On September 21st, the FDA issued a drug safety communication for Ocaliva (obeticholic acid), a medication used to treat primary biliary cholangitis (PBC).
The FDA warns that using Ocaliva can cause serious liver injury and even death when improperly dosed. The FDA has reviewed the 19 cases of death potentially caused by Ocaliva, and determined that in several cases patients with moderate to severe liver disease were receiving too high of a dose. This can result in an increased risk of serious liver injury or death.
What is Ocaliva indicated for?
Ocaliva is indicated in adults for the treatment of primary biliary cholangitis (PBC) with or without ursodeoxycholic acid.
Primary biliary cholangitis (PBC) is a rare liver disease in which your body begins to attack itself and destroy the bile ducts in the liver, leading to liver damage or eventual cirrhosis.
What are the signs and symptoms of associated with liver function?
If you or someone you know is taking Ocaliva, be sure to seek medical attention for the following signs and symptoms:
- New or worsening tiredness
- Weight loss
- Stomach pain
- Decreased appetite
- Nausea and vomiting
- change in behavior or confusion
- Anxiety or unease
- Stomach swelling
- Yellowing of the eyes or skin
- Bloody stool
What is being done to warn people about these serious side effects?
The FDA is reminding healthcare providers to determine patients’ baseline liver function before starting a patient on Ocaliva.
What does the FDA recommend prescribers do?
The FDA recommends the following:
- Patients with moderate to severe liver impairment should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dose.
- Healthcare professionals should monitor patients frequently for disease progression, and reduce the dosing frequency for patients who progress to moderate or severe liver impairment.
- All patients treated with Ocaliva should be monitored frequently for liver injury (e.g. worsened liver blood tests and adverse liver-related reactions).
- If liver injury is suspected, discontinue Ocaliva.
- After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment. Educate patients about the symptoms of potential liver injury.
Of the non-genetic causes of birth defects, medications are a well-known offender. Early in the first trimester, many women don’t yet know that they are pregnant. This is a high-risk time to be taking certain medications as this is the major period of organogenesis or development of the organs.
While the science is very limited (pregnant women are generally not included in medication safety studies) there are a handful of medications that are considered category X drugs, or drugs that should not be taken in women who are or may become pregnant. If you are of reproductive age, and not using a reliable form of birth control, know this list of category X medications and avoid them.
- Absorica (isotretinoin) is a pill taken for acne, and must not be used by women who are pregnant or who may become pregnant. there is an extremely high risk that severe birth defects can result if pregnancy occurs while taking isotretinoin in any amount. If you are taking Absorica, you will be enrolled in the iPLEDGE program where you must meet certain requirements, and show proof or a reliable birth control method, to obtain the medication.
- Lipitor (atorvastatin), lovastatin, Pravachol (pravastatin), Zocor (simvastatin) and Lescol (fluvastatin) are “statin” drugs used to lower cholesterol. They have been shown to cause fetal abnormalities in pregnant women and should not be used in women who are or may become pregnant. Why are statins so bad in early pregnancy? Cholesterol biosynthesis is important in fetal development and statins can affect that.
- Arthrotec (diclofenac sodium/misoprostol) is used for joint pain due to osteoarthritis or rheumatoid arthritis. Arthrotec contains diclofenac and misoprostol which can cause abortion, premature birth, or birth defects.
- Migranal (dihydroergotamine mesylate) is used for the treatment of migraine headaches. Dihydroergotamine is oxytocic meaning it is a medication that causes uterine contractions and increased tone of the uterus, which could be dangerous if you’re pregnant.
- Coumadin (warfarin) is a blood thinner used to treat or prevent clots in the veins, arteries, lungs or heart. Warfarin crosses the placenta and serious fetal abnormalities have been reported following early first-trimester exposure. For women on warfarin who plan on conceiving, a switch to Lovenox (low molecular weight heparin) or at least frequent pregnancy tests are recommended so you can substitute Lovenox as soon as pregnancy is confirmed.
- Soriatane (acitretin) is prescribed for the treatment of severe psoriasis. Acitretin must not be used by women who are pregnant, or who intend to become pregnant during therapy, or for three years following the discontinuation of therapy. Women of reproductive age who use Soriatane must prove they are using a form of contraception during treatment.
- Restoril (temazepam) is a benzodiazepine used for the treatment of insomnia in adults. All benzodiazepines are assumed to cross the placenta, increasing the incidence of premature birth and low birth weights.
- Danocrine (danazol) is used for the treatment of endometriosis, and for breast pain or tenderness due to fibrocystic breast disease. Danazol may result in androgenic (male hormone) effects on the female fetus.
- Arava (leflunomide) is an immune modulator used in the treatment of Rheumatoid arthritis. Women of reproductive potential must use effective contraception during treatment due to the potential for fetal harm.
- Lupron (leuprolide) is an injection used in women for the treatment of endometriosis and uterine fibroids and can be dangerous for pregnant women. Although leuprolide usually inhibits ovulation and stops menstruation, a non-hormonal contraceptive should be used in conjunction.
- Rheumatrex (methotrexate) is used for the treatment of psoriasis and rheumatoid arthritis. It has been reported to cause fetal death and/or congenital anomalies and is not recommended for women of childbearing potential.
- Tazorac (tazarotene) is a creme used for the treatment of acne, wrinkles, and psoriasis. Tazorac may cause fetal abnormalities and a negative pregnancy test should be obtained within 2 weeks prior to treatment.
Hope this helps!
If your child needs to use medication during the school year, making the proper accommodation with required school personnel is an important task for parents to complete at the beginning of the school year.
Here are some tips to help ensure that your child stays healthy during this school year.
Be up to date on the school’s policies and procedures
Every school will have different policies and procedures for students taking medication during school hours. Even if your child is staying in the school district, policies can change. Be sure to read up on the year’s policies to ensure there are no medication mix-ups.
Schedule medication dosing outside of school hours
If your child needs to take a medication three times daily, try giving it when you’re home rather than at school. Your child’s medication, if taken 3 times daily, can be given before school, after school, and at bedtime under your supervision. Giving medicine during school hours should be done only if it’s completely necessary as the potential for various issues or problems can arise.
Have your pharmacy give you an extra labeled bottle
If your child needs medication given during school hours, make sure you’re prepared. Ask your pharmacy to give you an extra labeled bottle with your child’s prescription information so you can provide it to the proper school personnel.
Have the doctor write an extra prescription
Some insurance companies will allow your doctor to write a prescription stating “for home” and “for school” for certain medications such as rescue inhalers, epinephrine for life-threatening allergic reactions or emergency seizure or diabetes medications. The following are examples of these medications:
- Rescue inhalers: Proventil, ProAir, Ventolin, Xopenex (levalbuterol)
- Epinephrine products: EpiPen & EpiPen Jr (epinephrine), Auvi-Q
- Emergency seizure medications: Diastat Acudial (diazepam gel)
- Emergency diabetes medications: Glucagon
Make sure your child has supplies on hand for low blood sugar
If your child is diabetic, make sure the school has supplies on hand to deal with low blood sugar. A quick sugar source such as a juice box, regular soda pop, or glucose tablets are easy for the school to store and can bring your child’s blood sugar up.
Store emergency information in their cell phone
Whether your child has an Android or Apple phone you can help them set-up important emergency information.
Android devices have an emergency info screen that will let you add details including name, address, date of birth, blood type, known allergies, medications, medical conditions, and more. You can also specify an emergency contact.
Apple phones also have a similar functionality with Medical ID built into the Health application for iPhones. It can also be accessed through the lock screen.
Proper disposal of sharp medical objects—like syringes, needles, or lancets—is important to prevent injury. The improper disposal of needles or sharps is dangerous and can increase the risk for a needle stick injury, which can spread blood-borne diseases like HIV or various forms of hepatitis.
Many states have laws regarding sharp disposal, so it’s important to understand proper disposal practices.
What are examples of sharps that require proper disposal?
Examples of types of medications that will require proper disposal include the following:
- Vitamin B-12 injections
- Testosterone injections
- Insulin injections like Humalog, Lantus or Toujeo
- Blood thinner injections like Lovenox (enoxaparin)
- Epinephrine injections like Epipen or Adrenaclick
- Migraine injections like Imitrex (sumatriptan)
How should I dispose of my sharps?
- Check for free options. Contact the manufacturer of your drug, or your health department to see if they have a free mail-back program, or free sharps containers. Trulicity, for instance, gives away free sharps containers on their website.
- Find a drop-off location. Hospitals, doctors offices, and health clinics are a good place to start. Oftentimes they have a sharps disposal drop-off box, but be sure to call first. You can also contact your state’s department of public health to find a drop-off location close to you.
What type of container can I use to dispose of my sharps?
You can use one of the following types of containers to dispose of your sharps or needle-containing products in your household:
- FDA-cleared sharps container
- Empty laundry detergent container
- Empty bleach container
- Empty Drano container
If you use an empty household container, be sure that you are following FDA guidelines. Proper sharps containers should be able to be properly closed and stand on its own, leak resistant, made of heavy-duty plastic, and should be properly labeled to warn of hazardous waste.
You can purchase an FDA-cleared sharps container without a prescription or you can ask your doctor to write a prescription for you so that your local pharmacy can try to bill your insurance to see if it’s covered.
Does each state have their own guidelines regarding sharps disposal?
Yes. If you have questions or would like more information specific to your state call Safe Needle Disposal at 1-800-643-1643 or e-mail at email@example.com.
Believe it or not, medications are recalled on a daily basis for numerous reasons. Medication recalls can range from minor to life-threatening incidents if not immediately and appropriately taken care of.
What are these drugs prescribed for?
Which products were recalled?
In this recall, only one lot was affected. The manufacturer, International Laboratories, released a company announcement detailing the states that may be affected by this recall. Read here for the full list.
This recall will affect the following:
- Drug: Pravastatin 40 mg tablets, 30-count bottle.
- Manufacturer: International Laboratories, LLC
- Lot: 115698A
- National Drug Code (NDC): 54458-0925-16
Why were these medications recalled?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recalls a particular medication.
In this case, International Laboratories has voluntarily recalled 1 lot of pravastatin 40 mg tablets, due to mislabeling. According to International Labs, the packaging labeled for pravastatin 40 mg actually contained the 300 mg bupropion XL tablets.
International Laboratories has notified its distributors and customers by letter and is arranging for the return of all recalled products.
What is the significance of this recall?
Taking the wrong medication may potentially cause severe adverse effects like:
- Drug interactions with other medications you take. For instance, bupropion XL can cause serotonin syndrome when mixed with other medications.
- Sudden worsening of your condition due to taking the wrong medication.
- Allergic reaction.
- Unwanted adverse reactions.
Have patients reported any adverse events to the FDA?
At this time, there have not been any complaints or reports of medical illnesses or harmful effects.
This lot was recalled when a pharmacist informed International Laboratories that the 30-count bottle was mislabeled.
What do I do if I think I have a recalled package?
Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund, or call a Customer Complaint phone number at International Laboratories, LLC 727-322-7146 (Monday – Friday 8 AM – 5 PM EST). You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using these drug products.
Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.