Wireless News via NewsEdge Corporation :
Bayer HealthCare (BHC) announced that its Consumer Care Division has signed an agreement with Mission Pharmacal Company to acquire their global Citracal line of over-the-counter (OTC) calcium supplements.
The companies have agreed not to disclose the financial terms of the transaction, which is expected to close during the fourth quarter of 2007 subject to regulatory approvals.
The acquisition will increase Bayer Consumer Care's market presence in the United States, the world's largest OTC market. It will also continue to build upon the company's already strong nutritionals business, which includes leading brands such as One-A-Day, Supradyn, Berocca and Redoxon. Further opportunity may also come by extending the Citracal brands' presence into other parts of the world, including key growth markets such as Asia Pacific, through Bayer's considerable global marketing, sales and distribution expertise.
"Our consumer health businesses are a key component of Bayer HealthCare and we will continue to invest in this area in order to maintain a diversified portfolio," said Arthur Higgins, Chairman of Bayer HealthCare. "This acquisition further affirms our strategy and commitment to grow our consumer health segments and will help to solidify our number two position in the global OTC market."
"The Citracal brand offers very attractive growth potential both in the critically important US market and for our nutritionals portfolio, which is a key growth driver for us now and in the future," said Gary Balkema, President of Bayer HealthCare's Consumer Care Division.
Citracal is primarily sold in North America and saw net sales of $47.0 million (EUR 36.2 million) for fiscal year 2007.
Commenting on the deal, Neill B. Walsdorf, Jr. President of Mission Pharmacal Company, said "With a strong entrepreneurial spirit, we have built the Citracal business by developing innovative products that fulfill unmet consumer needs and at the same time delivered solid growth and profitability. We are pleased to have entered into this agreement with Bayer to take this success to the next level. We believe that Bayer is in a strong position to continue the impressive growth already achieved for our brand under a new stewardship."
Bayer HealthCare, a subsidiary of Bayer AG, is a company providing healthcare and medical products industry. It is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada.
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<<Wireless News -- 09/04/07>>

FDA committee to review cough/cold product use in children
Chief area of concern is potential for adverse events in children 2 years of age or younger.
On October 18 and 19, FDA will convene an expert committee to address safety and efficacy concerns surrounding OTC cough and cold medication use in children. A primary Agency concern is that the risk for serious adverse effects with these products at any dosage outweigh the benefits in children 2 years of age or younger.
Other topics to be addressed by the Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee include the rationale behind dosing recommendations for age groups younger than 2 years, 2 to 5 years, and 6 to 11 years; misuse, potential for misuse, unintentional overdose, and excessive dosing; the aptitude of parents or caregivers to administer OTC cough and cold medications to children properly; the appropriateness of extrapolating efficacy data from adults to children for cough and cold products; and potential labeling revisions.
FDA provided guidance for parents and caregivers in an August 15 public health advisory that included several areas of interest to pharmacists:

• Requesting that a health care provider review potential drug interactions if a child is being given a combination of OTC and prescription medications.
• Asking a health care provider about appropriate cough and cold medications based on the child's symptoms, since these products vary in strength.
• Using the measuring device provided with the product and not a kitchen teaspoon. If such a device is not provided, one should be purchased in the pharmacy that is marked to correspond with the directions in the product labeling.
• Asking a health care provider if parents have difficulty understanding a product's instructions.

Ultrarapid metabolizers: Maternal use of codeine problematic during breast-feeding
Serious adverse effects possible when infants ingest morphine through mother’s milk.
FDA has warned that mothers who are ultrarapid metabolizers of codeine may have abnormally high levels of morphine in their breast milk that can produce serious, even fatal, adverse reactions in nursing infants. The announcement follows an Agency review of available research, prompted by the death of a 13-day-old breast-fed Toronto infant last summer.
Signs of a morphine overdose in nursing infants, according to FDA, include increased tiredness, difficulty breathing, limpness, and difficulty breast-feeding. Sandra Kweder, MD, FDA Deputy Director of the Office Of New Drugs, indicated in a news release that FDA’s current best-practice recommendation is to prescribe codeine at "the lowest dose needed for the shortest amount of time." Pharmacists are well positioned to counsel patients on the benefits and risks of codeine, which, as FDA asserts, has been used safely by breast-feeding mothers for many years.
Companies that produce prescription codeine medications will be required to include information on the ultrarapid metabolism of codeine in the product labeling. FDA also has posted resources online for patients and health care practitioners (link provided below).
The likelihood of being an ultrarapid metabolizer, according to FDA, varies among populations "from less than 1 per 100 people to 28 per 100 people." An individual must undergo an FDA-approved genetic test to determine whether he or she is classified in this metabolism category, but limited information exists regarding the use of the test for codeine metabolism.
In August of last year, Koren et al. reported in The Lancet the death of a 13-day-old infant as a result of morphine overdose. Tests indicated high levels of morphine in the blood of the previously healthy baby's blood, and genetic testing revealed that the mother, who was taking a smaller-than-normal dosage of codeine for episiotomy pain, was an ultra-rapid metabolizer of codeine.