Pregnancy and OTC Medications

General information to consider before taking medications while pregnant

• Risks and benefits of medications should always be evaluated when deciding to use medications during pregnancy.
• There may be times during pregnancy where you must decide whether or not you really need to take a medication for a simple symptom that you may be able to tolerate (i.e. stuffy nose, simple headache) or whether or not you need a medication for a more serious matter that requires chronic medical management (i.e. diabetes, asthma etc.).  
• If possible, try to avoid all use of medications during the 1st trimester since this is the time the fetus is developing and is at most risk from developing medication-related defects.
• No medication is considered to be totally safe despite the pregnancy risk rating below.
• Medications are rarely tested in pregnant women before they come to market because it is considered unethical to expose a pregnant woman to a drug with unknown effects.
• Most information for detecting birth defects is collected after the medication has already hit the markets.  However, only after a large number of defects have be seen can an association be made between a particular medication causing birth defects. (Note: In the general population there is a 3-5% risk of having a child with a birth defect or mental retardation.)
• The Food and Drug Administration (FDA) has developed letter categories for all prescription medications to help explain risks of taking medications during pregnancy.  However, OTC drugs do not have classification on their label, although many OTC drugs were once prescription medications (where they were classified in such a manner).
• OTC medications do not have a letter classification like below, but on the label it contains a statement regarding the safety and possible risks of taking the OTC medication during pregnancy.
• If you are not sure, please contact your physician or pharmacist before taking any OTC medication since they have appropriate references and databases to help verify the risks (and if necessary provide safe alternatives).

FDA's Pregnancy Letter Categories For Prescription Medications and Interpretation

• A    Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal    abnormalities to the fetus in any trimester of pregnancy.

• B    Animal studies have revealed no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women or animals which have shown an adverse effect. However, adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

• C    Animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in pregnant women (or studies in women and in animals are unavailable).Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

• D    Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

• X    Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Cough and Cold Medicines During Pregnancy

• It is important to remember that most cold symptoms are self-limiting.  Thus, it is recommended to try non-drug treatments first (i.e. hydration, saline nasal sprays, use of humidifiers etc.) to relieve symptoms especially during the first trimester.
• Drugs that are commonly utilized for a cough and cold may include the following classes of drugs: analgesics/antipyretics (to relieve pain and fever), antihistamines (to relieve runny nose and watery eyes), cough suppressants, expectorants (to help drain mucus from lungs) and decongestants (to relieve nasal congestion). 

Safest OTC Analgesics and Antipyretics During Pregnancy

• Acetaminophen or Paracetamol (Tylenol, Anacin Aspirin Free) is pregnancy risk B and is considered the safest analgesic/antipyretics and drug of choice during pregnancy. Safe for short term use. (However, I personally do not agree due to new reports about possible risks for acetoaminophen/paracetamol causing autism in newborns and in young children-Please see my latest post on Tylenol. Do not exceed more than 3 grams/day. Other analgesic/antipyretics (i.e. Aspirin, NSAIDS (non-steroidal anti-inflammatory drugs like ibuprofen(Advil, Motrin), naproxen (Aleve)) have more risk to the fetus and I recommend avoiding their use during pregnancy altogether.
• Natural alternative: Suggest eating fresh ginger root, taking ginger root capsules (not extract) up to 1500mg/day or drinking ginger tea.  The ginger can help reduce pain, swelling and fever.

Safest OTC Antihistamines During Pregnancy

• Doxylamine is preganancy risk category A (very safe), but unfortunately is usually found in combination products that have other ingredients like dextromethorphan or alcohol which should(i.e. avoided during pregnancy (i.e.Nyquil).  You can find this as a singular ingredient sold as an OTC sleeping aid (i.e. Unisom Sleep Tabs).  Dosage: Recommend taking 12.5mg every 6 hours if needed (half of a 25mg Unisom sleep tab).  Note: It can cause severe drowsiness.
• Chlorpheniramine (Chlor-Trimenton) is Pregnancy risk category B and considered a good choice if an antihistamine is needed during pregnancy. Do not exceed a dose of 24mg/day.  Normal doses may include 4mg every 6 hours.  Controlled release and sustained release formulations are available 8mg and 12mg tablets. May cause drowsiness.
• Diphenhydramine (Benadryl) Pregnancy risk category B.  May use during the first semester. Normal dose: 25mg every 6 hours.  May cause drowsiness.
• Clemastine (Tavist-Allergy) Pregnancy risk category B. If possible, avoid combination products (i.e. Tavist-D) with the decongestant  phenylpropanolamine or pseudophedrine (Pregnancy risk category C). Normal dose 1mg clemastine tablet every 12 hours if needed. May cause drowsiness.
• Cetirizine (Zyrtec) is a Pregnancy risk category B.  Note: This is a second generation antihistamine that has less potential to cause drowsiness. It may be used as a safe alternative to Doxylamine, Chlorpheniramine or Diphenhydramine except during first trimester.  Normal dose: 5-10mg/day.
• Loratidine (Claritin) is preganancy risk category B.  My also be used as an alternative to Doxylamine, Chlorpheniramine or Diphenhydramine except during first trimester since it causes much less drowsiness. If possible, avoid Claritin-D since it contains pseudophedrine unless absolutely necessary since it is a risk category C. However, if a decongestant is necessary, then pseudophedrine is considered the oral decongestant of choice during pregnancy except during the first trimester.  Normal dose: One 10mg tablet per day.

Safest OTC Decongestants During Pregnancy

• Oxymetazoline (Dristan Nasal Spray, Afrin Nasal Spray) Pregnancy risk category C. Limit use to 3 days.  Only use if necessary.  Considered decongestant of choice during pregnancy. Normal dose: 2-3 sprays per nostril ever 12 hours if needed.
• Pseudophedrine (Sudafed) Pregnancy risk category C. Considered the oral decongestant of choice during pregnancy.  Avoid use during the first trimester. Normal dose: 30mg every 6 hours if needed. Only use if necessary during pregnancy, otherwise avoid use altogether since it can impair placental blood flow.
• Natural Alternative: Use plain saline nasal spray or use saline water in neti pot. Also you may eat onions.

Safest OTC Expectorants and Cough Suppressants

• Guaifenesin (Robitussin, Humibid) Pregnancy risk category C. Avoid use during first trimester due to some risk for child developing inguinal hernia http://www.babycenter.com/0_hernias_1176787.bc with use. Probably safe if use after first trimester. Not that effective at clearing secretions. Normal dose: 200-400mg every 4 hours.  Max dose. 2.4 grams.  Recommend to use sparingly.
• Dextromethorphan (Delsym) Pregnancy risk category C. Use only if necessary to relieve cough to avoid possible risk to fetus. Doses vary based on formulations.  Normal dose for Delsym: 30mg every 12 hours if needed. Don't use more than 120mg/day. Found in many combination products (i.e. Robitussin DM).
• Natural alternatives: Use Honey and Ginger Tea to relieve cough and drink plenty of fluids to help clear secretions.

Learn More About Safe & Effective Drug-Free Therapies

From Targeted Medical Pharma   

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Sources for this post include:

http://www.foxnews.com/health/2011/05/26/women-using-medications-pregnancy/
http://www.otispregnancy.org/
http://www.otispregnancy.org/otis-fact-sheets-s13037#1
http://women.webmd.com/pharmacist-11/pregnancy-medicine
http://www.webmd.com/baby/guide/taking-medicine-during-pregnancy
http://depts.washington.edu/druginfo/Formulary/Pregnancy.pdf
http://www.womenshealth.gov/publications/our-publications/fact-sheet/pregnancy-medicines.cfm
Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002.
http://www.perinatology.com/index.html
Pharmacists Letter Database 2012.
http://www.webmd.com/pain-management/news/20110728/new-dosing-labels-for-extra-strength-tylenol
http://www.babycenter.com/0_chart-over-the-counter-medications-during-pregnancy_1486462.bc
http://www.motherisk.org/women/pregnancyResources.jsp
http://www.americanpregnancy.org/pregnancyhealth/naturalherbsvitamins.html
http://www.drweil.com/drw/u/QAA400749/Avoid-Ginger-While-Pregnant.html
http://www.livestrong.com/article/315819-is-ginger-root-safe-during-pregnancy/
http://www.acupuncturetoday.com/mpacms/at/article.php?id=27849
http://oregon.providence.org/ptkattachments/recommendedresource/medications%20that%20are%20safe%20during%20pregnancy[1].pdf
http://findarticles.com/p/articles/mi_m0689/is_8_56/ai_n27355452/
http://www.obfocus.com/reference/Formulary/Drugs%20in%20Pregnancy/Dextromethorphan.htm
http://www.obfocus.com/high-risk/meds1.htm
http://www.livestrong.com/article/516421-a-cough-suppressant-for-pregnant-women/

Proper Drug Storage and Safety

Important Tips to Consider When Storing Medications

• Most medications need to be stored at "controlled room temperature" which is defined as a room temperature 20-25 degrees Celsius (68 degrees Fahrenheit to 77 degrees Fahrenheit).
• Excessive heat (40 degrees Celsius/104 Fahrenheit) or freezing temperatures can result in loss of drug strength/potency or even alter the chemical characteristics of the medicine which can result in patient harm.
• Moisture can also reduce the potency of medications.  If you have a medication bottle that contains a cotton plug,  it is recommended to have it removed since that can draw moisture into your medication. Do not store medications in bathroom cabinets !!!
• Always check the expiration dates on stored drugs.  If expired, please dispose of the product by mixing the unused medicine in your trash or give back to your local pharmacy for disposal.
• During the summer make sure home has appropriate air conditioning or climate control measures to ensure that medications are not exposed to excessive heat.  Also, during the summer do not store your medications in the car or trunk to avoid extreme temperatures.
• If you are traveling by plane make sure you carry the medications with you rather placing them in your checked-in luggage to avoid possible extreme changes in temperature.
• You may consider refilling medications every month vs. every 3 months (mainly for prescription medications) to ensure the medication maintains its strength or potency.
• Keep medications out of reach of children and adolescents.  Sometimes they can abuse them and/or unknowingly poison themselves.
• If the product has changed color, texture or odor (regardless of the expiration date) please do not use the medication and dispose of properly.

Video From CVS Regarding Proper Medication Storage

Video From The FDA About Drug Safety with Children

Learn More About Safe & Effective Drug-Free Therapies

From Targeted Medical Pharma   

Read our Open Letter and Primer

https://tmpprimer.blogspot.com.tr/   

https://tmpopenletter.blogspot.com.tr/ 

Sources for this post include:

http://printer-friendly.adam.com/content.aspx?productId=117&pid=1&gid=007189&c_custid=758
Handbook on Injectable Drugs 11th edition 2001.
http://www.safemedication.com/safemed/MedicationTipsTools/WhatYouShouldKnow/TravelingSafelywithMedicines.aspx

Understanding OTC Product Labels

• Active Ingredient(s): This section lists the substance(s) that makes the OTC medicine or product work.
• Uses: This section tells you what symptoms or illnesses the OTC medicine or product is intended to treat.
• Warnings: 
• This section may provide information about particular medical conditions and certain circumstances where the OTC product may cause harm.
• This section tells you when not to use the product.
• When to ask your doctor if it is safe to take the medication if you have a certain medical  condition(s) or take a certain medication that is listed on the label.
• What side effects you may expect from the product
• When to stop using the product.
• What to do if you are pregnant or breast feeding.
• Directions:
• Provides information how to use the product safely. 
• Often here you will find different instructions for children that may be based on weight or age.
• Depending on the medication it may provide a maximal daily dose.
• Other Information:
• Provides additional safety and storage instructions. You may also find information regarding if the product contains substantial amounts of calcium, potassium or sodium in its formulation. 
• Inactive Ingredients:
• Inactive ingredients are added to all drug products to make them look and taste appealing, to maintain their shelf life and to help the active ingredients blend together properly.
• Often these "inactive ingredients" do not cause harm.  However, some people do experience untoward reactions to these ingredients.  Thus, if you have a known sensitivity or allergy to a certain "inactive ingredient(s)" (i.e. wheat, soy, milk, dyes etc.) it is important to review this section carefully before using an OTC product.
• It is important to note that children that have "Celiac Disease" (a known sensitivity to wheat, rye and barley) must be careful because there is no requirement for companies to place whether or not their product contains gluten on their label.  Thus, you may consider calling the company, talking to your pharmacist or going to the following website glutenfree.com to find out whether or not the OTC product contains gluten. 

Learn More About Safe & Effective Drug-Free Therapies

From Targeted Medical Pharma   

Read our Open Letter and Primer

https://tmpprimer.blogspot.com.tr/   

https://tmpopenletter.blogspot.com.tr/ 

Sources for this post include:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143551.htm
http://www.nclnet.org/health/100-over-the-counter-medicines/271-understand-your-otc-drug-facts-labels
http://www.excedrin.com/products/back-and-body.shtml
http://www.safemedication.com/safemed/MedicationTipsTools/WhatYouShouldKnow/GluteninMedication.aspx

Common Misconceptions and Knowledge Gaps about OTC Medications

• OTC drugs are very safe and do not have a risk of causing harmful side effects or toxicity since they can be obtained without a prescription. 
• All OTC medications are safe enough to be taken for as long as I need to treat a certain illness or symptom.
• OTC medications are very different than prescription therapies.
• Since it is an OTC medication, I can use higher doses than indicated in the directions.
• I never need to consult with my doctor or pharmacist before starting an OTC medication.  
• OTC drugs behave the same in adults as they do in children and the elderly.

Since many OTC drugs were once prescription medications, many of them carry similar risks and potential toxicities of prescription products. For example: Tylenol (acetaminophen) which is one of the most widely used OTC pain relievers is responsible for about 450 deaths from acute liver failure, 56,000 emergency room visits, and 2600 hospitalizations each year in the U.S. . Another group of pain relievers known as NSAIDS  (OTC versions Advil (ibuprofen), Aleve (naproxen), Aspirin etc.) are responsible for an estimated 100,000 hospitalizations and possibly up to 20,000 deaths each year. In addition, OTC cough and cold medicines  (decongestants, expectorants, antihistamines, and antitussives (cough suppressants) )are another group of OTC drug products that can cause also cause potential serious harm and should not be used in infants or children under the age of two years. Thus, it cannot be assumed that all OTC medications have an excellent safety record.  Lastly, OTC medications (like all medications) may not behave as predictably in children and the elderly (as they do in adults) which could lead to serious side effects, adverse reactions, medical emergencies or even death. 

Learn More About Safe & Effective Drug-Free Therapies

From Targeted Medical Pharma  

 Read our Open Letter and Primer

https://tmpprimer.blogspot.com.tr/   

https://tmpopenletter.blogspot.com.tr/ 

Sources for this post include:

http://www.nytimes.com/2006/12/20/health/20drug.html?_r=2
http://www.ncbi.nlm.nih.gov/pubmed/3066202
http://www.slate.com/articles/health_and_science/explainer/2011/12/emergency_contraceptives_over_the_counter_are_they_more_dangerous_than_other_drugs_.html
http://www.healthsentinel.com/joomla/index.php?option=com_content&view=article&id=2668:more-hospitalized-from-nsaid-bleeding-than-all-american-war-casualties&catid=5:original&Itemid=24
http://pediatrics.aappublications.org/content/123/6/1464.short
http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/drugsafetyinformationforheathcareprofessionals/publichealthadvisories/ucm051137.htm
http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/drugsafetyinformationforheathcareprofessionals/publichealthadvisories/ucm051137.htm
http://pediatrics.aappublications.org/content/59/2/309.abstract?sid=9705c742-f0f4-4973-b6d2-019ce9abb11d
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116839.htm

Important Tips Before Using OTC Medications or Supplements

Definition:

Over-the-counter (OTC) medicines or products can be purchased without a prescription. According to the FDA, OTC medications tend to have more benefits than risks, a low risk for drug abuse, and are easy to select and use without the help of a healthcare professional. However, not all OTC medications or products really meet this criteria and can be dangerous if not used correctly.

• Select a product that is intended to treat your symptom or symptoms with the least number of active ingredients to minimize risk for side effects or drug/nutrient interactions.
• Follow the OTC medication's or supplement's label carefully with respect to directions or warnings.
• Warnings may involve drug, food, disease interactions, cautions during pregnancy or certain age groups, or cautions regarding performing certain activities like driving or using heavy machinery.
• If you have any medical concerns or questions, please consult a physician or pharmacist before starting a new OTC medication or supplement.
• Store medications in a cool and dry place away out of reach of children.
• Check the expiration date before starting any OTC product.
• Always consult your physician or pharmacist if you are pregnant, breast feeding or taking a prescription medication before starting a new OTC drug therapy (since it could harm the unborn infant, enter the breast milk and potentially harm a breast fed baby or interact with your prescription medication).
• It is also important to note the maximum number of doses you can use per day and the number of days you can use the product before needing to contact a physician.
• It is important to remember that when people have decided to self-diagnose and medicate themselves using OTC products it may delay proper medical treatment. 

Learn More About Safe & Effective Drug-Free Therapies

From Targeted Medical Pharma  

Read our Open Letter and Primer 

https://tmpprimer.blogspot.com.tr/   

https://tmpopenletter.blogspot.com.tr/ 

Introduction

Welcome to the "OTC Guide to Common Medical Conditions". My name is Daniel C. Mizzi and I am a registered clinical pharmacist who understands the medical concerns of consumers. Unfortunately, due to many time constraints and other distractions, pharmacists often do not have the opportunity to properly counsel patients and evaluate their drug therapies.  Thus, in response to the reality of pharmacy practice today, I created this blog-site to help improve consumer awareness, education, safety and healthcare outcomes. Ultimately, I hope this blog-site will help consumers make rational decisions about OTC  medications and natural therapies used to treat common medical conditions.