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FDA releases risk summaries for newer drugs

WASHINGTON (Reuters) - U.S. health officials have started releasing summaries of safety reviews for recently approved medicines as part of their efforts to inform doctors and consumers about potential side effects.

The information comes in part from post-approval reports of health problems from consumers, doctors and companies, Food and Drug Administration officials said as they unveiled the program on Tuesday. Agency reviewers also look at medical literature and ongoing studies.

The FDA and companies track potential problems after a drug reaches the market as some side effects do not emerge in the smaller groups of people who take part in pre-approval testing.

A 2007 law required the FDA to prepare a safety summary for certain prescription drugs 18 months after approval or after they have been used by 10,000 people, whichever comes later. Those summaries will now be posted on the FDA website.

On Tuesday, the agency released summaries for 24 medicines and two vaccines for hypertension, allergies, HIV and other conditions. It included details on what action the agency was taking.

In the list, the FDA said it had reviewed reports of cases where Alvesco, an asthma drug sold by Dainippon Sumitomo Pharma unit Sepracor Inc, was ineffective. The reports “described problems with drug delivery (possible device malfunction) after a period of use,” the FDA said.

In that case, the agency said it had requested more information on the issue but decided no changes to the drug’s prescribing instructions are required at this point.

Sepracor spokeswoman Susan Adler said the company and its distribution partner, privately held Nycomed, have been working with the FDA throughout its review of the matter.

“This review has not resulted in any changes to the labeling or manufacturing process for Alvesco,” she said.

For most of the drugs, the FDA said no new issues were identified or problems had been investigated and determined to be unrelated to the medicine.

The findings show “for the most part, we know a lot from (pre-market) clinical development,” said Dr. Robert Boucher, an official in the FDA office that reviews post-approval drug risks.

The FDA will provide summaries for drugs approved after September 2007, when the law that required them took effect. New summaries will be released quarterly.

Serious issues that arise before the 18-month mark could be disclosed earlier, Boucher said.

A drug industry group said it believed the FDA should continue to monitor risks and benefits after a product’s approval.

“A medicine’s FDA-approved labeling should contain the most authoritative summary of its benefits and risks, and this is reflected in FDA’s new website” listing the safety summaries, said Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America.

The FDA has moved to make public more information about drug risks since running into criticism for its handling of problems with medicines including Merck & Co’s pain reliever Vioxx, which was pulled from the market in 2004 after it was linked to heart attacks and strokes.

The agency now alerts the public to early investigations of problems before scientists have determined if a drug is responsible.

Reporting by Lisa Richwine; editing by Matthew Lewis, Bernard Orr, Gary Hill

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