Drug Safety Developments

Pfizer confronts surge of lawsuits over Lipitor

Quoted from http://www.reuters.com/article/2014/08/08/us-pfizer-lipitor-lawsuits-insight-idUSKBN0G80E520140808

Pfizer confronts surge of lawsuits over Lipitor

By Jessica Dye

Fri Aug 8, 2014 1:22am EDT

(Reuters) - Pharmaceutical giant Pfizer is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public.

In the past five months, a Reuters review of federal court filings shows, lawsuits by U.S. women who say that taking Lipitor gave them type-2 diabetes have shot up from 56 to almost 1,000.

Lawsuits began to be filed not long after the Food and Drug Administration in 2012 warned that Lipitor and other statins had been linked to incidents of memory loss and a "small increased risk" of diabetes. According to plaintiffs' lawyers, women face a higher risk than men of developing diabetes from using Lipitor, and gain fewer benefits.

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Statins Linked to Raised Risk of Cataracts in Study

Quoted from http://www.philly.com/philly/health/topics/HealthDay680331_20130919_Statins_Linked_to_Raised_Risk_of_Cataracts_in_Study.html

Statins Linked to Raised Risk of Cataracts in Study

Steven Reinberg HealthDay Reporter

THURSDAY, Sept. 19 (HealthDay News) -- The statin medications that millions of adults take to lower their cholesterol levels may also raise their risk of developing cataracts, a new study suggests.

This is the latest of several studies looking for a link between statins such as Lipitor and Zocor and cataracts, a clouding of the lens of the eye. The results to date have been conflicting and inconclusive, the researchers note.

"Cataracts are a main cause of poor vision and blindness, specifically for the elderly," said lead investigator Dr. Ishak Mansi, of the VA North Texas Health System in Dallas.

"This study cannot identify that statins cause cataracts; rather, it identifies statin use as associated with a higher risk of being diagnosed with cataract," he added.

The report, published Sept. 19 in the online edition of JAMA Ophthalmology, involved almost 14,000 men and women, 6,972 pairs of statin users and nonusers, who were seen by the military health care system from October 2001 to March 2010.

Those taking statins had a 27 percent increased risk of developing cataracts compared with nonusers, the researchers found.

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Could Statins Raise Diabetes Risk?

Quoted from http://news.health.com/2013/05/23/could-statins-raise-diabetes-risk/

Could Statins Raise Diabetes Risk?

May 23, 2013

 

THURSDAY, May 23 (HealthDay News) — Certain statins — the widely used cholesterol-lowering drugs — may increase your chances of developing type 2 diabetes, a new study suggests.

The risk was greatest for patients taking atorvastatin (brand name Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor), the study said.

Focusing on almost 500,000 Ontario residents, researchers in Canada found that the overall odds of developing diabetes were low in patients prescribed statins. Still, people taking Lipitor had a 22 percent higher risk of new-onset diabetes, Crestor users had an 18 percent increased risk and people taking Zocor had a 10 percent increased risk, relative to those taking pravastatin (Pravachol), which appears to have a favorable effect on diabetes.

Physicians should weigh the risks and benefits when prescribing these medications, the researchers said in the study, which was published online May 23 in the journal BMJ.

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FDA warns Pfizer for not reporting side effects

Quoted from http://www.reuters.com/article/idUSTRE6586PE20100610

FDA warns Pfizer for not reporting side effects

Susan Heavey

Thu Jun 10, 2010 6:59am EDT

WASHINGTON (Reuters) - The U.S. Food and Drug Administration has warned Pfizer Inc for failing to quickly report serious and unexpected potential side effects from its drugs already on the market.

In a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples involving some of the company's top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica.

The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDA's letter that was released by Pfizer on Wednesday.

Ronald Pace, director of the FDA's New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use.

"FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated," Pace wrote.

Pace asked Kindler to arrange a meeting between the company and the agency over the violations. Pfizer said it received the letter June 3.

The FDA conducted a 6-week inspection of Pfizer's New York headquarters in July and August of 2009, where agency inspectors found system-wide lapses at the world's largest drugmaker.

The patient reports "contained serious and unexpected adverse events... that were not submitted until they were identified during the FDA inspection," Pace wrote. Efforts to fix the problem "have been shown to be ineffective," he added.

In a statement, Pfizer said it would work with the FDA to satisfy the agency "and to assure optimal surveillance and reporting of post-marketing adverse events."

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Statin Use Tied to Eye, Kidney, Liver Troubles

Quoted from http://www.businessweek.com/lifestyle/content/healthday/639313.html

Statin Use Tied to Eye, Kidney, Liver Troubles

But heart-healthy benefits of the cholesterol drugs outweigh these risks, experts say

By Steven Reinberg
HealthDay Reporter

 

THURSDAY, May 20 (HealthDay News) -- People taking cholesterol-lowering drugs called statins may be at heightened risk for liver dysfunction, acute kidney failure and cataracts, British researchers report.

Statins, which include the blockbuster drugs Lipitor, Pravachol, Crestor and Zocor, are recommended for patients with high cholesterol. Studies have shown that these drugs are effective in reducing the risk of heart disease and heart attack.

While the drugs have long been linked with a raised risk for muscle problems, the new study involving over 2 million patients found other "potential adverse effects of statins, namely myopathy [muscle problems], acute renal [kidney] failure, liver dysfunction and cataract, and shown that two of these have a dose-response effect," said lead researcher Dr. Julia Hippisley-Cox, professor of clinical epidemiology and general practice at the University of Nottingham.

On the more positive side, the study found no link between statin use and risks for a wide range of cancers (including stomach, colon, lung, renal, breast or prostate malignancies), as well as no connection to Parkinson's disease, rheumatoid arthritis, blood clots, dementia or fractures.

And experts say that, given the drugs' well-known benefit in cutting heart disease risk, the new findings are no reason for patients to shy away from statins.

The report is published in the May 21 online edition of the BMJ.

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New York State Appeals Court Knocks Out Lipitor Suits

Quoted from http://www.law.com/jsp/tal/digestTAL.jsp?id=1202437215921&New_York_State_Appeals_Court_Knocks_Out_Lipitor_Suits

New York State Appeals Court Knocks Out Lipitor Suits

By David Bario

December 22, 2009

Back in November 2008, we wrote that a New York State appeals court had affirmed lower court dismissals of three product liability actions (fourth item) against Pfizer by Michigan residents over injuries they allegedly suffered from taking the anti-cholesterol drug Lipitor. We noted then that the Michigan plaintiffs had hoped to sidestep their home state's defense-friendly tort laws in drug cases by bringing the cases in New York, where Pfizer is headquartered. Neither the trial judge nor the appellate court bought the plaintiffs' jurisdiction arguments in those cases, and now the pattern has repeated itself in a consolidated Lipitor product liability case brought by a Georgia man and 16 other out-of-state plaintiffs before the same New York courts.

On Tuesday, New York State's first appellate department affirmed a June 2008 ruling by trial judge Martin Shulman dismissing a case against Pfizer brought by Georgia resident Charles Wilson, who claimed to have suffered peripheral neuropathy, memory loss, disorientation, and depression from taking Lipitor in 2002 and 2003. The appellate court, considering an appeal of Wilson's case consolidated with 16 others, agreed with Judge Shulman's ruling on grounds of forum non conveniens.

The order, available here, addresses the plaintiffs' jurisdiction arguments pretty succinctly: "Wilson ... is a resident of Georgia; his physician who recommended and prescribed the drug, and on whose recommendation Wilson solely relied, lives in Georgia; Wilson ingested the drug in Georgia and suffered his injuries in Georgia; all of Wilson's treating physicians are in Georgia; and all of Wilson's witness are in Georgia."

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