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Is Your Medication on the FDA Watch List?

by The GoodRx Pharmacist on April 18, 2017 at 4:08 pm

If you have ever experienced a serious reaction to a medication, you are not alone. In 2000, the Institute of Medicine reported that more than 2 million serious adverse drug reactions occur each year. The FDA keeps track of these serious events through a reporting system and releases them quarterly. This system, the FDA Adverse Event Reporting System (FAERS), is a database that contains information on adverse events and medication error reports that have been submitted.

As of March 31st, 2017, the FDA released their current list of medications that have potentially serious risks or new safety information. If you are currently taking a medication on this list, feel free to speak with your doctor or pharmacist about the risks.

  • Contrave is prescribed to help with weight loss, and has been reported to cause loss of consciousness. The FDA is currently evaluating the need for further action.
  • Coumadin (warfarin, jantoven), Eliquis, Pradaxa, Savaysa, Xarelto are all blood thinners. There have been reports that they can cause female menstrual periods with abnormally heavy or prolonged bleeding. At this time, the FDA has decided not to do anything based on available information.
  • Depo-Provera (medroxyprogesterone) is a contraceptive injected for pregnancy prevention. There have been reports of it being confused with Depo-Medrol (methyprednisolone acetate), a steroid used to treat inflammation. In order to help differentiate between the two, the Depo-Provera carton and container labeling have been changed.
  • Diabeta is a tablet used to treat type 2 diabetes that has been seen to cause skin reactions. Because of this, the “adverse reaction” section of the labeling as been updated.
  • Imbruvica is a treatment for types of lymphoma. There have been reports of it causing Pneumocystis jirovecii pneumonia (PJP), a fungal infection that can lead to lung problems and pneumothorax.  The “warnings and precautions” section of the labeling has been updated to reflect this side effect.
  • Nitropress (sodium nitroprusside) is generally used to reduce blood pressure during surgery, or for congestive heart failure. It can cause carboxyhemoglobinemia, or carbon monoxide poisoning. The FDA is evaluating these reports to see if further action is needed.
  • Northera is used to treat dizziness, light-headedness, or the feeling of passing out. There have been reports of it causing strokes, so safety information on the labeling has been updated to reflect these side effects.
  • Nucala is indicated to treat severe asthma. Some patients have reported that has caused life-threatening allergic reactions. The “warnings and precautions” section of the labeling has been updated to reflect these reports.
  • Opsumit is used to treat pulmonary arterial hypertension, or PAH, a type of high blood pressure that affects arteries in the lungs and heart. It can cause excess fluid build-up. The “warnings and precautions” section of the labeling has been updated to reflect this side effect.
  • Otezla is indicated for the treatment of psoriasis, or arthritis due to psoriasis. There have been reports of it causing diarrhea, nausea, and vomiting. The FDA is currently evaluating the need for further action.

If you ever experience any serious reactions to a medication, you can report your event to the FDA’s MedWatch website. MedWatch allows you to voluntarily report a serious adverse event, product quality problem, product use error or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can report suspected counterfeit medical products to MedWatch as well.


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