Scott C. Gottlieb, Injury Law Attorney

In response to the study findings and the analysis of the post-marketing adverse event reports, the FDA has added additional information to the current warning in the Sporanox labeling. The warning now states that Sporanox should not be administered for the treatment of fungal nail infections in patients with evidence of cardiac dysfunction, such as CHF, or a history of CHF. The revised Sporanox warning also includes important information about heart-related adverse events caused by drug interactions. If signs and symptoms of CHF occur during treatment of fungal nail infections, the revised labeling recommends that the use of Sporanox should be discontinued. The advisory also alerts healthcare professionals to rare cases of serious liver problems including liver failure, transplantation and death associated with the use of Sporanox products and Lamisil tablets. While adverse liver effects were previously included in the labeling for both products, the FDA decided to include this information in the advisory because some cases involved patients with no preexisting liver disease or any serious underlying medical condition. As of March 2001, FDA has received and reviewed 24 cases of liver failure possibly associated with Sporanox, including 11 deaths. In almost half of the liver failure cases, subjects received Sporanox for fungal nail infections or other dermatological infections. Given the possible serious risks associated with Sporanox products and Lamisil tablets, the new labeling for both products now recommends that healthcare professionals should obtain nail specimens for laboratory testing prior to prescribing the medications for fungal nail infections, to confirm the diagnosis.

Stadol: A nasal spray form of analgesic (pain killer). Bristol-Myers Squibb claims that Stadol has a much reduced risk of the addictive qualities of other narcotics used to treat pain. Due to manufacturer’s claim of an extremely low potential for abuse, the FDA allowed physicians to prescribe Stadol without government control. Contrary to the manufacturer’s claims, in the last few years it has been revealed that the synthetic opiate in Stadol is extremely addictive and has been blamed for several deaths. The FDA has logged reports a significant amount of deaths and severe addictions associated with the drug. An injectable version took the blame in some of those cases. However the nasal spray has brought most of the complaints. The spray has been linked to hundreds of cases of addiction and numerous deaths. In February 1995 Bristol-Myers Squibb asked the FDA to recommend that Stadol NS be considered a controlled substance. A year later, the company expanded its request to contol Stadol NS by including the injectable form of the drug used to sedate patients before surgery. For Bristol-Myers, the request to control Stadol NS and restrict its sales was unprecedented. By making a drug a controlled substance, makes it more difficult for doctors to prescribe and may prompt some to choose another painkiller. The question arises as to why Bristol-Myers Squibb did not initially recommend Stadol NS to be labeled as a controlled substance and why the company worked hard to argue the drugs non-addictive benefits to FDA. These questions started to be asked when the suicide of a medical doctor's son occurred. The father was Morris A. Fisherl M.D., professor of neurology at Loyola University, Stritch School of Medicine, Maywood, Illinois. After Fisher's son conunitted suicide during treatment for an addiction for a supposedly "safe" treatment for migraine headaches, Dr. Fisher and investigative reporter Stephanie Glass gathered information on the drug. According to Fisher, medical professionals and patients are not being informed about the serious dangers associated with the drug Stadol which is delivered as a nasal spray. Medical evidence, says Fisher, has always indicated that Stadol should be scheduled for both effective control and as a caution to physicians and patients as an addiction/dependence drug. In 1978, the Federal Drug Administration Advisory Committee reviewed an indictable form of Stadol. The committee recommended scheduling Stadol as addictive, pointing out its abuse potential and withdrawal symptoms in people who had received the drug during clinical trials. The committee's recommendation was not followed.

Statute of Limitations: The time period within which a plaintiff must file his action against the defendant. This time frame varies by state. In North Carolina, the statute of limitations is three years.

Strict Liability: This holds manufacturers responsible for the goods they produce, especially if they cause consumers injury.

Subpoena: A form issued by the court requiring someone to appear in court and/or bring documents. (Also referred to as a “Summons.”)

Summary Judgment: In a civil action, any party may make this procedural motion, after the Discovery phase, to dispose of the suit before trial has begun. If a defendant files a summary judgment motion, it essentially means that the defendant believes that the plaintiff's case is too weak to go to trial and the suit should be thrown out.

Synthroid: On June 1st, 20001, the Wall Street Journal reported that the Food and Drug Administration has told Abbott Laboratories the maker of Synthroid, one of the nation's most frequently prescribed drugs, that the medicine has a "history of problems" and can not be recognized as safe and effective. Synthroid is taken by patients who have hypothyroidism or other disorders of the thyroid. Tyroid replacement therapy usually continues throughout the patient's lifetime. The agency's statements raise the possibility that the 40-year-old drug, which has never been officially approved for use by the FDA, will be subject to regulatory action that could possibly remove the drug from the market. Patients using Synthroid should be monitored with regular blood tests to assess the effect the medication is having on thyroid function and also to check for toxicity. Too much Synthroid can cause a condition known as "thyroid storm". Patients might experience heart rate irregularities. Clots can be dislodged, and, in some cases, may help lead to stroke. At worst, a general hyperactive metabolic state can even lead to death. The FDA has indicated that Synthroid needed to be approved by August 14, 2001, but as of June 1, 2001, Abbott has indicated that they have not even applied for approval. The FDA stated they wouldn't rule out asking for the drug's removal and noted that there are two other approved drugs in Synthroid's class that could potentially fill any void left by Synthroid. Synthroid had sales of $541.3 million in 2000 and, ranked by number of prescriptions written, was the third most frequently prescribed drug in the country, according to data compiled by IMS Health. Synthroid went on the market more than four decades ago and never received formal approval from the FDA. According to the Wall Street Journal, such approval was required but neither the agency nor the drug's current owner is certain why it was never received. In the mid-1990s, the FDA began compiling data on adverse events associated with the use of Synthroid as well as with the use of its competitors. In 1997, it noted that "almost every manufacturer" of such drugs had reported recalls because of potency problems.

Scott C. Gottlieb is licensed by the State of New York.