FDA Adds Boxed Warning to Liver Disease Medication for Correct Dosing – Drug for nerve pain boosts high for opioid abusers.

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FDA Adds Boxed Warning to Liver Disease Medication for Correct Dosing – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have added a boxed warning label to liver disease medicine obeticholic acid (Ocaliva, Intercept) to highlight the correct dosing for patients with rare chronic liver disease, according to a FDA safety announcement.

According to the announcement, obeticholic acid has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), increasing risk of liver injury. The addition of the boxed warning will clarify the current recommendations for screening, dosing, monitoring, and managing PBC patients taking the medication.

This information will be highlighted in the prescribing information of the drug label. The FDA is also requiring a medication guide for patients to inform them about this issue.

Health care providers should follow the recommended dosing regimen on the drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage. According to the safety announcement, dosing higher than recommended can increase the risk for liver decompensation, liver failure, and sometimes death.

Health care providers should also educate patients and caregivers on the symptoms of worsening liver function and temporarily stop obeticholic acid in those with laboratory or clinical evidence of worsening liver function.

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Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission – APhA submits compounding comments to FDA.

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Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission – APhA submits compounding comments to FDA. – (866) 348-2889

A multifaceted clinical pharmacist intervention could reduce the number of visits to the emergency department (ED) and readmissions to the hospital, according to new research. The clinical trial involved more than 1,400 Danish adults in an acute admission ward who were using five or more medications. The patients were randomized into three groups: usual care (no intervention), a basic intervention (medication review), and an extended intervention (medication review, three motivational interviews, and followup with the primary care physician, pharmacy, and nursing home.) Compared with the other two groups, the extended intervention had a statistically significant effect on the number of patients who were readmitted within 30 and 180 days after inclusion. The extended intervention also had a significant effect on the number of patients who experienced the primary composite endpoint–readmission or an ED visit within 180 days. There was a nonsignificant reduction in drug-related readmissions within 30 and 180 days after inclusion and in deaths. “This study shows that hospital pharmacists may play an important role in preventing hospital readmissions,” the authors conclude.

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FDA proposes risk-based enforcement for homeopathic products – Drug for nerve pain boosts high for opioid abusers.

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FDA proposes risk-based enforcement for homeopathic products – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

To protect consumers who choose to use homeopathic products, FDA recently proposed a new, risk-based enforcement approach in the draft guidance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry. This proposed new approach would update FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet good manufacturing practices.

Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the guidance and will remain available to consumers. FDA intends to prioritize enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without FDA approval in the following categories (in no particular order):

– Products with reported safety concerns
– Products that contain or purport to contain ingredients associated with potentially significant safety concerns
– Products for routes of administration other than oral and topical

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FDA Aims to Limit Packaging for Anti-Diarrhea Drug to Reduce Abuse, Misuse – APhA submits compounding comments to FDA.

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FDA Aims to Limit Packaging for Anti-Diarrhea Drug to Reduce Abuse, Misuse – APhA submits compounding comments to FDA. – (866) 348-2889

To encourage the safe use of the anti-diarrhea medicine loperamide (Imodium), the FDA is working to limit packaging for the medication through use of blister packs and other single-dose packaging, according to an agency safety announcement.1

Loperamide is FDA-approved to help control symptoms of diarrhea, including traveler’s diarrhea, and it is available for OTC use under the brand name Imodium A-D, as store brands, and as generics. The maximum approved daily dose for adults is 8 mg per day and 16 mg per day for prescription use.

The medication is safe to take at approved doses but can lead to severe heart rhythm problems and death if taken at much higher doses than recommended.

The FDA continues to receive reports of serious heart problems and deaths occurring with much-higher-than-recommended doses of loperamide, primarily among those who are intentionally abusing or misusing the product, despite the medication’s warning label, according to the announcement.

On June 7, 2016, the FDA issued a drug safety communication to warn individuals about the potentially harmful effects of taking excessive doses of the medication. The majority of reported serious heart problems occurred in individuals who were taking high doses of loperamide to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria, according to the announcement.

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FDA Approves Vancomycin Hydrochloride Oral Liquid Therapy for CDAD – Drug for nerve pain boosts high for opioid abusers.

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FDA Approves Vancomycin Hydrochloride Oral Liquid Therapy for CDAD – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved vancomycin hydrochloride (Firvanq, CutisPharma) for oral solution for the treatment of Clostridium difficile associated diarrhea (CDAD) and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, according to a press release.

The vancomycin hydrochloride oral solution will be available in 25 mg/mL and 50 mg/mL strengths in 150 mL and 300 mL sizes. The availability of an oral liquid therapy is expected to improve patient access and reduce pharmacist burden of having to compound liquid formulations.

“As a practicing infectious disease physician treating many patients with CDAD, having an FDA-approved vancomycin oral liquid formulation that is affordable and accessible to my patients is very beneficial,” Stuart Johnson, MD, Loyola University Medical Center, said in the press release.

CutisPharma anticipates Firvanq to be launched on April 2, 2018. The product will replace CutisPharma’s FIRST Vancomycin Unit-of-Use Compounding Kit.

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USP Encourages Pharmacists to Help Patients Find Quality Dietary Supplements – APhA submits compounding comments to FDA.

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USP Encourages Pharmacists to Help Patients Find Quality Dietary Supplements – APhA submits compounding comments to FDA. – (866) 348-2889

Recall announcements, enforcement actions, and reports challenging the quality of dietary supplements are problematic issues facing pharmacists who want to ensure that the over-the-counter (OTC) products they are recommending to patients are of good quality. Many consumers purchase OTC dietary supplements and herbal products, often assuming they are regulated like prescription medications. While the law requires pharmaceuticals to meet specific quality standards set by the US Pharmacopeial Convention (USP), the same requirements do not apply to supplements. For this reason, USP has created quality standards and a verification process specifically for these health products. Brands that display the USP Verified Mark signal to the public that “what’s on their label is what’s in the bottle.”

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FDA to Alert Public of Recalls Sooner – Drug for nerve pain boosts high for opioid abusers.

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FDA to Alert Public of Recalls Sooner – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

As part of a larger effort to increase transparency, empower consumers, and enhance public health, FDA is working to alert the public sooner whenever a product has been recalled. FDA has decided that the public would benefit by having recall information about FDA-regulated products as soon as possible, even though further evaluation remains to be done. Moving forward, FDA will include “not-yet-classified” recalls of human drugs, foods, and veterinary products in the agency’s weekly, web-based Enforcement Report, even while classification work is still ongoing.

Historically, only recalls that have already been classified into one of three categories based on the severity of the hazard have been listed in the report. However, recall classifications can sometimes take weeks or even months when FDA needs to conduct a complex evaluation, states Douglas Stearn, JD, FDA’s director of the Office of Enforcement and Import Operations in the Office of Regulatory Affairs.

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FDA Issues 2018 Compounding Priorities Plan and Three Final Guidances Related to DQSA – APhA submits compounding comments to FDA.

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FDA Issues 2018 Compounding Priorities Plan and Three Final Guidances Related to DQSA – APhA submits compounding comments to FDA. – (866) 348-2889

Food and Drug Administration (FDA) announced its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement certain key aspects of the Drug Quality and Security Act (DQSA) and other provisions of the law relevant to compounders. Many of these policy priorities are well underway, while other policies will be rolled out over the course of the coming year. Specifically, the plan describes how FDA will:

– address manufacturing standards for outsourcing facilities;
– regulate compounding from bulk drug substances;
– restrict compounding of drugs that are essentially copies of FDA-approved drugs;
– solidify FDA’s partnership with state regulatory authorities; and
– provide guidance on other activities that compounders undertake.

As part of FDA’s implementation of the 2018 Compounding Priorities Plan, the agency issued two final guidance documents explaining FDA’s policies on the “essentially a copy” provisions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The guidance documents describe the characteristics of drugs that may be considered “essentially a copy” and FDA’s policies regarding prescriber review of changes between compounded drugs and commercially available or approved drugs to determine whether they produce a significant or clinical difference for individual patients.

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FDA panel rejects Philip Morris’ claim that tobacco stick is safer than cigarettes – Drug for nerve pain boosts high for opioid abusers.

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FDA panel rejects Philip Morris’ claim that tobacco stick is safer than cigarettes – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

An FDA advisory committee on Thursday recommended the agency reject a bid by Philip Morris International to market a smokeless tobacco stick called IQOS in the United States as safer than traditional cigarettes. IQOS is an electronic penlike device that heats tobacco sticks but does not burn them. It releases nicotine vapor, which the company says is less hazardous than smoke. Philip Morris says the product, which contains tobacco as well as nicotine, offers a more natural smoking experience for the smoker than e-cigarettes. It is currently sold in 30 countries. The advisory committee considered the proposal to sell the product under the agency’s new “modified risk” category, created by Congress with the passage of the 2009 Family Smoking Prevention and Tobacco Control Act.

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FDA OKs Plecanatide for IBS with Constipation – APhA submits compounding comments to FDA.

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FDA OKs Plecanatide for IBS with Constipation – APhA submits compounding comments to FDA. – (866) 348-2889

Officials with the FDA have approved plecanatide (Trulance, Synergy) for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults, according to a Synergy press release. It is the second approved indication for the treatment.

Plecanatide was initially approved for the treatment of adults with chronic idiopathic constipation (CIC) and is the only prescription medication available for adults with CIC, and now IBS-C, that be taken once-daily with or without food.

The approval is based on the phase 3 IBS-C program, which included 2, 12-week trials evaluating the efficacy and safety of plecanatide in adult patients with IBS-C. More than 2100 patients received a once-daily tablet (3 mg or 6 mg doses) or a placebo. A 2-week, post treatment follow-up period was included in both trials.

In both trials, patients who received plecanatide experienced significantly reduced abdominal pain and improvement in stool frequency, stool consistency, and straining with bowel movements during the 12-week treatment period as compared to placebo.

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