On Tuesday, US health regulators released a rather concerning statement which said almost two hundred patients with alcohol dependence, following a treatment with Alkermes Inc's drug called Vivitrol, have experienced serious complications after getting their shots. 16 of them even required surgery for getting out of the situation.

Vivitrol was approved back in 2006 for treating alcohol dependence and has been marketed by Cephalon Inc. Since the drug’s release, reports of 196 patients have been sent to the Food and Drug Administration (FDA), describing a series of side effects it had caused. Complications such as swelling, pain, bleeding, liver damage, diarrhea, nausea and headaches were mentioned.

According to Candace Steele, Cephalon spokeswoman, the problems were provoked by the faulty injection of the drug, as it must be injected directly into muscle tissue, not in body fat. Obviously enough, the depth the needle reaches depends on the patients’ weight and gender and must be estimated on site.

According to the FDA, women are more likely to experience such unexpected reactions as they typically have "higher gluteal fat thickness." Out of the 16 patients who were rushed to the operating room, women had a much higher percentage than men.

Information about the total number of patients who have received the Vivitrol treatment since 2006 couldn’t be found; however, Candace Steele stated that about 70,000 doses have been shipped so far.