Complaints Will Be Posted Quarterly

The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency’s attention by drug companies, physicians and patients.

The FDA will name the drug and the nature of the “adverse events” but will not describe their seriousness or the number of complaints received, officials said yesterday. Being on the list does not mean the drug is unsafe, only that the FDA is looking into that possibility.

FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

The agency’s Adverse Event Reporting System (AERS) last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medication a patient was taking.

Presumably, many of the investigations that the FDA will now announce will not find any new problem with the drug in question.

“The risk is that people will read more into this than what it is, which is a statement that an evaluation is underway,” said Paul Seligman of the agency’s Center for Drug Evaluation and Research. He added that he hopes patients will not stop taking a medication simply because they saw it on the list.

Another official, Gerald Dal Pan, said that the FDA’s “post-market surveillance” system is not changing, only the timing and extent to which the public is informed.

“I think the public has told us in recent years that ‘we want to know what you are working on.’ We are telling the public at pretty much the earliest stage what we are working on,” he said.

A drug is evaluated for safety in many ways in the long process leading to the FDA’s decision to approve or reject it for sale. Nevertheless, rare side effects and interactions sometimes are not recognized until after a drug is on the market and taken by many more people — and people with more health problems — than those in pre-market studies.

In the last decade, the painkiller drug Vioxx was found to increase the risk of heart attack and stroke; the diabetes drug Avandia to increase the risk of congestive heart failure; and numerous anti-epilepsy drugs to increase the risk of suicide. In each case, the hazard was not fully recognized until years after the drug was approved.

The quarterly list, which can be found on the FDA Web site, will name only drugs being reviewed because of reports to the AERS program. The agency also starts investigations because of data from clinical trials and other studies. Those will not be on the list.

When the FDA finds that a drug has newly recognized hazards, it can add warnings to the official directions for the drug’s use (”the label”), send warning letters to physicians, require patients taking the drug to be monitored closely, or take the medication off the market.

FDA officials said yesterday that they had not yet decided how to inform the public when an investigation exonerates a drug.

The first quarterly report, covering Jan. 1 to March 31, listed 20 drugs. Four were being investigated for problems that already announced to the public: heparin and severe allergic reactions; the diagnostic “contrast agent” Definity and cardiopulmonary reactions; Cymbalta and urinary retention; and tumor necrosis factor inhibitors and cancer in children and young adults.

Some of the newly revealed investigations involve confusing names or packaging, not novel side effects. For example, FDA regulators are looking into problems caused when a cream with the trade name Carac used to treat precancerous skin conditions is confused with a cream called Kuric prescribed for fungal infections.

Amgen Inc drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the Food and Drug Administration said on Friday in approving the product for U.S. sales.

The injectable drug helps stimulate bone marrow into producing blood platelets in patients with chronic immune thrombocytopenic purpura (ITP), the FDA said. The agency approved its use for patients only after other available treatments fail to help.

“This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill,” said Dr. Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research.

Other approved ITP treatments include steroids, immune-suppressing drugs or surgery to remove the spleen.

“Until now there have been limited FDA-approved treatments available to patients suffering from chronic adult ITP, and the treatment options were often unsuccessful for long-term use,” Amgen said in a statement.

The total cost of care for Nplate patients is expected to be “less than or comparable to the total costs of care with standard treatment regimens,” the Thousand Oaks, California-based biotech company said.

Patients who still had their spleen fared better than those who did not, it added.

ITP occurs when the immune system destroys platelet cells that help the blood clot and low platelet levels can trigger life-threatening bleeding. Patients with the condition are also more likely to experience bruising.

Nplate, also known as romiplostim, is not expected to be a big seller and also faces competition. About 60,000 U.S. adults have chronic ITP, Amgen has said.

Some analysts expect it to earn anywhere from $66 million to $117 million in 2009 sales and peak around $200 million — small compared with Amgen’s 2007 revenue of $14.7 billion.

GlaxoSmithKline Plc’s rival drug, Promacta, or eltrombopag, faces an FDA approval decision by September 19.

Amgen’s shares were largely unaffected by the FDA’s decision, in part because the ruling had initially been expected in July before the agency postponed it.

Analysts have instead been buoyed by hopes for its experimental osteoporosis drug called denosumab, which is still in development.

“We are encouraged by the approval, but note that the small patient market for this drug will result in a modest contribution to the company’s revenues,” William Blair & Co analysts said in a research note.

“We continue to believe that the most meaningful revenue addition for Amgen will be pending approval of denosumab in osteoporosis,” they wrote.
Both Amgen and Glaxo shares closed up less than 1 percent on the Nasdaq and the New York Stock Exchange, respectively.

The company said it was seeking additional approval for Nplate in Europe, Canada and Switzerland. Australian authorities approved the drug last month.

But the agency says patients can still take the cholesterol-lowering drug

U.S. drug regulators said Thursday that they were investigating whether the cholesterol-lowering drug Vytorin might be linked to cancer.

The U.S. Food and Drug Administration said it has informed health-care professionals that the agency was investigating a report from the so-called Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and an increased risk of a variety of cancers.

Vytorin is a combination drug made up of the compounds simvastatin and ezetimibe that’s designed to reduce levels of LDL (bad) cholesterol and cut the risk of cardiovascular problems. It works by decreasing the production of cholesterol by the liver and inhibiting the absorption of cholesterol in the intestine.

In a statement released Thursday afternoon, the FDA said it had obtained preliminary results from the SEAS trial. The trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular problems in people with narrowing of the aorta, the body’s largest artery. The five-year trial did not show a reduced cardiovascular risk. But, a “larger percentage of patients treated with Vytorin were diagnosed with and died from all types of cancer combined, when compared to treatment with a placebo,” the statement said.

However, the FDA said patients can continue to take the drug. But the agency urged health-care professionals to monitor their patients for possible side effects and report them to the agency. While one recent clinical trial indicated higher rates of cancer for patients taking the drug, the FDA said two studies currently under way have shown no increased risk, the Associated Press reported.

The agency said it expects to receive a final study from the SEAS trial in about three months. It will then take an estimated six months to review and evaluate the trial data.

Vytorin is made by the drug companies Merck &amp Co. and Schering-Plough Pharmaceuticals. It’s a combination of Merck’s Zocor (simvastatin), a statin, and Schering-Plough’s Zetia. A report earlier this year found the drug failed to reduce the buildup of plague in arteries any better than the generic drug Zocor.

Following the FDA’s announcement Thursday about the possible Vytorin-cancer link, several Congressional lawmakers issued a demand for data on the trial that suggested a potential connection, the AP said.

Merck and Schering-Plough said they would cooperate with the requests. The companies defended the drug, saying it is effective at reducing cholesterol — the use for which it was approved, the AP reported.

Earlier this week, researchers who last year reported a possible link between cholesterol-lowering statin drugs and cancer now say that further analysis has disproved such an association.

“The bottom line is that there is no evidence from this work, the largest study published to date, that the cholesterol-lowering ability of statins increases the risk of cancer,” said Dr. Richard H. Karas, director of preventive cardiology at Tufts Medical Center and leader of a group reporting the finding in the Journal of the American College of Cardiology.

A little more than a year ago, a report by Karas and his colleagues in the same journal described a slight increase in cancer risk among statin users — about one extra case per 1,000 people. That finding came from 13 trials that gathered information on side effects reported by people who took the drugs.

The newer report had data from 15 controlled trials involving more than 437,000 person-years of follow-up. The analysis did find a relationship between low levels of LDL cholesterol — the “bad” kind that clogs arteries and that statins attack — and a higher incidence of cancer. However, the team concluded that statins, per se, “lack an effect on cancer risk across all levels of on-treatment LDL cholesterol.”

An even larger study by Sir Richard Peto, the renowned British epidemiologist, reported at a meeting but not yet published in a medical journal, came to the same conclusion, Karas said.

An association between low levels of LDL cholesterol and cancer is no surprise, said Dr. Daniel Steinberg, professor emeritus of medicine at the University of California, San Diego. He wrote an editorial accompanying the report.

“The so-called J-shaped curve has been seen repeatedly when cholesterol has been measured,” Steinberg said. “In such studies, persons with the lowest LDL cholesterol on entry show the highest death rate from cancer than those with higher LDL levels.”

One possible mechanism is that cancer itself reduces LDL cholesterol levels, he said. “This is especially true of cancers involving the blood cell system, but it also occurs with cancer of the kidney and elsewhere,” Steinberg said.

“Whatever the mechanism, the main point should be that studies of much larger numbers of people in statin trials find no excess of cancers,” he said.

The U.S. Food and Drug Administration granted marketing approval for Viread for the treatment of chronic hepatitis B, Gilead Sciences Inc. said reported late Monday.

Foster City-based Gilead (NASDAQ:GILD) said Viread is a once-daily tablet that works by blocking HBV DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells.

Viread has been available in the United States as a treatment for HIV infection in adults since 2001.

Because chronic HBV infection can persist for years without causing any noticeable symptoms, many people are unaware they are infected and do not seek treatment, Gilead said, adding that the disease disproportionately affects Asian Americans.

The approval of Viread expands Gilead’s hepatic health franchise. The company’s first treatment for chronic hepatitis B, Hepsera, is currently the most widely prescribed oral agent for the disease in the United States. The company is also developing small-molecule compounds for the treatment of hepatitis C and a hepatoprotectant for multiple forms of hepatitis-related liver fibrosis, including nonalcoholic steatohepatitis.

Viread was approved for the treatment of chronic hepatitis B in the European Union, Turkey, Australia and New Zealand earlier this year, and a marketing application is currently pending in Canada.

The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.
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