Mert asked
I am prescribed 20mg isotretonin tablets (Roaccutane). I stored them in a fridge in a line and some were pushed to the back. When I came back in 2 months time to move them to my mini fridge I found two packs at the back to be frozen with frost stuck onto it and two in front of those to be damp. When I opened inside there was drips of water against the foil where the tablets are held. Will this affect the pills effectiveness. For now I’ve moved the pills to packages that aren’t damaged.
Answer
It is not recommended to use medications that have been accidentally frozen or stored outside their listed storage conditions.
According to the package insert for Accutane, the medication should be stored as follows:
Isotretinoin capsules that have been frozen may have decreased efficacy and use is not recommended."Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light."
Frozen Accutane (Isotretinoin)
How low temperatures can affect solid dosage forms such as tablets and capsules isn't well studied.
Studies on solid dosage form medications indicate that the actual dosage form (e.g. a tablet or capsule) is more likely to be affected that the medication. Tablets, capsules and soft gels all contain trace amounts of moisture. The freezing of these products could cause the breakdown or degradation of the dosage form, potentially leading to a loss of actual medication resulting from this breakdown.
There may be some drug or molecular breakdown when solid dosage form medications are frozen, but there isn't a definitive list of drugs which are known to be specifically affected. The main concerning issue in regard to frozen medications is that we simply don't know which ones are likely to be affected, how they could be affected and to what extent.
Drug companies/manufactures do stability tests on their products at a certain temperature range. Most do not study the affect of cold temperature excursions on the product. In other words, the acceptable temperature range is known for a specific medication when it comes to stability. What is unknown, is how excursions from the accepted temperature range will affect the drug product. Most medication may be perfectly fine when frozen, but we just don't know. It is extremely important to be confident in the consistent potency and purity of your medication.
When they are stored outside of the required storage conditions, ambiguity sets in. For this reason, if your medication has seen extreme temperature excursions, it is recommended to get a replacement product to ensure an intact product.
