Linade Shampoo and Lindane Lotion, two popular used to treat head lice can be toxic, the Food & Drug Administration (FDA) has warned.   Morton Grove Pharmaceuticals, which makes Lindane Shampoo and Lindane Lotion, is the only U.S. maker of an insecticide-based treatment for head lice.  The company has stopped promoting the Lindane products after receiving a stern warning from the FDA in December that said Morton Grove’s marketing misled consumers by minimizing the rare, but very serious, risks of the insecticide-based head lice drugs.

There has been much controversy in recent years over prescription shampoo and lotion treatments used in the treatment of head lice and that contain the insecticide lindane.  As a matter-of-fact, lindane’s use is banned in California and lawmakers in Michigan, New York, and Minnesota are looking into restricting use of the products, as well. (more…)

Another Nephrogenic Systemic Fibrosis (NSF) study has tied the debilitating condition to Gadolinium contrast agents used in Magnetic Resonance Imaging (MRI).  This latest NSF research was conducted by the Centers for Disease Control (CDC), which examined a cluster of NSF patients at one unidentified St. Louis Missouri Hospital.  The CDC found that the exposure to Gadolinium contrast dyes during MRI was independently associated with the development of NSF.

NSF (sometimes called Nephrogenic Fibrosing Dermopathy or NFD) was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. (more…)

NuCel-brand eye drops and eye-ear wash are subject to a voluntary, nationwide recall due to possible contamination, the U.S. Food and Drug Administration (FDA) announced today. According to the FDA, the NuCel products are not sterile.

NuCel Labs of Idaho Falls, Idaho, initiated the nationwide recall following an FDA inspection in which testing indicated there was bacteria and particulate matter in the defective drugs, presenting a health risk. Non-sterile eye drops pose a risk of causing eye infections, which in rare cases could lead to blindness. (more…)

The Chinese manufacturer of the so-called “abortion pill” is accused of selling tainted cancer drugs in that country.  Shanghai Hualian is the only supplier to the U.S. of the abortion pill, mifepristone—or RU-486.   It is one of China’s largest state-owned pharmaceutical companies and exports to dozens of countries.  News that the company that makes the entire US supply of RU-486 is  at the center of a Chinese scandal over tainted drugs  is truly disturbing.

The FDA said RU-486 exported to the U.S. is made at another Shanghai Hualian plant, and the “abortion pill” plant passed inspection in May.  The agency said that “FDA is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone.”  When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, consumer advocate and FDA critic, said American regulators should be concerned because of rumors of cover-ups.   (more…)

Zyprexa maker Eli Lilly is in negotiations with state and federal prosecutors that could result in the company paying more than $1 billion to settle charges that it engaged in illegal off-label marketing of Zyprexa. According to The Wall Street Journal, Eli Lilly entered into settlement negotiations after it received a grand jury subpoena late last year, and faced a good chance of being criminally indicted.

Zyprexa was approved by the Food & Drug Administration to treat schizophrenia and severe bipolar disorder. Zyprexa is Eli Lilly’s biggest product with 2007 global sales of $4.76 billion. (more…)

The Avandia study that touched off a firestorm over the diabetes drug’s cardiac side effects was leaked to GlaxoSmithKline ahead of its publication in the New England Journal of Medicine (NEJM).  According to a report in the Wall Street Journal, a physician who was helping peer-review the Avandia article broke NEJM confidentiality rules and faxed a copy of the article to Glaxo 17 days before it was published.  The physician who leaked the study has received substantial speaking and consulting fees from Glaxo, and now one law maker wants to know if this relationship played a role in the Avandia study leak.

Avandia has been a subject of controversy since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In June 2007, Congress held hearings to discuss Avandia and the Food & Drug Administration’s (FDA) handling of its safety issues. At those hearings, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.  Thus, the public was not made aware of the Avandia heart attack risk until the publication of the Cleveland Clinic article. (more…)

Defective cauterizing devices used during tonsillectomy often burn areas around the lips and mouth. As it turns out, these cauterizing device burns are an underreported complication of tonsillectomy that can result in long-term problems, according to a study reported in the Archives of Otolaryngology and Head and Neck Surgery.

Removal of the tonsils (along with the nearby adenoid glands) “remains one of the most commonly performed surgical procedures in the United States,” Dr. Albert H. Park, of The University of Utah School of Medicine, Salt Lake City, and colleagues write. While most patients do very well, a number of complications can occur, included bleeding, pain, and voice changes, Park said. (more…)

Like sounding drug names could be behind a spike in medication errors.  Shockingly, medication mix-ups have more than doubled in the past few years since 2004 and can have deadly consequences.  The prevailing issue seems to be the result of so many prescription drugs being given similar names, according to a new report.

Researchers from MEDMARX—a database run by the United States Pharmacopeia—discovered obvious and, in some cases, fatal drug errors when reviewing the submitted records of 870 hospitals.  For example, the report discussed a disturbing story in which a child who was seen in an emergency room was prescribed Zyprexa, a drug used in the treatment of schizophrenia.  The child was supposed to have been prescribed the allergy medication, Zyrtec.  As a result, the child was rushed back to the ER after fainting.  It was during the second ER visit that the mix-up was discovered, the USP report said.
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Botox death reports have prompted Canadian regulatory authorities to take another look at the drug.  Health Canada is looking at the safety information on Botox, which is approved in Canada to fight wrinkles as well as for non-cosmetic purposes, including the treatment of spasticity or muscle stiffness.  “Health Canada’s review of safety information on the issue of toxin spread regarding Botox began after departmental experts’ review of European studies,” Health Canada spokeswoman Carole Saindon said, adding that “Canadians can be confident that after a thorough review, Health Canada will take action, if necessary.”

Botox made news last week when the lobby group Public Citizen wrote to the U.S. Food and Drug Administration (FDA) calling on it to “immediately require Allergan and Solstice Neurosciences to issue a warning letter to physicians regarding all formulations of botulinum toxin (Botox and Myobloc, respectively).  This letter would alert physicians to serious problems, including hospitalizations and deaths, resulting from the spread of the toxin from the site of injection to other parts of the body,” they said.  Public Citizen’s petition included an in-depth analysis of hundreds of mild and severely adverse reactions to Botox treatments, which have been reported since the late 1990s in both Europe and the U.S. (more…)

Vioxx plaintiffs in Florida are petitioning a federal court to expand Merck’s proposed $4.85 billion settlement to include those who did not file suit against the company by Nov. 9, 2007.  But many lawyers involved in the Vioxx settlement oppose the petition, fearing that adding more plaintiffs to the Vioxx settlement would lessen the awards each eligible participant would receive.  However, if the situation is not resolved, Vioxx patients who did not file suit against Merck by the November 9 deadline could still bring their own lawsuits.  But that means Merck’s Vioxx troubles – which the $4.85 billion settlement was supposed to resolve – would be far from over.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. (more…)