FDA warning -

Have you noticed an increase in the number of people with red eyes sneezing and constantly wiping their noses?  As people who suffer from severe allergies can attest, allergy season is in full effect, and those who experience reactions to pet dander, pollen in the air, and anything else will reach for an antihistamine in order to reduce their symptoms.  But as a new Food and Drug Administration report shows us, this can prove detrimental to driving ability and in turn safety.

Antihistamine medications aim to relieve symptoms associated with histamines, chemicals produced by your body which can cause swelling of nose tissue, hives, itchiness, and running eyes and nose.  But although antihistamines can counteract these effects, they can also reduce reaction time and make one excessively tired.

The FDA wants consumers to take precautions when using such medications.  They advise always checking the label to learn the correct dosing recommendations and to stick to those directives.  Persons should also understand the impact of the drugs.  Effects might take some time to kick in, and you should know what this timeframe is so you can avoid activities amid drowsiness.

If on drowsiness-inducing antihistamines, you should also refrain from operating a motor vehicle, an activity that can be particularly hazardous when you’re unable to react in time to avoid a crash.  You should also refrain from alcohol consumption on such medications.  And if you feel like the antihistamine isn’t doing its job properly, speak with a doctor rather than just increasing the dosage without guidance.

In December of last year, new regulations from the Food and Drug Administration regarding sunscreens came into effect.  No longer can a product make claims that it’s waterproof or that it can last for more than two hours without additional application.  And if a sunscreen doesn’t protect users from both UVA and UVB rays (known as broad spectrum protection), it has to carry a warning outlining the fact that it can’t prevent skin cancer, only sunburns.  That same warning is to be affixed if the SPF is lower than 15.

These regulations were put into place so that consumers would be kept better informed and thus could make the right choice when it comes to sunscreen products.  The FDA is relating this information, as well as some vital safety tips, in a new report released in honor of Don’t Fry Day next Friday.

Among the tips that consumers should consider is that sunscreen should go on a least a quarter of an hour before you head out into the sun.  If you have a baby, especially if they’re less than six months old, you should refrain from exposing them to direct sunlight.  You yourself should avoid being in the sun between 10 and 2, as this is where the sun’s rays are at their most fierce.

California’s beautiful beaches are the envy of the rest of the country, but we must be safe when we visit them.  Check out the EPA’s UV Index Report before you go to the beach to determine the level of radiation on any given day.

A news release finds the Food and Drug Administration warning pregnant women to take the proper precautions when it comes to medication.  The agency explains that drugs that might be alright to take pre-pregnancy could prove to be dangerous to either you or your unborn child during a pregnancy.

Instead of taking to the wilds of the internet to find out information, the FDA advises speaking with a doctor.  And if you just have a quick question you want answered without an appointment, the FDA recommends using one of their handy resources.  For instance, the organization offers a pregnancy website that offers a host of information dedicated to the safety of drugs, foods, medical devices, and more.

Drugs should also be taken with caution.  The FDA offers a resource about drugs and the effect that they might have on a pregnant woman.  The truth is, even relatively common pain relievers could pose risks under the right conditions.  Pretty soon, the FDA will roll out labeling changes that seek to better inform pregnant women of certain risks, but until then, you should always read the label carefully to determine if you would be endangered via consumption of a given medication.

Also understand that pregnant women are often not involved in clinical trials, and thus studies into effects of certain drugs can be lacking.  Thus, you might check up on the FDA’s Pregnancy Exposure Registry to figure out if a medication you have to take is currently under study.  By signing up, you can help improve health of pregnant women in the future.

The Food and Drug Administration has issued a communication warning consumers about the deleterious side effects that could be presented if they take Samsca for too long.  The drug, which is typically taken by those suffering from euvolemic and hypervolemic hyponatremia, will receive a new label detailing the potential threat posed when a user takes the product for more than a month.  Additional risks are also presented when the patient has some kind of liver disease.  Either of these circumstances in conjunction with the drug’s extended usage could lead to a liver injury that would necessitate a transplant.  The damage could even prove to be fatal.  Doctors should limit their patients’ intake of the drug to less than 30 days, and patients should understand the risks and contact a medical professional the moment adversity becomes apparent.

To learn more about the warning, follow this link.

The Food and Drug Administration has issued a report focused on a startling side effect that can occur when a patient takes Potiga, an anti-seizure drug.  Meant to be used by adults, the medication apparently has the potential to turn an individual’s skin a blue hue.  This tends to occur in the fingernails and lips of a patient, but there have also been reports of further discoloration of the legs and face.  There have also been instances where a patient’s retinal pigment has become discolored as well.  The FDA does not know if these conditions, which largely have occurred after about four years of drug usage (but have popped up over shorter timespans), can be reversed.  Patients are encouraged to submit to regular eye exams and report to their doctor the moment they notice any adversity.

To read the full warning, click here.

Spurred on by a wave of reports alleging injurious circumstances in conjunction with a substance known as DMAA (or dimethylamylamine), the Food and Drug Administration has issued a warning to consumers about the stimulant.  They’re also attempting to use this particular incident as a means to explain the difficulties of overseeing the safety of dietary supplements.

As of yesterday, the FDA had received 86 notices of a death or an injury linked with a supplement that uses DMAA as an ingredient.  Among the side effects reported were things like psychiatric problems, nervous system issues, and heart problems.  The FDA worries that consumers exposed to DMAA could be susceptible to heightened blood pressure that can lead to breathing difficulties or a heart attack.

Because DMAA is most commonly found in dietary supplements, the way the FDA reacts to this type of situation is different from how the agency would approach a potentially hazardous drug.  Dietary supplements do not have to go through a pre-market approval process, and thus consumers shouldn’t automatically think that an item being on sale automatically means the FDA has put it through the rigors.  Instead, the FDA must prove a lack of safety after an item has already been released and potentially made its way into the hands of consumers.  The FDA is usually able to step in once an active drug ingredient has been found in a dietary supplement.

In this instance, the FDA has asked makers of dietary supplements that use DMAA to cease including the ingredient.  Only one firm has failed to comply with this request, and the FDA is in the midst of putting together an appropriate response to that company.

The Food and Drug Administration is warning doctors and patients of the recently discovered increased risk of irregular heart rhythm that could confront users of azithromycin.  Known more commonly as Zmax or Zithromax, two studies recently turned up an issue wherein the heart’s electrical activity could experience abnormality leading to the aforementioned rhythm issue, which could turn fatal under certain circumstances.  Patients suffering from a slowed heart rate or magnesium or potassium deficiencies would be more likely to experience the issue.  The drug is fairly common, prescribed to patients suffering from things like pneumonia, sinusitis, and genital ulcer disease.  Healthcare professionals are being asked by the FDA to consider this heightened risk when prescribing Zmax to persons who are already in danger of suffering a cardiovascular event.

Follow this link for more information.

Latex allergies are far more prevalent than many people might realize.  In fact, the Occupational Health and Safety Administration figures that as much as 6% of the population is allergic to latex.  This number actually increases when looking at the healthcare industry, where up to 12% of people could have a sensitivity to the substance.

You would think the threat would be mitigated when a product includes such statements as “does not contain latex” or “latex-free.”  After all, this sends a signal to a sensitive individual that that product should be safe to make contact with.  However, as the Food and Drug Administration explains in a new report, these statements aren’t always accurate.

That’s because there are currently no tests (at least to the FDA’s knowledge) that can guarantee beyond a shadow of a doubt that an item is completely free of natural rubber latex proteins.  Ten days ago, the FDA sought to take steps to eliminate the aforementioned latex-free language by issuing draft guidance that will now be opened up to comments from the public.  In its place, they would like to see statements relating the fact that the items were not made with natural rubber latex, rather than stating that they don’t contain latex.

This move aims to address the idea that even when latex was not used as an ingredient in the making of a product, it could have contaminated a certain item at some point.  The FDA also hopes to make a distinction between natural rubber latex proteins, which can cause an allergic reaction, and synthetic latex, which does not due to its not having those proteins.

So just what types of items could pose a danger to those with latex sensitivities?  As you may have guessed, medical products are those which most typically are comprised of latex in some regard.  Bandages, gloves, crutches, sanitary napkins, condoms, catheters and more could all contain at least some latex.  And the more one tends to make contact with latex products, the greater their chances of developing some sort of sensitivity.  That could explain why a higher percentage of medical workers seem to have this sensitivity compared to the rest of the population.

The CDC explains that there are things an allergic person can do to mitigate their risk.  Healthcare workers are advised to refrain from using natural rubber latex gloves unless there’s a chance they’re going to be contacting something infectious.  When you must use them, make sure you don’t use an oil-based lotion or a glove that contains powder, as these can increase your exposure.  Finally, wash your hands after usage, and know what side effects to look out for.  When one experiences an allergic reaction, that reaction can manifest in the form of itching, hives or a rash, breathing difficulties, and in very rare instances, shock or even a fatality.

The Food and Drug Administration has grown concerned that patients aren’t taken warnings about a certain Hepatitis C treatment seriously enough.  Because of that, they have issued a more severe warning about the issue which has already led some patients to experience fatal side effects.

The drug in question is known as Incivek, a Hepatitis C drug typically provided in conjunction with with interferon and ribavirin.  These three medications are often given to those persons who still maintain partial function of the liver even when certain areas of the organ have been damaged.

When taken together, patients could experience a skin rash that could prove deadly if allowed to continue.  A label enlightening patients about this risk was already placed on the product, but the FDA found out that patients in certain circumstances continued to be treated with the three drugs.

The FDA is thus warning that this condition is nothing to be trifled with.  Although Vertex Pharmaceuticals says that fewer than 1% of patients were shown to develop the skin rash during a clinical trial, the FDA is nevertheless issuing a new black box warning that must be placed on the product.  Patients are being instructed to stop treatment the moment a skin rash becomes apparent, especially if that rash is accompanied by dizziness, mouth sores, or a fever.  Emergency treatment should be sought at once, and the entire incident should be reported to MedWatch.

Follow this link for even more information.

If a drug claim sounds too good to be true, chances are that it is too good to be true.  The rise of the internet, email, and social media has ushered in rampant marketing of fraudulent medications that have not received the approval of the Food and Drug Administration, and many consumers get taken in by these ads.

Don’t become victimized by one of these products.  Consult the tips provided in a new FDA report geared toward helping people avoid shady healthcare items.

First, all claims about treatment should be backed up by scientific evidence.  In lieu of this information, fraudulent drug marketing materials might instead offer testimonials from “customers.”  Marketing will also attempt to emphasize a quick solution to conditions that otherwise require intensive treatment over the course of years.  If such a solution is offered along with claims that the item is all natural, or a miracle drug, then you should be especially cautious.

In an attempt to explain why there isn’t scientific proof of the claims made by a fraudulent product, marketing might suggest some type of conspiracy is to blame.  Don’t buy into this faulty logic.  If a product hasn’t been approved by the FDA, it’s far more likely that it’s fraudulent than that the government and the pharmaceutical industry are working together to halt the item’s release.