Following the deaths of three babies within a two-week period, authorities in Holland have banned a batch of Prevenar, also known as Prevnar, reported Reuters. The babies all died within two weeks of receiving the vaccination.

“On average about five to 10 deaths are reported annually after babies get vaccines,” said a spokeswoman for the Dutch health institute RIVM, quoted Reuters. “We now have three cases in a short period, that is unusual and the reason for suspending the batch,” she added, noting that RIVM is looking into the infants’ cause of death. (more…)

The U.S. Food and Drug Administration (FDA) is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Stiff Nights contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra.

Following a consumer complaint, the FDA determined that the product contains sulfoaildenafil and warns that sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and may cause dangerously low blood pressure. (more…)

Drug giant Johnson & Johnson (J&J) continues to make news with a Justice Department investigation into accusations of Medicaid Fraud, announced Business Week. The Justice Department recently settled with Omnicare over kickback allegations to the tune of $112 million.

The massive settlement concerned kickbacks involving the United States’ biggest nursing home pharmacy, Omnicare and generic drug maker IVAX Pharmaceuticals and is just a part of a larger probe into potential Medicaid fraud by Big Pharma, said Business Week. Some feel the investigation focuses on industry paying consumer drug providers for special treatment, according to Business Week. The profits are believed to compromise patient care and increase costs. (more…)

American Regent is recalling more Ketorolac Tromethamine Injection. The company is now expanding its recall of the injectable painkiller to include all lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials; NDC# 0517-0601-25.

According to the Food & Drug Administration (FDA), this recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. The recalled drug product was distributed to wholesalers and distributors nationwide. (more…)

Bodybuilding.com has issued a nationwide recall for 65 dietary supplement products. All of the recalled supplements were sold through the Bodybuilding.com Web site. According to a notice on the Food & Drug Administration (FDA) website, the agency believes the recalled products contain ingredients that are steroids.

A list of the recalled dietary supplements can be accessed here. The recall includes all lots and expiration dates of the dietary supplement products listed. (more…)

We’ve long been saying so, and the issue has made headlines many times in recent months; now PLoS Medicine is writing that ties between Big Pharma and health professionals—are not sufficiently broad, reports Science Daily. In this case, the issue concerns Australian reporting standards; however, the problem has been noted in a variety of global sites, including the United States.

David Henry, from the Institute for Clinical Evaluative Sciences in Toronto, Canada, and colleagues, looked at information released by Medicines Australia, which is that country’s “pharmaceutical industry representative body,” said Science Daily. Since 2007, Medicines Australia has been mandated to report information from “industry-sponsored function and educational event for health professionals,” explained Science Daily. The information must also include the event’s venue, cost, attendees, and “hospitality” provided, but does not require disclosure regarding speaker names, finances transacted between industry and speakers, and the companies’ part in selecting a speaker, noted Science Daily. (more…)

A large study on the effects of antibiotics used during pregnancy and birth defects has been released. The Associated Press (AP) reported that the emerging study—the first of its kind to review the use of antibiotics during pregnancy—found a link between mediations for urinary tract infections and birth defects. The study appears in this month’s issue of Archives of Pediatrics and Adolescent Medicine, said the AP.

The AP added that penicillins, which are often prescribed in early pregnancy, appear to cause the least problems. Of note, bacterial infections can be problematic for a fetus if not treated, so antibiotics should not be avoided, but should be discussed with treating physicians, said the AP. (more…)

The labeling for Byetta, a drug used to treat type 2 diabetes, has been revised to include new safety information about possible kidney function problems, including kidney failure.

Byetta was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels. (more…)

Early last month, the U.S. Food and Drug Administration (FDA) issued a warning to the Procter & Gamble Company regarding how the drug maker marketed some of its Vick’s brand cold medications. The letter was immediately retracted, with the FDA saying there was a computer problem that inappropriately released the letter.

Now, reports the Associated Press (AP), the agency sent another warning letter to Procter & Gamble stating that the drug maker was illegally marketing two of its over-the-counter (OTC) Vicks cold and flu medications that contain vitamin C. The single-dose versions of Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are not legally marketable since they were never “proven safe and effective,” said the AP. (more…)

Pointe Scientific, Inc. has issued a recall of its Liquid Glucose Hexokinase Reagent due to test failures, according to the U.S. Food and Drug Administration (FDA).

Pointe Scientific, Inc, located in Canton, Michigan is initiating a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. (more…)