CDC and FDA Recommendation: Voluntary Recall of PharmaTech Liquid Medication Products

 Voluntary Recall of  PharmaTech Liquid Medication Products

 

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) released a statement and recommended a voluntary recall of ALL liquid medication products manufactured by PharmaTech and distributed by Rugby, Major, Bayshore, Metron, Centurion, and Virtus.

There is currently an ongoing investigation into a multi-state outbreak of Burkholderia cepacia. The CDC and FDA have indicated that liquid docusate was the vehicle for transmission, but at this time other liquid medication products are being investigated and may also be linked to the outbreak of 60 cases of Burkholderia infection. The entire affected product list may be found using this link to FDA.

 

In addition to the above recall of all liquid products manufactured by PharmaTech, both FDA and CDC continue to recommend that clinicians and patients not use any brand of liquid docusate sodium product as a stool softener or for any other medical purpose.

 

Additional information about Burkholderia cepacia and the outbreak is available on the CDC website.

 

https://www.cdc.gov/hai/outbreaks/b-cepacia/index.html

http://www.cdc.gov/HAI/organisms/bCepacia.html

 

Please email direct questions about the outbreak to haioutbreak@cdc.gov.

 

 

Congratulations Dr. McCullough!

Dr. McCullough and her husband Craig welcomed Addison McCullough on July 13, 2016.

CDC/FDA Information re: Colace (Docusate)

As of Monday, July 11, 2016, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are recommending that both children and adults stop using liquid docusate, a stool softener. Docusate is available by prescription and over-the-counter and may be known by its brand name Colace. Liquid docusate may be linked to a recent outbreak of a bacterial infection (B. cepacia complex), which the CDC and FDA are investigating.

Congratulations Dr. and Mrs. Robinson!

Dr. and Mrs. Robinson welcomed their first great-grandchild, Avery, on April 20, 2016.

avery lewis

FDA proposes limit on arsenic in infant rice cereals

The US Food and Drug Administration (FDA) announced today that it wants to reduce the amount of inorganic arsenic in infant rice cereal to protect children from possible developmental problems.

The FDA released draft guidance for the food industry that sets a limit or action level of 100 parts per billion (ppb) for inorganic arsenic in this ubiquitous baby food. The agency also encourages parents to feed their infants a variety of iron-fortified cereals, and not only iron-fortified rice.

Pregnant women should diversify their grain consumption as well, because recent studies have linked intake of relatively high levels of inorganic arsenic to adverse pregnancy outcomes, the agency said in a news release. In addition, fetal exposure to inorganic arsenic together with dietary exposure during infancy can “result in a child’s decreased performance on certain developmental tests that measure learning.”

However, “consumers can certainly eat rice as part of a well-balanced diet,” the agency stated in a question-and-answer article on its website.

Reducing arsenic levels in rice is especially important for infants, the agency said, because relative to body weight, their intake of rice — primarily through cereal — is roughly three times greater than that for adults.

“Our actions are driven by our duty to protect the public health and our careful analysis of the data and the emerging science,” said Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, in the news release. “The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants.”

Cancer Risk Also Assessed

Good manufacturing practices, the agency said, can produce infant rice cereal that complies with the proposed arsenic limit. Most manufacturers are already close. Of 76 infant rice cereals recently tested by the FDA, 47% did not exceed the proposed limit of 100 ppb, and 78% were at or below 110 ppb. Nonrice foods for infants and toddlers, in contrast, tested well below 100 ppb.

The agency noted that inorganic arsenic found in rice cereal and other foods is not an additive or ingredient, but something naturally absorbed by all plants from water, soil, and air. Rice tends to absorb more arsenic than most. Unlike organic arsenic, inorganic arsenic is not bonded to carbon, and when found in food, it is the more toxic of the two forms.

As part of its risk assessment, the FDA mathematically modeled the incidence of lung and bladder cancer associated with consuming inorganic arsenic in rice and rice products. It estimated that this exposure causes an extra four cases of lung and bladder cancer over the lifetime for every 100,000 people in the United States, the agency said. “This estimate would account for far less than 1 percent of the nation’s lung and bladder cancer cases.”

The US Environmental Protection Agency, the National Institutes of Health, and the US Department of Agriculture reviewed the FDA’s risk assessment of inorganic arsenic, as did nongovernment experts.

Once the industry guidance regarding inorganic arsenic levels in infant rice cereal is published on the Federal Register, the FDA will accept public comments for 90 days.

More information on today’s announcement is available on the FDA website.

Recall of children’s cough liquids due to mislabeled dose cups

The FDA announced a recall of several lots of cough liquids due to incorrect markings on the oral dosing cups. The affected products were manufactured by Perrigo, and distributed under several brand and store labels (e.g. CVS). A complete listing of affected product names, lot numbers, and consumer directions are posted on the FDA’s website, linked here: http://www.fda.gov/Safety/Recalls/ucm481411.htm

Recall of Auvi-Q epinephrine injection

Sanofi US is recalling ALL Auvi-Q epinephrine injection currently on the market.

Patients with questions regarding this recall can go to the company website www.auvi-q.com and call 1‑877‑319‑8963 or 1‑866‑726‑6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their Auvi‑Q devices. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto‑injectors with proof of purchase.

Call our office if you need an alternate prescription.

Expanded Vaccine Availability from Massachusetts Department of Public Health

The Massachusetts Department of Public Health is announcing the expanded availability of human papilloma virus (HPV) vaccine and meningococcal conjugate four-valent (MCV4) vaccines effective November 1, 2015 for all children through 18 years of age regardless of insurance status.

FLU VACCINE 2015-2016

We have recently received our first shipment of flu vaccine for the 2015-2016 season.

Flu vaccine will be offered when you bring your child in for routine care.  We will also be administering the flu vaccine by appointment only Tuesday through Friday throughout the flu season. Please call early in the day to schedule a same day nurse visit.   Please call the nurse’s line 781 356 6200 option 3 during regular business hours to schedule an appointment.

CDC recommends that everyone 6 months of age and older get a seasonal flu vaccine. This includes all children aged 6 months up to their 19th birthday. Vaccination is especially important for children younger than 5 years of age and children of any age with a long-term health condition like asthma, diabetes and heart disease. These children are at higher risk of serious flu complications, if they get the flu.

Click the link below for additional information about the flu vaccine:

http://www.cdc.gov/flu/protect/vaccine/index.htm

Currently we have flu vaccine available in the injectable form. Due to a manufacturer’s shortage, we do not have the intranasal form (Flumist) at this time. Flumist is approved for children age 2 and above, although not for those with certain health issues (allergic to eggs, gentamicin, gelatin, or arginine, are currently wheezing; have a history of wheezing, have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with heart, kidneys or lungs; have diabetes).  Please be advised that occasionally throughout the season we may be may be temporarily out of some formulations of the vaccines.  These supplies are replenished as we receive additional shipments from the state.

Please speak to our nursing staff if you have any questions about the flu vaccine.

American Academy of Pediatrics President Urges Parents to Vaccinate Their Children Against Measles

Please see the following message from the American Academy of Pediatrics:

American Academy of Pediatrics President Urges Parents to Vaccinate Their Children Against Measles

2/2/2015

 Statement by Sandra G. Hassink, MD, FAAP

As the measles outbreak linked to Disneyland continues to spread, pediatricians are deeply concerned about the children who have been infected, and those who are at risk because they have not been vaccinated. The American Academy of Pediatrics strongly urges parents to make sure their children have received the measles, mumps and rubella (MMR) vaccine. While it is best to get the vaccine as soon as your child reaches the recommended age, it is never too late to get your children caught up so they can receive the vaccine and be fully protected.​​

We know from many repeated studies that the MMR vaccine is safe and effective. It is in fact one of the most effective vaccines we have. And as the measles outbreak has shown, this virus is incredibly contagious. If you have not been immunized against measles and come near an infected person, you have a 90 percent chance of getting measles.

 

An infected person may not show symptoms for four days — meanwhile he or she can expose dozens of other people they encounter in daily life, at the park, grocery store, school, and other places where children commonly are. Measles affects all organs of the body, and can cause serious and in some cases life-threatening complications in children including pneumonia and encephalitis.

When measles was more common in the U.S., hundreds of children died from this virus every year. The fact that this disease has resurfaced for the first time in more than a decade has prompted pediatricians to reiterate the same recommendation to parents that we’ve made for decades with renewed urgency: Vaccines work. Delaying your child’s vaccines, or refusing the vaccine, leaves your child vulnerable to this invisible threat.  And puts other children in the community at risk.

 

Some children cannot be vaccinated because of problems with their immune system, or because they are too young to be vaccinated. It is heartbreaking to know that these vulnerable children may be at risk if parents refuse or delay getting their children vaccinated, allowing community immunization rates to fall below the rates necessary to protect the whole community. To protect your own child, as well as the other children in your community, make the decision to vaccinate your child. If you have questions about measles or vaccines, we encourage you to talk with your child’s pediatrician.

 

To help parents, the AAP has also assembled these resources: