Inside these posts: FDA

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FDA: Beware of fake potassium iodide products

In the wake of the crisis in Japan, the U.S. Food and Drug Administration is advising consumers to beware of inadvertently buying fake iodide products that are supposed to help protect against radiation.

Products to watch out for include fake tablets and liquids purporting to be iodide, as well as dietary supplements and other products that say they protect against radiation, said the spokesperson adding there are only three FDA-approved potassium iodide products that protect against radiation. Get the full story »

Pay up, compensation down for Abbott’s White

Abbott Laboratories Chairman and Chief Executive Miles White received a 2 percent raise last year, to $1.89 million, though his bonus and other stock awards dipped amid a turbulent year for the North Chicago-based drug and medical product giant.

Abbott, which failed to win  Food and Drug Administration approval for certain prescription drugs, valued White’s total compensation package at nearly $25.6 million in 2010, down from $26.2 million in 2009, according to the company’s annual proxy statement filed Tuesday afternoon with the Securities and Exchange Commission.. The total includes stock awards, bonus, salary and other compensation. Get the full story »

FDA: Teen use of menthol cigarettes growing

(Joe Raedle/Getty Images)

Use of menthol cigarettes is rising among teenagers and “very high” for minority youth, U.S. government advisers said in part of a draft report released Monday.

More than 80 percent of black adolescent smokers and more than half of Hispanic adolescent smokers use menthol cigarettes, advisers to the Food and Drug Administration said in a draft chapter for a report due next week. The FDA will use the report to help decide whether to ban or limit menthol cigarettes. Get the full story »

FDA to oversee 3 troubled McNeil plants

Johnson & Johnson’s McNeil division, beset by an unstemmed tide of consumer product recalls, said Thursday that it had finalized a consent decree that would put three of its manufacturing facilities under supervision of U.S. health authorities.

McNeil said in a statement it had finalized the terms of a consent decree with the Food and Drug Administration for its facilities in Las Piedras, Puerto Rico, and Fort Washington and Lancaster, Pa. Get the full story »

AstraZeneca settles deceptive marketing claims

British drugmaker AstraZeneca Plc has agreed to pay $68.5 million to resolve allegations by U.S. state regulators that its marketing of the multibillion-dollar antipsychotic drug Seroquel was deceptive.

The accord with 37 U.S. states and Washington, D.C., is the largest multistate, consumer protection-based pharmaceutical settlement on record, said Paula Dow, attorney general of New Jersey, which is among the settling states. Get the full story »

FDA issues warning letter to Lifeway Foods

US health regulators issued a warning letter to Morton Grove-based health food products manufacturer Lifeway Foods, saying certain products of the company were wrongly marketed as drugs on its website. Get the full story »

Johnson & Johnson recalls insulin cartridges

Johnson & Johnson, which has been beset by a seemingly endless stream of product recalls, has recalled five lots of potentially leaky insulin pump cartridges that could lead to serious health problems and death.

It also has been warned by the Food and Drug Administration over manufacturing concerns for heart devices made at its Cordis unit’s San German, Puerto Rico facility. Get the full story »

FDA to toughen warnings on migraine drug

The U.S. Food and Drug Administration said it will strengthen warnings on the anti-migraine and anti-seizure treatment Topamax and its generic equivalents after new data suggested a higher risk for cleft palates in babies born to women taking the drug.

The move represents a setback for health-care products giant Johnson & Johnson, which owns Topamax maker Ortho-McNeil Pharmaceutical LLC. The subsidiary last May pleaded guilty to promoting the drug for off-label uses and had to pay an $81.5 million fine. Get the full story »

Walgreens compounds Tamiflu amid shortage

With seasonal influenza widespread in more than 40 states, Walgreen Co. said it has begun “compounding” Tamiflu to keep with the antiviral drug in adequate supply.

In rare instances, pharmacists will “compound” or mix ingredients in order to fill a prescription. In this case, pharmacists take the Tamiflu capsules, break them down and mix them with a cherry syrup, said Walgreens spokesman Jim Cohn. A spike in demand for the liquid form, largely prescribed to children, has triggered a shortage. Get the full story »

FDA questions use of zinc in denture cream

The Food and Drug Administration suggested manufacturers consider taking zinc out of denture cream, after reports of neurological problems that might be associated with zinc poisoning.

Zinc is a mineral naturally present in some foods, available as a dietary supplement and added to certain products. Zinc has been added to denture cream to boost its adhesive properties. The FDA said in a Feb. 23 letter sent to denture-adhesive manufacturers that it’s received “numerous reports of adverse events related to the use of denture creams” consistent with zinc toxicity. Get the full story »

FDA approves Takeda blood pressure drug

Takeda Pharmaceuticals North America Inc.  in April will begin selling a new pill to treat high blood pressure after the  Food and Drug Administration approved the Deerfield-based company’s Edarbi tablets, the agency said.

Edarbi, which will cost about $75 for a month’s supply, enters a crowded field of blood pressure medications, including several cheaper generics that employers and consumer groups say work well and can cost pennies a day. Get the full story »

Pols want answers on Heparin contamination

Lawmakers scolded the FDA for still not knowing what or who was behind the contamination of the Baxter International’s blood-thinning drug Heparin, nearly three years after launching its investigation.

“It has been almost three years since the the FDA linked deaths and serious allergic reactions of patients to supplies of Heparin that came from China,“ Rep. Fred Upton (R-Mich.), wrote in a letter to FDA Commissioner Margaret Hamburg Wednesday. Upton said the House Energy and Commerce committee, which he chairs, will conduct its own probe into the matter. Get the full story »

FDA questions Sanofi reporting of side effects

U.S. health regulators have warned Sanofi-Aventis SA’s U.S. unit for failing to submit reports of possible serious drug side effects in a timely manner.

In a Jan. 28 letter made public Tuesday, the Food and Drug Administration said an early response from the drugmaker and its “promised corrective actions are inadequate to address the deficiencies.” Get the full story »

FDA OKs first 3-D mammography system

The Food and Drug Administration on Friday approved the first three-dimensional mammography system developed by Hologic Inc.  to screen for breast cancer with hopes the device will prove better than current mammography technology.

The device, the Silenia Dimensions System, augments traditional two-dimensional images produced by a mammogram with a 3-D image to be used in breast cancer screening and diagnosis. The system would provide both types of images during a scan so doctors could compare images with previous ones from prior, conventional mammograms. Get the full story »

Justice Dept. takes over Abbott probe

The U.S. Justice Department plans to take the lead in lawsuits accusing Abbott Laboratories of illegally promoting anti-seizure drug Depakote for uses not approved by regulators, including dementia.

The Justice Department filed notices last week in federal court in western Virginia saying it would intervene in at least three lawsuits against Abbott that were previously confidential under laws designed to protect would-be whistleblowers who come forward with information about alleged health-care fraud. The lawsuits were made public as a result of the department’s intervention. Get the full story »