The FDA and Roxane Labs have issued a recall of aziathoprine 50mg tablets (lot 558470A). One bottle from this lot was found to contain methotrexate 2.5mg tablets. Both tablets are yellow in color, but the shades are noticably different. The mixup has been found in only one bottle so far, but the entire lot is being recalled as a precaution.
Pharmacies that may have dispensed this lot number should contact patients to make sure they didn’t receive the incorrect drug. Only one lot number is involved in the recall, but pharmacists should check any bottle that is opened to make sure the correct drug is in the bottle. Any bottle with the wrong drug will also contain an incorrect number of tablets.
Recall information.
On Wednesday, the FDA approved Caraco Pharmaceutical Labs’ generic form of Mobic (meloxicam), made by Boeringher Ingelheim.
Meloxicam is a non-steroidal antiinflammitory drug (NSAID) used in the treatment of osteoarthritis and rheumatoid arthritis. It will be available in 7.5 and 15 mg tablets, with doses not to exceed 15 mg daily, due to serious GI problems.
Read the story.
More about Mobic.
The FDA, Wednesday, approved the first triple-drug pill for HIV/AIDS, called Atripla (tenofovir/emtricitabine/efavirenz).
The pill, which is taken once daily, combines three antivirals currently on the market – Viread (tenofovir), Emtriva (emtricitabine) and Sustiva (efavirenz), the latter two of which are also sold in combination as Truvada.
Unlike other treatments, which are taken twice daily (and in many cases, patients require more than one medication), Atripla is taken only once daily, a big boost for patient compliance; If a patient misses only 5% of their doses, drug resistant strains of the virus can emerge.
Atripla costs the same as Viread and Truvada – about $1150 for a one-month supply – but insured patients will only have to pay one copay instead of two.
Read the article…
As Exubera (inhaled human insulin) appears on the market later this month, health care providers are going to be getting questions from diabetic patients regarding its use and efficacy.
Today, I attended a webcast about just that. The webcast lasted about an hour, and had a live question and answer period at the end. There are four more webcasts scheduled, two on July 27th, and two on August 9th.
The main points pharmacists should take away from the webcast are:
- The medication is available in 1-mg and 3-mg blisters, and is titrated by weight by the milligram.
- Three 1-mg blisters are not the same as one 3-mg blister.
- Inhaler devices should be replace yearly, while the “release unit” must be replaced every two weeks.
- The inhaler should be cleaned weekly.
- Exubera is a meal-time insulin, and should be taken 10 to 30 minutes prior to meals.
I strongly suggest every healthcare provider, whether you’re a doctor, nurse, pharmacist or technician, view this webcast. Click the link below to sign up.
Exubera Webcasts
The current maximum daily dose of Tylenol (acetaminophen) is four grams per day, or 1000mg every six hours. However, a recent study shows that, even at those doses, some patients can get higher levels of liver enzymes, an early sign of liver damage.
Acetaminophen is contained in hundreds of pain and cold medications, notably Percocet (oxycodone/apap) and Vicodin/Lortab (hydrocodone/apap). Pharmacists and doctors should emphasize that patients should only take as much medicine as they need — and never more than four grams per day.
Read More…
Hana Biosciences has submitted a new drug application for Zensana, an oral spray version of odansetron (Zofran).
Odansetron is one of the most commonly used antiemetics in cancer patients. Currently, it must be either injested orally as a tablet, oral solution, or orally desintigrating tablet. An oral spray might allow patients that have difficulty swallowing injest the medication more quickly, allowing faster relief of nausea and vomiting symptoms.
If the drug is approved, Hana plans to begin marketing the drug sometime next year.
Read more.
Well, I almost missed it. (Okay, well, actually I did.) The Food and Drug Adminstration turned 100 years old on Friday, June 30th.
One hundred years ago last week, President Theodore Roosevelt signed into law the Pure Food and Drug Act of 1906, creating the agency we know today as the FDA.
Congratulations, FDA. May you continue for hundreds of years to come.
Read more at Pharmacist.com.
Generics week continues, as the FDA approved generic versions of the antidepressant Zoloft (by Pfizer).
Teva will begin distributing 25-, 50-, and 100-mg sertraline tablets later this month, and Roxane Laboratories will sell a liquid form of the drug. The generic forms are “authorized generics”, meaning Pfizer gave the generic manufacturers exclusivity rights to the drug in order to help cut the drug company’s losses.
Last month, Teva also received generic approval for Lexapro, but that release is pending litigation from the brand’s manufacturer Forest Laboratories.
Read More.
The FDA, friday, approved a new injectable treatment for age-related macular degeneration, or AMD.
The drug, Lucentis (ranbizumab), produced by Genentech and Novartis, treats the wet form of the disease. The wet form, while less common, is more destructive than the more common dry form.
Lucentis is injected into eyes up to five times a year. After twelve months, patients showed significant increase in vision, as opposed to other treatments, which just halt the disease’s progression.
Read More.
