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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

Antibiotic May Increase Heart Risks and Death

Taking the antibiotic clarithromycin may increase some patients’ odds of dying from heart-related causes, according to a new study conducted by Danish researchers.

While the risk is small, the antibiotic is taken by millions of people across the globe take the antibiotic, so the findings should be taken quite seriously. Clarithromycin – as well as another antibiotic called roxithromycin – are in a group of antibiotics called macrolides. The researchers believe that macrolides elevate the risk of potentially deadly heart rhythm problems. More Antibiotic May Increase Heart Risks and Death

FDA Warns of Adverse Effects Linked to Expression Injectable

The U.S. Food and Drug Administration warned in a safety alert that Enhancement Medical’s hyaluronic acid product Expression injectable should not be used off-label as a dermal filler.

Expression injectable received FDA approval as “an intranasal splint after surgery or trauma to minimize bleeding and swelling and to prevent adhesions between the septum and the nasal cavity,” MedScape.com reported. However, it is not approved as dermal filler. More FDA Warns of Adverse Effects Linked to Expression Injectable

Researchers Find Current Formulations of Birth Control Pills Increase Women’s Risk of Breast Cancer

According to a new study published in the journal Cancer Research, certain birth control pills increase the risk of breast cancer in women, including the popular Continuin, Femulen and Ortho 75.

The study is the work of investigators at the Group Health Research Institute, Group Health Cooperative, the Fred Hutchinson Cancer Research Center, and the University of Washington, all in Seattle, Washington, according to Examiner.com. More Researchers Find Current Formulations of Birth Control Pills Increase Women’s Risk of Breast Cancer

Pfizer to Pay $35 Million to Settle for Rapamune Marketing Practices

Drug maker Pfizer has agreed to pay $35 million to 42 states to resolve charges that it unlawfully marketed the drug Rapamune.

The states alleged that Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, used unlawful and deceptive practices by misrepresenting the uses and benefits of Rapamune, a drug given to patients to help prevent rejection of kidney transplants, jdnews.com reported. The states also accused the drug make of violating consumer protection laws by retaining doctors and paying for studies to encourage off-label uses of the drug, according to bizjournals.com. More Pfizer to Pay $35 Million to Settle for Rapamune Marketing Practices

FDA Tells Parents to Avoid Giving Teething Children Meds

The U.S. Food and Drug Administration (FDA) is issuing a warning about pain medication given to teething babies due to concern over serious side effects and even death.

Teething is a normal process that children go through between the ages of 6 months and three years. Many parents often want to help their child reduce the pain their child is in by grabbing a numbing gel from the medicine cabinet. However, recent studies have suggested that the best course for parent to chose may be to avoid these gels all together. More FDA Tells Parents to Avoid Giving Teething Children Meds

Pradaxa-maker Kept FDA in Dark about Bleeding Risks

Regulators were kept in the dark about important data Boehringer Ingelheim had about the safety of its oral direct thrombin inhibitor dabigatran (Pradaxa) while the drug was under review for approval in nonvalvular atrial fibrillation (AF), according to several documents published Wednesday in the British Medical Journal (BMJ).

The four documents indicate that Boehringer Ingelheim didn’t share its own analysis with U.S. or European regulators suggesting a severe reduction in bleeding risk when Pradaxa was dosed with guidance from anticoagulation monitoring. It is likely this information was withheld because if it made its way to the regulators, it would have undermined the key Pradaxa marketing message that no such monitoring would be required, MedScape.com reported. One of alleged benefits of Pradaxa was that unlike warfarin, routine monitoring was not required. More Pradaxa-maker Kept FDA in Dark about Bleeding Risks

FDA Plans August Meeting to Discuss the Confidentiality of Cardiovascular Outcomes Trials

The U.S. Food and Drug Administration (FDA) announced Monday that it will hold a public meeting in August on ways to keep cardiovascular outcomes trials (CVOTs) confidential until they are completed.

Drug manufacturers have typically been required to conduct extensive clinical trials to assess the cardiovascular risks associated with their products to the tune of upwards of tens of thousands of dollars. Since the mid-2000s, the FDA has approved many drugs on the condition that drug companies complete mandatory trials by pre-specified dates, according to RAPS.org. More FDA Plans August Meeting to Discuss the Confidentiality of Cardiovascular Outcomes Trials