Dangerous drug lawyers at Pintas & Mullins Law Firm report that the FDA recently canceled an advisory-committee meeting aimed at reviewing Merck & Co.’s surgery drug, sugammadex. The agency stated it needs more time to asses results of clinical trial inspections.
Advisory-committee meetings are typically called to review new types of drugs or products or when decisions are hotly debated within the agency. The FDA recently conducted an inspection into one of Merck’s clinical trial sites, which was one of about four the drug manufacturer used to study hypersensitivity reactions to sugammadex. The FDA requested the initial hypersensitivity review due to concerns from 2008 that the drug could cause reactions and internal bleeding when combined with blood thinners.
Despite positive recommendations from an advisory panel that year, the FDA rejected sugammadex due to these safety concerns. Advisory panels are made up of medical experts not employed by the FDA, and although their recommendations are considered, the agency does not have to abide by them. In 2009, Merck acquired the drug in its merger with Schering-Plough Corp. and decided to conduct further studies so it could be approved.
The purpose of sugammadex is to reverse the effects of drugs that paralyze the muscles before surgery (rocuronium and vecuronium), though it does so in a different manner than other post-surgery drugs already on market. It is currently vailable in about 40 countries outside the U.S., under the brand name Bridion.
Merck told the Wall Street Journal that it was currently in the midst of discussions with the FDA in attempt to discuss the necessary steps for the FDA to conduct its review. Merck has faced a number of setbacks recently, such as a recent FDA decision rejecting, or at least not immediately approving, a new drug to treat insomnia. The FDA told Merck that its insomnia medication, suvorexant, needed further examination if it was to be approved even in its lower doses.
Sugammadex is part of a new class of post-surgery drugs, the first of its kind, known as selective relaxant binding agents. The approval process for this drug has been long and expensive for Merck, though it continues to pursue its approval because it is touted as an important advance in anesthesia.
The initial hypersensitivity clinical trial was conducted about a year ago, in June 2012. A few months before this trial, a medical journal in Taiwan published a study concerning a hypersensitivity reaction caused by sugammadex in a seven-year-old boy.
The little boy had cerebral palsy and, just a few minutes after being given sugammadex, developed signs of upper airway stenosis (abnormal narrowing) and decreased oxygen saturation. He also experienced welts on his chest, neck and on his upper extremities. Fortunately, he was already in the hospital and immediately treated with adrenaline and hydrocortisone.
Also in 2012, the British Journal of Anesthesia
published a similar study examining three separate cases of sugammadex-induced hypersensitivity
reactions. All three patients were given the 100 mgs of the medication
immediately before removing breathing tubes, and for all three, hypersensitivity
was evident within four minutes, though with differing degrees of severity.
The first patient, a 41-year-old woman, developed facial redness and eyelid swelling, though fortunately no other serious reactions. The second patient, a 52-year-old woman, developed hypotension (low blood pressure), along with decreased oxygen saturation, increased airway pressure, and bodily swelling and rashes. She had to be resuscitated with I.V. infusion and injections, and improved about 45 minutes later after she was transferred to the intensive care unit. The third patient, an 89-year-old woman, developed a wheeze and decreased oxygen saturation about seven minutes after being given sugammadex. Her condition improved within 30 minutes.
Dangerous drug lawyers at Pintas & Mullins Law Firm will continue to report on studies, clinical trials and reviews concerning drugs that may cause serious injuries in patients. If you or a loved one was injured by a recalled, defective, or exceedingly dangerous drug, you have important legal rights, and may be entitled to significant compensation for your pain and suffering.