PHARMACY

Lack of new antibiotics raises concerns surrounding drug-resistant infections

BY Drew Buono

WASHINGTON The pipeline for antibiotics has been drying up amid the concerns that there is an increase in drug-resistant and potentially deadly bacterial infections, according to nj.com.

The reason for the lack of new drugs is that, pharmaceutical manufacturers are facing costs that are too high for new drugs and do not produce enough in revenues when these drugs hit the market. The companies are instead looking at other types of medications for profits, which include chronic diseases where patients will take medications a lot longer than the length of a typical illness.

According to the Diseases Society of America, there were 16 new antibiotics approved by the Food and Drug Administration between 1983 and 1987, and 14 between 1988 and 1992, an average of three a year. Those numbers have been steadily dwindling in the past 15 years, with only five new antibiotics winning approval between 2003 and today.

Ken Johnson, the senior vice president for the Pharmaceutical Research and Manufacturers of America, a major industry trade group, said there are 61 vaccines in the pipeline to help treat patients suffering from infectious diseases, and 34 antibiotic treatments in development. Many of these antibiotics are years away from being considered for approval by the FDA.

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PHARMACY

Heritage launches its formulation of the generic hydrochlorothiazide

BY Drew Buono

EDISON, N.J. Heritage Pharmaceuticals has launched its new drug hydrochlorothiazide.

The drug is used as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. The drug is also used in the management of hypertension.

The drug is available in 25 and 50 mg tablets in 100 and 1000 count bottles. Total annual market sales for Hydrochlorothiazide tablets in the U.S. were $30.8 million, according to March 2007 IMS data.

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Bayer pulls clotting drug from worldwide market

BY Allison Cerra

FRANKFURT, Germany Bayer has stopped worldwide sales of its anti-bleeding drug after a clinical study revealed the drug poses a higher risk of death.

Trasylol (aprotinin), designed to stem blood loss and enable patients receiving heart bypass surgery to avoid the use of transfusions, was tested in a Canadian clinical study last month. Preliminary results from that trial also suggested Trasylol increased the risk of death when compared with the other drugs.

Additional tests, which would have compared the safety and effectiveness of Trasylol with two others was halted after the initial results surfaced.

Leverkusen-based Bayer said Monday that it made the decision after discussions with the Food and Drug Administration, the German Federal Institute for Drugs and Medicine Products along with Health Canada.

Last week, the FDA said that evidence suggests Trasylol increased the risk of death compared with other drugs, and that the drug was blocking enzymes which dissolve blood clots, instead of aiding them. The agency began reevaluating the drug’s safety after the January 2006 publication of two studies that linked the drug’s use to serious side effects, including kidney problems, heart attacks and strokes.

The FDA approved the drug in 1993 to prevent the loss of blood and thwart the need for blood transfusions in surgeries to bypass clogged coronary arteries.

More recent studies have suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a “regrettable human error.”

Bayer said it wanted to review the results from the Canadian trials before moving forward.

“Once the complete … dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol,” the company said in a statement. “At that time the temporary marketing suspension will be reevaluated.”

Shares of Bayer gained nearly 1.6 percent to €57.57 ($83.36) in Frankfurt.

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