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Biotech / Medical : Merck -- Ignore unavailable to you. Want to Upgrade?

To: swedelo who wrote (981)	7/31/1998 4:02:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 1580

FDA Panel Considers Impact of Corticosteroids on Kids' Growth Bloomberg News July 30, 1998, 4:51 p.m. ET FDA Panel Considers Impact of Corticosteroids on Kids' Growth Bethesda, Maryland, July 30 (Bloomberg) -- Labeling on inhaled corticosteroid drugs, commonly used to treat asthma, shouldn't overemphasize their risks, drugmakers told an expert government advisory panel. The U.S. Food and Drug Administration called the panel to consider the drugs' effects on children's growth, and whether they should carry a standard precaution label. While the potential effect on growth has long been noted, new concerns about the corticosteroids cropped up after two drugmakers sought to switch their drugs to over-the-counter use, the FDA said. ''It is indeed important that potential effects on growth are defined,'' Anders Ullman, a vice president for clinical research and development at Astra AB, told the panel. ''These issues must not be overemphasized. That could definitely lead to under-treatment of asthma.'' Astra's Ullman was joined by representatives from Glaxo Wellcome Plc, Rhone-Poulenc Rorer Inc. and Schering AG, all makers of the corticosteroids. While the company officials had varying views of what should go on a standard label if one should exist at all, they all told the panel that any new label must stress that the drugs' benefits outweigh their risks. The panel is scheduled to take up discussion of the label and other issues tomorrow after hearing more presentations from experts. Inhaled corticosteroids are currently considered the best option for treatment of patients with chronic asthma, a lung disorder affecting some 15 million Americans. Analysts said a label change wouldn't have an immediate effect on sales of the drugs, which compete in a multibillion dollar market. ''The impact is likely to be more gradual,'' said Ira Loss, an analyst with HSBC Washington Analysis. New Alternatives Still, a label with more severe warnings or one which advises more frequent monitoring of growth could have an effect ''on the margins'' by encouraging patients and doctors to consider treatment with new alternatives, said James Kelly, an analyst with Credit Suisse First Boston. That could be good news for companies including Merck & Co., Zeneca Plc and Abbott Laboratories which in the last few years have introduced drugs in a new, non-steroid class of asthma drugs known as leukotriene blockers. They work by blocking substances in the body that act as co-conspirators in the inflammation suffered by asthma patients. Still, experts note that there's little long-term data on the newer drugs. FDA officials said they called this panel meeting because they're trying to figure out the best way to use corticosteroids and emphasized that they don't consider them unsafe. ''We in no way today are trying to frighten physicians or parents about the use of corticosteroids,'' said John Jenkins, director of the division that oversees pulmonary drugs. ''We're not trying to induce steroid phobia.'' Indeed, several experts speaking today noted that the drugs, which work by reducing the inflammation that exacerbates asthma, have a long, safe history of use. National Institutes of Health guidelines released last year recommended their use, calling them ''the most effective long- term control medication for asthma.'' The NIH also said the benefits of the drugs outweighed the risk of stunted growth. Risk Unclear And even that risk isn't agreed upon by everyone. Some of the company representatives said their studies have found no difference in growth between children taking their drugs and those taking a placebo. Other experts noted that asthma itself appears to cause a slowdown in growth, causing further confusion on the issue. The corticosteroids and the newer drugs such as Merck's Singulair and Zeneca's Accolate aren't intended as a treatment for an asthma attack. Patients should still use quick-relief medications for those. Currently, most patients use inhalers, which dispense medications in short blasts, to treat breathing attacks associated with asthma. Glaxo, Schering-Plough Corp. and Minnesota, Mining and Manufacturing Co. are among the companies that make and sell the inhalers. The U.S. market for asthma drugs is expected to grow to as much as $2.38 billion in 2005 from $1.18 billion in 1996. --Kristin Jensen in Bethesda, Maryland through the Washington