Health Headlines - January 21

FDA Review: Sale of Nonprescription Dose of Cholesterol Drug Poses Risks

Is it three strikes and you're out for over-the-counter (OTC) sales of the cholesterol-lowering drug Mevacor?

Twice before, the drug's maker, Merck & Co., has asked the U.S. Food and Drug Administration to approve it for OTC sales. The most recent was just last month, and an FDA advisory panel overwhelmingly recommended against approval.

Now, the Associated Press reports, an FDA review released last week still has major doubts. Positive news for Merck was that the staff reviewer found that nonprescription Mevacor would be "a reasonably safe and effective" option, the wire service reported -- if consumers used it as directed.

And that presents a big problem, the A.P. reports. An FDA review of a Merck-conducted consumer survey found there was too much confusion as to who should be taking Mevacor and for what reason.

The FDA conclusion: The survey results "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," according to the A.P.

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Biotech Firm Subpoenaed Over Questions About Psoriasis Drug

The large biotechnology company Amgen is being investigated by New Jersey's attorney general after two former company employees claimed they had been pressured by their managers to obtain confidential patient information.

The New York Times reports that New Jersey Attorney General Anne Milgram issued a subpoena late last week after her office obtained information that the former employees had claimed their supervisors strongly urged them to try and identify patients who might be candidates for Amgen's psoriasis drug Enbrel.

There are other issues as well, the Times reports. In a news release, the attorney general said she was also investigating whether Amgen had engaged in off-label marketing, an illegal practice that encourages using a drug for treatments beyond its FDA approval standards.

The newspaper quotes Amggen spokeswoman Mary Klen as saying the accusations were "completely without merit" and that Amgen would cooperate with the investigation.

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New HIV Drug Approved for Adults Who Fail Other Treatments

The anti-HIV medication entravirine has been approved by the U.S. Food and Drug Administration for adults who have failed treatment with other antiretrovirals.

Sold under the trade name Intelence, entravirine is a non-nucleoside reverse transcriptase inhibitor, which helps block an enzyme that the AIDS-causing virus needs to multiply, the FDA said in a statement. This is aimed at reducing the amount of HIV in the blood and boosting infection-fighting white blood cells.

In clinical testing, 599 adults who received entravirine and additional antiviral therapy had greater reductions in blood HIV levels than adults who received a non-medicinal placebo and the same additional therapy. The most common side effects reported were rash and nausea.

The long-term effects of entravirine haven't been studied, nor have the drug's effects in pregnant women or among people age 16 or younger, the agency said.

Entravirine is distributed by Tibotec Therapeutics, whose parent firm -- Ortho Biotech Products -- is based in New Jersey.

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Canned Bean Recall Expanded Over Botulism Concerns

Michigan-based New Era Canning Co. is expanding its nationwide recall of canned green beans and canned garbanzo beans to include all product distributed over the past five years, the U.S. Food and Drug Administration said. The beans may be contaminated with Clostridium botulinum, the bacterium that causes botulism.

Botulism can be a life-threatening condition with symptoms beginning six hours to two weeks after consumption of tainted food. Symptoms may include double or blurred vision, droopy eyelids, slurred speech, difficulty swallowing, and muscle weakness that feels like it's moving down the body. Botulism poisoning can also cause life-threatening paralysis of the breathing muscles.

There are no reports of illness from affected 6.5-pound institutional-sized cans, which may or may not have New Era's name on them. This FDA page lists all products currently involved in the recall.

Regardless of brand or product name, no cans should be opened or used. Even tiny amounts of C. botulinum can trigger serious illness if ingested, inhaled, or absorbed through the eyes or skin.

Any cans that may be affected should be carefully double-bagged and thrown away immediately, the agency warned.

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Recalled Heparin and Saline Flushes May Be Contaminated

Pre-filled syringes containing either the anti-clotting agent heparin or normal saline solution may be contaminated with a dangerous bacterium and are being recalled by the manufacturer, the U.S. Food and Drug Administration said Friday.

Both types of pre-filled syringe are manufactured by North Carolina-based AM2 PAT Inc. The products were distributed nationwide under two brand names, Sierra Pre-Filled Inc. and B. Braun.

One lot of the heparin flush was found to be contaminated with Serratia marcescens bacteria, which caused patient infections. Infections with Serratia marcescens are capable of causing life-threatening illness or death, the FDA said.

Consumers or facilities who have any of the recalled products should stop using them immediately and return them to the distributor or place of purchase, the agency said.

The following products and codes are affected:

NDC #	CATALOG #	Product Name
64054-1003-02	1003-02	Heparin Lock Flush 100units/ml 5ml
64054-1003-01	1003-01	Heparin Lock Flush 100units/ml 3ml
64054-3005-02	3005-02	Heparin Lock Flush 10units/ml 5ml
64054-3003-02	3003-02	Heparin Lock Flush 10units/ml 3ml
64054-3003-06	3003-06	Heparin Lock Flush 10units/mL 3ml (6ml syringe)
64054-3005-06	3005-06	Heparin Lock Flush 10units/mL 5ml (6ml syringe)
64054-0910-2	0910-12	Normal Saline Flush 10ml
64054-0905-2	0905-12	Normal Saline Flush 5ml
64054-0903-2	0903-12	Normal Saline Flush 3ml

Any adverse reactions associated with use of these products should be reported to the FDA at 1-800-FDA-1088.

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Smoking-Cessation Drug Chantix Gets Updated Warning

Packages of the smoking-cessation drug Chantix sold in the United States have been updated to more prominently display a warning that users should be monitored for suicidal behavior, depressed mood, and certain other serious mental health symptoms, MarketWatch reported.

Drug maker Pfizer Inc. said it made the label change after consultation with the U.S. Food and Drug Administration.

Since the drug was approved in the United States in May 2006, there have been a number of reports of erratic behavior, suicidal thoughts and other side effects in people taking Chantix. Last November, the FDA said it was investigating those reports and told doctors to monitor patients taking the drug, MarketWatch reported.

At that time, Pfizer added information about those potential side effects to the Chantix product label. The warning has now been moved to a more prominent location on the label to make it more obvious for doctors and patients.

There are 45 million Americans who smoke, and each year 70 percent report that they want to quit. Each smoker works to do so differently; the average former smoker makes eight to 11 attempts to quit, according to the American Legacy Foundation, which is dedicated to getting people to quit smoking.

The foundation says it has long recommended that smokers who want to increase their odds of quitting should make a plan, set a date, and talk with their physician to seek counseling on medications that will work best for them. They should also consider behavioral counseling in person or through telephone counseling from their state quitlines (1-800-QUIT-NOW).

The foundation was created as a result of the 1998 Master Settlement Agreement between attorneys general from 46 states, five U.S. territories and the tobacco industry.

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FDA Approves New Test for Respiratory Viruses

A real-time test for four common respiratory viruses has been approved by the U.S. Food and Drug Administration. The ProFlu+ test provides results within as few as three hours.

Other respiratory virus tests are fast but not as accurate or are accurate but not as fast, the FDA said.

The ProFlu+ test can analyze a single sample for influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV). These viruses can cause influenza, pneumonia and an infection of the airways called bronchiolitis. All the viruses are leading causes of lower respiratory tract infections.

"Antiviral drugs are most effective when initiated within the first two days of symptoms," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a prepared statement. "This new test, which is part of the new era of molecular medicine, can help the medical community quickly determine whether a respiratory illness is caused by one of these four viruses and initiate the appropriate treatment."

The ProFlu+ test is made by Prodesse, Inc. of Milwaukee.