Drug Recall Lawyer Blog

A recent study has found that there is new evidence that statins could increase women’s risk factor for type 2 diabetes.

Statins, often called wonder drugs, are medicines taken to lower cholesterol levels. Zocor, Lipitor, and Crestor are the most popular of these medications that reduce the risk of heart disease and stroke. Tens of millions of Americans take these medications, but a recent study that followed more than 150,000 women over the age of 50, with and without heart disease, found that those taking statin drugs had a 48 percent greater chance of developing type 2 diabetes. Doctors say that don't know why statins increase diabetes, and that the research does not implicate any single brand. These findings seem to confirm prior smaller studies.

Now, I’m not saying that anyone should panic and stop taking their medication, since heart disease is one of the major complications of diabetes, but the risk is certainly something to consider and, ultimately, discuss with your doctor. Does the benefit outweigh the risk? It is going to depend on the patient.

• Cardiomyopathy and Diabetes: Crestor Lawsuits
• Zocor Warnings Rewritten

The FDA is advising that an additional concentration of liquid acetaminophen marketed for “infants” is now available. The new concentration, 160 mg/5 ml, will affect the amount of liquid given to an infant, and should be especially noted by consumers who re used to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

The Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache.

Acetaminophen is marketed under brand names such as:

• Tylenol
• Little Fevers
• Triaminic
• Infant/Pain Reliever
• Pedia Care
• Triaminic Infants’ Syrup Fever Reducer/Pain Reliever
• store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.)

The FDA is recommending that consumers read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use.

• Hydrocodone/Acetaminophen Recall
• Tylenol Linked to Asthma?
• Use of Acetaminophen in Pregnancy Associated With Increased Asthma Symptoms in Children
• Tylenol Liver Damage Symptoms and Information

The FDA Safety Information and Adverse Event Reporting Program has announced that the FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

Gilenya is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults, and is used to reduce the frequency of flare-ups and delay physical disability.

The FDA believes - as do most neurologists - that Gilenya provides an important health benefit when used as directed, and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. The FDA recommends - obviously - that patients with MS not stop taking Gilenya without talking to their doctor.

The FDA is continuing to evaluate this case as they are not able to conclude whether the drug resulted in the patient's death. The FDA will communicate any new information that results from this investigation.

I suspect Gilenya is a great drug. But the FDA is doing the right thing is taking adverse reports seriously with all drugs, particularly those that are new to the market.

Last month brought changes to forty-eight (48) medical product labels (holding steady with 48 changes in October), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

Cerebyx (fosphenytoin sodium)
Dilantin (phenytoin sodium, USP)
Dilantin (phenytoin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Mytelase (ambenonium chloride)
Onglyza (saxagliptin)
Amturnide (aliskiren/amlodipine/hydrochlorothiazide)
Combivir (lamivudine/zidovudine)
Emtriva (emtricitabine)
Epivir (lamivudine)
Epzicom (abacavir sulfate and lamivudine)
Isentress (raltegravir potassium)
Lioresal Intrathecal (baclofen injection)
Methotrexate Sodium for Injection
Retrovir (zidovudine)
Tekamlo (aliskiren/amlodipine)
Toviaz (fesoterodine fumarate)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trizivir (abacavir sulfate, lamivudine, and zidovudine)
Twynsta (telmisartan/amlodipine)
VFEND (voriconazole)
Videx (didanosine)
Videx EC (didanosine, USP)
Vimovo (naproxen/esomeprazole magnesium)
Viread (tenofovir disoproxil fumarate)
Zerit (stavudine)
Ziagen (abacavir sulfate)
Zyflo CR (zileuton)

• October 2011 Medication Label Changes
• September 2011 Medication Label Changes
• August 2011 Medication Label Changes

An advisory committee to the Food and Drug Administration has met to discuss popular birth control pills such Yas and Yasmin, and has concluded that the information on the labels should be strengthened.

Currently, the labels suggest that these contraceptives have blood clot risks similar to those of other birth control pills that combine estrogens and progestins. The panel, which voted 21 to 5 in favor of changing the labels, has said the labels should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots. They stopped short of recommending that they warn that the drugs are more likely than other contraceptive pills to cause blood clots. Instead, the experts suggested that the labels note that the evidence about blood clots is conflicting.

Continue reading "Stronger Label Urged for Birth Control Products, Yaz and Yasmine" »

Companies need to do a better job of warning about the risk of its products. Often, then don't warn because it would hurt sales of the drug or device.

But warning are not always as simple as plaintiffs' lawyers make it out to me, either, as the Archives of Internal Medicine points out in a research letter published online.

This does not change my view that drug companies' repeatedly intentionally fail to properly warn doctors and patients about the risk. But there is a bit of nuance going on in some cases... that we sometimes try to ignore.

Here are this week’s stories:

• Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
• Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
• PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
• AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
• Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
• Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
• More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

Here are some stories to follow this week:

• Tylenol Recall: Johnson & Johnson’s statement about the recall is here, and they have a blog post here (with some interaction with consumers via comments).
• Vyvanase and Off-label Marketing: John Mack has an interesting post analyzing an ad that might be promoting off-label use through subtle imagery. Is it off-label, or is just a picture? You be the judge!
• Maalox: The FDA posted a statement (scroll to the bottom) under Patient Safety News regarding the problems with confusing various types of Maalox, which can have disastrous results.
• April 510k Clearances: viewable here.
• Topomax: After the $81 million settlement with the DOJ over its drug Topomax, Johnson & Johnson sales reps are going to be randomly observed during sales pitches (HT: FiercePharma).
• Preemption and Generic Drugs: post by the For the Defense.
• Fosamax: I’ve been trying to get a post on this important decision, but it’s been a busy couple of days. Tom Lamb has a description.

Happy Monday!

Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

• Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
• Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
• FDA Chastises GE: The FDA warns GE that its website for Visipaque is misleading. Visipaque is a drug used with x-rays to provide clearer images, and the FDA reports that there is no data showing it to be safer than other contrast agents. GE is currently facing lawsuits on it’s MRI contrast dye, Gadolinium.
• Meridia: Tom Lamb and the Drug Injury Watch report on a possible Meridia drug recall.
• Glaxo and Merck Disclose (Hide?) Payments to Doctors: The TortsProf Blog cites a story about Glaxo and Merck publicizing the money they give to doctors. The blog reports that the disclosure lists were “difficult to locate.”
• Hormone Therapy: Bloomberg reports that a judge denied Pfizer’s attempts to forcibly remove a YouTube video on hormone therapy, posted by Plaintiffs’ attorneys. The judge did, however, require the attorneys to rename the video and indicate it was not a news segment (which was obvious from watching the video). See the video here.

Happy Tuesday!

Some noteworthy news items to start your week:

• Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
• Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.
• FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
• Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:

Continue reading "Pennsylvania Appellate Court Overturns JNOV In Hormone Therapy Case" »

The Tylenol recall has been expanding. When it first started in November 2009, it was limited to five specific lots. Now, the FDA is reporting that the recall includes all Tylenol Arthritis Pain 100 Count with [Red] EZ-Open Cap.

The defect at issue is that the pills feature a moldy, musty smell, and some users have complained of nausea, stomach pain, diarrhea and/or vomiting. The source of that defect is the chemical 2,4,6-tribromoanisole (interestingly enough, also a component to some issues of cork taint in wine), which was used to treat wood pallets transporting and storing the packaging materials.

The Tylenol recall page has more information on refunds and returns. They’ve done a solid job of advertising the recall in the media and on their websites. Good job to the manufacturer, McNeil Consumer Healthcare.

Here are some links to what’s going on the world of drug and device recalls, and pharmaceutical litigation:

• Numerous blog posts featuring inside information on Vytorin and Zetia research studies, including the Arbiter 6 study that we recently posted on (courtesy Schearlings-Got-Plowed).
  
• Twitter hashtag of information on the FDA’s Social Media Meeting (courtesy @skypen).
• FDA celebrates International Internet Week of Action by sending 22 warning letters to operators of websites for illegally selling unapproved or misbranded drugs to U.S. customers.
• Procter & Gamble recalls three lots of Vicks Sinex Nasal Spray, because of bacterial contamination.
• Google Scholar now available to perform legal research—free opinions from U.S. federal and state district, appellate and supreme court opinions.
• Visit the Drug Industry Document Archive (DIDA) for over 1500 drug company documents, many only revealed after litigation. Included are some Wyeth ghostwriting documents (courtesy Tom Lamb).
• Fun new blog on Evidence in Medicine.

Here’s a list of some important stories we’ve been tracking.

• Boston Globe article probing the financial ties between Massachusetts doctors and Eli Lilly, a large drug manufacturer. “When the [drug] company provides the power point [for the doctor’s presentation], the risk of bias is even greater.”
• Seattle Post Intelligencer article examining the fatal overdose of a 15-year-old teen with autism. Michael Blankenship had a dental procedure and was given a Fentanyl Pain Patch. These are typically product liability cases, but it looks like Michael never should have received the patch in the first place, so Michael’s family has filed a medical negligence complaint.
• Drug Recall of specific lots of Infants’ and Children’s Tylenol (Johnson & Johnson) because of bacterial contamination.
• Update on Vioxx settlement: $4.85 billion.

Stevens-Johnson Syndrome, courtesy MayoClinic.com

Johnson & Johnson’s HIV drug Intelence may cause deadly allergic reactions and liver damage. It has been linked to Stevens-Johnson Syndrome (also known as toxic epidermal necrolysis), an allergic reaction that starts with flu-like symptoms and a rash, and which may develop into blisters and shedding of skin. There has been one reported death from Intelence-related Stevens-Johnson Syndrome.

The drug company has appropriately warned physicians to watch for possible reactions, and the drug’s label has been revised. A copy of the letter (through Johnson & Johnson’s subsidiary, Tibotec Therapeutics) is posted here.

The FDA just issued a press release describing problems with TNF Blockers. TNF blockers have been approved for treatment of immune system diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

The problems are severe—these drugs may cause an increased risk of lymphoma, leukemia and other cancers, particularly in children. The FDA first disclosed problems in a June 4, 2008 communication, based on about 30 reports of cancer in children. The updated FDA analysis leading to this week’s warning is based on a review of 48 cases of malignancies, including 11 deaths. The FDA also had reports of 147 cases of leukemia in children and adults, including 30 deaths. It is still unclear how strong the association is, because there is a small population of children on TNF blockers, and those children are typically concurrently prescribed other immunosuppressive therapies.

Exmples of these TNF blockers include:

• Simponi (golimumab) by Johnson & Johnson
• Remicade (infliximab) by Johnson & Johnson
• Humira (adalimumab) by Humira
• Cimzia (certolizumab pegol) by UCB SA
• Enbrel (etanercept) by Amgen Inc. and Wyeth

We expect that lawsuits will be coming in, though there remains much work to be done on the science end. Hopefully there aren’t many children who have been affected by these drugs.

Our Yasmin/Yaz lawyers are investigating potential Yasmin/Yaz lawsuits throughout the country for women who have taken this birth control medication and now suffer from deep vein thrombosis (blood clot), pulmonary embolism, and/or strokes.

Yasmin/Yaz lawsuits allege, among other things, that Bayer knew or should have known that Yaz/Yasmin caused risks and did not adequately warn doctors about the risk.

Click on the link to find out more about the Yaz/Yasmin lawsuits.

Last week, we briefly mentioned the FDA’s new requirement of a black box warning (yes, we’re going to continue calling it a “black box warning”). This week, we had a one day trial that turned into a three day trial, so we’re just now getting to follow up on it.

The warnings will affect Pfizer’s Chantix (varenicline), GlaxoSmithKline’s Zyban and Wellbutrin (bupropion) and generic smoking cessation drugs (note—buproprion like Wellbutrin are often prescribed for depression and seasonal affective disorder). In addition to the warnings, the manufacturers will be required to create patient medication guides to fully disclose the risks of neuropsychiatric symptoms. Symptoms to be on the watch for include: hostility, agitation, depression, suicidal ideation, and behavior changes not associated with nicotine withdrawal. Those medication guides will be given to all patients who are prescribed the drugs. Finally, manufacturers are now required to conduct clinical trials to more fully explore causation.

The requirement comes on the heels of the FDA’s analysis of their MedWatch reports, which show that there may be a link between the drugs and suicidal events in patients with no history of psychiatric disease. However, the FDA first broached the topic of a possible problem back on November 20, 2007. See also the FDA’s recent newsletter on the topic here.

Today, the FDA stated that it will require Black Box warnings on Chantix (and related generics) to reflect the serious neuropsychiatric symptoms associated with patients who use the drugs. In particular, suicide and attempted suicide have been widely reported among those who attempt to use Chantix as an aid to stop smoking.

We'll update on this issue later this week. For now, see the FDA's notification here.

The FDA just released its Drug Safety Newsletter (Vol. 2, No. 2). The purpose of the newsletter is to provide post-market information to doctors and other healthcare providers about drugs on the market, and to encourage reporting of adverse events through the FDA’s MedWatch program. You can find the newsletter here.

The current issue focuses on three drugs, highlighted here:

1) Qualaquin (quinine sulfate): approved to treat malaria, Qualaquin is frequently prescribed off-label for nocturnal leg cramps, restless leg syndrome, neuropathy, and other problems. The adverse reporting system indicates that it may hematologic events, including thrombocytopenia (low platelet count). There’s no indication that the off-label use is effective.
2) Reclast (zolendronic acid): Reclast is used to treat osteoporosis and Paget’s disease. This bisphosphonate may cause acute renal failure.
3) R-Gene 10 (argine hydrochloride injection): R-Gene 10 is used to evaluate pituitary function. Most of the adverse event reports center around medication errors, including fatal overdoses, hypersensitivity, and other events.

Of course, consumers and healthcare providers should take care to notify the FDA of potential problems with any drug or medical device at www.fda.gov/medwatch/report.htm or 1-800-FDA-1088. This will help to get dangerous drugs recalled, and provides the impetus for additional safety tests.