Medical, Health & Drug Prescription News » FDA MedWatch Drug Alerts

FDA Maintains Insulin Theft Alert

admin — Thu, 03 Sep 2009 18:22:28 +0000

The U.S. FDA warns the public that there is a potential for stolen long-acting insulin Levemir, produced by Novo Nordisk Inc, to still be active on the market.

Based on the FDA’s evidence, their proof suggests that the stolen insulin was improperly stored and handled, leaving the public vulnerable to risk. Many patients have informed the FDA of adverse side effects they experienced after using a vial from the stolen group, their glucose levels were incorrectly managed.

Since the FDA’s original warning of the insulin theft was made in June, only two percent of the 129,00 vials of Levemir has been retrieved.

As the FDA maintains their aggressive investigation and they recommend that all Levemir patients:

Check your current stock of insulin to verify whether you have Levemir insulin from one of the following lots: XZF0036; XZF0037; XZF0038. You can find the lot number on the side of the insulin box as well as on the side of the vial.

If your insulin originates from one of these lots do not use it! Exchange it with a vial of Levemir from another lot. If you must change to another insulin brand, do not do so before contacting your health care practioner, as you may require dosage modifications.

FDA Advises of Pure Red Cell Aplasia Found in CellCept Patients

admin — Wed, 19 Aug 2009 18:36:50 +0000

The U.S. FDA and Roche have informed healthcare practitioners that patients being treated with CellCept, have reported cases of Pure Red Cell Aplasia, also known as PRCA. As a result, the WARNINGS and ADVERSE REACTIONS portions of CellCept’s Prescribing Information has been reconsidered, in an attempt to demonstrate the new safety details.

PRCA is a form of anemia where there is a selective lessening red blood cell precursors on bone marrow examination. Patients suffering from PRCA may experience fatigue, lethargy and/or uncommon pallor. In some instances, PRCA was able to be reversed with dose minimization or termination of CellCept treatment. In transplant patients, lessened immunosuppression may put the graft in danger.

Safety Concerns Cease NHLBI’s Sickle Cell, Pulmonary Hypertension Trial

admin — Tue, 11 Aug 2009 16:36:45 +0000

The National Heart, Lung and Blood Institute (NHLBI) has halted a clinical trial involving drug treatment tests for pulmonary hypertension in adults who suffer from sickle cell disease. The trial comes to a premature end after only one year of study, due to safety concerns. These concerns come after a 16 week interim review was conducted of the 33 participants. Researchers discovered that participants actively taking sildenafil (Revatio), were experiencing an increase in consequential medical problems, versus the placebo participants. The most common effect were episodes of severe pain (sickle cell crisis), which required hospitalization for the participants. No deaths has occurred during the clinical trial.

Sickle cell disease is one of the most prevalent genetic blood disorders in the U.S. Pulmonary hypertension is an immobilizing high blood pressure condition that effects the arteries, potentially leading to heart failure and death. Approximately, 30 percent of sickle cell patients are expected to develop pulmonary hypertension.

The study coined walk-PHaSST, was the first of its kind to involve a multi-center, randomized clinical trial, intent on testing the the safety and effectiveness of sildenafil for sickle cell disease patients who have also developed pulmonary hypertension.

NHLBI Director Elizabeth Nabel M.D., reminds the public that because the walk-PHaSST medical problems were individually specific to sickle cell disease patients, these findings “should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective.”

US FDA Communicates Melamine Testing Recommendations

admin — Mon, 10 Aug 2009 15:53:07 +0000

The US FDA recently issued a recommendation advising that certain pharmaceutical components used in the production or composition of drug products should be tested for melamine.

What is melamine? Melamine is a man-made chemical with a range of commercial uses, such as in the construction of resins and foams, cleaning solutions, fertilizers and pesticides. If enough Melamine is swallowed, a person can suffer from kidney failure and possible death.

Despite the fact there has not been any reports or reason to believe that the US pharmaceuticals stock is tainted with melamine, the US FDA maintains precautionary measures because of recent events involving local pet and livestock food products, and infant milk products in China.

The FDA’s recommendations is a preliminary procedure to work with pharmaceutical producers, re-packers, other suppliers and pharmacists to begin melamine evaluations. Commissioner of Food and Drugs Margaret A. Hamburg MD, says “The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain.”

The US FDA has discerned particular pharmaceutical components in their recommendation that they suggest be tested for melamine. The recommendation also suggests that FDA – published methods of melamine detection in foods and proteins are applied. Although, the tests rely on machinery, these types of machines are commonly available to pharmaceutical manufacturers and contract testing labs. Currently, the FDA is also expanding to develop a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

FDA Warns Consumers of Body Building Products Promoted as Dietary Supplements

admin — Fri, 07 Aug 2009 21:03:53 +0000

The US FDA has advised healthcare practitioners and consumers of current safety information with regard to body building and increase muscle mass products, these products are commonly described as a substitute for anabolic steroids (used to increase muscle mass and strength), available both online and in retail establishments.

These products are typically publicized to refine athletes’ sports performance abilities and as a tool for injury recovery. Although they are promoted as dietary supplements, they are not dietary supplements at all. Actually, they are unapproved drugs that have not been evaluated by or endorsed by the US FDA for safety and benefit.

The FDA has received acquired event communications regarding body building products labelled as including steroid alternatives or steroids, taken by men, which lists: blockages of arteries in the lung, stroke, kidney failure and serious liver injury.

The FDA is concerned with the potential serious health risks involved with using these types of products. As a result, the US FDA strongly recommends that consumers cease usage of all over-the-counter body building products that claim to include steroids or steroid-like ingredients.

Steam Dietary Supplement Pulled From Pharmacy Shelves

admin — Fri, 07 Aug 2009 21:01:31 +0000

The FDA’s laboratory analysis discovered sulfoaildenafil, an analog of sildenafil. Sildenafil is a key ingredient in the FDA-approved drug for erectile dysfunction, which makes Steam an unsanctioned drug. As a result, healthcare practitioners and consumers have recently been advised by the US FDA and Nutracoastal Trading LLC of the national recall of dietary supplement Steam. Nutracoastal’s unreported element could possibly mix with nitrates found in some prescription drugs, incidentally lowering blood pressures to critical levels. Plus, the product could initiate side effects like headaches and flushing.

Steam was circulated to nationwide stores in white plastic bottles. Customers who have this prescription product should discontinue their usage and notify their doctor if they are experiencing any adverse effects that could be related to Steam.

FDA Demands TNF Blockers to Include Cancer Warnings

admin — Fri, 07 Aug 2009 16:27:01 +0000

The US FDA requires TNF blockers to include firm detailed warnings in the prescribing information. The warnings, which also involves an up to date box warning, spotlights the increase chance of cancer in children and adolescents who first obtain the drug to treat juvenile rheumatoid arthritis, inflammatory bowel disease, Crohn’s disease and other inflammatory diseases.

As well as, the FDA is determined to act alongside the manufacturers and consider new ways of further clarifying the risk of cancer in the children and adolescents who use the drugs.

TNF blockers are used to focus on and nullify factor-alpha, a protein that when becomes overproduced can lead to chronic inflammatory diseases, causes inflammation and bone, cartilage and tissue damage. Drugs in this category include: Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (cetrolizumab pegol) and Simponi (golimumab).

The FDA’s action is a result of the finalization of their investigation. Their analysis of U.S reports found that cancer in children and adolescents administered with TNF-blockers proved an increased cancer risk occurring on average after 30 months of treatment. Roughly, half the cancers were lymphomas and some were revealed to be lethal.

FDA Warns: Clarcon Skin Products Present Health Threats

admin — Fri, 07 Aug 2009 16:12:12 +0000

The US FDA cautions consumers of the harmful effects Clarcon skin products are having on the skin. They urge consumers to cease all usage of Clarcon Biological Chemistry Laboratory skin sanitizer or protectants, because of hazardous bacteria.

The Associated Press reports that the FDA states that some of the bacteria can lead to opportunistic infections of the skin and underlying tissues that could require medical or surgical treatment, potentially causing permanent damage.

Although, no cases of infection have yet to be proclaimed, consumers should discard of the products in their home garbage. Since 2007, over 800,000 bottles of the product, retailed under alternative brand names, have been circulated across the United States.

The Associated Press reports that US Marshals Service officers confiscated all skin sanitizer and protectant goods, and ingredients, at Clarcon’s Utah based establishment. The seizure occurred as a result of Clarcon’s compliance failure with an FDA order to liquidate immediately all said products.

FDA Makes Provisions to Botox/Botox Cosmetics, Dysport and Myobloc

admin — Fri, 07 Aug 2009 16:07:58 +0000

The US FDA has announced and advised healthcare providers of modifications to the well-known drug names for Botox / Botox Cosmetics, Dysport and Myobloc. These modifications are in the hopes to provide healthcare professionals advice on how to avoid medication inaccuracy, and reinforce individual potency. The modifications are also to provide additional information to patients, family members and caregivers.

Since the FDA began their safety review in February of 2008, they have informed healthcare providers that manufacturers of licensed botulinum toxin products are forced to reinforce product label warnings and include a boxed warning of the chances of harmful effects when the impacts of the toxin extends over the original site of injection.

The FDA has also demanded that manufacturers create and execute a Risk Evaluation and Mitigation Strategy, which will comprise of a communication plan to supply added advice regarding local injection risks coupled with the distant spread of botulinum toxin effects, as well as documentation explaining that botulinum products cannot be interchanged. The REMS also includes a risk factor Medication Guide for patients, families and caregivers. The FDA requires manufacturers to present safety data after numerous administrations of the product in a determined number of children and adults with spasticity to access the signal of serious risk regarding distant spread of toxin effects.

Ranbaxy Recalls Nitrofurantoin off U.S. Shelves

admin — Fri, 07 Aug 2009 15:29:55 +0000

Recently, Ranbaxy Pharmaceuticals Inc. announced their voluntary recall of all Nitrofurantoin Capsules lot (USP 100 mg capsules), that currently exist on the U.S. market.

Ranbaxy has decided to recall all lots based on product determination that revealed nonconformity with approved laboratory specifications. Ranbaxy maintains caution and commitment to the health and safety of patients as they continue to investigate the cause of laboratory nonconformity.

The recall is being conducted at the retail level and is in conjunction with FDA coordination. Ranbaxy, claims that to the best of their knowledge, the product in question does not cause any serious adverse side effects. However, Ranbaxy has reason to believe that there may be a possibility of non-serious gastrointestinal adverse effects such as nausea and vomiting. All patients who are currently consuming and/or has been prescribed Nitrofurantoin should consult a doctor for alternative treatment options.