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Products marketed to enhance sexual performance, such as the one used by Lamar Odom at a Pahrump brothel, might contain other ingredients that can pose risks to users, especially when used in combination with other drugs…more information is needed before any determination can be made about the cause of Odom's health complications…The former NBA basketball star was hospitalized...after being found unconscious at the brothel…Unapproved remedies for erectile dysfunction may include combinations of undisclosed ingredients or excessively high doses, both potentially dangerous situations…"I could take two herbal supplements off the shelf, and they could claim to be the same thing, and they won't be anything alike," said Jason Penrod, a member of the Nevada State Board of Pharmacy. "The only way you can know for sure is to take your 'herbal Viagra'...and analyze it in a biochemistry lab."…"They may or may not be effective," Dr. Michael Verni of the Urology Center of Las Vegas said. "All the vitamin makers have to prove is that their products are not harmful. They don't have to prove they work."

Ever since the Food and Drug Administration approved the use of ...OxyContin for certain children…it has faced unabated criticism from lawmakers and public officials who are wrestling with devastating rates of prescription opioid abuse in their communities…. The crux of the issue is whether the agency’s approval will lead to more prescriptions for OxyContin in young patients. For years, the powerful long-acting drug has been prescribed off-label to…children in severe pain… agency’s approval means those doctors will finally have "information about how to do it appropriately," like dosage recommendations…"This approval allows Purdue Pharma to market and promote this product for use in children, and the obvious concern is this approval will change the pattern of use.".. postmarketing data could prove revelatory and useful..."It’s not a given, but it could help us better address the problem of prescription drug abuse in adolescents....

Ensuring patients have access to needed medicines is critical, but importing medicines, whether from Canada or elsewhere in the world, is the wrong answer…Due to the Food and Drug Administration’s comprehensive drug approval process, medicines on the U.S. market are widely regarded as the safest in the world. The U.S.’s relatively closed distribution system plays a critical role in helping to keep the global proliferation of counterfeit medicines from infiltrating the U.S. prescription medicine system…Importation is often viewed as a means to lower drug costs, but these proposals ignore key facts about how importation impacts patient safety and access to new, innovative treatments. Consider the following four facts:

1. To date, not a single Secretary of the U. S. Department of Health and Human Services has been able to certify that importation will both 1) pose no additional risk to public health and safety, and 2) generate cost-savings that are passed on to American consumers.
2. Foreign governments will not ensure that prescription drugs entering the U.S. from abroad are safe and effective.
3. There is no guarantee any potential savings generated from the importation of medicines will be passed on to the patient.
4. Counterfeiters are becoming increasingly sophisticated with their technology and pose a significant health and safety risk to patients.

Summer was a busy season for FDA drug warnings...Now that fall is in full gear, pharmacists should get familiarized with the drug safety communications sent out this past summer...Here are the FDA’s medication safety alerts since June, starting with the most recent:

1. Ceftazidime and avibactam (Avycaz) - drug strength
2. Tramadol (Ultram, Ultram ER, Conzip) – pediatric use
3. Clozapine (Clozaril) – neutropenia management , REMS Program
4. Ingenol mebutate (Picato) - adverse reactions
5. Dipeptidyl peptidase-4 (DPP-4) inhibitors - joint pain warning
6. Fingolimod (Gilenya) - progressive multifocal leukoencephalopathy
7. Gadolinium-based contrast agents for magnetic resonance imaging - brain deposits
8. Vortioxetine (Brintellix) and ticagrelor (Brilinta) – name confusion
9. Codeine-containing cough-and-cold medications – pediatric use, respiratory conditions
10. Methylphenidate transdermal system (Daytrana patch) - permanent skin discoloration

DNA4Life announced the…launch of its Pharmacogenetic Report, which will be available…to patients… DNA4Life’s test analyzes a person’s DNA to predict how they will respond to 120 commonly prescribed medication. One of the main goals of pharmacogenetics is avoiding adverse drug reaction…"Our differentiated and more comprehensive analysis will assist healthcare professionals in customizing a personalized treatment plan for their patients…particularly those being treated for chronic conditions, like high cholesterol, depression, ADHD or pain."

PCSK9 inhibitors…offer the promise of reductions in blood cholesterol levels…This broad indication sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models…reserved for drugs that benefited relatively limited patient populations…these therapies may also lead to savings down the road, by reducing rates of cardiovascular events…There will surely be formal economic evaluations of these data, and there are long-term outcome studies under way to elucidate the potential effect of these therapies on cardiovascular event rates…it is apparent that the prices for these drugs will result in net costs to the health care system, even if they may eventually be found to offer good value for the money…expected total annual costs in the billions, it's important to ask who will bear these costs...Pricing pressure on innovative products would drive a fundamental restructuring of the industry and further increase the financial challenges of bringing scientific innovations to the market. It is important that we manage these downside risks carefully as we work toward a more sustainable pricing model in this market..

..nation’s biggest pharmacy benefits manager has decided to cover two new drugs that lower…cholesterol but raise concern over prices that can top $14,000 a year…Express Scripts said…that it will pay for prescriptions of…Repatha as well as Praluent…under a few conditions designed to control costs…It will require prior approval…before any prescriptions are filled…will need to see a patient’s cholesterol levels first as well as proof that the older statins failed…is requiring the drugmakers to provide rebates if prices climb more than a set amount each year…Express Scripts also has agreed to cover any costs that exceed a certain amount per person, annually.

With two dozen scheduled executions in limbo, Ohio sent a forceful letter to Washington… asserting that the state believes it can obtain a lethal-injection drug from overseas without violating any laws…stopped short of suggesting Ohio is moving forward to obtain the powerful sedative sodium thiopental…the state asked to begin discussing with federal officials about acquiring the substance legally…FDA had warned Ohio in June that importing the restricted drug could be illegal…setting up the latest roadblock that Ohio and several other states have faced in carrying out the death penalty…States have struggled to obtain lethal injection drugs since pharmaceutical companies discontinued the medications they traditionally used or put them off limits for executions…"My sense is that the Food and Drug Administration…was never designed to create an additional impediment to states trying to carry out lawful sentences,"…

…Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration…met to consider marketing applications for the new molecular entities alirocumab (Praluent) and evolocumab (Repatha)on the basis of their ability to lower low-density lipoprotein cholesterol levels…These first-in-class medications are fully humanized monoclonal antibodies that inactivate proprotein convertase subtilisin–kexin type 9…consequent lowering of LDL cholesterol levels…has led to optimism regarding the potential — but as yet unproven — cardiovascular benefits…LDL cholesterol reduction as the surrogate measure of clinical benefit. No efficacy data on cardiovascular outcomes were provided…Establishing evidence of improved cardiovascular outcomes is key to evaluating medications from any new drug class intended to reduce such risk….definitive evidence of reduced cardiovascular event rates is essential…to provide such evidence should elucidate the medications' true clinical benefits and possible risks.

Food and Drug Administration…approved Alkermes Plc's longer-acting injectable version of … schizophrenia pill Abilify (Aristada,aripiprazole lauroxil), making the treatment available in two doses…Abilify, developed by Japanese drugmaker Otsuka Pharmaceuticals and sold…by Bristol-Myers Squibb Co, is already facing generic competition.