting many who may be awaiting a life-saving kidney transplant. And critically important to this life-saving dialysis process is ensuring that the drug products given to dialysis patients neutralize the acid that builds up in their blood.
NuvaRing, a contraceptive approved in 2001, is a flexible plastic-like ring that is inserted into the vagina and which releases a continuous dose of hormones into a women’s system to prevent ovulation. Since NuvaRing’s approval it has become one of the most popular birth control options for women due to the perceived freedom of not having to remember to take a daily pill.
The Yaz story does not end with Yaz. As most Yaz users have recently learned, there is a significantly increased risk of blood clots, heart attacks and strokes when taking Yaz compared to other birth control pills. What some users may not be aware of though – is that Beyaz is basically the same drug with identical risks.
Pradaxa is another example of a new drug gone bad. Marketed as the latest and most improved version of anti-clotting medications, it turns out to be much riskier that well-established drugs already on the market. Since 2010, Pradaxa has been prescribed by physicians to prevent stokes, particularly in elderly people who have an irregular heartbeat. A devastating acknowledgment, however, by the German manufacturer of Pradaxa, Boehringer Ingelheim, notes that hundreds of deaths since 2010 may be the result of uncontrollable internal bleeding caused by Pradaxa.
Plavix is prescribed by physicians in order to reduce the risk of a new heart attack or stroke in patients who have a recent history of heart attack or stroke. Plavix and aspirin are both used to reduce the amount of platelets in the blood, which can clump together to form blood clots. These blood clots can cut off supply of blood to the heart or brain, causing a stroke or heart attack. Real questions remain, however, as to whether aspirin is just as effective as and safer than Plavix and aspirin used together.
The Ortho Evra Patch provides women with a simple solution for their birth control needs. A patch applied to the skin once a month is more convenient than a pill taken every day. As with most medicines today, there are always side effects to go along with the benefits of taking a certain drug. But at what point do the risks start to outweigh the benefits and conveniences of taking it? Most hormone based contraceptives increase your risk for developing blood clots, but the risk is three times greater with the Ortho Evra Patch. This increased risk comes from higher levels of estrogen as well as the constant dosage of estrogen found in the Ortho Evra Patch but not the pill.
Proton Pump Inhibitor Drugs (PPIs) like Nexium and Prilosec are among the most popular drugs in the world but perhaps they may be the most dangerous when taken over the long-term. I have written about the risks of this class of drugs multiple times in prior blogs (see blogs regarding dependency, bone fractures, infections, among others) but I believe it is necessary at this point to support Public Citizen's petition with the FDA to finally put a Black Box warning on these drugs. see www.citizen.org/petition-asking-fda-to-add-warnings-to ppis.
Doctors have been prescribing Fosamax for years to prevent bone loss. And last year, for the first time, the FDA required manufacturers of bisphosphonates, including Fosamax, to warn about the fact these drugs can cause a serious bone fracture. Ironically, the drug causes the very indication that the drug was supposed to prevent. This isn’t the first time we’ve seen drugs cause the very problems that they were prescribed to protect against. We had seen this before with antidepressant drugs that were supposed to prevent suicide but actually caused it.
The FDA’s action was apparently prompted by a study of more than 300 women who had suffered leg fractures while taking these drugs. And earlier this year, the FDA mandated that manufacturers of bisphosphonates include language in their labels stating that the optimal duration for patient use has not yet been determined.
Last December, Ortho McNeil-Janssen Pharmacetuicals added new labeling to its blockbuster antibiotic Levaquin. This updated black box warning, states that "Fluoroquinolones, including Levaquin, may exacerbate muscle weakness in persons with myasthenia gravis," a neuromuscular disorder. Levaquin and other fluoroquinolones have neuromuscular blocking activity and have been linked to serious adverse events in patients with myasthenia gravis, including ventilatory support and deaths. This warning is in addition to the July 2008 Black Box warning concerning the increased risk of tendonitis and tendon rupture.
The FDA recently announced in late May that 15 infants who had been given the product SimplyThick developed a life-threatening intestinal condition known as necrotizing enterocolitis (NEC), and that two have died. This has led the FDA to warn all parents, caregivers, and health care providers NOT to use SimplyThick to help with swallowing problems in babies who were born prematurely. Nearly all of the 15 infants who developed the condition had been born prematurely (before 37 weeks) but had been released by the hospital with a diet regimen that included SimplyThick to be mixed with their milk or formula in order to thicken it so that the babies would be able to keep their liquids down.
The FDA has an announced a joint initiative with the Federal Trade Commission (FTC) to combat fraudulent over-the-counter products that claim to be treatments for sexually-transmitted diseases.
Between 1997 and 2009, the FDA received 13 reports of death associated with GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose test strips in which there was interference from maltose or other non-glucose sugars. Some of the reports indicated that hypoglycemia, confusion, neurologic deterioration, brain damage and coma occurred prior to death. The medical community sometimes refers to this as fatal iatrogenic hypoglycemia, and its reasonable to suspect that there are significantly more cases of hypoglycemia that go unreported or unidentified.
In an article published in the March 2011 issue of The Journal of Sexual Medicine, researchers from the Boston University School of Medicine seem to have confirmed what recent lawsuits have already alleged, namely that there is a link between the use of dutasteride (Avodart) and finasteride (Proscar and Propecia) and temporary and sometimes permanent sexual dysfunction including erectile dysfunction and loss of labido. Notably, more than double the percentage of men reported erectile dysfunction while on one of the drugs (8%) compared to placebo (4%). Further, a loss of sex drive was reported more than twice as frequently among those taking one of the drugs (4%) compared to placebo (1.8%). Other reported side effects of Avodart, Proscar and Propecia included depression, reduced semen production and growth of male breast tissue.
The most devastating information presented, however, relates to symptoms of the side-effects persisting even after the medication was discontinued. In fact, in a second study reported within the same volume of The Journal of Sexual Medicine, Dr. Michael S. Irwig interviewed 71 otherwise healthy men who reported sexual side effects after taking finasteride and determined the mean duration of the negative sexual impact to be 40 months after stopping the drug. Despite the absence of any such information on the drugs' labeling in the United States, these prolonged side-effects do appear on the updated labeling for these drugs in European nations such as Great Britain, Sweden and Italy.
The FDA has placed the anticonvulsant drug Topamax, and its generic equivalent topiramate, in Pregnancy Category D as a result of new data illustrating an increased risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax during the first trimester of pregnancy. The data showed a Pregnancy Category D means that there is positive evidence of fetal risk based upon human data. Topamax is manufactured by Ortho-McNeil-Jannsen and has been marketed in the United States for almost 15 years for the treatment of some patients with epilepsy and for the prevention of migraine headaches. In addition, it has been used off-label for other conditions, many of which are not considered serious. Over four million (4,000,000) patients have filled prescriptions for Topamax and/or topiramate in the United States over the last four years.
On November 19, 2010, the FDA sent letters to the makers of the controversial prescription painkillers Darvon, generically known as propoxyphene, and Darvocet to request that the products be voluntarily removed from the U.S. market. The request for withdrawal comes after additional data supported the conclusion that the drugs cause significant changes to the electrical activity of the heart thereby putting patients at risk for potentially fatal heart rhythm abnormalities. The new evidence confirms that the risk is present even at recommended doses. Since the release of propoxyphene under the brand name Darvon in 1954, this was the third and final push to have the drugs banned due to evidence of side-effects ranging from cardiac events to overdose.
Beginning in September, 2005, an ISMP Medication Safety Alert brought attention to the issue of inaccurate blood glucose readings in some monitoring systems. The FDA had previously issued a warning in July, 2005, and did so again several times over the next four years. They found that these devices, which had become a major tool for hospital personnel and outpatient treatment, could actually be extremely dangerous, if patients and practitioners were not educated in administration methods. They cited a specific example with an elderly patient who was given a high level of insulin after his blood sugar falsely read very high, which resulted in profound hypoglycemia, irreversible neurological damage, and death.
Earlier this week, a panel of the Pennsylvania Superior Court issued an opinion for publication in Lance v. Wyeth, a pharmaceutical case in which the plaintiff alleged that her use of Wyeth’s obesity drug, Redux, caused the development of Primary Pulmonary Hypertension (PPH) and ultimately death. The Superior Court’s opinion is significant for consumers and plaintiffs lawyers because the opinion affirmatively recognizes for the first time the viability of a claim in Pennsylvania for negligent design defect.
The American Journal of Gastroenterology recently reported the results of its Proton Pump Inhibitor (PPI) clinical trial in “Dyseptic symptoms development after discontinuation of a proton pump inhibitor: a double-blind placebo-controlled trial, which confirmed an earlier study in Gastroenterology, entitled “Proton-pump inhibitor therapy induces acid-related symptoms in healthy volunteers after withdrawal of therapy,” - concluding that these types of medications actually induce the very symptoms they are used to treat. In other words, many of the people taking these medications to treat heartburn-related symptoms, end up with worse heartburn if they attempt to stop taking the medications. These studies finally provide an answer as to why so many people have been taking these medications for so many years and are resigned to taking them for the rest of their lives.
A new study published in the Archives of Otolaryngology – a journal of the American Medical Association – reports a link between over-the-counter zinc cold remedies and a loss of smell.
While Obama’s new Healthcare Reform laws have given approval to the next generation of lower cost, breakthrough drugs, called “biosimilar” drugs, these drugs will apparently not be required to undergo the same intensive clinical trial scrutiny as most other drugs. And while these drugs are similar, they are not the same and surely carry additional and different risks. Biosimilars are virtually identical formulas of drugs previously approved by the FDA; however, these “follow on-biologic” drugs are compounded drugs that are subsequent versions of innovator biopharmaceutical products – the are NOT generic drugs.
On July 13, 2010, the Food and Drug Administration reported in a drug safety alert, that it is requiring Sanofi-Aventis to place a black box warning on its rheumatoid arthritis drug, Arava. Since Arava warnings were strengthened more than seven years ago in 2003, at least 14 people have died due to Arava-induced liver damage and another 49 people suffered severe liver injury. And this is after Public Citizen a consumer watchdog organization, warned the public that there were at least 130 cases, including 56 hospitalizations and 12 deaths prior to 2002. Since 2003, there has been a bolded warning on the label alerting physicians to the possibility of liver injury from Arava.
Add blindness to the growing list of side effects caused by antidepressants like Paxil, Celexa, Lexapro, Effexor and Zoloft. It is well-known that these drugs have been linked to suicide and cardiac birth defects, among others, but now, a June article published in the medical journal Opthamology, has connected these popular drugs with cataracts in the elderly, potentially resulting in blindness for those individuals over the age of 65.
A June 30, 2010 article published in the New England Journal of Medicine and recently reported in Business Week, and Reuters has concluded that a new testosterone gel appears to raise the risk of heart-related problems in older men with limited mobility. This topical gel, thought to increase muscle mass in older men, prevents disabilities by helping them sustain strength and energy; however, the results of this recent study show that this gel also may cause heart attacks, strokes and chest pain, as well as skin problems.
On February 16, 2010, a unanimous New Jersey jury awarded over Twenty-Five Million Dollars ($25,000,000) to a young man who had five surgeries and had his colon removed as a result of Accutane-induced Inflammatory Bowel Disease (IBD). This verdict was reached after a retrial of the same case where a previous jury awarded $2.62 million and is the largest verdict of the six Accutane lawsuits to go to trial. Since the verdict, over one hundred (100) new Accutane cases have been filed in New Jersey alone, adding to the over eight hundred (800) cases still awaiting a trial date.
The Food and Drug Administration has recently added a warning to the popular diets drugs, alli® and Xenical®.
Johnson & Johnson strengthened the warnings concerning the risk of suicide with painkillers Ultram and Ultracet after deaths were reported in patients with a history of emotional disturbance or drug and substance abuse. Ultram and Ultracet are indicated for the management of moderate to moderately severe chronic pain. In letters released yesterday by the U.S. Food and Drug Administration ("FDA"), J&J has informed doctors the Prescribing Information for the drugs has been updated to explain that the active ingredient, opioid tramadol, contained within the drugs may be more potent when combined with alcohol, different painkillers or drugs that depress the central nervous system.
A division of Johnson & Johnson has recalled 43 over-the-counter medicines made for infants and children, including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl, as a result of deficiencies at the company’s manufacturing facility.
With over 1.2 million women in 32 countries currently using it, the NuvaRing, a plastic ring of hormones inserted vaginally once a month, has become a popular alternative to daily oral contraceptives. Despite its popularity, however, many users of the NuvaRing are reporting serious side effects, which include blood clots, deep vein thrombosis, heart attack, pulmonary embolism, and stroke.
Last week, the Food and Drug Administration issued a new warning that high doses of Zocor, a popular cholesterol drug, and its generic forms, can cause serious and lethal muscle and kidney damage.
Last Friday, the Food and Drug Administration said that it will add a Black Box warning to the popular blood thinner, Plavix. The drug is marketed to physicians and patients on television as a drug that will prevent against a future heart attack or stroke. Notably, the Plavix website makes no mention of the recent black box warning.
Two new studies recently indicate that certain osteoporosis drugs, which are supposed to strengthen bones and protect people from fractures, are actually increasing the risk of spine and hip fractures if taken for more than five years. These bisphosphonate drugsare some of the most widely prescribed drugs in the world.
The drug Fentora is Cephalon’s next generation narcotic painkiller which is only approved for cancer patients who are in severe pain and already taking morphine or other painkillers. In other words, this drug should only be used for those cancer patients whose normal pain medications are not providing pain relief. This highly addictive drug is considered a “Class II” opiate, 80 times more powerful than morphine. So why are thousands of patients taking this drug for migraines, back pain and other injuries?
Recently, the safety warnings were strengthened for the diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease. Specifically, the US Food and Drug Administration ("FDA") notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.
According to a recently released Danish study, pregnant women taking an SSRI were twice as likely to have pre-term delivery as other women, and their babies were also more likely to be admitted to an intensive care unit after delivery. Specifically, women taking an SSRI delivered their baby an average of five days earlier and babies exposed to antidepressants during pregnancy were far more likely to have a five-minute Apgar score -- a measure of a newborn's health scored between 0 and 10 -- of seven or below. Any score below seven is generally regarded as low.
Additionally, the study found that women who take more than one SSRI quadrupled the risk of their babies experiencing a septal heart defect, which is a defect in the wall that divides the heart’s left and right sides. For those women taking only one SSRI, the study revealed that use of Celexa and Zoloft early in pregnancy doubled and tripled the risk for the heart defect, respectively. While the association between SSRIs and birth defects has been reported for several years, this is the first study to specifically highlight the increased risk with Celexa and Zoloft.
On July 16, 2009, the FDA announced that it has begun a safety review of Genentech's asthma drug Xolair (omalizumab) after reports of an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The Xolair safety review was prompted by interim results from an ongoing study of 5,000 patients with allergic asthma, in which half of the patients took Xolair and half did not. The early results showed a "disproportionate increase" in certain cardiovascular and cerebrovascular problems in patients treated with Xolair.
On August 11, 2009, the British Medical Journal published an article detailing the results of a study aimed at measuring the association between modern antidepressants (Prozac, Paxil, Zoloft, Celexa, Lexapro, etc.) and increased suicidal thinking and conduct. August 11, 2009 BMJ Article
On August 4, 2009, the Food and Drug Administration stated that it had completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. Therefore, the FDA said that a new cancer-related warning will be added to the black boxed warning that’s already on this category of drugs, which includes Remicade, Enbrel, Cimzia, Simponi, and Humira. Additionally, the FDA is requiring that the warning also be modified to specifically reflect the occurrence of leukemia and new-onset psoriasis in patients of all ages being treated with TNF blockers. The current boxed warning only alerts users to a risk of serious infections that can be fatal.
Recently, the FDA advised consumers to stop using Zicam intranasal products, including Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs (Kids Size). These products contain the active ingredient zinc gluconate and are manufactured by Matrixx Initiatives, Inc., which had been marketing and selling the products as over-the-counter homeopathic cold remedies.
On July 29, 2009, the FDA reported a voluntary recall of the dietary supplement “Steam,” which is manufactured and sold by Nutracoastal Trading, LLC. FDA Safety Summary.
Yesterday, July 28, 2009, the FDA issued a Public Health Advisory recommending that consumers not use certain over-the-counter products marketed as containing “steroid-like ingredients.”
In his July 24 ruling, U.S. District Court Judge Bill Wilson, Jr., granted public access to evidence that Wyeth Pharmaceuticals "ghostwrote" medical articles regarding its hormone therapy drug Prempro, which a national study has shown increases a woman's risk of stroke, heart attack, blood clots, cardiovascular disease, and cancer. The Arkansas federal judge held that there was no good cause for secrecy and ordered that the documents be made publicly available as of 5:00 p.m. on Friday, July 31.
The European Association for the Study of Diabetes ("EASD"), which publishes the journal Diabetologia, released new data suggesting that there is a “possible link” between French drug maker Sanofi-Aventis’s Lantus insulin (or insulin glargine) and a higher risk of cancer. Lantus insulin has been widely used since 2000 among diabetes patients who depend on insulin to regulate blood sugar because the injection is needed only once-a-day in lieu of more frequent therapies. Of particular import is that this type of insulin is synthetic, not human insulin. The EASD article suggests that further evaluation of the possible association is necessary but does not purport to recommend that anyone stop taking their insulin.
A new study from the May 27 issue of the Journal of the American Medical Association (JAMA) entitled "Acid-Suppressive Medication Use and the Risk for Hospital-Acquired Pneumonia" has found that hospital patients who are given certain heartburn drugs like Prilosec, Nexium, and Prevacid are at higher risk for pneumonia than those who are not given these medications. In fact, the study determined that there was a 30% increased risk for pneumonia among hospital patients taking these types of medications, called proton-pump inhibitors (PPIs).
This week, the Food and Drug Administration (FDA) notified doctors and other healthcare professionals about the risk of serious liver injuries, including liver failure and death, related to use of the antithyroid drug Propylthiouracil. Propylthiouracil is considered a second-line drug to Methimazole in the treatment of hyperthyroidism and Graves' Disease. Methimazole only had five reports of serious liver injuries associated with it compared to the thirty-two (32) reported cases associated with Propylthiouracil. Thirteen of those thirty-two cases resulted in death.
Earlier this month, the Food and Drug Administration and AS Medications Solutions LLC (a repackaging company) announced a nationwide recall of all lots of Caraco brand digoxin distributed prior to March 31, 2009. There is uncertainy over the actual amount of the active ingredient present in each pill, with some tablets containing more or less than the intended .25mg. Digoxin is a drug used in the treatment of heart failure, atrial fibrillation, and abnormal heart rhythms. Accordingly, any unintended dosage can have serious consequences. An overdose of digixin can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, slow heart rate, and even death in extreme cases. Meanwhile, a patient getting a lower dose than expected is at risk for heart failure or abnormal heart rhythms.
At the end of February, the FDA ordered that a "black box" warning highlighting the risk of tardive dyskinesia ("TD") and other serious neurological side effects be placed on all drugs that contain metoclopramide, including Reglan. Although the FDA has long been aware of the risk of TD when dopamine blockers such as Reglan are used, apparently the drug is still being prescribed for longer periods of time than the 4-12 week recommendation, which only further increases the likelihood of developing TD, an untreatable disorder with life-altering, sometimes permanent, symptoms.
As we reported in October, pharmaceutical drug manufacturer, Genentech, was required by the Food and Drug Administration (FDA) to put a black boxed warning on the labeling for Raptiva regarding its association with dangerous and life-threatening infections like progressive multifocal leukoencephalopathy ("PML"). Today, Genentech voluntarily withdrew Raptiva, a psoriasis drug, from the market as a result of those risks.
The U.S. Federal Food & Drug Administration is warning healthcare professionals today that transdermal patches (medicated patches applied to the skin) “containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch.”
Before having a colonoscopy, patients have to go through the process of flushing out their bowels. However, new information indicating that this may be the most dangerous part of the procedure, as the drugs products that assist in the flushing may pose a risk of acute kidney injury.
The Food and Drug Administration has mandated Salix Pharmaceuticals Ltd., the manufacturer of two of the most commonly used prescription flushing products, Visicol and OsmoPrep, to put a "black box" warning on its labels. A "black box" warning is the most severe warning that the FDA issues on prescription medications. The agency further directed the drug manufacturer to conduct a clinical trial to specifically assess the risk of the products, especially to the kidneys.
The FDA recently announced that it would consider whether to pull GlasxoSmithKline’s former top-selling drug, Avandia, off the market or allow it to stay on the market with stronger warnings after discovering evidence indicating that the drug may cause liver toxicity, resulting in liver failure and death.
A recent article published by the Public Library of Science Medicine (PLoS Medicine), has highlighted new innovative ways in which pharmaceutical companies are promoting medications for off-label use.
Pfizer has recently announced that it will "resolve substantially all of the personal injury cases, consumer fraud cases and state attorneys general claims involving its non-steroidal anti-inflammatory (NSAID)" pain medications Bextra and Celebrex, which Pfizer voluntarily withdrew from the U.S. market in 2005.
Just this week, the psoriasis drug Raptiva received a “black box” warning, the FDA’s strongest, regarding progressive multifocal leukoencephalopathy (PML) and other potentially fatal infections. Raptiva, manufactured by Genentech, is a medication given via weekly injection to treat moderate to severe plaque psoriasis in adults only. Raptiva is a biologic drug that works to suppress the immune system with the goal of fewer psoriasis flare-ups. However, as with any immunosuppressant, the use of Raptiva compromises the immune system to such an extent that it increases the risks of serious infections, some fatal, and other malignancies.
In newly filed court documents, evidence has surfaced showing that top marketing executives from Pfizer "suppressed a large European study suggesting their blockbuster medication Neurontin was ineffective for chronic nerve pain."
A recent government study published in the American Journal of Psychiatry, has concluded that two of the most commonly prescribed atypical anti-psychotics, Janssen's Risperdal and Eli Lilly's Zyprexa, “neither performed any better in children and adolescents than an older generic drug.”
On August 28, 2008, the Law firm of Pogust, Braslow, & Millrood, LLC filed a complaint in the U.S. District Court for the District of Minnesota, against Johnson & Johnson, Inc., alleging that its antibiotic Levaquin caused a woman to suffer a tendon rupture.
The American Medical Association (AMA) is ramping up its efforts to stifle the stigma of impropriety among consumer advocates and patient groups, by proposing to add specific guidelines requiring physicians to disclose their financial ties to the pharmaceutical and medical device industry with patients.
Use of the cholesterol drugs Zocor (Simvastatin), Zetia (Ezetimibe), and Vytorin (Simvastatin + Ezetimibe) may be associated with an increased risk of some types of cancer.
On August 21, 2008, the FDA posted an alert on its website, advising that early results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial indicated not only that Vytorin appears to be ineffective in reducing overall cardiovascular risk, but that the drug may bring with it an increased risk of a variety of cancers, including skin cancer.
In typical fashion, the FDA’s communication, available at http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm, follows the language alerting of the SEAS results with language equivocating as to the accuracy of the results, stating that other larger studies have shown no link between cholesterol-lowering drugs and cancer.
Although the FDA advises that consumers should not stop taking these drugs, it does not expect final SEAS results for another 3 months and will take an additional 6 months to review those results.
If your doctor has advised you that your ingestion of a cholesterol lowering drug may have contributed to any form of cancer that you have developed and you would like to consult with an attorney, please visit our website at http://www.pbmattorneys.com, or call us directly at (888) 348-6787.
Yet another supposed “all natural” or “herbal” supplement for erectile dysfunction contains precisely the ingredient that frequent users are intending to avoid. After an FDA lab analysis of a sample of the Viapro revealed that it contained an undeclared and potentially harmful ingredient, thio-methisosildenafil, EG Labs, LLC, announced that it is recalling all lots of its supplement product in 375mg capsules. Thio-methisosildenafil is an analog of sildenafil, which is the active chemical ingredient of several FDA-approved drugs used for Erectile Dysfunction (ED) in men to enhance sexual performance.
In a 2006 presentation at an American Academy of Orthopedic Surgeons meeting, evidence was presented that showed that the anesthetics contained in pain pumps used after shoulder surgery lead to Postarthroscopic Glenohumeral Chondrolysis (PAGCL). In fact, studies now suggest that up to 63% of arthroscopic shoulder surgery patients who receive a post-operative pain pump may develop PAGCL. The condition leads to a lifetime of suffering, has no consistently successful treatment, and often results in permanent shoulder pain, loss of mobility and further surgery, specifically shoulder replacement surgery.
The Associated Press is reporting Schering-Plough and Merck's recent clinical trial fiasco involving their highly touted anti-cholesterol pill Vytorin, whereby a “European study in patients with heart valve disease found the drug didn't prevent worsening of the disease or lower the need for valve surgery.”
The American Academy of Pediatrics is now recommending cholesterol screening of children and adolescents, starting as early as the age of 2 and no later than the age of 10, especially if they come from families with a history of high cholesterol or heart attacks before 55 for men and 65 for women.
The FDA has now issued a Black Box Warning to healthcare professionals setting forth the "increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use."
On January 31, 2008, the FDA issued a warning to Health Care Professionals of an “increased risk of patients having suicidal thoughts and behaviours as a result of taking antiepileptic drugs for epilepsy, bipolar disorder, migraines, and other conditions.”
The current labeling for Levaquin presently warns that “ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin.”
On November 18, 2004, Pfizer, Inc., the manufacturer of Depo-Provera, a contraceptive injection, issued a warning to Health Care Professionals that “women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density.”
Hormone therapy has been in use as a purported treatment for women’s menopausal symptoms and the prevention of osteoporosis for almost three decades. Throughout the United States, in both State and federal courts, there are currently about 7,900 claims pending by women who have allegedly been injured by combination hormone therapy. The thrust of these lawsuits, which are being prosecuted against Wyeth and other makers of synthetic hormones, is that combination hormone therapy (horse estrogen plus synthetic progestin) can cause breast cancer, that Wyeth and the other drug makers have known about this risk for decades, and that the drug makers failed to warn physicians or consumers until they were forced to do so in July 2002. Publication of the results of a government-run study entitled the Women’s Health Initiative (WHI) in July 2002 revealed that women taking combination therapy, including Wyeth’s Prempro, are at in increased risk for invasive breast cancer, heart attack, stroke, pulmonary emboli, and deep vein thrombosis. The lawsuits also allege that Wyeth and the other drug makers illegally promoted the drugs for unapproved indications, including the prevention of cardiovascular disease, and that the companies over-promoted the benefits of the drugs while attempting to downplay their risks.
Products liability cases involving modern antidepressants in the class known as Selective Serotonin Reuptake Inhibitors (“SSRIs”) have enjoyed a relatively consistent, if intermittent, place in the media spotlight since the turn of the millennium. The SSRI group includes Prozac, Paxil, Zoloft, Luvox, Celexa, and Lexapro, and there have been a number of events thrusting these drugs into the spotlight, including two of the more prominent cases: that of 12-year-old Christopher Pittman, who killed his grandparents while he was experiencing what was alleged to be a violent reaction to Zoloft and Paxil; and that of 60-year-old Donald Schell, who killed his wife, their daughter, their granddaughter, and then himself after taking only two doses of Paxil. The former resulted in a murder conviction and thirty-year jail sentence in South Carolina, while the latter resulted in a civil verdict of approximately $8 million in Wyoming federal court against the maker of Paxil, SmithKline Beecham.
The deadly effects of SSRIs on children and adolescents has been well-documented: the potential to initiate or exacerbate depression or even cause suicidal thinking or behavior. Several manufacturers began sending out “Dear Dr.” letters warning physicians of these risks in and throughout 2004. By January 2005, manufacturers of SSRIs – and a few other modern antidepressants not technically considered SSRIs (e.g., Effexor, Wellbutrin, Cymbalta) – began warning of the risks in a black box warning contained on the labeling for each of the drugs. In 2006, the black box warning was extended to those beyond their adolescent years, all the way up to age 25.
It continues to amaze me that some physicians still do not warn their patients of the dangers of anti-depressants despite the specific and bold warnings on these drugs to carefully monitor patients for worsening depression and suicidality. Even the drug manufacturers admit that it is absolutely necessary for patients’ families to closely monitor patients for any changes in behavior after beginning or changing a dose with antidepressant drugs.
Recently, the pharmaceutical drug Digitek was recalled because Actavis Group, the manufacturer of Digitek, produced the drug with twice the intended dose of the active ingredient. In other words, a defect in the manufacturing process led to a doubling of the active ingredient contained in each tablet. Therefore, patients prescribed Digitek were receiving twice the intended dosage of the drug, and as expected, suffered severe adverse reactions effects to this unintended overdose - especially if they were previously suffering from renal failure.
Recently, Baxter recalled its heparin products in the United States because of a contaminant found in the drug. Heparin is a drug used to prevent the formation of clots in the blood. The contaminant, a compound that looks like heparin under the microscope, was most likely added to the manufacturing process of the drug while in China.
The Federal Drug and Food Administration issued in June of 2006 (and later with additional FDA Alerts in December 2006 and May 2007), a warning to Health Care Professionals, concerning Gadolinium Based Contrast Agents (GMCAs), used for Magnetic Resonance Imaging (MRI) and the risk of contracting Nephrogenic Systemic Fibrosis (NSF).