Drug Safety Developments

Study in mice sheds light on Ambien side effects

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSN2938439820090629

Study in mice sheds light on Ambien side effects

Mon Jun 29, 2009 6:03pm EDT

By Julie Steenhuysen

CHICAGO, June 29 (Reuters) - A new study in mice may help explain some of the rare but strange side effects in people taking the sleep drug Ambien, including sleep walking, midnight binges and even driving while not fully awake.

Ambien, made by Sanofi-Aventis, can shut down powerful brain circuits responsible for inhibiting brain activity under certain circumstances, leaving other brain circuits unchecked, researchers at Georgetown University Medical Center in Washington said.

"You are kind of releasing the brakes," said Molly Huntsman of Georgetown, who worked on the study that appears in the Proceedings of the National Academy of Sciences.

This may stimulate brain circuits that would normally be silenced. "In a way, Ambien is awakening other circuits because the brakes are not in place," Huntsman said.

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Biogen Reports a 13th Sick Patient on MS Drug

Quoted from http://online.wsj.com/article/SB124631389418370485.html

Biogen Reports a 13th Sick Patient on MS Drug

By KEITH J. WINSTEIN

Biogen Idec Inc.'s disclosure of a debilitating brain infection in a patient taking its Tysabri multiple-sclerosis medicine sparked a selloff in shares of the biotechnology company Monday.

The disclosure, made Friday evening, marks the 13th case of the infection, called progressive multifocal leukoencephalopathy or PML, in a Tysabri patient. Three of the patients have died....

Tysabri was pulled from the U.S. market in 2005 after three initial cases. After holding hearings to weigh Tysabri's risks and benefits, the Food and Drug Administration allowed it to be reintroduced in 2006, under monitoring rules and a prohibition on using it in combination with other MS drugs. The system was aimed at reducing PML incidence.

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Mentor mom Lynne Faraone helped sound the alarm over side effects from popular Singulair

Quoted from http://www.cleveland.com/healthfit/index.ssf/2009/06/mentor_mom_lynne_faraone_helpe.html

Mentor mom Lynne Faraone helped sound the alarm over side effects from popular Singulair

by Diane Suchetka/Plain Dealer Reporter

Monday June 29, 2009, 8:45 AM

Lynne Faraone created this wall of inspiration in her Mentor home. She says hope especially helped her as she fought for a warning label on the asthma and allergy medication Singulair.It's one of the most popular medicines in America -- last year, pharmacists filled about 28 million prescriptions for it.

So chances are good that you or someone you know is taking Singulair.

What you may not know is that hundreds of people taking the allergy and asthma medication have reported frightening side effects, including depression, hallucinations and suicidal thoughts.

Word is spreading now.

That's at least in part because the U.S. Food and Drug Administration recently told the makers of Singulair and three less widely used asthma drugs -- Accolate, Zyflo and Zyflo CR -- that the drugs' labels must list a dozen mood and behavior changes as possible side effects.

When the FDA took that action this month, eight women throughout the United States celebrated.

They'd been pushing for the warning for more than a year. Each of them said she joined the effort after her child's life was turned upside down by the drug.

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C.B. Fleet says its laxatives are safe

Quoted from http://www.newsadvance.com/lna/news/local/article/c.b._fleet_says_its_laxatives_are_safe/17323/

      C.B. Fleet says its laxatives are safe

By Bryan Gentry

Published: June 29, 2009

Six months after pulling two laxative drugs off drug store shelves, Lynchburg-based C.B. Fleet has collected thousands of cases of the drugs and is considering ways to put them back on the market.

Meanwhile, 38 lawsuits against the pharmaceutical company were consolidated last week into one federal court so pretrial work can continue smoothly. The lawsuits allege that the drugs C.B. Fleet recalled have caused serious kidney damage.

Chris McDaniel, chief scientific officer for C.B. Fleet, said the company continues to assert that the recalled drugs are safe when used as directed. C.B. Fleet wants to sell them again if it can ensure that they would be used correctly, he said.

The drugs in question use a formula that C.B. Fleet has made in Lynchburg for more than 100 years. Fleet Phospho-soda is a laxative, and Fleet Phospho-soda E-Z Prep Bowel Cleansing System is a double dose of the laxative used to clean the intestines before a colonoscopy.

Both drugs are classified as oral sodium phosphates and were available without a prescription.

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Study: Sanofi’s Lantus Insulin Has Possible Cancer Link

Quoted from http://blogs.wsj.com/health/2009/06/26/study-sanofis-lantus-insulin-has-possible-cancer-link

Study: Sanofi’s Lantus Insulin Has Possible Cancer Link

By Shirley S. Wang

New data published today suggest that there is a “possible link” between French drug maker Sanofi-Aventis’s Lantus insulin for diabetes and a higher risk of cancer, according to Diabetologia, the journal in which the data were published.

The European Association for the Study of Diabetes, which publishes the journal, also made an “urgent call for more research” studying Lantus and cancer. It said the concern was specific to artificial insulin like Lantus, not human insulin, and urged patients not to stop taking their insulin but to consult their doctor if concerned.

Of the four studies published, the one that first prompted concern was conducted on 127,000 insulin-treated patients from a German insurance database. Researchers found that one additional person out of every 100 who used Lantus for an average of 1 1/2 years compared with human insulin was found to have cancer compared with those using human insulin. The higher the dose of Lantus used, the greater the risk of cancer, they said.

But results from three other studies, conducted in Sweden, Scotland and the U.K., were mixed. One also found a positive link while the other two showed no statistically significant link.

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Roche Pulls Accutane Off Market After Jury Verdicts

Quoted from http://www.bloomberg.com/apps/news?pid=20601087&sid=a7Oj2q25ZHZ8

Roche Pulls Accutane Off Market After Jury Verdicts

By Jef Feeley and Sophia Pearson

June 26 (Bloomberg) -- Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

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Sanofi may suffer, whatever final Lantus verdict

Quoted from http://www.reuters.com/article/euPrivateEquityNews/idUSTRE55P2PM20090626

Sanofi may suffer, whatever final Lantus verdict

Fri Jun 26, 2009 7:33am EDT

By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON (Reuters) - The history of past drug scares suggests concerns over the safety of Sanofi-Aventis's diabetes treatment Lantus will hit sales, whether or not a suggested link to cancer proves real.

Shares in the French drugmaker sank 7 percent on Friday, extending losses from the previous session, on growing concern that researchers are about to publish a damaging analysis of the company's modern, or analog, insulin drug.

"Our information is that indeed a study is likely to be published soon raising the possibility of a link between Lantus use and a certain cancer type," Sanford Bernstein analyst Tim Anderson said in a research note.

"We understand this will not come out in a small medical journal, but rather one of the major medical journals and it will be the first time that such a high-profile analysis has been published linking the drug to cancer in humans."

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Caraco Drugs Seized at Michigan Facilities, U.S. Says

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=arhknAxBB0SE

Caraco Drugs Seized at Michigan Facilities, U.S. Says

By David Olmos

June 25 (Bloomberg) -- Generic drugs made by Caraco Pharmaceutical Laboratories Ltd. were seized by U.S. authorities, who cited violations of manufacturing standards, sending shares down the most in 15 years.

Drugs and raw ingredients for pain, heart ailment and psychiatric medications were confiscated today at three Caraco facilities in Michigan to prevent the Detroit-based company from distributing its products until the manufacturing deficiencies are corrected, the U.S. Food and Drug Administration said in a statement.

The drug seizure could lead to shortages of one pill, choline magnesium trisalicylate, a generic pain-relief medication, the FDA said. The FDA suggested that consumers contact their doctors about other alternative pain-relief medications.

Inspectors who visited the Caraco facilities in May 2009 found “serious violations” of manufacturing standards and “serious deficiencies” in quality control, Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said today in a briefing with reporters.

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Zicam nasal products recall starts

Quoted from http://www.reuters.com/article/healthNews/idUSTRE55N2NE20090624

Zicam nasal products recall starts

Wed Jun 24, 2009 8:49am EDT

NEW YORK (Reuters) - Matrixx Initiatives has started to notify U.S. customers of its recall of nasal versions of its Zicam cold remedy, a week after U.S. regulators told the company to stop selling the products.

Matrixx said on Wednesday that it was in the process of formally notifying retailers, wholesalers and distributors of its recall of all Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs, even as the company maintained it "vigorously disagrees" with the U.S. Food and Drug Administration over allegations that the products are not safe and were unlawfully marketed.

The company "is conducting this recall because of its desire to cooperate with the FDA," Matrixx said.

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Heart study questions diabetes drugs

Quoted from http://www.nature.com/news/2009/090622/full/news.2009.588.html

Heart study questions diabetes drugs

A molecular pathway could explain how a class of drugs leads to heart failure.

Published online 22 June 2009 | Nature

Charlotte Schubert  

Researchers who study how tumours balloon in size have discovered one way that enlargement of the heart can lead to heart failure. The work, although mostly done in mice, could help explain why a class of diabetes drugs called thiazolidinediones (TZDs) increase the risk of heart failure.

These drugs have been controversial since a 2007 analysis1 of Avandia (rosiglitazone), a TZD made by GlaxoSmithKline, suggested that patients taking it are at increased risk of heart attack. Less controversial are data linking TZDs with heart failure, a distinct condition in which the heart cannot pump enough blood through the body.

"We already knew if you had heart failure you probably should not be taking these drugs, but this paper provides an additional explanation why," says Clay Semenkovich, an endocrinologist at the Washington University School of Medicine in St Louis, Missouri.

The work suggests that a molecule activated by TZDs, called PPAR-γ, underlies one aspect of heart failure.

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