Drug Safety Developments

‘Our family is forever changed’

Quoted from http://www.novanewsnow.com/News/2013-06-25/article-3291840/%26lsquoOur-family-is-forever-changed%26rsquo/1

‘Our family is forever changed’

Katelynne “Katt” Fisher died at 18 as the result of a blood clot that, her mother was told, may have been caused by the Yaz birth control pill. (Submitted photo)

Published on June 25, 2013 Ashley Thompson  
The Hants Journal

Falmouth mother joins class action lawsuit against birth control manufacturer

Leah Fisher knows no amount of money will bring her daughter back.

She knows the class-action lawsuit she joined against the makers of the commonly used birth control pill she believes to be linked to her daughter’s death will be a hard-fought battle that could very well end in disappointment.

And, she knows the manufacturers of the multi-billion dollar product could likely handle a multi-million dollar payout to all of the complainants involved in the lawsuit and continue on with business as usual.

What she doesn’t know is why a product that may have played a role in the deaths of multiple Canadian women is still on the market.

Fisher says her daughter, Katelynne, started taking the Yaz birth control pill manufactured by Bayer about one month before she suffered a seizure induced by a large blood clot in her brain.

The 18-year-old spent eight days in a coma, suffered strokes and endured an 11-hour surgery as doctors attempted to break the clot apart. The clot proved to be too large, and Katelynne never regained consciousness.

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Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents

Yaz and Yasmin: An Unacceptable Level of Risk?

Quoted from http://msmagazine.com/blog/2013/06/25/yaz-and-yasmin-an-unacceptable-level-of-risk/

Yaz and Yasmin: An Unacceptable Level of Risk?

June 25, 2013 by Elizabeth Kissling

Don’t feel bad if you missed last week’s headline news about the deaths of 23 young women from their birth control. It was a top story for CBC news and a few other Canadian sources, but it was barely a blip on the radar of most U.S. news outlets. Yaz and Yasmin, two similar new-generation birth control pills from Bayer, are suspected in the recent deaths of these young Canadian women.

These are among the best selling oral contraceptives in the world, but this is not the first time Yaz and Yasmin have been suspected of causing death or adverse effects. Earlier this year, Bayer agreed to pay up to $24 million to settle claims from plaintiffs with gall bladder injuries caused by the drugs,and the company set aside $1 billion to settle claims from approximately 4,800 women who have suffered blood clots due to Yaz or Yasmin.As of February, 2013, approximately 10,000 lawsuits against Bayer are still pending in the U.S., and an additional 1,200 unfiled claims are pending. The company anticipates additional lawsuits—and additional settlements—regarding blood clot injuries, such as pulmonary embolisms or deep-vein thrombosis.

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FDA probes deaths of two patients on Lilly schizophrenia drug

Quoted from http://www.reuters.com/article/2013/06/18/us-elililly-fda-idUSBRE95H0NP20130618

FDA probes deaths of two patients on Lilly schizophrenia drug

 

Tue Jun 18, 2013 10:55am EDT

(Reuters) - The U.S. Food and Drug Administration on Tuesday said it was investigating the deaths of two patients who died following injections with Eli Lilly and Co's long-acting treatment for schizophrenia, called Zyprexa Relprevv. 

The agency said the patients died three to four days after receiving an appropriate dose of the medicine, and had very high levels of the injectable drug in their bloodstreams. 

The medicine's package insert label carries a prominent "black box" warning of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an injection, causing greatly elevated levels of the drug in the bloodstream.

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Drugmakers to cooperate in safety review of diabetes drugs

Quoted from http://www.reuters.com/article/2013/06/12/us-diabetes-safety-idUSBRE95B17J20130612

Drugmakers to cooperate in safety review of diabetes drugs

By Bill Berkrot

NEW YORK | Wed Jun 12, 2013 5:14pm EDT

NEW YORK (Reuters) - Global drugmakers said on Wednesday they would cooperate with an independent review to address concerns of a potential link between widely used diabetes medicines and pancreatic cancer and other safety problems.

The American Diabetes Association (ADA) this week called for a new evaluation of clinical data on drugs used to control blood sugar for patients with type 2 diabetes. They include Merck & Co's $4 billion a year Januvia franchise, Novo Nordisk's Victoza, and Byetta and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc, among others.

"People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment," Dr. Robert Ratner, ADA's chief scientific and medical officer, said in a statement.

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Merck Joins Novo to Reassure FDA of Diabetes Drug Safety

Quoted from http://www.bloomberg.com/news/2013-06-12/merck-joins-novo-to-reassure-safetynof-diabetes-drugs.html

Merck Joins Novo to Reassure FDA of Diabetes Drug Safety

By Anna Edney - Jun 12, 2013 10:57 AM ET

Merck & Co. (MRK), Novo Nordisk A/S (NOVOB) and other makers of popular treatments for diabetes may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.

The Food and Drug Administration said it’s considering setting up a study, either through the agency or the companies, that looks deeper into whether medicines for Type 2 diabetes, including Merck’s Januvia and Bristol Myers-Squibb Co.’s Byetta, cause pancreatic cell growth that could turn cancerous. One option is a large clinical trial designed to show patterns of adverse events, said Morgan Liscinsky, an FDA spokeswoman.

A debate swirled in the medical community in March with talk of unpublished findings that the FDA said may show pre-cancerous cellular changes in diabetics taking drugs called incretin mimetics. The FDA is reviewing the data and scientists from the agency and the companies are gathering today at the National Institutes of Health to sort it out.

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Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents

Quoted from http://www.vancouversun.com/health/Yasmin+birth+control+pills+linked+deaths+Health+Canada+documents/8510364/story.html

Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents

By Sheryl Ubelacker, The Canadian Press June 11, 2013

The popular birth-control pills Yaz and Yasmin have been linked to the deaths of at least 23 Canadian women —the youngest just age 14, Health Canada documents say.

The deaths are among about 600 adverse reactions reported among women taking the contraceptives between 2007 and Feb. 28 of this year, Health Canada confirmed Tuesday.

Doctors and pharmacists who submitted the reports to the Canada Vigilance Program said Yaz and Yasmin are suspected in the 23 deaths. The reports say most of the women died suddenly after developing blood clots, a known risk with the pills.

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FDA panel votes to relax Avandia restrictions

Quoted from http://www.reuters.com/article/2013/06/06/us-avandia-fda-idUSBRE9540K120130606

FDA panel votes to relax Avandia restrictions

By David Morgan

WASHINGTON | Thu Jun 6, 2013 6:11pm EDT

WASHINGTON (Reuters) - U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the biggest drug controversies in recent years.

The vote, by a divided Food and Drug Administration advisory committee of outside health experts, could modestly enlarge the market for Avandia in the United States and lay the groundwork for further research into the drug's health risks. FDA will now take the vote into consideration for a final decision on how the pill also known by the generic name rosiglitazone can be used.

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Battleground FDA: How Tomorrow's Avandia Panel Could Help Shape The Future Of Diabetes

Quoted from http://www.forbes.com/sites/matthewherper/2013/06/04/battleground-fda-how-tomorrows-avandia-panel-could-help-shape-the-future-of-diabetes

Battleground FDA: How Tomorrow's Avandia Panel Could Help Shape The Future Of Diabetes

Matthew Herper, Forbes Staff , June 4, 2013

Avandia, once the best-selling diabetes pill on the planet, is now given only to a few thousand Americans. In much of the rest of the world it has been pulled from the market because of analyses that showed it might increase the risk of heart attacks. The controversy over the drug changed the way the Food and Drug Administration regulates diabetes medicines, resulting in steep requirements that new drugs prove they are unlikely to cause heart side effects.

Tomorrow, three years after an FDA advisory committee voted that Avandia’s use should be sharply curtailed or that the drug should be pulled, a new FDA advisory committee will take two days to reconsider that opinion. It’s possible that Avandia could go back into wider use, or that it could be withdrawn from the market entirely. Whatever happens could have far-reaching consequences for diabetes-focussed companies like Novo Nordisk, Sanofi, and Eli Lilly.

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Glaxo Findings on Avandia Safety Supported in Reanalysis

Quoted from http://www.bloomberg.com/news/2013-06-03/glaxo-findings-on-avandia-safety-supported-in-reanalysis.html

Glaxo Findings on Avandia Safety Supported in Reanalysis

By Anna Edney - Jun 3, 2013 10:21 AM ET

A second look at GlaxoSmithKline Plc (GSK)’s once-best-selling diabetes pill found it doesn’t increase overall cardiac death risk, U.S. regulators said.

Findings by London-based Glaxo that Avandia doesn’t raise the overall risk of death, heart attack or stroke appear to be supported in a reanalysis by independent researchers, some Food and Drug Administration staff said in a report today. FDA advisers will reconsider restrictions imposed on Avandia in 2010 at a meeting June 5-6, according to the report.

“It is important to note that FDA has not reached any final updated conclusions” on the cardiovascular safety of Avandia based on the reassessment, said Mary H. Parks, director of the FDA’s division of metabolism and endocrinology products.

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Second Thoughts on Safety of Avandia Stir a Dispute

Quoted from http://www.nytimes.com/2013/06/03/business/second-thoughts-on-safety-of-avandia-stir-a-dispute.html

F.D.A. to Reconsider Restrictions on Diabetes Drug

By KATIE THOMAS and SABRINA TAVERNISE

Published: June 2, 2013

Three years ago, in one of the more notable drug-safety scandals in recent history, the diabetes drug Avandia was all but banned from use in the United States after researchers found that thousands of people had heart problems after taking it. Today, it is a drug of last resort for people with diabetes who are so sick that a heart attack is worth the risk.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, was the first to sound a public alarm about Avandia, as early as 2007.

But now, in a highly unusual move, the Food and Drug Administration has decided to reopen the case on Avandia and will ask a panel of experts this week whether the agency must reconsider the restrictions on the drug.  

That is just one of several options before the advisory committee, but lifting the limits would amount to a major policy reversal and could be a huge victory for the drug’s maker, GlaxoSmithKline. Avandia was once a top-selling drug, reaching more than $3 billion in sales in 2006 before controversy flared. It could also help rewrite one of the most embarrassing chapters in the F.D.A.’s recent history.

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