State officials have connected a Central Texas compounding pharmacy to a bacterial outbreak that sickened 17 patients in Corpus Christi hospitals earlier this year, the Associated Press reported. Officials said the most recent results showed a “genetic match” between the bacteria found in the product and bacteria in blood samples of 15 of the patients. The investigation continues and authorities have not concluded that Cedar Park-based Specialty Compounding is to blame for the illnesses. In September, an inspector—hired by Speciality Compounding—found no link to the infection, which has killed two patients.
Food and Drug Administration investigations have become second nature for Dallas-based USP Labs, after a recent look by the federal agency linked one of the company’s supplements to a hepatitis outbreak in Hawaii. The FDA issued a warning last week linking the company’s bodybuilding supplement OxyElite Pro to an outbreak of non-viral hepatitis. Nearly 30 patients have been hospitalized with acute heptatitis so far, two dozen of whom had used OxyElite Pro. Two of those have required liver transplants, and one has died. “The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient… Full Story
UPDATE: From Galderma spokeswoman Virginie Naigeon: Francois Fournier has decided to leave his position as president of Fort Worth-based Galderma Laboratories, L.P. The company most recently announced the FDA approval of Mirvaso for the topical treatment of the facial erythema (redness) of rosacea. “I am proud to have completed the successful launch of Mirvaso, a game-changer in the treatment of patients suffering from rosacea. However, after an amazing 13 years with Galderma, I have decided it is time to pursue other professional opportunities and move on to the next phase of my career. This is not a decision that I have… Full Story
In September, Fort Worth-based pharmaceutical company Galderma was granted Food and Drug Administration approval for Mirvaso, the only topical drug approved to treat [the facial redness of] rosacea. The drug is expected to generate as much as $100 million in revenue for the company, which also produces Cetaphil, a popular over-the-counter skin care line. We sat down with Galderma USA president Francois Fournier to discuss the product, and Galderma’s future. In broad terms, what does Galderma do? It’s a very unique company because we specialize only in dermatology. It’s only about the patients with skin conditions. The inception of the company… Full Story
A Woodlands compounding pharmacist who provided eight vials of the drug pentobarbital to the Texas Department of Criminal Justice for use in executions now wants the drugs back, stating that he didn’t know his company’s name would be public information. According to Texas justice blog Grits for Breakfast, Jasper Lovoi, the owner and pharmacist-in-charge of The Woodlands Compounding Pharmacy, sent a letter to the state last week, requesting the drugs be returned: Based on the phone calls I had with Erica Minor of TDCJ regarding its request for these drugs, including statements she made to me, it was my belief that this information… Full Story
Texas has turned to a suburban Houston compounding pharmacy to replace its expired execution drugs, according to documents released to the Associated Press Wednesday. Compounding pharmacies custom-make drugs, but are not subject to federal scrutiny. Under new, proposed federal regulation, the Food and Drug Administration might soon have greater oversight over the pharmacies, monitoring them similarly to the way it regulates pharmaceutical companies. On Tuesday, a federal lawsuit was filed for three death row inmates who are challenging the use of the drugs, claiming the use of untested drugs during an execution would violate the U.S. Constitution’s protection against cruel and unusual punishment. “Use of… Full Story
Although Amgen is the world’s biggest biotechnology company, the drugmaker has lacked a presence in one of the industry’s largest sectors: cancer drugs. On Sunday, that changed. The company agreed to buy Onyx Pharmaceuticals for close to $10.4 billion in cash, the Associated Press reported. The transaction is expected to close at the beginning of the fourth quarter, subject to regulatory approval. Amgen’s purchase ranks among the five biggest-ever takeovers of a biotechnology company, according to the New York Times. It’s also the second-biggest takeover in Amgen history, trailing only the company’s $17 billion deal for Immunex in 2002.
CVS Caremark has revoked the dispensing privileges of more than 36 health care providers that it has identified as having extreme patterns of prescribing high-risk drugs, Reuters reports. In an article published last week in the New England Journal of Medicine, the pharmacy company disclosed that the suspensions followed an analysis of prescriptions for hydrocodone, oxycodone, alprazolam, methadone, and carisoprodol that were filled at its stores between March 2010 and January 2012. From a database of close to one million providers, CVS identified several dozen prescribers with the highest rates of dispensing high-risk drugs. In one case, a doctor was prescribing on average more than… Full Story
Two Texas patients who developed blood infections after receiving a recalled drug have died, but state health officials have not found definitive proof to link the death to the drug, the Associated Press reports. Last week, the Food and Drug Administration recalled all products produced by Specialty Compounding of Cedar Park, in the wake of reports of bacterial infections affecting 17 patients at two Corpus Christi hospitals. Texas health officials are working with the Centers for Disease Control and Prevention, which is analyzing samples of the bacteria taken from the patients to see if they’re all the same strain and come from the same source. Results… Full Story
An Austin-area compounding pharmacy has recalled all its sterile products after 15 people who got calcium injections developed bacterial infections, the Food and Drug Administration announced Sunday. The FDA received reports of 15 patients from two Corpus Christi hospitals who received an infusion of calcium gluconate, supplied by Cedar Park-based Specialty Compounding. The patients then developed bacterial bloodstream infections, thought to be related to the infusions. The bacteria rarely infects people, but any infectious bacteria directly injected into the bloodstream or muscle can cause trouble. “Giving a patient a contaminated injectable drug could result in a life-threatening infection,” Dr. Janet… Full Story