Drug Injury Lawyer Blog

Two Recent Studies Underscore Addiction Risks of Nexium and Prilosec

2010-07-31T20:14:46Z

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.

]]> In prior blogs regarding drugs like Nexium and its sister Prilosec, we have discussed the increased risk of bone fractures, infections and pneumonia, among others, but now it turns out that not only do these drugs carry serious risks, they are addictive.

Certainly, there is no question that these drugs are very effective in relieving heartburn and treating other very serious esophageal conditions. AstraZeneca has earned billions of dollars marketing and selling Prilosec and Nexium over the course of the last two decades. However, please keep in mind that these PPIs were only approved for the treatment of short-term heartburn – and now millions of patients are forced to take these drugs for the rest of their lives – and not without risks.

Physicians who prescribed these medications in the 1990s and over the course of the last ten years were never warned of the risk of addiction or withdrawal symptoms. How many millions of patients approached their physician and tried to explain that their heartburn symptoms are worse whenever they stop taking their Prilosec? How many millions of patients and doctors thought they were beginning a short course of risk-free heartburn treatment, only to later realize that they could not stop taking the drug without disabling and painful heartburn – worse than it ever was prior to treatment?

The manufacturers of these drugs should be held responsible for failing to adequately warn physicians and patients about the risk of worsening heartburn upon completion of therapy.

Zinc Cold Remedies Linked to Loss of Smell

2010-07-23T15:13:15Z

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.

]]> This is yet another indictment of zinc-based intranasal cold remedies. Last year, in June 2009, the FDA issued a Public Health Advisory warning consumers to stop using intranasal – i.e., gel and swab – Zicam products. The agency cited consumer reports of hyposmia (partial loss of smell) and anosmia (total loss of smell). At the time, the FDA also sent a warning letter to the maker of Zicam, Matrixx Initiatives, advising the company that it was not permitted to market the product without FDA approval. The FDA’s June 2009 actions came on the heels of Matrixx’s settlement of over 300 lawsuits arising from adverse effects on the sense of smell.

Next Round of Product Liability Lawsuits Could Go Against Makers of Biosimilar Drugs

2010-07-22T20:15:20Z

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.

]]> The safety record of biosimilar drugs, according to recent reports from "The Hill", indicate that Congress will allow the FDA to base its approval of biosimilars, in part, on the safety and efficacy record of the original breakthrough drug, rather than conducting new clinical trials. This will allow drug companies to put their drugs on the market much faster.

Unlike the more common small-molecule drugs, biologics generally have a high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to other processes necessary to manufacturer the drug safely. All they have access to is the commercialized innovator product. Health experts warn that differences in impurities and/or breakdown products can have serious health consequences, which was shown by a few instances in which manufacturing changes for innovator biologics led to adverse events . Naturally, this has created a concern that copies of biologics might perform differently than the original branded version of the product.

Although the principle for low cost, accessible pharmaceuticals is obviously very appealing, many medical experts remain firm that these drugs are not safe without thorough clinical trials to analyze their safety and efficacy. Pharmaceutical companies have consistently proven that their priorities are not consumers, but their own profits, and the competition to put the next great product on the market may cause safety protocols to be overlooked – leading to a new round of lawsuits involving biosimilars.

Finally a Black Box Warning for Arava

2010-07-16T21:44:08Z

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.

]]> According to the FDA, those patients at greatest risk of liver failure due to Arava are those patients who already had pre-existing liver problems and those taking other drugs like NSAIDs (Advil), acetaminophen, naproxen, hydroxychloroquine or statins. In addition, patients who are taking Arava should have regular blood tests to monitor their liver enzyme levels and pay particular attention to any usual symptoms, such as itchy, yellow eyes or skin, dark urine, loss of appetite, or light-colored stool.

Consumers have been urged to contacted their healthcare provider immediately if they experience any of these symptoms while taking the drug, as it could be indications of Arava liver injury.

Benefits of ADHD Drug Overstated

2010-07-14T15:01:35Z

Last week, as reported by the Associated Press, the FDA forced Shire, PLC to retract certain promotional materials after it scrutinized the claims made by the company regarding the benefits and risks of its drug Intuniv.

]]> According to the Intuniv label, the drug is approved for the treatment of symptoms related to attention deficit hyperactivity disorder in patients between the ages of 6 - 17. In a letter to Shire, dated June 22, 2010, the FDA stated that there were no clinical studies to support the company’s claims for improvement of “individual behavioral problems,” such as “bedtime blowups,” “homework hassles,” and “mall meltdowns” - issues that would obviously be appealing to frustrated and exhausted parents.

Further, the FDA cited serious health risks associated with certain inactive ingredients in Intuniv, such as hypotension, bradycardia, and syncope if given to patients with a history of hypersensitivity to these ingredients. It also emphasized that the way in which the drug was marketed was misleading and false, noting the clinical brochure’s pictures and phrases. For example, the “Parents’ Guide” presented the image of a child in a monster suit, representing a patient with ADHD, and depicted it next to statements such as “Reveal the kid within, A difference the whole family can see… (Brochure Holder, Waiting Room Brochure cover…that’s where INTUNIV comes in…”(Parents’ Guide). “Imagine the moments ahead,” was a recurring tagline in the promotional materials, as well.

The FDA cited numerous specific discrepancies between Shire’s claims and the medical community’s research, and ended with a request for Shire to immediately withdraw the promotional materials for Intuniv, as described in the letter.

Rapamune Off-Label Marketing Allegations

2010-07-06T16:24:21Z

In February 2010, federal prosecutors opened an investigation into promotional efforts by Wyeth – which is now under the umbrella of Pfizer, following their merge in late 2009 – relating to its transplant drug, Rapamune (sirolimus). Rapamune is a “immunosuppressive agent indicated for the prophylaxis of organ rejection in patients … receiving renal transplants.” In other words, the drug is meant to help the body accept a kidney transplant.

]]> In May, two former Wyeth hospital sales representatives, Marlene Sandler and Scott Paris, filed a whistleblower lawsuit against Wyeth in federal court in the Eastern District of Pennsylvania. The suit alleges that Wyeth illegally promoted Rapamune – which is indicated only for kidney transplants – for treatment in patients recovering from a variety of other transplant types, including heart, lung, liver, and pancreas.

Now, Congress has joined in the investigation, and Rep. Edolphus Towns (D-NY), Chairman of the House Committee on Government Oversight and Reform, is decrying the allegations in the whistleblower suit that Wyeth’s off-label tactics were targeted at African Americans. In Rep. Towns’ letter to Pfizer CEO, Jeffrey Kindler, he has requested that the company turn over a variety of information and documents related to Rapamune and Wyeth’s promotional tactics. Although the letter requested production of these materials to the House Committee by the close of business on Monday, June 28, 2010, there is still no word as to whether Pfizer has complied, or if it has complied, what the materials show.

Antidepressants Now Linked to Cataracts, Blindness

2010-07-02T18:42:44Z

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.

]]> According to Medpage Today the researchers opined that the link between these medications and cataracts is due to serotonin receptors found in the lens of the eye.

Researchers quoted in Opthamology claim that while the chances of developing cataracts are generally increased by about 15 % with an antidepressant, it is even worse for some specific kinds of antidepressants — Fluvoxamine (Luvox) increases the risk by 39 percent, venlafaxine (Effexor) increases the risk by 33 percent and paroxetine (Paxil) increases the risk by 23 percent.

And with 10% of the U.S. population taking antidepressants, even at just a 15 % increased risk, 22,000 Americans would theoretically develop cataracts as a result of their antidepressant use, the study authors noted, according to USNews and World Report.

However, the good news is that increased cataract risk is only associated with current antidepressant use, not prior use.

Testosterone gel linked to heart attacks and stroke

2010-07-02T18:14:30Z

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.

]]> The study, funded by the National Insitute of Aging of the National Institute of Health, called Testosterone in Older Men with Mobility Limitation (TOM Trial) involved the testosterone gel product, known as Testim manufactured by Auxilium Pharmaceuticals The study was terminated before enrolling all of the subjects, because so many subjects were developing serious cardiac and dermatologic problems. More than 20% of the subjects in the study developed heart-related problems, and these health risks lasted up to three months after ending the study. There was one death reported in the trial, apparently from a heart attack.

In a Reuters interview with the author of the study, Shalender Bhasin, MD, of Boston University, Dr. Bhasin cautioned that prescribing testosterone to older individuals raises important safety questions and treatment poses a serious risk. Notably, testosterone is not approved by the FDA for older men with mobility issues.

Questions are now being raised about whether the age of the recipients is the main issue, and whether the product may be safe to give to younger men.

J&J and McNeil Recall Update

2010-07-01T15:17:29Z

Add five more lots of over-the-counter medicines – four of Benadryl and one of Extra Strength Tylenol – to the growing number of products recalled by Johnson & Johnson’s McNeil Consumer Healthcare division this year.

]]> If you’re counting, this is McNeil’s sixth product recall of 2010. And the year is only reaching its midpoint. The recalls have now mounted so significantly for McNeil – one in January, three in March, one in April, and one in June – that is has created a “recall” website for the sole purpose of keeping consumers informed and updated about the company’s various tainted products.

Although McNeil and the FDA continue to reiterate that they do not believe that the recalled products pose any “serious” risks, it is becoming disturbingly clear that many adults and children have used or been exposed to a wide range of very common – indeed, staple – cold and pain remedies that should not have been on the shelf.

Veteran’s Affairs Hospital Infection Scandal

2010-07-01T15:07:23Z

Earlier this week, the John Cochran VA Medical Center in St. Louis, Missouri began sending letters to armed forces veterans to advise them that they may have been exposed to blood borne pathogens while receiving dental care at the facility.

]]> Specifically, the letters are being sent to approximately 1,800 veterans in Missouri and Illinois who were treated at the facility between February 2009 and March 2010, warning them that they may be at risk for hepatitis B, hepatitis C, and HIV. According to a CNN report, the exposure was the result of improper cleaning of dental instruments by staff at the facility. Apparently staff members were hand-washing tools in addition to using cleaning machines, and hand-washing is against standard rules and protocol.

Rep. Russ Carnahan (D-MO) is outraged, commenting that the facility’s failure to maintain basic health standards is “simply unacceptable” and calling for those responsible to be disciplined.

If you or a loved one received a letter from John Cochran VA Medical Center or believe you were affected by this health risk, you may have a legal claim. Contact our firm today to help you assess your claim and explore your rights.

Inflammatory Bowel Disease Lawsuits on the Rise Even After Accutane is Pulled From the Market

2010-06-10T17:32:34Z

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.

]]> Accutane had been available to treat acne sufferers since its introduction in 1982, but its manufacturer, Roche Holding AG (Roche), pulled it from the market exactly one year ago in June 2009. Accordingly, while there are still generic versions of Accutane available, suits against Roche will most likely come to an end over the course of the next year as fewer and fewer people will no longer be ingesting Roche’s long-standing drug. The reasons for pulling Accutane seem quite obvious: multiple jury verdicts as a result of Roche’s failure to strengthen Accutane’s warnings concerning IBD, ulcerative colitis, birth defects and depression – along with increased competition from generic manufacturers.

Despite the significance of these verdicts, these lawsuits, like all pharmaceutical cases, are won and lost based upon manufacturer’s conduct. Proving liability can be difficult, especially when warnings related to the risk at issue are already on the drug’s label.

The labeling regarding Accutane has, at a minimum, cautioned physicians about the association between Accutane and IBD. And by 2000, the label contained warnings concerning IBD. Still, despite these warnings, multiple New Jersey juries have now found that these precautions and warnings were inadequate to warn physicians about the true risk of this drug. In other words, these juries concluded that Roche was not being completely truthful with physicians concerning the extent of the IBD risk caused by Accutane and that caused the plaintiff’s injury.

In late 2009, a study presented to the American College of Gastroenterology, concluded that the chance of developing IBD was increased 68% for people who ingested Accutane, compared to those who did not. The risk of developing IBD increased as patients ingested more of the drug.

If you or a member of your family has suffered damages as a result of ingesting Accutane, please contact us at Pogust Braslow & Millrood.

"Phantom Recall" of Motrin by McNeil Consumer Healthcare in 2009

2010-06-04T17:15:46Z

Even after the recent string of product recalls, including a massive May 2009 recall of over 40 children’s medications, for McNeil Consumer Healthcare, the pharmaceutical arm of Johnson & Johnson, the bad news keeps piling up.

]]> This blog has been covering the expansive May 2009 recall and recently reported on the Congressional investigation and the May hearing before the House Committee on Oversight and Government reform. Consumers can watch a webcast of the hearing and access related documents and links from the committee’s public website.

But McNeil’s headache appears far from over. The committee’s investigation turned up a McNeil internal memorandum, dated June 12, 2009, wherein the company sent out orders to contracted agents to go into stores and pharmacies and buy up a tainted Motrin product, Motrin IB Caplet 8 ct. Vial. McNeil dubbed the project the “CSCS Motrin Purchase Product,” and apparently attempted to effectuate the buy-up procedure in lieu of any public notice or official product recall. Apparently the FDA eventually became aware of McNeil’s efforts, and McNeil went along with an official Class 2 recall that was then initiated. Still, it is unclear to the FDA and to the House committee whether McNeil ever made any effort to alert the public of the Motrin issue at the time.

The House committee is less than pleased about the memo, and committee Chairman Edolphus “Ed” Towns (D-NY) sent a letter to Johnson & Johnson CEO, William C. Weldon, requesting that the company produce documents related to the “phantom recall” by June 7, 2010.

Intravenous Medications Recall

2010-06-01T17:25:07Z

The FDA has announced a Public Health Alert and a recall of a handful of intravenous medications manufactured by Claris Lifesciences.

]]> The recall covers the medications metronidazole and ciprofloxacin, which are antibiotics, as well as ondansetron, which is an antiemetic used to treat nausea and vomiting induced by chemotherapy or surgery. All three medications were produced on the same manufacturing line but were sold under labeling by Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals. The recall stems from reports of “floating matter” in IV bags, including white matter found in at least one IV bag of metronidazole. The substance was later identified as Cladosporium mold, which can cause infections in susceptible patients.

Alli and Xenical Diet Drugs Can Cause Liver Damage in Rare Cases

2010-05-27T15:24:48Z

The Food and Drug Administration has recently added a warning to the popular diets drugs, alli® and Xenical®.

]]> The FDA identified 13 instances of liver damage associated with these diet drugs. alli® is sold over the counter and is manufactured by GlaxoSmithKline. According to Glaxo, more than 10 million people have used alli® since it first came to the market in 1999. Xenical® is the prescription version and is manufactured and marketed by Roche.

The FDA has urged doctors and patients to watch for signs of liver injury, which include yellow eyes and skin, itching and loss of appetite.

If you have any questions regarding these updated warnings or drug-related side effects, please contact Pogust Braslow & Millrood for more information.

Suicide Warnings on Two Painkillers Increased

2010-05-26T21:28:42Z

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.

]]> These warnings describe and emphasize the risks of suicide in patients who are addiction-prone, and taking tranquilizers or antidepressant drugs. Further, tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause depression, which can lead to accidental overdose, the effects of which can include CNS depression, respiratory depression and death.

Accordingly, J&J now recommends in bold faced print that healthcare providers use extreme caution when giving Ultram and Ultracet to depressed patients, to those on tranquilizers or antidepressants, or to those who drink excessive alcohol. Additionally, J&J specifically states that the drugs should NOT be prescribed to patients who are suicidal or prone to addiction.

This news comes only several weeks after J&J was forced to into a massive recall of over 40 varieties of children's cold medicines (including infant Tylenol, Benadryl and Motrin) after finding quality control problems at a plant in Pennsylvania including bacterial contamination and higher than expected dosages in the medication.

If you have any questions regarding these updated warnings, recalls, or any other adverse drug related side-effects, please contact Pogust, Braslow and Millrood for more information.