Drug Safety Developments

Sanofi, Takeda drugs on FDA early safety probe list

Quoted from http://www.reuters.com/article/2011/01/31/fda-drugs-idUKN3123796920110131

Sanofi, Takeda drugs on FDA early safety probe list

* FDA probing Sanofi heart drug, Takeda diabetes pill

* List does not mean drug causes problem, FDA says

WASHINGTON Jan 31 (Reuters) - U.S. regulators have launched early investigations into potential risks of drugs from Sanofi-Aventis (SASY.PA), Takeda Pharmaceutical Co and other companies, the Food and Drug Administration said on Monday.

The FDA released its quarterly list of investigations into possible drug-safety problems. The newest list covers probes launched between July and September 2010.

Appearing on the list does not mean the FDA has concluded a drug causes the listed problem, the FDA said. The list was posted at bit.ly/eKC2cp .

Among the probes, the agency is reviewing a possible interaction between Sanofi's heart drug Multaq and the bloodthinner warfarin. Takeda's diabetes drug Actos is under review for rhabdomyolysis, a potentially serious type of muscle injury.

Officials at Sanofi and Takeda could not immediately be reached for comment.

GlaxoSmithKline Settles Avandia Heart Attack Death Litigation on Trial Eve

Quoted from http://www.bloomberg.com/news/2011-01-31/glaxosmithkline-settles-suit-on-avandia-diabetes-drug-heart-attack-death.html

GlaxoSmithKline Settles Avandia Heart Attack Death Litigation on Trial Eve

By Jef Feeley - Jan 31, 2011 12:22 PM ET

GlaxoSmithKline Plc said it settled on the eve of trial a lawsuit alleging its Avandia diabetes drug caused a North Carolina man to die of a heart attack, avoiding a jury determination over risks associated with the medicine.

The U.K.’s biggest drugmaker resolved the suit by the family of James Burford, an Avandia user who died in 2006. The company declined to provide details of the accord’s terms. The resolution eliminates the risk Glaxo would face a large jury award, said Navid Malik, a drug-industry analyst at Matrix Corporate Capital in London.

Investors worried it “could lead to substantial punitive damages,” Malik said in a Jan. 25 interview. The company has already agreed to pay almost half a billion dollars to resolve claims it hid the drug’s health risks. “GSK needs to successfully settle as many of these cases as possible.”

The lawsuit, scheduled for trial this week in Philadelphia federal court, was the first of 2,000 heading to court alleging London-based Glaxo hid Avandia’s health risks. Regulators in Europe had the drug withdrawn from the market and U.S. sales were limited because of heart attack risks. Glaxo had also said it was setting aside money to address federal prosecutor probes of its marketing of at least nine drugs, including Avandia.

Mary Anne Rhyne, a U.S.-based spokeswoman for Glaxo, said in an e-mailed statement yesterday that the company settled the Burford case to avoid the risks and costs of litigation.

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In Avandia Case, Motion Hearing Delayed as Attorneys Huddle With Judge

Quoted from http://thelegalintelligencer.typepad.com/tli/2011/01/in-avandia-case-motion-hearing-delayed-as-attorneys-huddle-with-judge.html

 

In Avandia Case, Motion Hearing Delayed as Attorneys Huddle With Judge

By Shannon P. Duffy
U.S. Courthouse Correspondent

Monday, January 24, 2011

Global settlement talks just might be underway in the massive federal multi-district litigation of thousands of products liability suits filed by diabetics who took the drug Avandia, but for now the lawyers are saying nothing.

On Monday, a team of defense lawyers for GlaxoSmithKline and the lead plaintiffs lawyers in the MDL assembled in the courtroom of U.S. District Judge Cynthia M. Rufe for a final round of pretrial hearings.

Rufe was expected to hear arguments about how to conduct the first “bellwether” trial, and court records show that the lawyers were arguing over whether to empanel an “advisory” jury that would focus only on causation.

But those hearings never took place.

Instead, throughout the morning and most of the afternoon, a sizable group of spectators waited in the courtroom for the hearings to begin only to watch groups of lawyers shuttling back and forth between Rufe’s chambers and private conference rooms.

Rufe was on the bench only briefly for a few minutes in the morning and again at the end of the day when she announced that she was continuing the proceedings until next Monday.

GSK said earlier this month that it expects to record a legal charge of $3.4 billion for the fourth quarter of 2010, primarily related to Avandia. The company said the charge is related primarily to the investigation by the U.S. Attorney's Office for the District of Colorado into the sales and promotional practices of Avandia, as well as Avandia products liability cases.

Sanofi expects EU to ask for patient alert on Multaq

Quoted from http://www.reuters.com/article/idUSTRE70H7NJ20110118

Sanofi expects EU to ask for patient alert on Multaq

By James Regan

PARIS | Tue Jan 18, 2011 5:35pm EST

PARIS (Reuters) - French drugmaker Sanofi-Aventis expects European medical authorities to request it to alert doctors about possible safety risks related to its Multaq heart drug, following a similar move in the United States.

The U.S. health regulator said on Friday it had received several reports of liver damage in patients taking Multaq. It was "continuing to review reports of possible adverse events and drug interactions" with Multaq.

A Sanofi-Aventis spokesman said on Tuesday the company was working closely with all healthcare authorities and reiterated that no causal link had been formally established between liver damage and the medicine, which treats irregular heartbeat.

"We expect in the coming days the recommendation from the EMA (European Medicines Agency) to give information to patients and healthcare professionals in Europe as it has been done in the United States," the spokesman said.

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Glaxo Takes $3.4 Billion Charge on Legal Problems

Quoted from http://www.nytimes.com/2011/01/18/business/18drug.html

Glaxo Takes $3.4 Billion Charge on Legal Problems

By DUFF WILSON

Published: January 17, 2011

The British drug maker, GlaxoSmithKline, announced Monday that it was setting aside $3.4 billion to pay for United States government investigations and for product liability cases over its marketing of the diabetes drug Avandia in the face of heart attack risks.

The one-time charge is expected to wipe out its fourth-quarter profits, by consensus analyst estimates. GlaxoSmithKline’s European shares fell about 2 percent on the news.

Avandia, once the world’s top-selling diabetes medicine, was severely restricted in September by the Food and Drug Administration and banned by the European Medicines Agency after safety reviews.

GlaxoSmithKline took a $2.36 billion charge last summer to settle what it called “the substantial majority” of Avandia product liability lawsuits, as well as Paxil product liability cases and a Puerto Rico manufacturing case.

But it has received “substantial” new claims since then, the company said in a statement Monday to the London Stock Exchange. The $3.4 billion charge will be used for those product liability claims as well as costs related to an ongoing investigation by a federal prosecutor, the company said in the statement.

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Heart drug Multaq to be monitored in Canada

Quoted from http://www.cbc.ca/consumer/story/2011/01/17/multaq-heart-liver.html

Heart drug Multaq to be monitored in Canada

U.S. added warnings after liver damage reports

Last Updated: Monday, January 17, 2011 | 1:45 PM ET

CBC News

The heart drug Multaq continues to be approved for use in Canada, but Health Canada says reports of its connection to liver damage will be reviewed.

On Friday, the U.S. Food and Drug Administration added new warnings to the label of the Sanofi-Aventis drug after several reports that patients suffered liver damage.

Multaq was approved in July 2009 to treat atrial flutter and atrial fibrillation — irregular heart rhythms that can reduce blood flow and lead to stroke.

Liver toxicity is among the most common drug-related side-effects in a number of medication classes.

Health Canada says that in Canada the drug is not to be used by patients with severe liver problems. It says that should new safety information be identified, it will take appropriate action — including keeping health-care professionals and other Canadians informed.

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Sanofi-Aventis drug Multaq linked to liver damage in a handful of patients

Quoted from http://lubbockonline.com/health/2011-01-15/fda-warns-liver-damage-reports-sanofi-drug

Sanofi-Aventis drug Multaq linked to liver damage in a handful of patients

Posted:January 15, 2011 - 12:02am

By MATTHEW PERRONE AP Health Writer

WASHINGTON — Federal health officials are warning doctors and patients that a recently-launched heart drug from Sanofi-Aventis SA has been linked to liver damage in a handful of patients.

The Food and Drug Administration said Friday it has received several reports of liver damage with Multaq tablets, including two cases in which patients had to have their livers removed. Both patients were women and roughly 70 years old. They had been taking the drug for 4.5 months and 6 months, respectively.

The FDA approved Multaq in July 2009 to treat atrial flutter and atrial fibrillation which are irregular heart rhythms that can reduce blood flow and lead to stroke. More than a half-million prescriptions for Multaq have been written since the drug was approved.

In an online notice, the FDA said it would add a new warning about the risk for liver damage to the label of Multaq. The agency said patients should contact their doctor if they experience signs of liver injury, including nausea, vomiting and fever. If doctors suspect a toxicity issue they should discontinue use of the drug and test the patient's liver enzymes.

Liver toxicity is among the most common drug-related side effects across a number of medication classes.

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Abbott Sued Over Claims Arthritis Drug Caused Cancer

Quoted from http://www.bloomberg.com/news/2011-01-12/abbott-labs-arthritis-drug-humira-caused-lymphoma-cancer-texas-suit-says.html

Abbott Sued Over Claims Arthritis Drug Caused Cancer

By Laurel Brubaker Calkins - Jan 12, 2011 8:21 PM ET

Abbott Laboratories was sued by a Texas rheumatoid arthritis sufferer who claims she developed lymphoma after taking its drug Humira in a company-sponsored clinical trial in 2005.

“Abbott had the data in its possession by January 2005 to alert people to the three- to fivefold potential risk of cancer for patients taking Humira,’’ lawyer Andy Vickery said in a lawsuit filed yesterday in Houston federal court. “Abbott did nothing to warn patients directly about the risks of Humira- induced cancers’’ until federal regulators required it in 2009.

Gayathri Murthy, a Houston hospital worker, began taking Humira as part of a clinical trial in early 2005, for treatment of rheumatoid arthritis, according to the complaint. Her doctor warned her the drug increased the risk of tuberculosis and said other side effects were similar to the “side effects of aspirin.’’

She remained on the drug until she was diagnosed with lymphoma in February 2006, according to the complaint.

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Roche Sued by Patient Claiming Cancer From Pulled Psoriasis Drug Raptiva

Quoted from http://www.bloomberg.com/news/2011-01-08/roche-sued-by-patient-claiming-cancer-from-pulled-psoriasis-drug-raptiva.html

Roche Sued by Patient Claiming Cancer From Pulled Psoriasis Drug Raptiva

By Laurel Brubaker Calkins - Jan 7, 2011 7:52 PM ET

Roche Holding AG’s Genentech Inc. was sued by a Texas psoriasis sufferer who alleges he developed lymphoma while taking Raptiva, a drug the company stopped selling in 2009 when studies linked it to a fatal brain infection.

Genentech, a unit of Basel, Switzerland-based drugmaker Roche, began a phased withdrawal of Raptiva in April 2009 after three patients taking it were diagnosed in the preceding six- month period with progressive multifocal leukoencephalopathy, or PML, a rare, incurable brain disease.

Houston-area psoriasis patient Cary Massa, 51, was diagnosed with classic Hodgkin’s lymphoma in March 2009, after taking Raptiva from February 2006 to January 2008, according to a complaint filed today in Houston federal court.

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Ala. judge preparing for anti-smoking drug suits

Quoted from http://www.bloomberg.com/news/2011-01-04/ala-judge-preparing-for-anti-smoking-drug-suits.html

Ala. judge preparing for anti-smoking drug suits

Jan 4, 2011 6:48 PM ET By The Associated Press

BIRMINGHAM, Ala. (AP) — A federal judge in Birmingham is overseeing about 1,200 lawsuits involving pharmaceutical giant Pfizer Inc. and its stop-smoking drug Chantix, many of them with smokers and their families claiming the drug left them with a variety of psychological problems, including anxiety, aggressiveness and suicidal thoughts.

In one of the lawsuits, Billy Bedsole of Demopolis, claimed he suffered memory loss, depression, mood swings and anxiety after he started taking Chantix.

"A lot of folks had a terrible reaction to the drug," said the lead plaintiffs' attorney, Ernest Cory of Birmingham.

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