Drug Safety Developments

Jury selection begins in Neurontin suicide trial

Quoted from http://lawyersusaonline.com/blog/2010/03/29/jury-selection-begins-in-neurontin-suicide-trial/

Jury selection begins in Neurontin suicide trial

By Nora Lockwood Tooher
Staff writer
Published: March 29, 2010

 

BOSTON - Jury selection began Monday in the second wrongful death trial alleging Pfizer’s off-label promotion of its anti-epilepsy drug Neurontin caused a patient to commit suicide.

Hartley Shearer, 57, a Massachusetts resident, took Neurontin from October 2000 to February 2002 when he committed suicide, according to lead plaintiffs’ trial counsel Ronald Rosenkranz, a partner at Finkelstein & Partners, Newburgh, N.Y.

According to court documents, Shearer was prescribed Neurontin for treatment of his paralysis, but became depressed and suicidal after taking the drug.

About 1,200 lawsuits have been filed, alleging that Warner-Lambert, which was acquired by Pfizer in 2000, knew before the drug was introduced in 1993 that it increased the risk of suicide.

Although Neurontin was approved only as an anti-seizure medication, the drug company aggressively promoted a variety of non-approved uses, including pain control, the suits allege.

 

The federal lawsuits have been consolidated in U.S. District Court in Boston.

The first wrongful death trial ended bizarrely in a mistrial in July 2009, after an anonymous donor offered to put money in a trust fund for the 10-year-old daughter of a Susan Bulger, a 39-year-old Massachusetts woman who committed suicide after taking Neurontin.

Houston attorney Mark Lanier headed the plaintiffs’ trial team in the Bulger trial, and was expected to represent Shearer’s family. But in a change of plans, Lanier is not on the Boston trial team. He is still, however, scheduled to try the third Neurontin personal injury case, slated for trial in state court in Tennessee in May.

Opening arguments are expected Wednesday in the Shearer trial on Wednesday before Judge William G. Young. Rosenkranz is dividing plaintiffs’ trial team duties with Jack W. London, a solo attorney in Austin, Texas, and Kenneth B. Fromsom, a partner in Finkelstein & Partners.

While the Bulger was picked by Pfizer, the Shearer case was picked randomly, according to Rosenkranz.

The trial is expected to last about two and a half weeks.

Bayer Schering Pharma Set To Update Yasmin Label In EU

Quoted from http://otc.pharmaceutical-business-review.com/news/bayer_schering_pharma_set_to_update_yasmin_label_in_eu_100329/

Bayer Schering Pharma Set To Update Yasmin Label In EU

Published: 29-Mar-2010

Bayer Schering Pharma is planning to update its label for Yasmin (drospirenone / ethinylestradiol) in the EU to include results of four epidemiological studies. Bayer sponsored two large observational post authorisation safety studies (Euras and Ingenix) on combined oral contraceptive (COC) use for European and US (FDA) Health Authorities.

Bayer Schering Pharma said that these prospective cohort studies conducted by independent investigators found that the risk for venous thromboembolism (VTE) in Yasmin users is comparable to the risk found for women who use levonorgestrel-containing COCs.

Bayer Schering Pharma is expected to update the European Summary of Product Characteristics for Yasmin with these results. At the request of the pharmacovigilance working party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) two recently published retrospective studies (Lidegaard et al, van Hylckama Vlieg et al) will also be included in the update.

[Article continues at original source]

Yaz, Yasmin pills to remain on market

Quoted from http://worldradio.ch/wrs/news/wrsnews/yaz-yasmin-pills-to-remain-on-market.shtml

Yaz, Yasmin pills to remain on market

Friday, 26 March, 2010, 11:21

The contraceptives Yaz and Yasmin will remain for sale.

The birth control pills were reviewed by Swissmedic the following their involvement in the death of one young woman and another who is now severely disabled.

Swissmedic says although the risk of thrombosis is higher with this generation of Yaz and Yasmin, the risk remains, as they say “within reasonable limits.”

Bayer, which manufactures the pills, says it has updated its information for medical professionals and patients.

Researchers Puzzled by Role of Osteoporosis Drug in Rare Thighbone Fractures

Quoted from http://www.nytimes.com/2010/03/25/health/25bone.html

Researchers Puzzled by Role of Osteoporosis Drug in Rare Thighbone Fractures

By GINA KOLATA

Published: March 24, 2010

The case reports first surfaced about two years ago and they were frightening. A few orthopedists reported that women taking osteoporosis drugs to prevent broken bones were showing up with rare and serious fractures of their thighbones. The bone was snapping like a twig, sometimes splintering. Often there was no trauma, like a serious fall, to bring it on.

And some of the women were younger, in their 50s, with pre-osteoporosis but without the extremely fragile bones of people with the full-blown degenerative condition.

But case reports can be hard to interpret — they may or may not indicate a real cause and effect. And the Food and Drug Administration says it has not been able to find evidence of an increased risk of the unusual fractures in its analyses, including one of data from makers of bisphosphonates, the osteoporosis drugs.

Now, a paper published online Wednesday in The New England Journal of Medicine, also fails to find clear evidence that bisphosphonates are causing the fractures.

The researchers, led by Dennis M. Black, a professor of epidemiology and biostatistics at the University of California, San Francisco, report that the thighbone fractures are so rare, even in women taking bisphosphonates for up to 10 years, that it is not clear whether the drugs make them more likely. And, they report, if there is a risk, it is far outweighed by the drugs’ clear benefit in preventing fractures of the hip and spine in people with osteoporosis.

Thighbone fractures “are much much less common than typical hip fractures,” said Dr. Elizabeth Shane, a professor of medicine at the College of Physicians and Surgeons at Columbia University, who wrote an editorial accompanying Dr. Black’s paper. “While these fractures are devastating, so are the more common types of hip fractures that are prevented by bisphosphonates.”

[Article continues at original source]

Glaxo Avandia Study Spurs Journal to Urge Review Rule

Quoted from http://www.bloomberg.com/apps/news?pid=20601124&sid=aNNloBopUC9g

Glaxo Avandia Study Spurs Journal to Urge Review Rule

By David Olmos

March 23 (Bloomberg) -- Industry-sponsored drug research should be analyzed by scientists without ties to the company developing a product, said an editorial in the Journal of the American Medical Association.

The authors cited a GlaxoSmithKline Plc study of its diabetes drug Avandia as a “disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial,” in today’s editorial. Academic researchers should have “full access” to study data, and medical journal editors should require an independent statistical analysis before publishing company-funded research, wrote Catherine DeAngelis, editor of the journal, and Phil Fontanarosa, executive deputy editor.

The authors cited a report released Feb. 20 by U.S. Senators Max Baucus and Charles Grassley that said London-based Glaxo rushed a company-sponsored study on Avandia into publication in 2007 to refute other research linking the drug to heart attacks. The report said Glaxo attempted to undermine the scientific steering committee on its sponsored study and failed to acknowledge fully Avandia’s significant heart risks.

“It is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance,” DeAngelis and Fontanarosa wrote in the editorial. “This approach would add powerful support to the fundamental principle that physicians must first do no harm.”

[Article continues at original source]

Saudi Arabia suspends Glaxo diabetes drug Avandia

Quoted from http://www.reuters.com/article/idUSLDE62L1M320100322

Saudi Arabia suspends Glaxo diabetes drug Avandia

 

Mon Mar 22, 2010 11:29am EDT

LONDON, March 22 (Reuters) - Saudi Arabia has suspended GlaxoSmithKline's (GSK.L) diabetes drug Avandia for six months, arguing that potential heart risks outweigh its benefits.

The Saudi Food and Drug Authority (SFDA) was the first healthcare regulator to take such action. Its decision means detailing and advertising of Avandia is banned and patients on Avandia will be referred to their doctor for consultation. The SFDA said on its website it was concerned about the safety of Avandia, or rosiglitazone, based on growing evidence from clinical studies indicating serious cardiovascular risks. (link.reuters.com/zab74j)

The six-month suspension will give Glaxo "the opportunity to provide the SFDA with evidence as to why rosiglitazone and combination products containing rosiglitazone should not be permanently removed from the Saudi Arabian market," it said.

The Saudi move follows a highly critical report on the drug from U.S. Senators last month, which suggested Glaxo knew of possible heart attack risks associated with Avandia years before the issue became public.

Glaxo has denied the Senators' allegations.

A spokeswoman said on Monday the company would provide the SFDA with data from six clinical trials demonstrating the cardiovascular safety of Avandia. "We stand behind the safety and efficacy of Avandia when it is used appropriately."

May need wider eczema caution for kids: FDA

Quoted from http://www.reuters.com/article/idUSTRE62H2NZ20100318

May need wider eczema caution for kids: FDA

Thu Mar 18, 2010 10:07am EDT

WASHINGTON (Reuters) - Novartis AG and Astellas Pharma eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in children, U.S. Food and Drug Administration staff said in documents released on Thursday.

Agency scientists said 46 cancer cases and 71 infection cases have been reported in patients aged 16 and younger from 2004 to 2008 with Novartis' Elidel and Astellas' Protopic.

Both drugs -- also known as pimecrolimus and tacrolimus respectively -- already carry strong warnings about cancer and infection, but officials should consider expanding them to include the new post-marketing reports, they wrote.

The documents were released ahead of an FDA advisory meeting Monday to weigh potential safety concerns with a variety of drugs used in younger patients.

 

[Article continues at original source]

Antibiotic Avelox may be linked to rare liver injury

Quoted from http://www.cbc.ca/consumer/story/2010/03/22/avelox-antibiotic-liver-health-canada.html

Antibiotic Avelox may be linked to rare liver injury

Last Updated: Monday, March 22, 2010 | 1:03 PM ET

CBC News

The antibiotic Avelox may be linked to a rare but potentially life-threatening liver injury, Health Canada warns.

Avelox, or moxifloxacin, is used to treat a broad spectrum of bacterial infections, including respiratory illnesses.

"Health Canada has conducted a safety review and concluded that Avelox may be associated with the rare but potentially life-threatening risk of liver injury, including liver failure," the department said in a release Monday.

Symptoms of liver problems include:

• Abdominal pain.
• Loss of appetite.
• Yellowing of the skin and eyes.
• Severe itching.
• Dark urine.
• Pale-coloured stools.

"Patients who experience any of these symptoms are advised to stop taking Avelox and contact a health-care professional immediately," Health Canada advised.

Drug maker Bayer Inc. is updating the product label to draw attention to the potential side-effect, the regulator said.

Avelox is a quinolone type antibiotic and can be taken by tablet form or given as an injection.

 

Patients with questions or concerns regarding the use of Avelox should talk to their pharmacist or physician, Health Canada said.

US Medicare panel eyes ESA use in kidney patients

Quoted from http://www.reuters.com/article/idCNN1715734820100319

US Medicare panel eyes ESA use in kidney patients

Fri Mar 19, 2010 6:41pm EDT

By Susan Heavey

WASHINGTON, March 19 (Reuters) - Closer government scrutiny of controversial anemia drugs made by Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N) is likely to reopen debate on how much the drugs should be used and could further depress sales.

Next week, the Centers for Medicare & Medicaid Services (CMS) plans to seek advice from a panel of outside experts over use of the blockbuster drugs in patients with chronic kidney disease, given concerns over possible heart dangers.

The drugs, known as erythropoiesis-stimulating agents (ESAs), have already weathered recent warnings and restrictions over their use in cancer patients that have caused doctors to lower doses and sales to slump.

On Wednesday, the agency will ask its panelists how confident they are that current data supports use of the drugs -- Johnson & Johnson's Procrit and Amgen's Aranesp and Epogen -- in a smaller group of patients with all stages of kidney disease.

CMS, which insures more than 45 million elderly, disabled and poor Americans, currently has no formal reimbursement policy for such use, leaving it to vary region by region.

Analyst Joshua Schimmer, managing director of biotechnology research at Leerink Swann, said CMS is ultimately likely to push for less use of the drugs nationwide.

"It's probably going to clip sales to some extent," said Schimmer, who estimates sales could dip 15 percent to 20 percent. "At the end of the day, we're all expecting it."

ESAs have come under scrutiny in recent years after studies emerged showing high doses could lead to heart complications or even death. While dosing has been affected, the costly drugs are still widely used.

[Article continues at original source]

Bisphosphonates and unusual leg breaks

Quoted from http://www.latimes.com/features/health/la-he-closer-20100322,5,4989919.story

Take bisphosphonates, break a leg?

Though two reports contend a connection exists between taking the drugs over a long period of time and getting these fractures, the FDA says so such connection exists.

By Jill U. Adams

Special to the Los Angeles Times

March 22, 2010

Long-term use of osteoporosis drugs seems to change bones in a way that could lead to unusual leg fractures, according to two reports presented earlier this month at a meeting of orthopedic surgeons. Doctors have reported seeing the unusual fractures in some patients on bisphosphonate drugs such as Fosamax.

It seems paradoxical that a medicine designed to protect against bone fractures in fact might be the cause of broken legs. Adding to the confusion, the U.S. Food and Drug Administration released a statement in the same week as the medical conference that said there is no clear connection, based on available evidence, between the bisphosphonates — including Actonel, Boniva and Reclast in addition to Fosamax — and atypical femur fractures.

The unusual bone breaks — called atypical subtrochanteric femur fractures — were first documented in small clinical reports and through the FDA's MedWatch system, which monitors side effects of drugs after they've been approved. Such reports do not necessarily mean the drug is the cause of the problem, but multiple reports of the same side effect with the same drug can spur additional investigation. Other potential side effects of bisphosphonate drugs have been identified through the FDA's reporting system, including serious jaw deterioration and esophageal cancer.

Here's a closer look at what's known about the safety and effectiveness of bisphosphonates.

[Article continues at original source]