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GlaxoSmithKline’s diabetes drug Avandia is in the spotlight again.

Confidential government reports say the medication can harm the heart and increase the possibility of heart attacks and heart failure in users, according to a recent New York Times (NYT) article. The Food and Drug Administration (FDA) reports say the drug should be removed from the market, writes the Times.

A Senate report quoted by the Times and released over the weekend says that GlaxoSmithKline (GSK) was aware of  possible cardiac risks associated with Avandia for years before such evidence became public.

The Senate report is the result of a two-year inquiry conducted by Sen. Max Baucus, chairman of the Senate Finance Committee, and Sen. Chuck Grassley, the committee’s ranking Republican. The two senators also asked the FDA to describe the steps it has taken to protect patients in an ongoing Avandia clinical trial since the agency has estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007, according a Senate press release.

GSK issued statements rejecting the conclusions of both the Senate and NYT reports and saying the drug is safe.

Avandia (generic name rosiglitazone) is prescribed to treat Type 2 diabetes. In 2007, the New England Journal of Medicine published a study warning of the possible cardiovascular risk of Avandia. Following the study, the FDA issued a warning about Avandia and GSK relabeled the diabetes medicine to flag the risk of heart failure. However, the FDA has allowed the drug to remain on the market.

As always, do not change medications without first consulting your doctor.

According to published reports, U.S. drug reviewers are calling on federal regulators to further study the effects of atypical antipsychotic medicines in children.  In a report published earlier this month, the staff of the FDA said a study of the medical literature found a direct link between treatment with atypical antipsychotics and adverse metabolic effects including abnormal weight gain and increases in cholesterol and blood pressure, particularly among younger age groups.

Specifically, the FDA analysis showed increased reporting of metabolic problems with Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel.

The concerns about Zyprexa and Seroquel are just the latest in a long history of potentially dangerous side effects associated with prescription medications.

To me, these reports are extremely concerning.  Back in January, a study in the New England Journal of Medicine suggested that newer, second-generation antipsychotics such as Seroquel might pose heart risks — specifically, a higher risk of sudden death due to cardiac arrest.  Then in April, the FDA found that Seroquel had too many safety concerns to make it a first-line treatment against depression or anxiety disorders.

That’s a lot of concern being raised about one drug in a single year.  Overall it seems that Seroquel — like many drugs — can be quite effective for certain patients. However, for many other patients there are wide reports of dangerous side effects.  More troubling is the fact that these drugs are often prescribed for children.

When you look at the three adverse studies that have come out this year, one wonders whether the FDA has done all the diligence it should to ensure that the drug is safe.  Do we know all we should about the side effects? Or should we expect a new round of research to tell us of even more risks?  Against this backdrop; perhaps the safety of the drug is not the only thing in question, perhaps the credibility and effectiveness of the FDA are as well.

There’s more on the newer class of antipsychotic medications at the U.S. Food and Drug Administration.

News developments that we’ll be watching at Sokolove Law:

Oil giant BP was ordered to pay $100 million in damages to contract workers after a federal  jury found that the company exposed the workers to toxic substances at its Texas City oil refinery in 2007, writes the Houston Chronicle. The story says that the plaintiffs alleged exposure to carbon disulfide while working on two refining units. BP said it will appeal the decision.

Tough new rules regarding the use of anti-psychotic drugs are being sought in the wake of a recent Chicago Tribune investigation that found the medications were sometimes used to “chemically restrain” elderly patients in Illinois nursing homes.  The Tribune reports today that health advocates are urging Gov. Pat Quinn’s Nursing Home Safety Task Force to target the problem.

People with pacemakers should think twice before undergoing an MRI scan.  ScienceDaily reports that FDA researchers have found that MRI scans may cause certain cardiac pacemakers to inadequately stimulate a patient’s heart due to the magnetic pulses from the MRI mixing with the electronic pulses from the pacemaker. This lack of stimulation could create a potentially dangerous situation for these patients, according to the article.

Industrial launderer Cintas has agreed to pay $6.5 million to settle a class action lawsuit alleging that it failed to pay a living wage to some of its laundry workers, writes the Associated Press. The tentative settlement provides $3.3 million in back wages and interest for more than 500 Southern California Cintas laundry workers at the company’s Ontario, Pico Rivera, and Whittier locations, according to a Workers United/SEIU press release. Cintas doesn’t admit wrongdoing in the settlement, says the AP.

Recent Recalls: The U.S. Consumer Product Safety Commission (CSPC) and the National Highway Traffic Safety Administration announced that Dorel Juvenile Group is voluntarily recalling about 477,000 Dorel infant car seat/carriers. These carriers were also sold under the Safety 1st, Cosco, Eddie Bauer, and Disney brands. Dorel said it has received 77 reports of the carrier handle fully or partially falling off. At least three injuries to infants have been reported, including a head injury, bumps, and bruises. The product can still be used as a car seat when properly installed, according to the CSPC.

We’ll be watching these developments here at Sokolove Law.

An Associated Press article says that the number of reported baby deaths linked to defective Simplicity cribs has risen to 11 total, including a September incident in which a 7-month-old died after part of a crib broke.  The Consumer Product Safety Commission said yesterday that 11 babies have died, according to AP; earlier recall announcements had reported only three deaths.  The recall of Simplicity-manufactured drop-side cribs began in December 2005, writes the AP. Hardware problems have led to more than 2 million being recalled.

Taking antidepressants may  slightly raise the risk of stroke and death in older women who take these medications, according to a new finding from the Women’s Health Initiative study. A
WebMD report says the study found that stroke risk was greater in postmenopausal women who took selective serotonin reuptake inhibitor (SSRI) antidepressants, although their overall risk was still very low.  Older women who took SSRI or tricyclic antidepressants also had a slightly higher risk of dying from all causes, compared to those who did not take the drugs, writes WebMD.

Recent Recalls

Around 22,000 toy dart guns sets are being recalled after an 8-year-old child who chewed on one of the darts died after it became lodged in his throat. The Consumer Product Safety Commission says that OKK Trading, which imported the Action Team play set, is voluntarily recalling the toy, sold at discount department stores nationwide from December 2006 through March 2008.

A nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, was announced yesterday by The Medicines Company and the Food and Drug Administration (FDA).  The product was recalled due to the potential presence of inert stainless steel particles. The particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs, according to the FDA.

News developments that we’ll be watching at Sokolove Law:

Grocery chain Albertson’s LLC agreed to pay $8.9 million to settle discrimination lawsuits filed by 168 black and Hispanic workers who claimed they faced racial taunts and graffiti while working in the company’s Denver warehouse distribution center, according to an Associated Press report. The three suits were initially filed on behalf of the workers by the Equal Employment Opportunity Commission. The AP said that Albertson’s maintains that the incidents occurred before it took over the distribution center in June 2006.

Cover Your Ears: Time writes that a unpublished report by German researchers has found that exposure to jet noise increases a person’s  increased risk of stroke, high blood pressure, and heart disease. The study, due to publish in January, reports that women exposed to jet noise have a 93% higher rate of hospitalization for cardiovascular problems (69% for men). Women also are 172% more likely to have a stroke due to jet noise exposure, says the magazine.

San Francisco may become the first US city to require cellphone radiation labels, writes the Associated Press. AP says that San Francisco Mayor Gavin Newsom is pushing legislation requiring cell phone retailers to post radiation levels next each phone in type as large as that advertising the price.

Recall: Atlas Operations, Inc. and the U.S. Food and Drug Administration (FDA) have notified consumers of a nationwide recall of the company’s dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. The FDA said its lab analyses found that some of the products tested contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making these products unapproved drugs. The active drug ingredient is not listed on the product labels. The undeclared ingredient may pose a consumer health threat because its interaction with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels.

At Sokolove Law, we’re here to help.

News developments that we’ll be watching at Sokolove Law:

Radiation from computerized tomography or CT scans performed in 2007 will cause an estimated 29,000 cancers that will result in the deaths of 15,000 Americans, warns a study published in the Archives of Internal Medicine. Two-thirds of the projected cancers will occur in women, one-third in people ages 35-54 at the time of their CT, and 15 percent in children or teens, according to a Reuters article. About 70 million CT scans were done on Americans in 2007.

The U.S. Consumer Product Safety Commission (CPSC) recalled millions of Roman shades and blinds today after receiving reports of several strangulation deaths in young children. CPSC has received reports of five deaths and 16 near strangulations, since 2006, in Roman shades, and three deaths, since 2001, in roll-up blinds. The CPSC and the Window Covering Safety Council are working to provide repair kits for the recalled shades, which were sold by retailers including Wal-Mart, Pottery Barn, Ace Hardware, West Elm, The Land of Nod, and JCPenney.

New Orleans Saints coach Sean Payton will carry the ball in a class-action lawsuit against Knauf Plasterboard Tianjin Co. Ltd., says a blog post at The Times-Picayune. Knauf is a Chinese company that made drywall that is believed to be corroding homes and making people sick. Payton, the suit’s lead plaintiff, was one of the first in Louisiana to link media reports of defective Chinese drywall to his family’s health problems and the failure of electrical and other equipment in his home. It is estimated that at least 550 million pounds of Chinese drywall has been imported into the United States since 2006 — enough to build 60,000 average-size homes.

Resolving Paxil lawsuits has cost GlaxoSmithKline almost $1 billion, according to a Bloomberg News report that cites court records and people familiar with the cases. This figure includes $390 million to settle suicide or attempted suicide cases linked to the anti-depressant drug, and $200 million to settle Paxil addiction and birth-defect cases. Bloomberg says Glaxo declined to confirm the $1 billion figure. Paxil went on the market in 1993.

Nursing home administrators in Illinois may soon face tougher disciplinary sanctions in cases of patient harm in their facilities as state officials push to improve elder safety. The Chicago Tribune writes that administrators are now seldom punished by the state entity charged with licensing them and other professional nursing home staff, despite reports of elder abuse.

Keep those you love protected from harm. At Sokolove Law, we’re here to help.

News developments that we’ll be watching at Sokolove Law:

Hardly kid stuff: Crucial safety data often goes unpublished from drug trials studying children, according to a new study in the Archives of Pediatrics and Adolescent Medicine. Even when such studies appear in peer-reviewed journals, half don’t focus on the new safety findings, writes Reuters.

First test: Law.com reports that January marks when the first in a long string of lawsuits over contrasting agents that allegedly cause nephrogenic systemic fibrosis (NSF) comes to trial. The suit, scheduled to take place in a San Francisco courtroom, focuses on Bayer’s Magnevist, a gadolinium-based contrast agent used to help doctors read MRIs.

Three years after the Vioxx scandal, the FDA has yet to implement key changes proposed by the GAO and others to help it better monitor drug safety, according to a story by the Associated Press. The recommendations followed in the aftermath of the FDA’s embarrassment over Vioxx, a blockbuster drug it approved in 1999 and had to pull in 2004 after it was linked to heart attack and stroke.

Rare but serious complications – including bleeding, infection, and death – may result from the use of negative pressure wound therapy (NPWT), according to the FDA. NPWT devices help in the healing and closure of wounds. The agency has issued a notification to health professionals and advice for patients regarding the complications.

Labeling change for Voltaren Gel (diclofenac sodium): Endo, Novartis, and the FDA notified healthcare professionals of revisions to the Hepatic Effects section of the anti-inflammatory drug’s prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

Bad things do happen to good people. Sokolove Law is here to protect your rights.

Pharma giant Pfizer Inc. was told by a Philadelphia jury this week it must pay $28 million in punitive damages to an Illinois breast cancer survivor who had used its hormone replacement drugs for more than a decade.

The decision follows an earlier $6.3 million award the jury ordered the company to pay to plaintiff Donna Kendall after deciding the drugs Premarin, Prempro, and Provera were “a substantial contributing factor” to her breast cancer and that pharma representatives failed to adequately warn her doctors about the drugs’ cancer risks.

The drugs are made by Pfizer business units Wyeth (Premarin and Prempro) and Pharmacia & Upjohn (Provera). Pfizer plans to challenge the verdict.

Kendall had taken the combination hormome-replacement therapy (HRT) for 11 years to counter the effects of menopause. More than 6 million women have used the therapy.

In 2002, the NIH-sponsored Women’s Health Initiative study asserted HRT patients had an increased risk of breast cancer, stroke, blood clots, and heart attacks—findings serious enough that researchers halted the study three years early.

Sokolove Law continues to evaluate cases surrounding Prempro and other estrogen and progestin combinations.

It is undoubtedly one of the miracles of modern medical technology.  Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) are minimally invasive medical tests that help physicians diagnose and treat medical conditions.

But about four years ago some concern began to arise about the use of so-called contrast agents that are injected into the body to assist in the development of MRI and MRA images. Now, the FDA is increasingly concerned that certain contrast agents may pose a risk of a fatal skin disease.

In fact, the FDA recently announced that it is convening a team of outside experts in December to review a link between certain gadolinium-based contrast agents and a rare skin disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NSD).

NSF/NSD is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs.  NSF is characterized by areas of tight and rigid skin that make it difficult to bend joints. It may also result in fibrosis or scarring of body organs resulting in the inability of body organs to work properly and can lead to death.

Other signs of NSF/NSD also include:

•    Burning
•    Itching
•    Swelling
•    Hardening and tightening of the skin
•    Red or dark patches on the skin
•    Yellow spots on the whites of the eyes
•    Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet
•    Pain deep in the hip bones or ribs
•    Muscle weakness

The FDA has previously issued a variety of health warnings about these contrast agents, particularly for patients with severe kidney problems, but last week it issued the latest results of a review that found that gadolinium-based contrast agents may increase the risk of NSF/NSD.

Specifically, a staff review found the highest risk of the skin disease was associated with GE Healthcare’s Omniscan, Bayer AG’s Magnevist, and Covidien’s Optimark.

In 2006 and 2007, the FDA issued a series of communications pertaining to the risks for NSF/NSD in association with gadolinium-based contrast agents. In 2007, following FDA requests, manufacturers of the agents revised their labels to include a boxed warning and other information intended to lessen the risk for NSF/NSD.  Part of the reason for the outside review is to determine whether that labeling is still sufficient in light of recent findings.

In November, Covidien told the FDA it would voluntarily relabel Optimark to contraindicate its use in MRI procedures with patients with severe renal impairment.

There are currently five gadolinium-based contrast agents are approved by the FDA for use during an MRI. The trade names for these products are:

Omniscan
OptiMARK
Magnevist
ProHance
MultiHance

If you or someone you know has experienced side effects related to one of these drugs, you may have legal rights. Please visit our website to find out more.

A study released earlier this month could lead to the complete withdrawal of already problematic acne medication Accutane (isotretinoin). The latest study indicated that users of the medication have over four times the risk of developing ulcerative colitis and nearly twice the risk of developing inflammatory bowel disease than people who have never used the drug.  Presenting their findings at the annual meeting of the American College of Gastroenterology in San Diego, researchers from UNC Chapel Hill described inflammatory bowel diseases [[related to the drug]] that sometimes require surgery. Though the latest problem to plague Accutane, they’re not the only issue; other side effects include liver toxicity, elevated cholesterol, headaches, joint and muscle pain, and increased sun sensitivity.

In June, 2009, Roche Holding took Accutane off the market. With these mounting issues, how does the generic form stay on the market?  In 2005, the FDA launched a program requiring patients, doctors, and pharmacies to join a risk-management registry.  In addition, women who take the drug must use two forms of birth control and submit to monthly pregnancy tests.  The only other medication that requires such a registry is thalidomide.

Though Roche has pulled Accutane from the market, plaintiffs have already won an estimated $33 million in judgments against Roche for their bowel disorders.  What should you do if you’re suffering from both acne and such side effects of treatment?  Sokolove has a wealth of additional information to share with you.