FDA stops firm marketing unapproved cold medicines

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Posted on 10th April 2009 by Gordon Johnson in Uncategorized

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Date: 4/10/2009

WASHINGTON (AP) — Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Friday that East Windsor, N.J.-based Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Neilgen, which also does business as Unigen Pharmaceuticals, is based in Westminster, Md.

“Consumers in possession of these products should discontinue using them and discuss FDA-approved treatments with their health care professional,” the FDA said in a statement.

Company executives Bharat Patel and Pragna Patel agreed to destroy their inventory of unapproved drugs, under a consent degree handed down in the U.S. District Court of Maryland. The agreement also bars the executives from manufacturing any new drugs without FDA approval and requires them to hire outside consultants to assess their operations before resuming production.

Company leaders did not immediately respond to calls for comment Friday afternoon.

Friday’s action comes the same week the FDA ordered a number of medical device manufacturers to submit data on products that were never approved. The devices, which range from pacemaker generators to dental implants, were released to market before the 1976 law which gave FDA authority to regulate new devices.

Copyright 2009 The Associated Press.

Hong Kong drug firm suspended over expiration dates

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Posted on 13th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/13/2009

By DIKKY SINN
Associated Press Writer

HONG KONG (AP) — Hong Kong police have arrested four employees of a drug manufacturer for allegedly lying about the expiration dates on more than 200 over-the-counter medicines, officials said Friday.

Marching Pharmaceutical Ltd. has had its license suspended for one month while authorities look into claims the company was selling medicines with expiration dates that went beyond a product’s shelf life, a Health Department spokesman said on condition of anonymity, citing internal policy.

Authorities have also ordered the company to recall 216 products — including dozens of cough syrups and antifungal creams, he said.

The spokesman said the products being recalled are low-risk drugs and that there was no immediate risk to human health.

Police arrested four employees Thursday in connection with the case. They have been released on bail pending further investigation, police spokesman T.K. Ng said.

Nobody has fallen ill from using the company’s products, but the Health Department spokesman said “some of the documents provided by this company are not consistent, so we’ve asked police to step in and investigate.”

Repeated calls to MPL rang unanswered Friday.

Copyright 2009 The Associated Press.

–According to http://www.news.gov.hk

Department of Health Chief Pharmacist Anthony Chan stressed that the case only involved product stability – not safety of the products which were low-risk drugs.

The recalled products are low-risk drugs. Most are non-prescription products including vitamins, minerals and cough and cold preparations. Others are prescription topical preparations such as skin creams.

The manufacturer has set up a hotline, 2781 6320, to answer questions.

FDA urged to recall cold medicines for youngsters

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Posted on 2nd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/2/2008 3:14 AM

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids’ coughs and sniffles. Doctors question the drugs’ benefits and worry about their risks.

Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.

“Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner. “There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6.”

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers.

The industry says OTC medicines have been used for decades in treating kids’ colds and are safe for those older than 2. Nonetheless, manufacturers are carrying out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said older children could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

But Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

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On the Net:

Food and Drug Administration background: http://tinyurl.com/3emy54

Copyright 2008 The Associated Press.