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The FDA warned Friday, July 15th that a painkilling skin patch marketed under the name Duragesic by Janssen, a company owned by Johnson & Johnson, could cause drug overdoses that may have resulted in 120 deaths.

The agency is currently investigating reports of serious side effects, as well as 120 deaths possibly linked to overdoses from the patches, which contain the narcotic fentanyl. Duragesic is intended for people with moderate to severe chronic pain requiring treatment around the clock for an extended period of time that cannot be controlled by other narcotics alone. An FDA spokeswoman said the 120 deaths had occurred since Duragesic was first approved in 1990.

It is still unknown whether the skin patches actually caused the deaths and other problems reported in users, but the FDA issued a public health advisory describing fentanyl as a “very strong narcotic.” The advisory warns doctors and patients to be aware of signs indicating an overdose, including breathing difficulties, extreme tiredness and feelings of faintness or dizziness. Should a fentanyl overdose occur, a person can ultimately stop breathing, and taking the patch off cannot reverse the effects since the drug has already built up in the person’s system and can continue being absorbed from the skin for 17 hours or more.

Drinking alcohol, experiencing an increase in body temperature or being exposed to heat from sources like heating pads, electric blankets, heat lamps, saunas, hot tubs or heated water beds and taking certain medicines, including antifungals and some drugs used to treat HIV, can lead to a fentanyl overdose in people wearing the patches. The agency warned fentanyl patches should only be used in patients who have successfully used opioids in the past and should not be a patient’s first exposure to an opioid.

Mylan Laboratories put a generic version of Duragesic on the market in February. The company said it is working with U.S. regulators because of the possible dangers.