What should patients know about prescription drug safety?

| Dec 19, 2018 | Firm News

Pharmaceutical companies should try to find ways to treat conditions and illness in as safe a manner as possible. Unfortunately, medications that these companies produce do have risks. It is imperative that patients take the time to understand what they are putting into their bodies and how it might impact them.

Patients being given a new medication should ask their doctor and pharmacist about the side effects of the drug. In this process, there are some common terms that might come up.

What is an adverse drug reaction?

An adverse drug reaction is another term for side effects. This term covers mild to severe things that might happen when you take the medication. Dizziness, a skin rash and dry mouth are a few common side effects. Women who are pregnant or of childbearing age should find out if there are any birth defects listed as side effects for a drug.

What is anaphylaxis?

While you are speaking to the doctor or pharmacist, they should also talk about signs to look for that indicate you are having an allergic reaction. These usually include trouble breathing, tongue or facial swelling, itching and hives. A person who is having an allergic reaction to the drug might be suffering from anaphylaxis, which requires emergency medical care.

What is boxed warning?

One important question to ask is whether there is a boxed warning for the medication. The U.S. Food and Drug Administration requires a boxed warning if there are serious or life-threatening risks for the drug. For example, Invokana has a “black box warning” because of the increased risk of amputation in patients who are taking it.

How are side effects monitored?

After a drug is released to the market, it is monitored using post-market surveillance. One of the tools to do this is the FDA Adverse Event Reporting System, or FAERS. Another is MedWatch. These work together to allow the administration the ability to see if there are any adverse effects that are impacting patients at an alarming rate, if there are some that are serious or if there are any that weren’t initially reported.

What are drug recalls and withdrawals?

A drug recall means that a medication is taken off the market because of a violation of the law. There are three classes of recalls, with Class I being the most serious. A drug withdrawal means that the FDA has found that the risks of the drug outweigh the benefits and that it should be removed from market.

Patients who are seriously harmed by medications can take legal action to hold liable parties accountable for the damage. Time limits do apply to these cases, so act quickly if you are in this position.