Guest guest Posted July 10, 2006 Report Share Posted July 10, 2006 http://www.nj.com/news/ledger/index.ssf?/base/news-7/1152419969107890.xml & co ll=1 Uncertified medicines a 'serious' safety issue Thousands of drugs lack FDA approval Sunday, July 09, 2006 BY ROBERT COHEN STAR-LEDGER WASHINGTON BUREAU WASHINGTON -- Several thousand prescription medicines including cough remedies, painkillers and sedatives are being sold by pharmaceutical companies, prescribed by doctors and dispensed by pharmacists without ever receiving Food and Drug Administration approval. In a startling disclosure, the FDA last month acknowledged a wide range of pharmaceuticals -- most on the market long before Congress strengthened the nation's drug law in 1962 -- have never been certified as safe and effective or checked for manufacturing quality and adequate labeling. " It is unfortunate that many older or existing drug products continue to be marketed in this country without required FDA approval, " Galson, director of the FDA's Center for Drug Evaluation and Research, said in a statement. " We consider it a significant and serious drug safety issue that must be addressed since these products may pose a risk to consumers. " The FDA said the unapproved medicines represent less than 2 percent of the multibillion dollar U.S. prescription drug market. Yet they include several thousand separate products using several hundred different unapproved active ingredients. They cover a broad range of therapies and bring their makers hundreds of millions of dollars a year in revenue. The FDA also announced it will begin systematically cracking down on the unapproved prescription medicines, focusing on those that may represent potential safety risks, lack evidence of effectiveness or constitute health fraud. " I am a little surprised there are so many of these prescription medicines out there that haven't been already removed from the market, " said Colaizzi, dean of the Rutgers University Ernest School of Pharmacy. " For me as a pharmacist and for the public, there is an assumption that all the products have been tested and certified for both safety and effectiveness. " The FDA said it does not have complete data on unapproved medications because " the universe of such products is constantly changing as some products enter and leave the market, " and as companies mix known prescription ingredients in various strengths, combinations and dosages. In general terms, the FDA said the major categories of unapproved prescription drugs now on the market include some cough and cold preparations with antihistamines, certain single-ingredient narcotics and sedatives. Cole, president of the Branded Pharmaceutical Association, said there also are unapproved analgesics for pain, anti-inflammatory drugs, gastrointestinal medicines and many other products. " No one knows for sure how many are out there, " said Cole, whose association represents small manufacturers that have sold some of these drugs for decades. " There are some products without formal approval for probably any kind of therapy you can think of. " 'GRANDFATHERED' DRUGS Most of these medications were on the market before Congress made successive changes to the drug approval process, including 1962 amendments that required pharmaceuticals not only be safe but also effective. While most pre-1962 prescription remedies were later evaluated by the FDA, many claimed exemptions because they or similar drugs were marketed before a 1938 drug safety law. The FDA said some of the " grandfathered " drugs actually have since changed their formulations, dosages, how they are administered and what patients and conditions they are recommended for -- making them " new " drugs requiring formal review and approval. Cole said most of the unapproved products have been prescribed for decades and have been considered safe and beneficial by doctors and their patients. " How could these drugs now be illegal? " he asked. Tom J. Cassio, a pharmacist since 1966 and owner of Twin City Pharmacy in South Plainfield, said medicines with antihistamines such as Pheniramine and some of the other drug categories cited by the FDA were once widely prescribed but are fading in popularity. " The trend is going in the opposite direction. There is lack of use of a lot of these older remedies, and doctors are not really prescribing them, " Cassio said. EVEN EXPERTS UNAWARE The FDA said many doctors and pharmacists may not suspect some medications they rely on are unapproved because they have been available for so long. Many of these products may be listed in guides such as the Physicians' Desk Reference and advertised in medical journals, the FDA said. Cole said the FDA should not pull these therapies off the market or force small drug companies to spend large sums of money on clinical trials and to take other steps required for new drug approvals. Instead, he said the FDA should set up a simpler system for expedited review of classes of medications that have a long history of safety and effectiveness. The FDA has rejected this view, maintaining the longevity of a product on the market or the " absence of known safety problems " is not enough to prove safety and effectiveness. Galson said one cannot assume a product's indications and directions for use are appropriate, or be sure it is safe for children or for other vulnerable populations, without examining the scientific evidence. When the FDA placed manufacturers on notice recently, it announced it was targeting an estimated 26 companies that market about 120 prescription allergy medications containing the sedating antihistamine carbinoxamine. Carbinoxamine has been used for at least five decades in prescription products, but the FDA said only two products made by Mikart Inc. of Atlanta have been approved to treat allergic symptoms. The FDA said other carbinoxamine products are being sold illegally, some labeled for treatment of coughs and colds, an indication for which carbinoxamine has not been found to be safe and effective. In addition, the FDA said companies are selling the product in drops and syrups labeled for use in children as young as 1 month old, but carbinoxamine has never been studied in young children. The agency said it has received reports of 21 deaths in children under age 2 years associated with drugs containing carbinoxamine since 1983, although a definitive connection has not been established. The maker of one carbinoxamine product, Everett Laboratories in West Orange, said it will be taken off the market. Company president Everett Felper said the medication, one of several sold under the brand name Tussafed, has been used safely for years, but " the FDA makes the rules and we have to live with it. " Cohen covers the federal government. He may be reached at rcohen@... or (202) 383-7800. -------------------------------------------------------- Sheri Nakken, R.N., MA, Hahnemannian Homeopath Vaccination Information & Choice Network, Nevada City CA & Wales UK $$ Donations to help in the work - accepted by Paypal account earthmysteriestours@... voicemail US 530-740-0561 (go to http://www.paypal.com) or by mail Vaccines - http://www.nccn.net/~wwithin/vaccine.htm Vaccine Dangers On-Line course - http://www.nccn.net/~wwithin/vaccineclass.htm Reality of the Diseases & Treatment - http://www.nccn.net/~wwithin/vaccineclass.htm Homeopathy On-Line course - http://www.nccn.net/~wwithin/homeo.htm Quote Link to comment Share on other sites More sharing options...
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