Drug Safety Developments

Consumer group urges FDA to reject Arena diet drug

Quoted from http://www.reuters.com/article/2012/06/26/us-arena-publiccitizen-idUSBRE85P1D220120626

Consumer group urges FDA to reject Arena diet drug

 

By Susan Kelly

Tue Jun 26, 2012 5:48pm EDT

(Reuters) - Watchdog group Public Citizen urged U.S. regulators on Tuesday not to approve Arena Pharmaceuticals Inc's experimental diet pill lorcaserin, citing concerns it could increase patients' risk of heart valve damage. 

The U.S. Food and Drug Administration is expected to rule on whether to approve the drug by Wednesday.

Public Citizen, a nonprofit consumer advocacy group, said physicians at last month's FDA advisory panel meeting on lorcaserin raised serious concerns about evidence of increased valve disease risks in patients who used the drug in clinical trials. The panel of independent experts voted 18 to 4 to recommend approval of the pill despite the concerns. 

If approved, lorcaserin would become the first new diet drug on the U.S. market in more than a decade.

Heart valve problems were among the issues that led FDA to pull the anti-obesity drug known as fen-phen from the market in 1997, Public Citizen said.

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No excess suicide risk found with asthma drugs

Quoted from http://www.reuters.com/article/2012/06/27/us-excesssuicide-asthma-idUSBRE85Q11G20120627

No excess suicide risk found with asthma drugs

By Amy Norton

NEW YORK | Wed Jun 27, 2012 11:05am EDT

NEW YORK (Reuters Health) - Despite some reports of suicide among people taking certain asthma drugs, a new study finds no increased risk of attempted suicide among children and young adults on the medications.

In 2008, the Food and Drug Administration (FDA) said it was investigating reports of mood and behavior changes, suicidal thinking and suicide among people taking asthma medications known as leukotriene modifiers.

The drugs include Singulair (known generically as montelukast), Accolate (zafirlukast) and Zyflo (zileuton).

After reviewing clinical trial data on the drugs, the FDA concluded there was no evidence of a link to suicidal behavior. Still, in 2009 the agency asked manufacturers to add a precaution in the drugs' prescribing instructions about reports of suicide and other psychiatric problems.

But single reports of serious effects among medication users can only hint at a problem.

"Case reports don't prove there actually is an association between a drug and an adverse event, because there are so many other factors that could be at work," said Glen T. Schumock, a professor of pharmacy practice at the University of Illinois at Chicago who led the new study.

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Insight: Top heart doctors fret over new blood thinners

Quoted from http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614:

Insight: Top heart doctors fret over new blood thinners | Reuters

Insight: Top heart doctors fret over new blood thinners

By Ransdell Pierson

NEW YORK | Thu Jun 14, 2012 6:50am EDT

NEW YORK (Reuters) - For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.

But growing complaints of risks and deaths tied to the new crop of drugs have made some top U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used.

Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s.

"The good news is you now have an alternative to warfarin," said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California. "The bad news is you can kill a patient as easily with the new drug as you could with the old drug" if it is not handled properly.

"The average patient doesn't understand anything about the new drug, or what the risks are, or what other medicines he can or can't take," said Jacobson, citing interactions with common painkillers and other drugs that can alter Pradaxa blood levels.

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Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Quoted from http://health.msn.com/womens-health/birth-control-that-uses-combined-hormones-raises-heart-risk-study

Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Overall odds of heart attack and stroke, however, are still low

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, June 13 (HealthDay News) -- Sweeping new research comparing various forms of hormonal contraception -- including birth control pills, vaginal rings and skin patches -- suggests that the risk for heart attacks and strokes is twice as high among users of combined estrogen-progestin versions.

These include brands such as Yasmin and Yaz pills, the NuvaRing vaginal ring and Ortho Evra patches. The overall odds of suffering such debilitating effects, however, are still quite low.

Analyzing 15 years of observational data from more than 1.6 million women aged 15 to 49, Danish scientists found that those taking low-dose estrogen birth control pills combined with various progestins suffered heart attacks and strokes between 1.5 and 2 times more often than women not using hormonal contraception. The risks were between 2.5 and 3 times higher among users of vaginal rings and transdermal patches compared to non-users.

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Diabetes Drugs Avandia, Actos Linked to Vision Woes

Quoted from http://health.usnews.com/health-news/news/articles/2012/06/11/diabetes-drugs-avandia-actos-linked-to-vision-woes

Diabetes Drugs Avandia, Actos Linked to Vision Woes

They may raise risk of macular edema, researchers report

June 11, 2012

By Steven Reinberg
HealthDay Reporter

MONDAY, June 11 (HealthDay News) -- British researchers report that thiazolidinediones, diabetes medications that are used to help control blood sugar levels, may cause eye problems in those who take them.

The drugs that fall into this group include Avandia and Actos, which have been tied to increased risk of heart attack in the case of Avandia and bladder cancer in the case of Actos. Now it is possible that these drugs may also cause diabetic macular edema, the study authors said.

"Patients who received a thiazolidinedione were at two- to three-fold increased risk of developing macular edema," said lead researcher Dr. Iskandar Idris, an associate professor in diabetes medicine at the University of Nottingham.

However, the risk of macular edema is very small, about 0.2 percent, so the increased relative risk translates into an absolute risk of less than 1 percent.

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Drugs most frequently reported for adverse reactions

Quoted from http://www.philly.com/philly/blogs/healthcare/157042255.html

Drugs most frequently reported for adverse reactions

by Michael R. Cohen, R.Ph.

You may be surprised to learn that in 2011, the Food and Drug Administration received 179,855 reports of serious or fatal adverse drug reactions. This was an increase of 15,386 reports (9.4 percent) from the 2010 total. Reports reached the FDA through two mechanisms. Voluntary reports from health professionals and consumers and reports from manufacturers. There were 21, 002 voluntary reports and 158,853 from manufacturers. Manufacturers must report serious events within 15 days of becoming aware.

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. Keep in mind that this is not a scientific study of the frequency of adverse drug events in clinical practice. These are the medications that health professionals and consumers told the FDA were causing serious and fatal side effects during 2011. It is interesting to note that just two of these drugs were first introduced in the last decade (Pradaxa and Cymbalta), and only one in the previous year (Pradaxa), suggesting that major drug safety issues are not confined to recently approved drugs.

Pradaxa surpassed all other monitored drugs in several categories, including overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure. Coumadin has been prominent in the rankings for many years. It accounted for 1,106 reported ADEs overall, including 731 reports of hemorrhage and 72 deaths.

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Allergan wins new trial in big Botox damages case

Quoted from http://www.reuters.com/article/2012/06/01/allergan-botox-trial-idUSL1E8H1B1F20120601

Allergan wins new trial in big Botox damages case

By Nate Raymond

June 1 | Fri Jun 1, 2012 3:26pm EDT

June 1 (Reuters) - Allergan Inc has been granted a new trial in a case brought by a man who won a $212 million jury verdict last year after claiming he was disabled by taking Botox injections.

Douglas Ray Jr's jury award had already been slashed to less than $13 million total under Virginia state law, and now, after a federal judge's ruling on Friday, he will have to make his case all over again.

Ray accused Allergan of failing to warn doctors of the risk that Botox injections could cause autoimmune reactions that lead to brain damage. Ray alleged that he suffered a severe reaction that left him completely disabled after receiving Botox injections to treat a movement disorder in his right hand -- an off-label-use for the wrinkle-smoothing drug.

In April of last year, jurors in U.S. District Court in Richmond, Virginia, awarded Ray $12 million in compensatory damages, along with $200 million in punitive damages that were later reduced to $350,000 due to a cap under Virginia law.

But Judge Robert Payne ruled Friday that Allergan deserved a new trial because it should have been made clear to the jury that the company could not add a so-called "black-box" warning to Botox packing inserts on health dangers without prior approval from the U.S. Food and Drug Administration.

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Study details cancer risk of Takeda diabetes pill

Quoted from http://www.reuters.com/article/2012/05/31/takeda-actos-idUSL5E8GVEEO20120531

Study details cancer risk of Takeda diabetes pill

Thu May 31, 2012 6:30pm EDT

* Two years use of Actos doubles risk of bladder cancer

* Absolute risk still low, study finds

LONDON May 31 (Reuters) - Taking Takeda Pharmaceutical's diabetes drug Actos for more than two years doubles the risk of bladder cancer, although in absolute terms the risk is still low, researchers said on Thursday.

A study by Canadian researchers, published online by the British Medical Journal, quantified the risk by analysing the records of more than 115,000 British patients newly treated with diabetes drugs between 1988 and 2009.

They found that Actos use of two years or more was associated with 88 extra cases of bladder cancer per 100,000 person years. This rose to 137 extra cases among patients who had taken more than 28,000 milligrams of the drug.

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