The U.S. Food and Drug Administration (FDA) has issued a warning not to share insulin pens due to the risk of blood borne infections. Insulin pens are pen-shaped injector devices that contain a disposable needle and a source of insulin that are approved only for single-patient use.

FDA officials want to remind both doctors and patients that insulin pens and the cartridges they contain should not be used to administer medication to more than one patient. While the devices typically contain enough insulin for a patient to self-administer several doses before the reservoir or cartridge is empty, the pens should only be reused by the same patient. Sharing the pens raises the risk of transmitting blood borne diseases such as HIV and hepatitis.

The FDA said they had received reports of two unnamed hospitals using the same insulin pen to administer medication to more than 2,000 patients. While the hospitals reportedly replaced the needles, they continued to reuse the same insulin cartridge. The FDA wants to stress that this is an unsafe practice, the pens are designed for safe use by only one patient. Even if the needles are changed between each patient the risk of disease transmission may still exists.

Want to learn more about insulin administration for diabetes? Join the Healia Support Community for Diabetes Type I or the Healia Support Community for Diabetes Type 2.

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A report released Thursday by congressional investigators shows that the Food and Drug Administration (FDA) is allowing some high risk medical devices to be approved without the close scientific review required by law. The Government Accountability Office (GAO), Congress' audit, evaluation and investigative arm, says that despite a Congressional order in 1990 to resolve the issue, the FDA approved 228 medical devices between 2003 and 2007 without a complete review of their safety and effectiveness.

The report found that two-dozen distinct types of devices approved without close scrutiny, including metal hip joints used in hip replacement surgery, external defibrillators used to rescue people who are having a heart attack, and electrodes for pacemakers.

The problem arises from a 1976 law that implemented a three-tiered classification scheme to categorize medical devices. That law divides medical devices into three classes: class I devices are low risk such as reading glasses and tongue depressors, class II includes devices with more risk such as electrocardiograph (ECG) machines and mercury thermometers, and class III devices are considered high-risk because they are implanted in the body or they can mean the difference between life and death, such as pacemakers and replacement heart valves.

Manufacturers of high-risk devices are required to demonstrate the safety and effectiveness of their device before taking it to market. However, an exception was written into the law that allows new versions of already-approved high-risk devices to bypass this step. In order to get a new device approved this way, manufactures must simply demonstrate that their new device is “substantially equivalent” to an existing device. This leaves a lot of room for interpretation, so in 1990, Congress ordered the FDA to stop approving devices in this way. The GAO report shows that despite agreeing in principle, the FDA has not fulfilled its promise.

Some of the high-risk devices approved this way have been removed from the market. The GAO study did not examine whether anyone was harmed as a result of using the un-scrutinized devices.

The GAO report urges the FDA to act quickly to end this method of approving high-risk devices. They also suggest that the FDA carry out full reviews of the devices already approved this way and reclassify devices as lower risk where appropriate.

Read the full GAO report at the GAO Web site. If you have a question about medical devices, ask the experts at Healia Health Communities.


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If you are looking for a little help with your upcoming New Year’s resolution to shed those extra pounds, the U.S.Food and Drug Administration recommends that you stay away from the computer. Yesterday the FDA issued a warning to consumers to avoid 28 weight loss products sold online because they contain unlisted ingredients that may be dangerous.

The pills are mostly promoted and sold on various Web sites but some are also sold in retail stores. They are sold under names such as Perfect Slim, 2 Day Diet, and Zhen de Shou. Most of the diet pills appear to be coming from China, but for others the provenance is unknown.

Many of the products are touted as “natural,” or “herbal,” or as new versions of "ancient Eastern remedies,” but actually contain potentially harmful ingredients not listed on the product labels or in advertisements. FDA testing found that the pills contained high doses of a powerful anti-obesity drug, as well as a suspected carcinogen and a pharmaceutical that has not been approved by the FDA.

Many of the pills contain sibutramine, a powerful appetite suppressant that is related to amphetamine. Sibutramine is the active ingredient in the prescription drug Meridia, which is used to treat obesity. But FDA testing found that some of the diet pills contain nearly three times the recommended daily dose.

Even at recommended doses, possible side effects of sibutramine include high blood pressure, seizures, tachycardia, palpitations, heart attack, and stroke, especially in people with a history of heart problems. Sibutramine can also interact with other medications but since it is not listed as an ingredient, people taking the pills are unlikely to be aware of these risks.

Rimonabant, another ingredient found in some of these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

Several of the pills also contain phenolphthalein, a solution used in chemical experiments and as a laxative that is being withdrawn from the market because it increases the risk of cancer.

According to the FDA, if a product sounds too good to be true, it probably is. If you are taking one of the diet pills on the list, the FDA recommends you taking these pills stop immediately and consult your healthcare professional right away.

The list of tainted pills can be found here on the FDA’s Web site.

For information on healthy ways to lose weight, see the Healia Health Guide on Weight Management. If you want to connect with others interested in losing weight and exchange stories of weight loss successes and frustrations, join the Healia Health Community for Weight Management.

Related blog post: Quick Tips for Eating Healthy and Making Your New Year’s Resolution Come True


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The government is paying millions of dollars each year for potentially dangerous drugs that are not approved by the Food and Drug Administration (FDA). That shocking conclusion comes from a recent analysis conducted by the Associated Press, which finds that the Federal government spent nearly $200 million dollars on unapproved drugs between 2004 and 2007.

The analysis found that Medicaid, the nation’s low-income health insurance program, shelled out money for more than 100 different drugs that have not gone through the FDA testing normally required for the U.S. market. The FDA says these drugs are a public health problem and need to be removed from the market yet concede that there may be thousands of unapproved drugs on the market.

So how could this happen? How can one government agency be spending so much money on drugs that another government agency says could be dangerous? And why are these drugs on the market in the first place?

The answer has to do with the history of federal laws regulating pharmaceutical products. It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market, mainly for common conditions like colds and pain, were also supposed to be evaluated. But some manufacturers claimed their medications were grandfathered under earlier laws, and even under the 1962 bill. Many of these drugs remained on the market and are still there today. The FDA says it is trying to eliminate them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.

Among the unapproved drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant; and ICAR Prenatal, a vitamin tablet.

In most cases, doctors, patients, and pharmacists are unaware that the drugs are not approved. Since the drugs have never been tested, no one knows how effective or safe they are. Additionally, no one is monitoring the effects of these drugs on the people currently taking them so major adverse events might go unnoticed.

Learn more about unapproved drugs on the FDA’s Unapproved Drugs Website. Although the FDA does not maintain a complete list of unapproved drugs still on the market, you can find out if a drug you are taking is approved by comparing it to the FDA’s list of approved drugs. If you find out that you are taking an unapproved drug, talk to your doctor about what you should do next. If you have questions about any of the drugs you are taking, ask the experts at Healia Health Communities.

 

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How dangerous is the chemical known as bisphenol A (BPA)? According to an independent panel of scientific advisers, it’s much more dangerous than a recent Food and Drug Administration (FDA) report suggested.

BPA is a chemical used to harden plastics and is found in several products including baby bottles, plastic food packaging, and the lining of food cans.

The panel charges that the FDA ignored scientific evidence and used flawed methods when it issued its draft risk assessment of BPA in August stating that an “adequate margin of safety” existed for BPA exposure. The FDA stated that the small amounts of BPA that migrate from food containers into the food they hold are not dangerous to infants or adults.

The panel, set up specifically to review the FDA's risk assessment of BPA, said that the FDA had relied on industry-funded studies and ignored a mountain of data including more than 100 scientific studies that have linked BPA to health problems in laboratory animals including breast and prostate cancers, diabetes, hyperactivity and reproductive problems. The panel also questioned the methods used in the FDA studies to determine the levels of BPA in infant formula, concluding that the FDA report "creates a false sense of security” and recommending that the agency redo its risk assessment.

Environmental groups want to ban BPA in infant products because the chemical can mimic the effects of the hormone estrogen and interfere with their development. Infants may be at increased risk of exposure because their kidneys do not eliminate the chemical from the body as fast as adults. Babies can be exposed to BPA through bottles and through baby formula packaged in containers made with the chemical, including cans.

If you want to lessen your family’s exposure to BPA, you can avoid eating foods from plastic containers labeled with the number 7 (usually found on the bottom of the container, inside the recycle symbol), which often contain BPA. You can also limit your use of canned foods and infant formula, most of which come in cans lined with BPA.

Have more questions about BPA and other food contaminants? The members and health experts of Healia Health Communities are waiting to help you.

 

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The Food and Drug Administration (FDA) has issued a warning to avoid any infant formula imported from China because of potential contamination with melamine. Melamine was the chemical that contaminated pet food last year, resulting in thousands of poisoning cases in dogs and cats. There is no evidence that any tainted formula is being sold in the U.S. In China, the implicated formula has been associated with dozens of cases of kidney stones in infants and one death.

Manufacturing of baby formula is strictly regulated in the U.S. and it is illegal to import baby milk from China or any unapproved sources. But several years ago, in at least one case, a Chinese brand of formula was found in a New York store.

To be safe, parents should only purchase infant formula from reputable retail sources.

Have questions about about infant formula? Healia Communities members can help.

Today, the U.S. Food and Drug Administration (FDA) announced that it is starting to post online information about specific drugs that it is evaluating for potential safety risks. The FDA emphasized that the listing of a drug on the FDA list does not mean that there is a definite safety issue with the drug but only that the FDA is evaluating whether there is a true drug safety risk.

The first quarterly report was posted on the FDA's website today, and new ones will be posted each quarter. Apparently, the information is being posted publicly under a recent law requiring FDA to inform the public of new potential safety information based on adverse drug event reports sent to the FDA.

According to the Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research at the FDA, "…Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently." 

If you suspect that you have a possible side effect to a drug or medical device, you should report this to your doctor as soon as possible. Physicians are required to forward reports of confirmed drug and medical device safety issues to the FDA.

Readers with questions about drug safety issues may wish to post a question at Healia Communities.

Last week, the Food and Drug Administration (FDA) reinstated warnings about LASIK surgery and its potential side effects. The FDA emphasized that LASIK surgery may have certain associated risks such as lost vision, painful dry eye, glare, and other night-vision problems.

The Mayo Clinic suggests that consumers be aware of what the surgery entails and what could go wrong. There are also other vision correction options or surgeries to consider. As with all surgical procedures, make sure to weigh all the options and confirm with your doctor that you are a good candidate for whichever procedure you choose. There are several kinds of vision correction surgeries and they all have associated risks.

Do you have a question about LASIK surgery? Visit Healia Communities and Ask an Expert. If you need additional information about LASIK surgery, you can also search LASIK surgery or vision correction on healia.com.

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