Uncertified medicines a 'serious' safety issue

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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

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