Medicine.org - Government Regulation & Oversight

Deaths Reported in Users of Diabetes Drug Byetta

Fri, 29 Aug 2008 21:20:06 -0400

According to Amylin Pharmaceuticals and Eli Lily, six patients who were prescribed the type 2 diabetes drug Byetta reportedly have died from pancreatitis. The Food and Drug Administration reported the Byetta patient deaths and will now strengthen its warnings about serious pancreatitis problems linked to the drug.

Byetta was approved by the FDA in 2005 for the treatment of type 2 or adult onset diabetes in patients whose diabetes was not well-controlled on other oral medication. The medication is injected subcutaneously twice per day using a pre-filled pen device and began being widely used after its approval, in part because it promoted weight loss, in contrast to insulin and many other diabetes medications. Byetta can improve blood sugar control and can be and has been combined with other diabetes drugs.

FDA Proposes New Drug Labeling System for Pregnant Women

Sun, 01 Jun 2008 00:16:43 -0400

The Food and Drug Administration has proposed replacing a 30-year-old system for classifying prescription medications in order to provide women with far more detailed information about a medication’s risks and benefits during pregnancy and breast-feeding. Should the proposal be approved, new prescription drug labels would list the potential risks and benefits for both the mother and the fetus when taking the medication and how those risks might change during pregnancy. The new labels will help women become better informed about their prescription drugs, and doctors will be better able to counsel patients about using prescription drugs.

No More Cold Medicine for my Child! Now What?

Sat, 20 Oct 2007 15:32:05 -0400

Any parent can tell you that when a child has a cold, the entire household suffers. Not only baby are awake all night, but so are Mom and Dad. Now, cold syrups have been ruled as a potential source of easy overdosing for children, and stores have voluntarily pulled them from the shelves. What are Mom and Dad to do? Plenty. Below are several actions recommended by Pediatricians.

Humidifier

Advertisements Misleading with Dietary Supplements

Tue, 16 Oct 2007 16:41:15 -0400

Controversy over the proper authority for supplementals has been in existence for generations. However, the heat has really been turned up in the past few years, as consumer awareness of drug interactions with supplements has surfaced. Additionally, findings of a prescription drug being used extensively in a common supplement for cholesterol occurred only a few months ago. Safety, Safety, Safety!!!!

A 3-Tiered System for Drug Purchase Is Considered by FDA

Mon, 08 Oct 2007 13:03:41 -0400

Americans have seen an insidious trend for more and more drugs to be sold over the counter (OTC). Sometimes, the only difference between the OTC drugs and prescription drugs is the dosage. For instance, Motrin is sold OTC at 200 mg. Prescription doses are 800 mg. However, it doesn’t take an active imagination to know that we could take 4 Motrin OTC of 200 mg to have the same dose as provided by our physicians.

World Health Organization: One Step Closer to Bird Flu

Mon, 27 Aug 2007 14:33:48 -0400

The World Health Organization has stated we are now in the 3rd phase of a 6 phase wait for the expected bird flu pandemic.

Prescription Drug Found in Dietary Supplements

Mon, 13 Aug 2007 22:07:54 -0400

Products advertising red yeast rice products have been on the web for a long time. Along with diet and exercise, the manufacturer’s claim these products will help to reduce one’s cholesterol. Purportedly, this product has been used in Asia for almost 3000 years (and we all know Asians are petite and thin and healthy, right?).

The manufacturer’s are commended for placing warning labels on all of their products which state:

Treatment for GERD (Heartburn) May Cause Heart Attacks

Sat, 11 Aug 2007 14:19:44 -0400

Gastroesophageal reflux (GERD) is a common condition that often occurs without symptoms after meals. In some people, the reflux is related to a problem with the lower esophageal sphincter, a band of muscle fibers that usually closes off the esophagus from the stomach. If this sphincter doesn't close properly, food and liquid can move backward into the esophagus and may cause the symptoms.

Per FDA, Zelnorm May Be Used In Select Cases

Wed, 01 Aug 2007 21:50:59 -0400

FDA Permits Restricted Use of Zelnorm for Qualifying Patients

The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.

Food Safety May Get An Upgrade via FDA New Rule

Wed, 01 Aug 2007 21:45:19 -0400

FDA Announces Program to Enhance States’ Food Safety Programs
Goal is to Strengthen Safety of Food Facilities Overseen by States

The U.S. Food and Drug Administration today launched a national program to bring about the adoption of more uniform, equivalent, and high quality regulatory programs by state agencies responsible for regulating facilities that manufacture, process, pack, or hold food under FDA’s jurisdiction.

Virginia Shootings Prompt Calls for Inclusion of Mental Health Information in Gun Check System

Thu, 28 Jun 2007 22:09:55 -0400

Congress is currently considering a bill to States will be required to provide the FBI with information on their Residents and Mental Health Care they may have received. This bill is a response to the devastating catastrophy at Virginia Tech in which a student killed 32 people. The student had a history of mental health care prior to purchasing a gun.

The National Instant Criminal Background Check System (NICS) Improvement Act (HR 297) has a high possibility of passing Congress this year. In addition to the above mandate it is also expected to provide grants to States to help them establish their data bases. Data bases would not only include Mental Health Care received, but any convictions of domestic violence or subjects of mental health adjuciations and commitments.

FDA Panel Nixes Long Awaited Obesity Drug

Fri, 15 Jun 2007 18:42:45 -0400

Zimulti (Rimonabant) is indicated for overweight patients (NOTE: BMI > 27 with one cardiovascular risk factor, or BMI > 30, if no cardiovascular risk factors).

Body Mass Index (BMI) is the proportion of total fat when height and weight are calculated. The National Health Institute has demonstrated that anyone who has a BMI of 25 or greater is at risk for health problems; therefore, a BMI of 25 and less than 30 is considered overweight; while greater than 30 is obese.

Contact Lenses Were Voluntarily Recalled by Manufacturer

Sun, 27 May 2007 13:40:46 -0400

In March 2006, CDC was alerted to a small cluster of contact lens-associated Fusarium keratitis infections (which can cause a severe infection of the cornea and may require surgical intervention) in New Jersey. By April, over 100 patients with suspected contact lens associated fungal eye infections were under investigation across the country. All contact lens wearers who remembered what type of solution they had used reported using the same brand, prompting that company to voluntarily stop shipment of the implicated product.

Avandia: Needless Panic?

Fri, 25 May 2007 16:54:54 -0400

The New England of Journal recently published a scathing report on the adverse cardiovascular effects of Avandia. Avandia has been used since 1999 to treat diabetes II, and was approved by the FDA with the knowledge that minimal cardiovascular effects existed, but not more than with any other diabetic drug which existed. However, the risk for people with congestive heart failure was slightly higher.

Prestigious National Institute Advocates Safe Cigarettes

Fri, 25 May 2007 16:50:37 -0400

This past September, the Institute of Medicine (IOM) published the report Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction.,1 The report's leading conclusion is that tobacco products of reduced risk, and especially less hazardous cigarettes, are within technical reach and should be officially endorsed and regulated. The report speaks of unparalleled public health opportunities in tobacco harm reduction and in the abatement of the awesome morbidity and premature mortality of more than 1 billion smokers worldwide.1(p23)