It’s no secret that prescription drugs have risks. In fact, most drugs on the market today have some level of side effects, which can range from nausea or headaches to serious medical implications.Social learning and social cognitive theory many of these side effects are found during the research stages of a drug’s approval, but some aren’t discovered until months or years after they’ve been used by consumers.Social learning and social cognitive theory for the most serious risks, the FDA steps in and orders a black box warning. What “black box” means

But when industry professionals talk about boxed warning drugs, there is a negative connotation that goes along with it.Social learning and social cognitive theory drugs only receive this label in the case of serious, often deadly adverse reactions, which have been reported to the FDA after the drug was originally approved.Social learning and social cognitive theory in some cases, the manufacturers of these drug hid their knowledge of the side effects to speed the approval process, so the problems weren’t found until after release.Social learning and social cognitive theory

FAERS allows industry professionals, including healthcare providers and pharmacists, as well as consumers, to report any concerning or undesired effect or side effect associated with a particular drug.Social learning and social cognitive theory while consumers are welcome to report issues voluntarily, physicians and other professionals are mandatory reporters, meaning they must report adverse events that they see in patients.Social learning and social cognitive theory

Once an event is reported to the system, the incident is reviewed by clinicians in the center for drug evaluation and research (CDER) and the center for biologics evaluation and research (CBER).Social learning and social cognitive theory if the reviewers are concerned, a deeper investigation begins. If that investigation brings forward red flags, the FDA is then able to take regulatory action.Social learning and social cognitive theory it’s at this point that the FDA could require a boxed warning to be added to a drug’s labelling and marketing materials. However, regulatory actions could also include other labelling restrictions, restrictions on how and when the drug can be used, and, in the worst cases, the reversal of FDA approval on the medication.Social learning and social cognitive theory why black box warnings are important

According to a 2006 study, nearly 40% of patients in ambulatory settings were prescribed drugs that had a boxed warning.Social learning and social cognitive theory in some of the recorded cases, pregnant women even received medications where the boxed warning made the drug contraindicated in pregnancy. With over 600 medications carrying these severe side effect warnings, it’s imperative that healthcare providers and patients understand what FDA warnings mean.Social learning and social cognitive theory

• abilify: abilify is used to treat various mental health and mood disorders, such as schizophrenia, depression and bipolar disorder. However, studies demonstrated that the drug could cause certain compulsive behaviors, such as binge eating and compulsive gambling, and the FDA required a label change to include a new boxed warning in may 2016.Social learning and social cognitive theory at least 2,500 patients who experienced these extreme compulsive behaviors have filed abilify lawsuits.

• pradaxa: commonly used as a blood thinner, pradaxa’s warning actually has to do with stopping the use of the drug.Social learning and social cognitive theory while pradaxa has an increased possibility of serious bleeding during use, stopping the drug before its course is complete may lead to a stroke or heart attack due to blood clots.Social learning and social cognitive theory pradaxa lawsuits, however, are more focused on the risk of internal bleeding than strokes.

If you’re searching your medicine cabinets and seeing black boxes, don’t panic, and never stop taking a medication without speaking with your doctor first.Social learning and social cognitive theory A good physician will know about the warning, and will have assessed the risks and benefits in your situation before grabbing their prescription pad.Social learning and social cognitive theory if you’re concerned about any of your medications, here are a few questions to discuss with your physician. You can also always ask your pharmacist questions about medications; it’s their job to know these drugs better than anyone else.Social learning and social cognitive theory

• what is your drug representative policy? Many private practices and even some hospitals allow drug representatives to come in and pitch their medications to physicians.Social learning and social cognitive theory some may offer kickbacks to physicians who prescribe certain drugs, which makes it difficult for doctors to be objective about medications. Your doctor should tell you if they work with reps from a certain company, or if their relationship with a drug representative pushed them to prescribe a boxed warning drug to you.Social learning and social cognitive theory

While your doctor is obligated to report adverse events they see or that you tell them about, it’s important to be proactive if you experience a concerning side effect.Social learning and social cognitive theory luckily, the FDA makes it easy to report these types of events, which means you have a great way to help other consumers stay safe. If you or a family member has experienced a severe drug side effect that is not covered in the side effects section of the medication guide on the drug, there are a few ways you can alert the FDA.Social learning and social cognitive theory

• submit an electronic report: the FDA uses a system called medwatch to track electronic complaints. You can visit them to submit complaints about serious drug side effects, medication errors/product use errors, product quality problems, and therapeutic failures.Social learning and social cognitive theory medwatch should not be used for reporting issues with vaccines, investigational drugs (still under study), or dietary supplements.

You can also check in on your report, or ask for the general information regarding adverse events linked to a drug.Social learning and social cognitive theory the 1996 amendments to the freedom of information act give you the right to access this information at any time. Healthcare providers and third parties are also allowed to access the information, and may view your report, but they cannot see your patient files without written consent from you.Social learning and social cognitive theory taking medications with confidence

It’s important to remember that black box warnings are just that: warnings. They are meant to inform prescribing decisions, so that your physicians can make the best drug choices for you.Social learning and social cognitive theory it’s rare for any drug to have no side effects at all, and most affect every individual differently; medication is about what is the best option, not what’s perfect and risk-free.Social learning and social cognitive theory

If you’re ever unsure about a drug or its side effects, talk with your doctor or pharmacist, and make sure you’re being properly monitored for adverse events.Social learning and social cognitive theory always follow dosing guidelines, and make sure to call for help in the case of a medication mix-up or drug overdose. In the case of an adverse reaction, help your fellow consumers by reporting the issue to the FDA.Social learning and social cognitive theory that way, we can take one more step toward ensuring the health and safety of every patient, whether they’re taking life-saving drugs for a severe illness or simply medicine to stem a winter cold.Social learning and social cognitive theory