Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Some of the manufacturing deficiencies include products that may contain a higher concentration of active ingredient than specified; others that contain inactive ingredients that may not meet internal testing requirements; and others that may contain tiny particles. (more…)

This afternoon the Jets face the San Diego Chargers for the chance to play the Indianapolis Colts in the AFC Championship Game.  The Jets and their fans go into the game brimming with confidence and excitement.  But in a complaint filed Friday by the U.S. Attorney in Boston, prosecutors alleged that health care giant Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would improperly medicate more patients on Risperdal, a powerful schizophrenia medicine, and other drugs – prescription pain relievers Duragesic and Ultram, and the antibiotic Levaquin.  Although approved for treating schizophrenia and bi-polar disorder, Risperdal is not approved for use in elderly patients with dementia but is, nonetheless, administered to just such patients. Also on Friday, Johnson & Johnson issued a massive recall of over-the-counter drugs including regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin because of a moldy smell that has made people sick. (more…)

In a recent blog, we wondered why a television advertisement for the stop-smoking drug Chantix contained an exhaustive list of side-effects yet did not disclose that the drug was subject to a U.S. Food and Drug Administration (F.D.A.) “black box” warning. By virtue of this omission, a viewer might easily underestimate the seriousness of the televised side-effects. We honestly thought that Pfizer, the drug’s manufacturer, would so tenaciously fight against mentioning the existence of a “black box” warning that its inclusion in an ad was not a realistic possibility. But shortly after this blog (maybe we are a bit behind), we viewed a television ad for the most popular birth control medication in the U.S., Yaz, that began, “You may see some Yaz commercials that were not clear. The F.D.A. wants us to correct a few points in those ads.” (more…)

Last week, just one week before the opening of Michael Moore’s new movie, Capitalism: A Love Story, the U.S. Food and Drug Administration (FDA) admitted what has been known for a while – that its approval of the Menaflex device in December, 2008, came after intense political pressure from politicians made just months after they received significant campaign contributions from the manufacturer of Menaflex.  In issuing its approval, the FDA overrode the agency’s scientific reviewers who repeatedly and unanimously over many years decided that the device was unsafe because the device often failed, forcing patients to get another operation.  This was the first time that the agency publicly questioned the process behind one of its approvals, admitted that a regulatory decision was influenced by politics, and accused a former commissioner of questionable conduct.  You have to know it’s really bad. (more…)

Yesterday morning an advertisement for smoking cessation drug Chantix came on my television. The ad featured a man extolling how much better his life is now that Chantix (and support, slips in the ad) has helped him kick his smoking habit. Then an announcer came on and read, for what seemed like an extraordinary time for the disclaimers usually heard on drug commercials, a litany of side-effects and warnings. These warnings included suicidal thoughts, personality changes, and skin rashes.  The announcer did not state, however, that many of the side-effects announced are the subject of an FDA-mandated black box warning. (more…)

The U.S. Food and Drug Administration (FDA) announced on July 1, 2009, that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) and to update the Medication Guides for patients that further discuss the risk of mental health events when using these products. The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal ideation and behaviors when taking these drugs.  The FDA has received additional information bolstering the suggestion of a possible association between both varenicline and bupropion and serious neuropsychiatric symptoms, in both patients with and those without previous history of psychiatric illness.  The FDA first informed the public about the possibility of serious neuropsychiatric symptoms with Chantix on November 20, 2007. (more…)

In a press release dated June 16, 2009, the U.S. Food and Drug Administration (FDA) advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued “kids size” swabs. The FDA’s advisory stated that the products are associated with the loss of sense of smell, called anosmia. Anosmia may be long-lasting or permanent. In addition to a loss of the sense of smell, patients have also complained of a loss of the sense of taste. The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products.   Many people experienced a loss of smell said the condition with the first dose; others reported a loss of the sense of smell after multiple uses. (more…)

A principal underlying assumption regarding limits on and ethics guidelines addressing pharmaceutical promotion is that smaller gifts are unlikely to exert influence on prescribing decisions. Nonetheless, a substantial body of marketing and psychology literature suggests that even trivial items can exert influence irrespective of economic value. Adding a small gift such as personalized mailing labels, a pen or a coffee mug to a solicitation for donations has been shown to significantly increase donations. These types of gifts can also influence prescribing behavior, according to a study that appears in The Archives of Internal Medicine. (Arch Intern Med. 2009;169(9):887-893). The experiment found that exposure to these items results in more favorable attitudes toward marketed products and that medical school policies that restrict pharmaceutical marketing mitigate this effect. (more…)

Cataract surgery is the most commonly performed operation in the United States today, with nearly 2 million cataract operations performed in the United States each year. Benign prostatic hyperplasia (BPH), an enlarged prostate, is common in older men, affecting nearly 3 out of 4 men by the age of 70 years. BPH is often treated with tamsulosin hydrochloride (Flomax), an alpha-blocking drug that accounted for more than $1 billion in sales in 2007. This BPH/cataract combination is dangerous: A study to assess the risk of adverse events following cataract surgery in older men prescribed Flomax found that exposure to tamsulosin within 14 days of cataract surgery was significantly associated with serious postoperative ophthalmic adverse events. (more…)

The Alien Tort Statute, 28 U.S.C. §1350, a 1789 law, gives foreigners the right to raise tort claims in federal court to vindicate violations of ‘the laws of nations.’  The 10-principle Nuremberg Code was formulated as part of a war crimes trial conducted after World War II in which 15 doctors were convicted of crimes against humanity for conducting unconsented experiments.  Seven of the doctors were sentenced to death.  The 1789 law and the 20th Century Nuremberg Code intertwined recently as the U.S. Court of Appeals for the Second Circuit revived Nigerian families’ damage claims for billions of dollars against Pfizer for allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis outbreak. (more…)