Drug Safety Developments

Ariad suspends sales of blood cancer drug, shares sink

Quoted from http://www.reuters.com/article/2013/10/31/us-ariad-drug-suspension-idUSBRE99U0H620131031

Ariad suspends sales of blood cancer drug, shares sink

Thu Oct 31, 2013 8:23am EDT

(Reuters) - Ariad Pharmaceuticals Inc said it would suspend sales of its blood cancer drug Iclusig, barely two weeks after it stopped an ongoing trial of the drug due to safety concerns. 

The development, which drove down Ariad shares 31 percent before the bell, is a major setback for the company after it won an accelerated approval for the drug from the U.S. Food and Drug Administration last December. 

An accelerated approval is granted based on promising data from early trials. But the process still requires the company to conduct further studies to prove the drug is as effective as initially thought. 

Iclusig is used to treat two rare blood cancers.

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Janssen Faces Second Trial Over Drug’s Link to Birth Defects

Quoted from http://www.businessweek.com/news/2013-10-29/janssen-faces-second-trial-over-drug-s-link-to-birth-defects-1

 

Janssen Faces Second Trial Over Drug’s Link to Birth Defects

By Sophia Pearson, Bloomberg News

October 29, 2013

Johnson & Johnson’s Janssen Pharmaceuticals unit is facing a second trial over the links between its Topamax seizure drug and birth defects.

A trial began today in Philadelphia over claims brought by a South Carolina couple, Michael Gurley and Haley Powell, on behalf of their 5-year-old son who was born with a cleft lip. The boy’s injuries were caused by Topamax, lawyers for the Gurleys told jurors today. Another case involving Topamax’s alleged effect on a 6-year-old Virginia boy is scheduled to close tomorrow in the same court.

Topamax, approved by the Food and Drug Administration in 1996, was one of New Brunswick, New Jersey-based J&J’s top sellers before it lost patent protection in 2009. Janssen is being blamed by users for failing to inform expectant mothers of the drug’s risks of birth defects including cleft palate and lip. There are about 134 cases pending in state court in Philadelphia over the epilepsy drug, according to plaintiffs’ lawyers.

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FDA Investigates Brain Infection-Gilenya Case

Quoted from http://www.webmd.com/multiple-sclerosis/news/20131018/fda-investigate-gilenya

FDA Investigates Brain Infection-Gilenya Case

By Kathleen Doheny
WebMD Health News Reviewed by Michael W. Smith, MD

Oct. 18, 2013 -- The FDA is continuing to investigate a possible link between the multiple sclerosis drug Gilenya (fingolimod) and a case of a rare brain infection in a European patient.

The patient took the drug for nearly 8 months before being diagnosed with the brain infection. The FDA issued an alert at the end of August to inform the public of its investigation.

The brain infection, sometimes fatal, is called PML (progressive multifocal leukoencephalopathy). The European case is the first reported in a patient who has not previously taken the drug Tysabri (natalizumab). Tysabri is already known to be linked with a higher risk for PML.

The maker of Gilenya, Novartis, issued a statement saying it had reviewed all available evidence and that the case of PML in Europe is unlikely to be linked to the drug.

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Janssen’s Topamax Users Blame Seizure Drug for Birth Defects

Quoted from http://www.businessweek.com/news/2013-10-15/janssen-s-topamax-users-blame-seizure-drug-for-birth-defects-1 

Janssen’s Topamax Users Blame Seizure Drug for Birth Defects

By Sophia Pearson
Bloomberg News
October 15, 2013

Johnson & Johnson’s Janssen Pharmaceuticals failed to inform expectant mothers of risks that its epilepsy drug Topamax could cause birth defects, a lawyer for the mother of a Virginia 6-year-old told a jury.

April Czimmer wouldn’t have taken Topamax for more than six months had she known the risks associated with the drug, her attorney Tommy Fibich said in opening statements today in state court in Philadelphia.

Czimmer blames the drug for her son’s cleft palate and lip and claims Janssen negligently failed to inform patients about its risks until the U.S. Food and Drug Administration ordered stronger warnings in 2011.

“It is the pharmaceutical equivalent of a drive-by shooting,” Fibich said. “The pharmaceutical company, when they put this drug out into the market knowing it has these causes, they don’t know who it’s going to hit.”

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FDA probing serious adverse events linked to Ariad's cancer drug

Quoted from http://www.reuters.com/article/2013/10/11/us-fda-ariad-idUSBRE99A0IH20131011

FDA probing serious adverse events linked to Ariad's cancer drug

 Fri Oct 11, 2013 10:50am EDT

(Reuters) - The U.S. Food and Drug Administration said it is investigating an increasing number of reports of serious and life-threatening adverse events in patients taking Ariad Pharmaceuticals Inc's leukemia drug, Iclusig. 

Ariad's shares fell 7 percent in early trade on Friday. 

In a safety notice posted on its website, the regulator advised patients taking Iclusig to seek immediate medical attention if they experience symptoms suggesting a heart attack. 

The notice comes after Ariad disclosed on Wednesday that the FDA asked the company to stop enrolling patients in clinical trials of Iclusig. The agency had identified a number of patients who had experienced blood clots and heart damage after taking the drug. 

Iclusig was approved by the FDA in December 2012 to treat adults with two rare types of blood cancers - chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. The drug's label contains information about the risks of blood clots.

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