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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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Cervical cancer vaccine: key questions

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Cervical cancer vaccine: key questions

Cervical cancer is malignant neoplasm of the cervix uteri or cervical area. It may present with vaginal bleeding but symptoms may be absent until the cancer is in its advanced stages. Treatment consists of surgery (including local excision) in early stages and chemotherapy and radiotherapy in advanced stages of the disease.

Pap smear screening can identify potentially precancerous changes. Treatment of high grade changes can prevent the development of cancer. In developed countries, the widespread use of cervical screening programs has reduced the incidence of invasive cervical cancer by 50% or more.

The initial post mortem said was “most unlikely” the vaccine was the cause of death. It could have been nothing more than a coincidence, although one scenario that has been presented is she had a very rare severe allegric reaction to the vaccine, known as anaphylaxsis, which can be fatal.

Signs and symptoms

The early stages of cervical cancer may be completely asymptomatic. Vaginal bleeding, contact bleeding or (rarely) a vaginal mass may indicate the presence of malignancy. Also, moderate pain during sexual intercourse and vaginal discharge are symptoms of cervical cancer. In advanced disease, metastases may be present in the abdomen, lungs or elsewhere.

Symptoms of advanced cervical cancer may include: loss of appetite, weight loss, fatigue, pelvic pain, back pain, leg pain, single swollen leg, heavy bleeding from the vagina, leaking of urine or faeces from the vagina, and bone fractures.

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