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Cancer, bowel drugs on FDA safety scrutiny list

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Cancer, bowel drugs on FDA safety scrutiny list

More than a dozen drugs including a cancer therapy and a bowel medicine are under early scrutiny for potential side effects, U.S. regulators said in a quarterly list released on Thursday.

The Food and Drug Administration said it was investigating cases of liver failure in patients treated with Pfizer Inc’s cancer drug Sutent. The agency also is reviewing gastrointestinal perforation reported with Relistor, a drug from Wyeth and Progenics Pharmaceuticals for treating opioid-induced constipation.

Appearing on the list “means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the agency said.

The FDA releases a quarterly list of safety probes as part of an effort to inform the public about early investigations of potential side effects that have been reported. The list released on Thursday covers issues identified between January and March 2009.

Pfizer said in a statement it would “work with the FDA to assess the reports (on Sutent) and determine a path forward.”

In clinical trials, liver failure was seen in less than 1 percent of patients with solid tumors who were treated with Sutent, the company said.

“We stand behind the safety and efficacy of Sutent,” Pfizer said. The drug is approved for treating advanced kidney cancer and a digestive cancer known as gastrointestinal stromal tumor.

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Inhalers may raise risk of asthma in some children

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Inhalers may raise risk of asthma in some children

Common asthma reliever drugs taken by millions of children around the world may increase the risk of asthma attacks in some patients with a particular genetic make-up, British scientists said on Tuesday.

The researchers found that salbutamol, a popular blue inhaler medicine also known as Ventolin, as well as salmeterol, an ingredient in GlaxoSmithKline’s Advair, are less effective in children with a specific gene variant and may in some cases make their asthma worse.

The scientists said their findings suggest that carrying out genetic tests on children before treatment could be a more cost-effective way of treating them.

“This is a global question that needs to be addressed,” said Somnath Mukhopadhyay of Brighton and Sussex Medical School.

Salbutamol is called albuterol in the United States and is very widely used, the researchers told a news conference.

U.S. drug regulators have cautioned in the past that asthma drugs like Advair and Serevent, also made by Glaxo, may actually increase asthma risk in some patients. Glaxo said in a statement it had carried out its own studies with Advair and Serevent and found no genetic variation response differences, although the 500 patients in its study were older than 12.

“Albuterol is one of the commonest drugs right across the world. It is used in the United States, in Africa, India…” said Mukhopadhyay. “It’s cheap, it’s popular, and it’s good stuff — when it works.”

Asthma affects more than 300 million people worldwide and is the most common children’s chronic illness. Symptoms include wheezing, shortness of breath, coughing and chest tightness.

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Bowel disease drugs increase cancer risk: study

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Bowel disease drugs increase cancer risk: study

Some treatments for inflammatory bowel disease increase the risk of infection-related cancers, French scientists said on Monday, but the benefits of the drugs still outweigh the risks.

Thiopurine drugs — immunosuppressive medicines that inhibit the body’s immune system — are regularly used to treat inflammatory bowel disease, the researchers said, but can increase the risk of cancers linked to viral infections.

Laurent Beaugerie and colleagues at the Saint-Antoine hospital in Paris looked at more than 19,000 patients with inflammatory bowel disease. Around 30 percent of the patients were taking thiopurines, 14 percent had stopped taking them and 56 percent had never taken them.

Following up after almost 3 years, the researchers found 23 new cases of cancers — one of Hodgkin’s lymphoma and 22 of non-Hodgkin lymphoma.

Statistical analysis showed that patients receiving thiopurines — like azathioprine produced by several generic drugmakers and by GlaxoSmithKline as Imuran — had a more than five-fold increased risk of lymphoma compared with those who had never received the drugs, the researchers said in a study published in The Lancet journal.

Older male patients with a longer history of inflammatory bowel disease also had increased lymphoma cancer risk.

“The absolute cumulative risk…in young patients receiving a 10-year course of thiopurines remains low — (less than 1 percent) — and does not undermine the positive risk-benefit ratio of these drugs,” the researchers wrote.

But for elderly patients and for unlimited treatment periods, more studies were needed to assess the risk, they said.

Commenting on the study, Geert D’Haens of the Imelda GI Clinical Research Center and Paul Rutgeerts University Hospital Gasthuisberg, both in Belgium, said doctors should be cautious in prescribing thiopurines for prolonged periods.

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