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Parents, Beware of Topical Teething Anesthetics

Topical anesthetics containing Lidocaine Viscous are popular with parents trying sooth their little ones’ teething pain, but the medications can seriously injure, even kill, young patients.

In June, the U.S. Food and Drug Administration (FDA) warned against use of the products, particularly those containing more than 2 percent Lidocaine Viscous. The FDA said that it would require a new Boxed Warning, the FDA’s strongest warning, to all packages of the numbing agents. More Parents, Beware of Topical Teething Anesthetics

Hospira Receives FDA Warning for Drug Manufacturing Violations

The Food and Drug Administration has sent a warning letter to Hospira Inc. over “significant violations” of current good manufacturing practice (CGMP). The FDA said the company has not taken adequate steps to correct the violations, which include “visible particles” in lots of a chemotherapy drug.

In an inspection conducted from February 24 to March 1, 2014 at Hospira’s manufacturing facility in Mulgrave, Australia, FDA inspectors discovered “visible particles” in an injectable drug, The Chicago Tribune reports. The company said it is considering what corrective actions it needs to take but said it intends to respond fully to the warning letter. At this time, the FDA is not restricting the production or shipment of pharmaceutical products from the Mulgrave plant, but could do so if the violations are not corrected. More Hospira Receives FDA Warning for Drug Manufacturing Violations

Billions Paid to Doctors by Drug Firms and Medical Device Makers

Records released this week under a provision of the Affordable Care Act reveal that drug makers and medical device companies paid at least $3.5 billion to doctors and teaching hospitals during the final five months of 2013.

The Physician Payments Sunshine Act, part of the 2010 health care law, requires drug makers and manufacturers of medical devices to disclose payments to physicians and teaching hospitals, The Wall Street Journal reports. The Centers for Medicare and Medicaid Services compiled the records into a database posted online on Tuesday. CMS said about 40 percent of the payment records will not identify the recipients because of data problems. More Billions Paid to Doctors by Drug Firms and Medical Device Makers

New Jersey Man Alleges Eli Lilly Testosterone Replacement Product Caused Him a Heart Attack

Drug maker Eli Lilly is facing a lawsuit filed by a New Jersey man in federal court in Newark over the company’s testosterone replacement drug Axiron.

According to the lawsuit, the patient stated that he began taking Axiron at age 54 in September 2012 and suffered a heart attack on October 3, 2012. Had the patient known that Axiron could increase users’ risk for heart attack, he would not have started taking it, the suit states. More New Jersey Man Alleges Eli Lilly Testosterone Replacement Product Caused Him a Heart Attack

Viagra Linked to Increased Risk of Skin Cancer

Use of Viagra is linked to an increased risk of a form of skin cancer, according to a study published online in April in Jama Internal Medicine.

Viagra (sildenafil) was associated with an increased risk for melanoma, the most dangerous form of skin cancer. These cancerous growths grow when unrepaired DNA damage to skin cells triggers genetic defects that lead the skin cells to multiply quickly and form malignant tumors, SkinCancer.org reported. About one person dies every hour in the U.S. due to Melanoma.   More Viagra Linked to Increased Risk of Skin Cancer

SSRI Antidepressant Drugs Linked to Reduced bone Formation and an Increased Risk of Bone Fractures

A group of antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs) reduce bone formation and increase bone fracture risks, according to a new study.

Bone metabolism is affected by osseointegration so researchers took a closer look at the association between SSRIs and the risk of failures in osseointegrated dental implants, wrote HNGN.  More SSRI Antidepressant Drugs Linked to Reduced bone Formation and an Increased Risk of Bone Fractures

Court Mandates Takeda to Pay $6 Billion in Actos Trial

The national law firm, Parker Waichman LLP, reports that a United States district court mandated Takeda Pharmaceuticals Co. to pay $6 billion in punitive damages relating to a lawsuit brought by a man alleging he developed bladder cancer after taking the diabetes drug, Actos.

This was the first federal lawsuit tried against Takeda over allegations that Actos can lead to bladder cancer. More Court Mandates Takeda to Pay $6 Billion in Actos Trial

Teva Recalling Parkinson’s Drug Due to Potency Concerns

The U.S. Food and Drug Administration (FDA) announced Teva Pharmaceutical Industries is recalling one lot of its generic Parkinson’s combo drug carbidopa/levodopa because of concerns that it could contain too much of an active pharmaceutical ingredient.

The recall FDA labeled the recall as Class II status. Teva said the recall, which is nationwide, involved 3,881 bottles of carbidopa/levodopa 25 mg/100 mg. The company issued the recall out of precaution after stability testing found that the product might be super-potent, according to FiercePharmanufacturing.com. More Teva Recalling Parkinson’s Drug Due to Potency Concerns

FDA Orders BioAnue Laboratories to Terminate Sales of Supplements

A federal court has ordered the dietary supplement manufacturer BioAnue Laboratories to stop illegally marketing its products as treatments for disease and to terminate the sale of supplements.

The order will remain intact until the company complies with the U.S. Food and Drug Administration’s (FDA) manufacturing regulations and other requirements. A federal judge issued the order against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber, according to the FDA notice. More FDA Orders BioAnue Laboratories to Terminate Sales of Supplements

Hydrocodone Combination Products Reclassified as Schedule II Drugs

The U.S. Drug Enforcement Administration (DEA) is following the recommendation by the U.S. Food and Drug Administration (FDA) to begin regulating all hydrocodone combination products as Schedule II drugs under federal law.

The rule, which will come into effect in 45 days, will impact some of the U.S.’s most popular painkillers, including Vicodin. More Hydrocodone Combination Products Reclassified as Schedule II Drugs