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FDA warns company over unapproved flu remedy

Tue, 29 Jan 2013 17:37:00 +0000

WASHINGTON (AP) — Federal regulators say a Florida company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.

The Food and Drug Administration and the Federal Trade Commission issued a warning letter to Flu and Cold Defense LLC for making misleading, unproven claims about its GermBullet inhaler.

The Boca Raton, Fla.-based company advertises the product as a "proprietary blend of 11 organic botanicals." The company's website claims that "an FDA recognized virology lab" tested the formula and "confirmed that it has the potential capability to kill cold and flu viruses."

But FDA regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations. All new drugs marketed in the U.S. must be submitted for approval to the FDA before they can be sold to consumers. The GermBullet is sold online through retailers like CVS.com and at a handful of small pharmacies and natural food stores in Florida.

A man reached by phone at Flu and Cold Defense's office could not immediately comment on the warning letter.

The warning comes amid a worse-than-usual flu season that has hit the elderly particularly hard. So far, half of confirmed flu cases are in people 65 and older.

FDA approves diet pill

Wed, 27 Jun 2012 17:50:00 +0000

WASHINGTON (AP) — The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.

FDA orders lower doses in prescription painkillers

Thu, 13 Jan 2011 21:50:00 +0000

Federal health regulators are limiting a key ingredient found in Vicodin, Percocet and other prescription painkillers that have been linked to thousands of cases of liver damage each year.

The Food and Drug Administration said Thursday it will cap the amount of acetaminophen in the drugs at 325 milligrams per capsule. Current products on the market contain doses of up to 700 milligrams.

Acetaminophen is a ubiquitous pain reliever found in Tylenol, Nyquil and thousands of other medicines used to treat headaches, fever and sore throats. The ingredient is also used at larger doses in prescription combination drugs that mix it with narcotic drugs like oxycodone.

Those products are not dangerous by themselves but can cause toxic overdoses when patients combine them with a second acetaminophen-containing drug like Tylenol.

FDA officials said the labeling on prescription drugs often does not make it clear that they contain acetaminophen, instead using abbreviations for the ingredient like 'APAP.'

"One of the real challenges we have is that patients taking these products don't know they're taking acetaminophen at all," said FDA deputy director for new drugs, Dr. Sandra Kweder, in a telephone briefing with reporters "They don't realize that they are overdosing."

FDA moves to withdraw unproven blood pressure drug

Mon, 16 Aug 2010 19:55:00 +0000

Federal health regulators are pushing to withdraw a blood pressure drug that has been on the market for 14 years in spite of the manufacturer's failure to submit evidence that it actually helps patients.

The Food and Drug Administration approved Shire Laboratories' drug ProAmatine in 1996 based on promising early results in treating low blood pressure. But the company has never conducted a mandatory follow-up study to actually prove the long-term benefits of the drug.

In letter to the company posted online Monday, the FDA proposes withdrawing the drug from the market and gives Shire an opportunity to schedule a hearing to discuss the matter. The letter marks the first time the FDA has threatened to pull a drug off the market due to missing follow-up data, though it has long held that power.

"This proposal is necessitated by Shire's failure to conduct postmarketing clinical trials that verify and describe the clinical benefit" of ProAmatine, the agency states.

Calls placed to Dublin, Ireland-based Shire seeking comment were not returned Monday afternoon.

Johnson & Johnson execs briefed on “phantom recall” of Motrin

Fri, 11 Jun 2010 21:24:00 +0000

Documents obtained by The Associated Press indicate Johnson & Johnson executives were briefed on an outside contractor's plan to buy up defective painkillers instead of issuing a recall.

Emails sent to J&J last spring by contractor Inmar show the company was informed that the plan to purchase thousands of packets of Motrin could "draw scrutiny."

Lawmakers began scrutinizing the J&J after a slew of product recalls, most recently involving dozens of children's medicines.

The communication between J&J and the contractor appears to contradict testimony from a J&J executive, who told lawmakers last month that J&J was unaware of the plan to use contractors posing as customers to buy the defective products off retail shelves.