drug safety -

Safety advocates and lawmakers have grown concerned about a potential loophole in the law that leaves a grey zone in the regulation of compounding pharmacies.  Last year, over 700 people became ill and 50 died because they were exposed to contaminated steroid injections from a compounder.  To make sure such an incident never happens again, a bill was drafted that would bolster the Food and Drug Administration’s ability to oversee such institutions.  Now, that measure has received the unanimous approval of the Senate Health, Education, Labor, and Pension Committee.  As the bill currently stands, compounders would have to register and report adversity to the FDA.  They would also be privy to inspections, the costs of which would be offset with a fee paid by the compounder itself.

For more about this initial approval, click here.

Today, the Food and Drug Administration will convene an expert panel to offer recommendations about a new insomnia drug from Merck.  The company is seeking the approval of suvorexant, which is designed to help people suffering from insomnia fall asleep.  In preparation for today’s meeting, the FDA has made their concerns about the drug known to the public.  They worry about studies which have shown inconsistent results with the drug, as well as the potential for the medication’s effects to linger long after they should have worn off.  This can lead to instances of daytime sleepiness that have the potential to compromise driving ability.  These factors, combined with concerns about the appearance of suicidal thoughts among users, may prompt the FDA to only approve lower doses of suvorexant.

For more about the pending approval, click here.

The potential for particulate formation has prompted Sandoz to announce the recall of Methotrexate Sodium Injections available across the country and in Poland.  Lot CL0996 and Lot CJ4948 are impacted by the recall, which was initiated once a quality test of a sample product identified the presence of particulates.  If the drug, which is typically used for the treatment of things like psoriasis, arthritis, and various neoplastic diseases, contains particulate matter, patients could be subjected to a host of medical complications.  This could include a microembolism, most likely in the lung.  No complications have been reported at this time, and to ensure that continues, healthcare professionals should take the proper precautions with the recalled drugs and patients should report to a doctor the moment they experience any kind of adversity.

For more about the recall, follow this link.

Today saw the release of the ExpertRECALL Index, a compilation of the various recalls that have taken place throughout the first quarter of the year.  The trends contained therein are important to understand, as they can help regulators take steps to protect consumers, food companies eliminate circumstances which typically lead to a recall, and consumers themselves become more aware of injurious conditions.

In regards to food recalls, which for the first time included Department of Agriculture data about things like meat and poultry, a whopping 73.4% of recalls involved a company that announced more than one recall.  The reason has to do with one defective ingredient typically being found in more than one product.

Food recalls most often had their genesis with the presence of foreign materials, with 28% of food recalls stemming from that issue.  The second most common reason for a recall was the presence of an undeclared allergen.

Recalls of consumer products (which can be found on the website of the Consumer Product Safety Commission) were down even as the number of units affected went up.  More than 6 million units in this category were recalled, but it’s important to note that one particular recall accounted for 2.3 million items.

Drug recalls are also on the rise, with the number of recalls issued by compounders increasing dramatically thanks to increased attention from the Food and Drug Administration after a widespread outbreak last year.

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.

A debate is still ongoing as to whether or not the Food and Drug Administration should be granted extended regulatory powers over compounding pharmacies.  The issue was brought to the forefront after contaminated steroid injections from the New England Compounding Pharmacy led to a widespread outbreak that claimed the lives of more than 50 people and caused 700 to suffer an illness.  The Senate Health, Education, Labor, and Pensions Committee looks to be largely in favor of the creation of a new “compounding” category that would be subject to FDA regulations.  However, the bill does not curry the same kind of support in the House, where lawmakers are more divided on the issue.  Nevertheless, state regulators and the FDA alike have spoken about the need for such a law.

Click here for more about the bill.

All sterile products manufactured by the St. Petersburg, Florida-based The Compounding Shop are being recalled because said sterility cannot be guaranteed.  The move was made following a Food and Drug Administration inspection of the company’s facilities that highlighted conditions which could lead to the sterility of the compounded items being compromised.  This is the latest in a long line of recalls issued on sterile products after a widespread outbreak last year brought to light certain inconsistencies with how such companies were monitored by authorities.  In order to prevent a patient from suffering an infection, healthcare professionals are being asked to check their supply of drugs to see if they have received anything from The Compounding Shop.  If so, the products should not be administered to patients.

Click here for more about the recall.

The threat of a mix up between two medications used for the treatment of breast cancer has prompted the Food and Drug Administration to issue a warning to doctors.  The potential mix-up involves Herceptin and Kadcyla.  Although these items don’t sound like one another, their non-proprietary names are somewhat similar:  Kadcyla is referred to as ado-trastuzumab emtansine and Herceptin is referred to as trastuzumab.  Many publications and electronic systems will drop the “ado” prefix from the former drug, which could cause confusion as to what drug is supposed to be administered to a patient.  No adversity has been reported at this point, although clinical trials did see a mix-up take place.  The FDA advises that the full names of each drug always be referenced by healthcare professionals and that employees be made aware of the difference.

For more about this warning, click here.

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.

Versions of Piperacillin and Tazobactam for Injection, USP 40.5 grams with expiration dates ranging from this month to April of next year are being recalled by Apotex Corporation and Hospira because of a possible threat to patient health.  In 15 lots of this product, the IV line or bag could sustain crystallization or precipitation, a condition that may not only prevent proper delivery of the aforementioned drugs, but that could also lead to a host of complications, such as vasculitis, renal impairment, phlebitis, and more.  The drug, which is typically given to patients suffering from certain infections, should not be used.  Instead, doctors are being asked to quarantine the products and arrange for the proper return of the drugs with GENCO.

To learn more about the recall, follow this link.